Kornimate/medical-research-clean huggingface dataset:
correlation between popliteal vein compliance and venous clinical severity score

Conditions: Chronic Venous Disease (CVD), Vein Compliance, Venous Clinical Severity Score (VCSS)

Summary: when the liquid flow increases, the luminal caliber's stretching amplitude decreases, leading to a higher hydraulic pressure according to poiseuille's law. in this study, investigators measured the caliber change of the popliteal vein under a rated pressure gradient and evaluated the relationship between popliteal vein compliance and venous clinical severity score (vcss).


Eligibility criteria:
inclusion criteria: * c1 to c6 disease using the ceap (clinical, etiologic, anatomic, pathophysiologic) classification. exclusion criteria: * acute or chronic thrombosis of deep veins, previously received intravenous surgery or injection sclerotherapy, ankle brachial index\<0.90, and concomitant cardiovascular, pulmonary, renal, or metabolic diseases.
reliability and validity of the turkish version of the coping strategies questionnaire

Conditions: Chronic Musculoskeletal Pain

Summary: chronic musculoskeletal pain is a major health problem in 35% of the general population in most developed countries. in addition to interventional therapies, the cognitive and behavioral abilities of the patient, are important for the solution of chronic pain. all of these abilities of patients are called coping strategies of pain.

the coping strategies questionnaire (csq) is commonly used to measure methods of coping with various forms of chronic pain, including musculoskeletal pain. csq aims to evaluate the frequency and success of coping strategies with cognitive and behavioral pain. the validity and reliability of the questionnaire was tested and satisfactory results were obtained and it became a widely used tool in pain studies. the aim of this study was to translate and culturally adapt the original english version of the csq into turkish version and to assess the validity and reliability of this instrument in patients with chronic musculoskeletal pain.

Eligibility criteria:
inclusion criteria: * being eighteen years old or older, * being diagnosed with chronic musculoskeletal pain (at least 6 months), * being a native turkish speaker and being able to read turkish, * receiving no treatment between test-retest assessments. exclusion criteria: * inability to complete the form due to significant psychiatric or psychological disorder, * having a neurological disease, * pregnant women.

Keywords: coping strategies questionnaire cross-cultural adaptation reliability validity
a study to evaluate vtx2735 in patients with cryopyrin-associated periodic syndrome

Conditions: Cryopyrin Associated Periodic Syndrome

Summary: this is a study to understand if taking vtx2735 is safe and effective in participants diagnosed with cryopyrin-associated period syndrome (caps). approximately 10 patients will take vtx2735 dose a or vtx2735 dose b. the study consists of a screening/washout period of up to 28 weeks, a 2 week treatment period, a treatment withdrawal period of up to 2 weeks, another 2 week treatment period, and a 4 week follow up period. the maximum length of treatment is 4 weeks.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosis of caps and fcas subtype and mild clinical phenotype * at least one flare during screening/washout * women must not be of childbearing potential or must agree to use two methods of highly effective contraception during the study and for 30 days after the last dose of the study product * men with a partner who is of childbearing potential must agree to use condoms plus another highly effective form of birth control during the study and for 90 days after the last dose of study product exclusion criteria: * unwilling to comply with washout of anti-il-1 therapy and tolerate symptoms of disease flare * moderate or severe caps manifestations or significant damage or any caps feature that presents a contraindication to washout of anti-il-1 therapy * has a history of chronic or recurrent infectious disease * has a known immune deficiency or is immunocompromised * has hepatitis b or hepatitis c infection, human immunodeficiency virus (hiv), acquired immunodeficiency syndrome (aids), or active tuberculosis (tb) * has another clinically important medical disorder that would compromise safety

Keywords: cryopyrin-associated periodic syndrome ventyx zomagen vtx2735 caps
engaging patients to help achieve increased patient choice and engagement for afib stroke prevention

Conditions: Atrial Fibrillation; Atrial Flutter; Stroke; Cardiac; Heart Failure; Arrhythmia

Summary: a multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for atrial fibrillation stroke prevention

this study will test to see if a new type of decision-making process tool, called a shared decision making pathway, can make a difference in decreasing the risk of stroke due to a condition called atrial fibrillation (afib.) this online tool is designed to help doctors and patients decide together on treatment options for afib.

