Kornimate/medical-research-clean huggingface dataset:
elucidation and monitoring postprandial endothelial function

Conditions: Cardiovascular Disease; Endothelial Dysfunction

Summary: the primary aim of this study is to evaluate the effect of a high fat challenge on several measures of endothelial function. the secondary aim of this study is to elucidate the mechanism of postprandial endothelial dysfunction and to identify early biomarkers

endothelial dysfunction (ed) is a hallmark for the initial stage of vascular dysfunction and has been associated with diet-related disorders such as cardiovascular disease. this makes prevention of ed an important health target. from previous studies we know that a high-fat (hf) meal (challenge) impairs postprandial endothelial function (ef). current studies only evaluated the effect of a hf meal on flow mediated dilatation (fmd), a measure of macro vascular ef. this methodology (fmd) however, is time consuming and large variations in reproducibility are reported in literature. the question remains whether other types of macro- and micro vascular ef measurements can be used to observe ed after a hf meal that are more accurate, faster and easier to perform. in addition, it is know that the postprandial phase results in activation of leukocytes. this activation of leukocytes is likely to contribute to ed, but the exact underling mechanism remains unclear.

Eligibility criteria:
inclusion criteria: * male, caucasian exclusion criteria: • allergic to cow milk or dairy products * body mass index (bmi) \ 25 kg/m2 * urine glucose concentrations outside normal ranges (\>0,25 g/l) * fasting blood glucose outside the normal range (3 - 5.5 mmol/l) * tobacco smoking * taking medication or food supplements. * received inoculations within 2 months of starting the study or planned to during the study * donated or intended to donate blood from 2 months before the study till two months after the study * blood hb values below 8.4 mmol/l * diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure) * high blood pressure (systolic bp\> 140 mmhg and/or diastolic bp\>90 mmhg)

Keywords: endothelium, postprandial microvascular macrovascular
a clinical study evaluating the safety and tolerability of pf-04427429 in healthy adult volunteers. the pharmacokinetics and pharmacodynamics of pf-04427429 will also be investigated

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of pf-04472429 administered intravenously to healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as non clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests) * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight of 50 to 100kg inclusive * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial exclusion criteria: * evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated symptomatic, seasonal allergies at time of dosing) * history of febrile illness within 5 days prior to the first dose * a positive urine drug screen

Keywords: safety tolerability pharmacokinetics pharmacodynamics chronic pain
alk21-010: long-term safety of medisorb® naltrexone (vivitrol®) in alcohol-dependent adults

Conditions: Alcoholism

Summary: this was a phase 3, multi-center extension of alkermes' study alk21-003ext (nct01218971) to further assess the long-term safety of repeat monthly doses of medisorb® naltrexone (vivitrol®).

enrolled subjects continued to receive the same dose strength of medisorb naltrexone (ie, 190 mg or 380 mg) they had received in study alk21-003-ext (nct01218971). assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. placebo was not administered.

Eligibility criteria:
primary inclusion criteria: * completed study alk21-003-ext (nct01218971), receiving all 13 injections * willing and able to return for scheduled clinic visits and study assessments * noncustodial, stable address and phone * written, informed consent primary exclusion criteria: * pregnancy or lactation * terminated early from study drug in study alk21-003-ext (nct01218971)

Keywords: alcohol dependence
smoking cessation in women with gynecological conditions

Conditions: Cervical Dysplasia

Summary: this feasibility study will compare two smoking cessation methods, traditional nicotine replacement therapy and electronic nicotine delivery systems (electronic cigarettes) in patients with gynecological conditions.

this study will allow women with serious gynecological conditions to sample both traditional nicotine replacement therapy (nrt) and electronic nicotine delivery systems (electronic cigarettes, ends). whether the woman samples nrt or ends first will be randomized. women will choose the product they wish to try for a 6-week intervention period for smoking cessation. women choosing nrt will receive a 6-week intervention of a daily nicotine patch plus either nicotine gum or lozenges to use (as needed) throughout the day. the ends group will receive an electronic cigarette device with refills to last the 6-week duration of the study. both groups will receive identical tobacco cessation counseling. as part of the study, each subject will complete a survey conducted at baseline, 6-weeks into the study during intervention, and upon completion of a 6 week follow-up period in which participants receive no intervention. at the 12-week measurement period we will add a qualitative interview that will allow us to ask the women whether the methods were acceptable, caused any problems, and if so, what the problems entailed.

