Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and effectiveness of novantrone therapy followed by copaxone for multiple sclerosis.

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: it is thought that treating multiple sclerosis with novantrone for a short period of time prior to treatment with copaxone may enhance the onset effect of copaxone.


Eligibility criteria:
inclusion criteria: 1. definite ms as determined by the mcdonald criteria (ann neurol, july 2001) with a relapsing disease course. 2. 2.edss 0.0 - 6.5 inclusive 3. 18 to 55 years of age 4. 1 or more t1 gadolinium-enhancing lesions but no more than 15 lesions 5. able and willing to sign and date an informed consent form exclusion criteria: 1. patients ever treated with glatiramer acetate or mitoxantrone. 2. patients treated with interferons or iv immunoglobulins (iv ig) in the previous 4 weeks prior to screening visits. 3. patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits. 4. patients ever treated with cyclophosphamide or total lymphoid irradiation (tli), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy. 5. patients treated with intravenous or oral steroids within 28 days prior to initial mri. 6. female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator. 7. male patients and their partners must use contraceptive methods deemed reliable by the investigator 8. lvef \< 50% 9. patients using catheters or foley catheters 10. patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: als, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), b12/folate deficiency, lyme disease, htlv 1-myelopathy 11. patients with immune deficiency or other medical condition that would preclude treatment with mitoxantrone or glatiramer acetate 12. abnormal screening blood tests exceeding any of the limits defined below: alanine transaminase (alt) - twice the upper limit of normal aspartate transaminase (ast) - twice the upper limit of normal total white blood cell count \ 1.5 mg/dl prothrombin time greater than 150% upper limit of normal 13. patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
evaluation of sleep changes in inflammatory bowel diseases (ibd) patients.

Conditions: Disease Bowel; Crohn Disease; Ulcerative Colitis

Summary: inflammatory bowel diseases (ibd) go through two phases: flare and remission. prediction of flares and identification of patients in remission but at high risk of flare are a major issue when taking care of ibd patients. considering close interactions between sleep, immunity and intestinal inflammation, sleep disorders could be a predictor of flares. the purpose of this study is to demonstrate that sleep efficacy decreases before ibd flare. patients in remission will be assessed for ibd symptoms (activity scores, biological factors) and sleep disorders (actigraphy, dreem®, questionnaires) during one year.


Eligibility criteria:
inclusion criteria: * patient over 18 and under 65 years of age. * patient with inflammatory bowel disease diagnosed for at least 3 months. * patient in remission, for at least 3 months: 1. clinical remission: harvey-bradshaw score (hbi) \< 5 for cd and a mayo score \< 3 for uc 2. and biological remission: absence of objective inflammation defined by crp \< 5 mg/l and/or fecal calprotectin \< 250 µg/g. * patient must sign informed consent form to participate to the study. * patient affiliated to or benefiting from a social security plan. exclusion criteria: * patient with complications (obstructive symptoms, fistulas or intra-abdominal abscesses in the previous three months). * patient with extensive bowel resection (\> 40 cm of small bowel). * patient with an ileostomy or colostomy. * patient diagnosed with sleep disorders. * patient without legal capacity to consent. * pregnant, parturient or nursing women. * persons deprived of liberty by judicial or administrative decision. * persons under psychiatric care. * persons admitted to a health or social institution for purposes other than research. * persons of full age who are subject to a legal protection measure (guardianship, curators).

Keywords: inflammatory bowel diseases crohn's disease ulcerative colitis sleep deprivation relapse
an expanded access open label protocol of remune (hiv-1 immunogen) in hiv-1-infected adults with cd4 count 550 cells /ml and greater.

Conditions: HIV Infections

Summary: to provide an alternative therapy to hiv-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.


Eligibility criteria:
inclusion criteria patients must have: * hiv-1 seropositivity. * cd4 counts \>= 550 cells/ml. note: * if a patient's cd4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days for study 806 or wait 6 months before entering the expanded access program. * patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies. * patient must not meet inclusion criteria for other remune trials. * patient must have laboratory tests within specified limits. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * clinically significant cardiac, hepatic, renal or gastrointestinal dysfunction. * current participation in a remune study. concurrent medication: excluded: * use of any immune-modulating drugs. * induction therapy or initiation of new treatment regimen for an aids-defining condition. * current participation in a remune study. patients with any of the following prior conditions are excluded: previous participation in a remune study. prior medication: excluded: * previous participation in a remune study. excluded within 30 days of study entry: * use of any immune-modulating drugs. * induction therapy or initiation of new treatment regimen for an aids-defining condition within 30 days of day 1 visit.