Eligibility criteria:
inclusion criteria: * ≥ 18 y/o * non-valvular atrial fibrillation or atrial flutter (afib) * cha2ds2-vasc stroke score of: * men: 1 or more * women: 2 or more * able to consent in english or spanish (if resources allow) and follow study instructions exclusion criteria: * moderate to severe mitral stenosis * mechanical valve replacement * absolute contraindication to anticoagulation (based on clinician judgment) * indication for anticoagulation therapy for a condition other than atrial fibrillation * left atrial appendage exclusion (by surgery or device placement) * at the clinical discretion of the investigator
the effect of high and low roasted coffee on vascular response

Conditions: Cardiovascular Disease

Summary: evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular effects. coffee is a good source of phenolic compounds called chlorogenic acids (cga), however the level of cga is reduced during the roasting process. the aim of this study is to investigate the effect of coffee roasting on vascular response. the investigators hypothesize that coffee roasted to a lesser extent will exert a favourable vascular response over more heavily roasted coffee due to the higher levels of cga.


Eligibility criteria:
inclusion criteria: * male * a signed consent form * age 19-35 years * body mass index - 18.5-30 kg/m2 * normal blood pressure at screening (\< 150/90) exclusion criteria: * blood pressure \> 150/90 mmhg * haemoglobin (anaemia marker) \< 125 g/l * gamma gt (liver enzymes) \> 80 iu/l * cholesterol \> 6.5 mmol/l * had suffered a myocardial infarction or stroke in the previous 12 months * suffers from any reproductive disorder * suffers from any blood-clotting disorder * suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases) * any dietary restrictions or on a weight reducing diet * drinking more than 21 units per week * on any lipid-modifying medication * on any blood pressure lowering medication * on any medication affecting blood clotting * planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study * regular or vigorous exercise (3 times/week, 20 minutes each session) * smoking * vegetarians or vegans
role of citicoline in treatment of neonates with hypoxic ischemic encephalopathy

Conditions: Hypoxic Ischemic Encephalopathy of Newborn

Summary: hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births. infants afflicted with moderate hie face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. the prognosis is graver for severe hie, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

a number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations. citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. it has rapid absorption through enteral route where it breaks into cytidine and choline. citicoline is a favorable recently developed neuroprotector in hie as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ros synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair. in this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe hie.

Eligibility criteria:
inclusion criteria: 1. all indoor newborn babies with hie ii and iii 2. who have not received therapeutic hypothermia exclusion criteria: 1. grade i hie 2. babies on th 3. babies whose parents do not give consent for inclusion in study 4. babies with major congential malformations -
safety and efficacy of romiplostim in immune thrombocytopenia (itp) in the " real-life " : result of the french experience in 72 adults

Conditions: Thrombopenia

Summary: the purpose of this study is to review the charts of the first 100 patients included in the french compassionate program including patients with immune thrombopenia receiving romiplostim.

inclusion criteria: * subject has a diagnosis of itp according to the american society of hematology guidelines (george et al., 1996). * subject is equal to or greater than 18 years of age. * before any study-specific procedure, the appropriate written informed consent must be obtained. * subject receiving romiplostim in the compassionate program * available follow-up of one-year exclusion criteria: •secondary itp e.g: thrombopenia related to hepatitis c, hiv, chronic lymphocytic leukemia... the goal of this study is to review retrospectively the charts of the 100 first patients including in this program in france during the period of january 2008 and july 2008.