Eligibility criteria:
inclusion criteria: * female * smokers (defined as those who have smoked at least daily for the last year and who have smoked greater than or equal to 10 or more combustible cigarettes per day during the last year. * patients with diagnoses of cervical dysplasia, cervical cancer and lower genital tract dysplasia and cancer * ages 18-65 years exclusion criteria: * patients unwilling to commit to a 6-week intervention that may include either nrt or ends. * patients with previous diagnoses of or treatment for cancer - with the exception of non-melanoma skin cancer. * presence of any known stroke, heart disease, heart attack, or irregular heart beat. * pregnancy and lactation. * plan to continue to use other nicotine in addition to the products supplied by the study. these would include: chewing tobacco, snuff, an additional nicotine patch or other nicotine containing products. * high blood pressure, not well controlled with medication. * patients using a non-nicotine "smoking cessation medication." * patients taking a prescription medicine for depression or asthma.

Keywords: smoking cessation traditional nicotine replacement therapy electronic nicotine delivery devices electronic cigarettes cervical dysplasia
compression device safety study

Conditions: Venous Insufficiency

Summary: to evaluate the safety of the compression device to subjects with venous insufficiency and oedema.


Eligibility criteria:
inclusion criteria: * subjects over 18 years, willing and able to provide written informed consent. * subjects able to wear the amadeus device and follow the requirements of the clinical investigation plan * subjects who have an ankle to brachial pressure index (abpi) of abpi \>0.8 * subjects with chronic lower limb oedema (i.e. ceap classification of c3, c4 or c5 1.) * subjects who have chronic venous insufficiency (cvi), which has been present for 6 weeks or longer and who have refluxes \>0.5 sec in one or more major venous segments, superficial or deep or both (ceap classification: c3-c5 1.; ep,s; as,d; pr). exclusion criteria: * subjects with a history of skin sensitivity to any of the components of the study product. * subjects who have previously been entered into the study before * subjects who have a history of deep vein thrombosis (dvt) within the last 6 months * subjects who have an active leg ulcer (i.e. ceap classification of c6 1). * subjects with active cardiac disease or significant history of cardiac disease (including history of myocardial infarction, heart failure, valvular disease, arrhythmia and those with a pacemaker or have previously had a pacemaker). * subjects who have initiated treatment or changed the dose within the past month of pharmaceutical agents that reduce clotting e.g. aspirin (except low-dose aspirin), anti-platelets, anti-coagulants and coumarin. * subjects who are currently taking pharmaceutical agents that can modify the amount of leg oedema (e.g., diuretics, dihydropyridine calcium channel blockers, phlebotonic drugs, or fluctuating doses of systemic steroids) or have taken these agents within the last 10 days. * subjects who are pregnant * subjects who have worn compression therapy in the last 48 hours * subjects who have leg sizes outside the following range: * ankle 17cm - 32cm * calf 27cm - 47cm * below knee 29cm - 51cm
interest of cardiac coherence in the prevention of chronic post-traumatic stress disorder: pilot study

Conditions: Post-traumatic Stress Disorder

Summary: ththe aim of this study is to determinate the potential benefits of a respiratory training program (cardiac coherence, cc) in patients suffering from acute stress disorder, after a potentially traumatic event. using this method is supposed to prevent the onset of chronic post traumatic stress disorder after 3 months. this pilot study will help to determinate the need of developing this kind of complementary and alternative program, and will also provide knowledge about the feasibiility and acceptability of this program for the patients.

each patient will be teached how to use cardiac coherence with a trained practitioner at the inclusion visit. a respiratory guide on smartphone will be given to the patient aswell as a diary in order to keep tracks of the patient's compliance to this program.

Eligibility criteria:
inclusion criteria: * patients seen at medico-psychological emergency cell * patients with an acute stress disorder, diagnosed by dsm-5 * patients who have experienced a potentially traumatic event for the last 3-15 days (vctim or witness) * patients able to read and write in french language * person affiliated or beneficiary of a social security scheme. * person who agrees to participate in the study exclusion criteria: * patients with respiratory pathology not allowing cardiac coherence training * patients currently practicing a regular respiratory control technique or within the last 6 months * patients taking beta-blocker, betamimetic, anti-arrhythmic, opioid, antidepressant * patients with a pacemaker or suffering from severe cardiac illness * patients with non-stabilized psychiatric disorder at inclusion * patient taking benzodiazepine unable to wean off in the week following the inclusion * patients with addiction * patients with a cognitive deficit * patients under guardianship or curatorship, under judicial supervision
long term prognosis of taiwanese patients with osa

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to explore long-term prognosis and to identify the predictors in taiwanese osa patients. validation of the prediction model derived from nhird with the database of national taiwan university hospital (ntuh) sleep center is planed to determine the effects of different treatments on long-term prognosis.