Keywords: acquired immunodeficiency syndrome aids vaccines cd4 lymphocyte count salk hiv immunogen
concurrent fluorescence and sonographically guided eradication of contrast-enhancing gliomas and metastases

Conditions: Glioma, Malignant; Metastases to Brain

Summary: objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ala) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ala alone.

fluorescence-guided resection of contrast-enhancing gliomas and metastases increases extent of tumor resection. but the main drawback of this method is an inability to observe tumor fluorescence while it is covered with normal brain. ultrasound can resolve this problem, allowing to reveal such tumor remnants. by the time there are published results of randomized control trials comparing these two technics. objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ala) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ala alone. participants of the study will be randomly operated using both fluorescence with 5-ala and intraoperative ultrasound versus fluorescence with 5-ala alone. extent of resection will be assessed in postoperative mri by blinded radiologists.

Eligibility criteria:
inclusion criteria: * single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas) * one or several brain metastases from any cancer * newly diagnosed * karnofsky performance status 60-100% * age 18-79 years * performed magnetic resonance imaging with contrast enhancement exclusion criteria: * tumor spreading to corpus callosum or brainstem * previously performed brain radiotherapy * planned supratotal tumor resection until neurophysiologically revealed eloquent areas * known hypersensibility to 5-aminolevulinic or to porphyrin * hepatic or renal insufficiency * porphyria * pregnancy * breast feeding

Keywords: contrast-enhancing glioma brain metastasis sonography ultrasound fluorescence 5-aminolevulinic acid 5-ala
the effect of metamin 3d on the lipid and glucose in subjects with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: to evaluate the effect of metamin 3d on improvement of glucose and lipid on taiwanese subjects with metabolic syndrome.

the metamin 3d consists of mixed extractives of nature plants, including soy bean protein, bitter melon, red yeast rice, green algae and trisodium glycyrrhizinate. the improvement of lipid and glucose was reported respectively previously. we design a prospective, double-blinded and placebo-controlled study to evaluate the improvement on metabolic syndrome.

Eligibility criteria:
inclusion criteria: * age between 30 and 75 years * fasting plasma glucose \>= 100 mg/dl * triglyceride \>= 150 mg/dl * one of the criteria following 1. hdl \<40 mg/dl in man or \<50 mg/dl in woman 2. blood pressure \>= 135/85 mmhg or anti-hypertension drug treatment 3. waist \>90cm in man or 80cm in woman * signed the inform consent exclusion criteria: * fasting plasma glucose \> 180mg/dl * treated by more than two types oral hypoglycemic agents in past 3 months * treated continuously by anti-lipid agents for 3 months in past 6 months * treated by thiazolidinedione or digitalis at present * serum creatine \> 2.5mg/dl * liver function (got or gpt) more than 3-fold upper limit * severe systemic disease by investigator's judgement * pregnant or nursing women * enrolled in other clinical study in recent 1 month

Keywords: hyperglycemia dyslipidemia hypertension obesity
sanger human cell atlasing project

Conditions: Human Development; Genetic Disease

Summary: "cell atlasing" refers to a novel strategy to characterise cells in tissues at the molecular level in a quantitative manner. the international human cell atlas consortium brings together a community of biologists, clinicians, technologists, physicists, computational scientists, software engineers, and mathematicians to capitalise on drawing together leaders with various biological, technical and computational expertise. the project is based on the aim to define all human cell types in terms of their distinctive patterns of gene expression, physiological states, developmental trajectories, and location. this will pave the way to create a reference map of all human cells as a basis for understanding human health and diagnosing, monitoring, and treating disease.

previous methods for quantifying molecular states of cells included microarray and standard rna-seq analysis on a tissue section (rna-seq is a technique to look at the activity of all the genes in a cell). these methods estimate the activity of any given gene by averaging the signal from millions of cells. given the heterogeneity of cell populations (i.e.how uniform they are), measurement of the mean values of signals overlooks the internal interactions and differences within a cell population that may be crucial for maintaining normal tissue function and facilitating disease progression. the sanger human cell atlasing project will adopt various genomic approaches that will provide genome-wide information in a single experiment. this project aims to scale up the single cell genomics and high-throughput highly multiplex spatial gene expression profiling approaches. coupled with powerful computational methods, this strategy will produce a comprehensive and systematic reference map of human cells, providing a fundamental blueprint of cell states for both basic biological research and clinical practice.