Eligibility criteria:
inclusion criteria: * inclusion criteria: * subject has a diagnosis of itp according to the american society of hematology guidelines (george et al., 1996). * subject is equal to or greater than 18 years of age. * before any study-specific procedure, the appropriate written informed consent must be obtained. exclusion criteria: * exclusion criteria: * secondary itp

Keywords: immune thrombopenia thrombocytopenia romiplostim compassionate program
efficacy and safety of aju-s56 in dry eye syndrome patients

Conditions: Dry Eye Syndromes

Summary: this study is planned to evaluate the efficacy and safety of test drug (aju-s56) compared to control drug(vehicle) in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: * male and female who over 19 years old * moderate to severe dry eye disease patients * must meet all criteria listed below at least in one eye or both eyes. tcss (national eye institute (nei) scale)≥ 4 schirmer test(without anesthesia) ≤ 10mm in 5 mins tear break-up time ≤ 6 secs * written informed consent to participate in the trial exclusion criteria: * those who have clinically significant eye disease not related to dry eye syndrome * those who have medical history with intraocular surgery 12months before screening visit * use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks * participation in other studies within 4weeks of screening visit

Keywords: dry eye
evaluation of changes in visual acuity in patients with diabetic macular edema (dme) starting treatment with an approved anti-vegf therapy

Conditions: Ophthalmology; Macular Edema; Macular Degeneration

Summary: polaris : a non-interventional study in patients with diabetic macular edema (dme) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-vegf) treatment regimens.


Eligibility criteria:
inclusion criteria: * patients diagnosed with type 1 or 2 diabetes mellitus * patients diagnosed with dme with central involvement (defined as the area of the center subfield of optical coherence tomography \[oct\]) * patients for whom the decision has been made to treat with an approved anti-vegf therapy prior to inclusion into the study * patients who received the first approved intravitreal anti vegf treatment from october 01, 2012 * patients who give informed consent in writing for study participation exclusion criteria: * treatment with any anti-vegf therapy prior to the start of the observation period (october 01, 2012) or enrolment into the study * participation in an investigational program with interventions out of clinical routine practice

Keywords: longitudinal studies, observation epidemiology
development and validation of novel mri methods for the detection of prostate cancer aggressiveness

Conditions: Prostate Cancer

Summary: the purpose of this study is to develop, validate, and evaluate the correlation of novel magnetic resonance imaging (mri) methods with prostate cancer aggressiveness and histological data obtained during prostatectomy.

prostate cancer is one of the most common neoplastic diseases in men. prostate specific antigen (psa) has only a limited role in the diagnosis and characterization of prostate cancer. the diagnosis of prostate cancer is still most commonly done by transrectal ultrasonography (trus) guided biopsy. however, trus guided biopsy carries a risk of increase in complications. there is an increasing interest in developing more accurate non-invasive imaging modalities which could potentially detect prostate cancer aggressiveness. diffusion weighted imaging (dwi) and rotating frame relaxation measurements have shown to be particularly promising in prostate cancer detection and characterization. this study which focuses on further development and validation of dwi and rotating frame relaxation measurements will enroll 200 men with histologically diagnosed prostate cancer who will undergo magnetic resonance imaging (mri) before prostatectomy. anatomical mri and novel acquisition methods focusing on dwi and rotating frame relaxation measurements will be performed using surface coils to non-invasively detect and characterize prostate cancer.

Eligibility criteria:
inclusion criteria: * age: 35 to 85 years * language spoken: finnish * performance status: karnofsky score 70 or better or who performance status 2 or better * diagnosis: histologically confirmed adenocarcinoma of prostate * no previous surgical, radiation or endocrine treatment for prostate carcinoma * clinical stage t1c-t3an0 based on transrectal ultrasound, pelvic ct and bone scintigraphy * time period between the last biopsy and scheduled radical prostatectomy less than 8 months * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethics committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * previous prostate surgeries, e.g. turp (transurethral prostatic resection) * symptomatic acute prostatitis * contraindications for mri (cardiac pacemaker, intracranial clips etc) * uncontrolled serious infection * claustrophobia
does an educational video for aneuploidy screening improve informed choice among pregnant women?

Conditions: Aneuploidy; Down Syndrome; Pregnancy Early

Summary: informed decision-making regarding aneuploidy screening has been reported to be low. poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. we conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.

women attending the antenatal clinic with a viable singleton pregnancy below 14 weeks were randomized to receive routine counselling by their obstetrician or the intervention, where they watched a 16-minute educational video on aneuploidy screening before their consult. the primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice (mmic) questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.

Eligibility criteria:
inclusion criteria: * aged 21 years or older * english speaking * had a viable singleton pregnancy below 14 weeks gestation exclusion criteria: * women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy

Keywords: prenatal screening informed choice randomized controlled trial
safety and efficacy of gratisovir (sofosbuvir)- ribavirin therapy in pediatric patients

Conditions: Pharmacological Action

Summary: evaluation of safety and efficacy of gratisovir (sofosbuvir)- ribavirin therapy in egyptian pediatric patients with chronic hepatitis c infection aged 10- 18 years old.

male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis c virus, willing and able to complete all study visits and procedures. acceptance from the parents will be recruited for giving a verbal and written informed consent. patient with childs pugh class b or c, compensated cirrhosis may be enrolled. patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml and patient with coinfection of hepatitis b virus or hiv will be excluded. participation in the study procedures is anticipated to last up to 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase. a detailed treatment log of the returned investigational product will be established with the investigator (or the pharmacist) and countersigned by the investigator and the monitoring team. compliance is assessed by counting the number of returned tablets at each visit. a discontinuation is defined as a period with at least seven consecutive days without study drug intake. safety and efficacy will be compared between cirrhotic versus non-cirrhotic subjects in multivariate model to test the impact of this pretreatment characteristic on safety, tolerability and efficacy endpoints. safety analysis:clinical adverse events will be displayed by body system (soc) for each study subject and by treatment group, using meddra coding. summary of statistics of safety and efficacy endpoints will be displayed by stratification parameters.

Eligibility criteria:
inclusion criteria: male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis c virus. willing and able to complete all study visits and procedures. acceptance from the parents will be recruited for giving a verbal and written informed consent. patient with child,s pugh class b or c, compensated cirrhosis may be enrolled. exclusion criteria: 1. patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml. 2. patient with coinfection of hepatitis b virus or human immunodeficiency virus will be excluded. 3. creatinine clearance \< 50 ml/minute. 4. albumin\<3 gm/dl. 5. aspartate aminotransferase or alanine aminotransferase \> 10 upper limit of normal. 6. pregnant and lactating females. 7. associated morbidity such as uncontrolled diabetes mellitus, schistosomiasis.

Keywords: direct acting antiviral drugs, chronic hepatitis c virus infection
nutritional, metabolic and respiratory status in cystic fibrosis

Conditions: Cystic Fibrosis; Diabetes

Summary: diabetes is a important complication of cystic fibrosis (cf). the improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (cfrd). cfrd is associated with accelerated pulmonary decline and increased mortality. pulmonary effects are seen some years before the diagnosis of cfrd implying that impaired glucose tolerance may be very early detrimental. insulin treatment is clearly indicated in patients with cfrd to control symptoms and reduce complications. however, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.the recent introduction of the continuous glucose monitoring system (cgms), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. this device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. previous studies of continuous glucose monitoring have been realized in cf patients with normal glucose tolerance and diabetes and compared with non cf controlthe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.


Eligibility criteria:
inclusion criteria: * patients 10 years and older with cystic fibrosis * not known diabetics with fasting blood glucose \<1.26 g / l * outside periods of exacerbation and / or glucocorticoid therapy * affiliated to a social security scheme * having received the results of the mandatory medical examination * having signed an informed consent exclusion criteria: * patient transplanted lung and / or liver * subject during participation in an interventional clinical trial * unable to give informed about the information * patient under judicial protection * patient under tutorship or curatorship * pregnancy * breastfeeding * patient treated with the combination lumacaftor and ivacaftor