Eligibility criteria:
inclusion criteria: * samples are from the living and the deceased age 0 to 99+ from healthy and diseased individuals. * all samples will have fully informed consent for use in research. exclusion criteria: * samples taken without consent for use in future research * samples taken from individuals without the capacity to consent to use in research
analysis of breath volatile organic compounds after dyspnea induced in the healthy subject.

Conditions: Healthy Subjects

Summary: the dyspnea is a common symptom in patients with many respiratory diseases particularly chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in the deconditioned healthy subjects. called volatolom corresponds to the set of volatile organic compounds (vocs) contained in exhaled air. the analysis of volatolom can be done either by the methods based on mass spectrometry which allows the identification of each voc in the exhaled air or by the use of electronic noses which are more simple to use, less specific and produce a quantitive signal change based on pattern recognition algorithms providing a global profile of the voc without identifying them. the aim of the study is to determine whether the analysis of vocs in exhaled air would identify biomarkers related to the intensity and type of experimental dyspnea.


Eligibility criteria:
inclusion criteria: * healthy subject * no dyspnea * non smoking or daily smoking more than 5 years packs * perfect knowing of the french language * the consent form signed * affiliated to a health insurance plan exclusion criteria: * chronic disease * history of asthma or chronic obstructive pulmonary disease (copd) * personal or family atopy * cannabis use * electronic cigarette * medication except contraception * pregnant woman * without liberty or guardianship

Keywords: volatolom volatile organic compounds (vocs) dyspnea electronic nose mass spectrometry
special drug use investigation for arixtra® (fondaparinux) venous thromboembolism treatment

Conditions: Ataxia

Summary: the purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (vte). ("arixtra" is a trademark of the glaxosmithkline group of companies.)


Eligibility criteria:
inclusion criteria: * patients with acute pulmonary thromboembolism or acute deep venous thrombosis * fondaparinux injection must be prescribed for the first time exclusion criteria: * not applicable
evaluation of implant survival in patients with a pinnacle ultamet device in conventional total hip joint replacement

Conditions: Arthropathy of Hip

Summary: the objective is to evaluate the implant survival rate for patients implanted with a pinnacle® ultamet™ metal-on-metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.


Eligibility criteria:
inclusion criteria: * patients susceptible to receive a pinnacle® ultamet™ implant as per routine practice exclusion criteria: * patient refusal to participate to the data collection * pregnant woman * patients age is less than 18 years old * the planned intervention is a revision of a previous intervention on the studied hip joint * previous metal implant, except for pure titanium or titanium alloys * exposure to cobalt and chromium that could influence serum metal ions levels * planned bilateral intervention * patient residing outside france * patient not implanted with a pinnacle(r) ultamet(tm)
acid lactase in combination with yoghurt bacteria for improvement of lactose digestion in lactose malabsorbers

Conditions: Lactose Malabsorption

Summary: fermented dairy products, especially real yoghurt, are often tolerated better by lactose malabsorbers than unfermented dairy products. the intake of dietary supplements containing acid lactase derived from aspergillus oryzae with lactose containing foodstuffs is known to reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. the study aims to compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose malabsorbers. it is hypothized that the combination preparation will be more effective and/or will show a more reliable effect than the two mono-preparations.


Eligibility criteria:
inclusion criteria: * subjects of african or asian origin. * older than 18 years * written informed consent exclusion criteria: * participation in a clinical study with a drug or a medical product withing the last 30 days; * inability to comply with the study protocol; * allergy to milk protein; * intolerance against lactase preparations; * known metabolic or gastrointestinal diseases which affect the absorption, metabolism or excretion of food components except lactose maldigestion; * intake of drugs influencing resorption of food components or gastrointestinal motility; * surgery within the last three months which still affect the current status of health; * psychiatric diseases * epilepsia * risk for suicide * eating disorders, e.g. anorexia, bulimia * alcohol or drug abuse * legal incapacity

Keywords: lactose malabsorption lactose intolerance lactose digestion lactose maldigestion acid lactase yoghurt bacteria
skin conduction device and patient diary for measuring hot flashes in postmenopausal women with hot flashes

Conditions: Hot Flashes

Summary: rationale: measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary. purpose: this clinical trial is studying a skin conduction device and a patient diary for measuring hot flashes in postmenopausal women with hot flashes.

objectives: * determine the differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary in postmenopausal women with hot flashes. * assess the recordings made by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period in these patients. outline: patients wear an ambulatory sternal skin conductance hot flash device continuously for 24 hours. patients complete hot flash diaries over 24 hours. patients undergo treadmill exercise over 30 minutes and record hot flash activity using the skin conductance device during 10 minutes of sweating. patients also complete the comfort, bother, and weight questionnaire at the completion of the study. projected accrual: a total of 3 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of bothersome hot flashes, defined by their occurrence ≥ 4 times/day * daily hot flashes that have been present for ≥ 1 month patient characteristics: * female * postmenopausal * ecog performance status 0-1 * no history of allergic or other adverse reactions to adhesives * no other medical condition known to cause sweating and/or flushing * no implanted pacemakers or metal implants * no reliance on electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors) prior concurrent therapy: * not specified

Keywords: hot flashes
level of social support and associated factors among diabetic patients in bahir dar city public hospitals, amhara regional state, north west ethiopia, 2023

Conditions: Social Support and Associated Factors Among Diabetic Patients

Summary: supplementary: english version of the questioner part 1- questions related to socio-economic characteristics identification no.__________________ no. question circle the appropriate option 100 gender of the respondent? 1. male 2. female 101 what is the age of the respondent? age in years _______ (yy) 102 residence 1. urban 2. rural 103 what is the educational status of the respondent? 1. no formal education 2. grade1-8 3. grade 9-12 4. college \& above 104 monthly income of the respondent _______ etb 105 marital status 1. married 2. single 3. widowed 4. divorced 106 do have health insurance 1. yes 2. no 107 occupation 1.private business 2.government employee 3.private employee 4.other part 4: clinical parameter 200 types of diabetes 1. type 1 2. type 2 201 type of current diabetic treatment 1. insulin 2. oral drug 3. both 202 duration of dm after first diagnosis. 1. \ 10years 2. 5-10 years 203 comorbid status 1.yes if specify ----------- 2.no 204 blood glucose level 1______,2_________,3¬¬_______mg/dl part 3 oslo social support scale (osss-3) s.no question response 300 how many people are so close to you that you can count on them if you have great personal problems? 1 'none' 2 '1-2' 3 '3-5' 4 '5+' 301 how much interest and concern do people show in what you do? 1 'none' 2 'little' 3 'uncertain' 4 'some' 5 'a lot' 302 how easy is it to get practical help from neighbors if you should need 1 'very difficult' 2 'difficult' 3 'possible' 4 easy 5 very easy


Eligibility criteria:
inclusion criteria:the study population was a diabetic patient with a follow-up who fulfilled the eligibility criteria - exclusion criteria:those patients who are critically ill and those less than 18 years old was excluded because they couldn't provide adequate information related to the study. -

Keywords: social support, diabetes mellitus, family support, support system
recognize high pressure areas in human body to prevent decubitus ulcers

Conditions: Pressure Ulcer Stage 1

Summary: prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer. underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain. bedsores are caused by pressure against the skin that limits blood flow to the skin and nearby tissue. others factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. three primary contributing factors are sustained pressure, friction and shear. bedsores are easier to prevent than to treat.

* age * weight * high * bmi * pressure scanning map * alimentary status * diseases

Eligibility criteria:
inclusion criteria: * any patient admitted for elective surgery, * patients above 18 y.o., * patient admitted for surgery that required 3 or more days in hospital exclusion criteria: * patients under 18 * patients that require emergency surgery * patients that have bedsores before admission

Keywords: bmi pressure bedsore