obstructive sleep apnea (osa) is a common disorder characterized by intermittent hypoxia and sleep fragmentation. osa is associated with cardiovascular morbidity and mortality, metabolic dysregulation, and neurocognitive dysfunction, which may bring worse prognosis. continuous positive airway pressure (cpap) is the standard treatment of osa while the oral appliance and surgery are the alternative treatments. the differences of craniofacial features among races contributed to the race-specific presentations of osa. up to date, only limited studies investigated the long-term prognosis of osa and most of them recruited caucasians and african americans. moreover, most studies didn't address the impact of treatment other than cpap on the long-term prognosis. . national health insurance research database (nhird) in taiwan enrolled 99% of whole taiwan's population and has longer period of 10 years for follow-up, which is suitable for investigation of long-term prognosis and predictors in osa. however, due to limited parameters for diagnosis and treatment, the results could be biased in such secondary database research. center of sleep disorder in national taiwan university hospital (ntuh) established from 2006 has 2,600 sleep studies annually. therefore, database and cohort from sleep center could offer the validations of the prognosis and predictors determined from nhird. in addition, the impact of all three treatment modalities, namely cpap, oral appliance, and surgery, on long-term prognosis could be studied in the prospective way. therefore, in this project, we aimed to achieve three goals (1) to explore long-term prognosis and identify the predictors in taiwanese osa patients with nhird, where the prediction mode of prognosis was established (2). to validate the prediction model derived from nhird with the database of ntuh sleep center (3) to determine the effects of different treatments on long-term prognosis with prospective following ntuh sleep center cohort.

Eligibility criteria:
inclusion criteria: * nhird - \>=20 y/o; osa icd-9-cm code: 780.51,780.53,780.57, or 327.23; coexisted with psg procedure code: 17008b,17008a. * ntuh cohort - \>=20 y/o; psg ahi\>5 exclusion criteria: * patients refusing to anticipate our study

Keywords: obstructive sleep apnea national health insurance research database in taiwan survival analysis validation studies cohort studies
a trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder (sad)

Conditions: Seasonal Affective Disorder

Summary: this is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for seasonal affective disorder (sad, winter depression), for subjects with a dsm iv diagnosis of major depression, with seasonal pattern, winter type, to examine efficacy of treatments for this condition. the trial has a 1 week baseline phase and a 4 week treatment phase.

this is a randomized, controlled clinical trial comparing an inactivated negative ion generation (placebo condition) and light-emitting photodiode therapy (active condition), for seasonal affective disorder (sad, winter depression), for subjects with a dsm iv diagnosis of major depression, with seasonal pattern, winter type, to examine efficacy of treatments for this condition. exclusion criteria included any other current treatment for sad, as well as bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full remission for at least one year. the trial has a 1 week baseline phase and subjects were seen weekly during a 4 week treatment phase. the study was double-blind. the study was conducted at 8 sites in the us, canada and the netherlands.

Eligibility criteria:
inclusion criteria: * seasonal affective disorder * age 18 to 65 exclusion criteria: * psychotropic medication treatment * history of light treatment for sad * history of mania or psychosis

Keywords: sad winter depression
irreversible electroporation(ire) for unresectable urinary bladder neoplasms

Conditions: Urinary Bladder Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable urinary bladder neoplasms.

by enrolling patients with unresectable urinary bladder neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable urinary bladder neoplasms.

Eligibility criteria:
inclusion criteria: * head and urinary bladder diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable urinary neoplasms
evaluation of tip urethroplasty with spongioplasty-dartosoraphy reinforcement in pediatric hypospadias

Conditions: Hypospadias; Complication,Postoperative

Summary: the study aimed to evaluation of tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group a) through comparing of functional and cosmetic results of this technique with the conventional tip urethroplasty (group b).


Eligibility criteria:
inclusion criteria: * lees than 14 years distal hypospadias urethral plate size more than 6mm glans size more than 14 mm exclusion criteria: * recurrent cases proximal; hypospadias

Keywords: distal and midpenile hypospadias tipu spongioplasty-dartosoraphy pediatric hose
investigation of v520 in a hiv vaccine dose refinement study (v520-027)(terminated)

Conditions: HIV Infections

Summary: this study will test the safety and immunogenicity of an investigational human immunodeficiency virus (hiv) vaccine. immunogenicity will be measured by evaluating the immune response to several different dose levels.


Eligibility criteria:
inclusion criteria: * demonstrates good general health * human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), and hepatitis c (hcv) seronegative * low risk of acquiring hiv infection * alt lab value within normal range exclusion criteria: * previously received an investigational hiv vaccine * has a known or suspected impairment of immunologic function * has a clinically significant chronic medical condition that is considered progressive * has a major psychiatric illness * has any history of malignancy, with the exception of basal cell or squamous cell skin cancer * weighs less than 105 lbs. * has a recent (within two years) history of chronic alcohol abuse * has a contraindication to intramuscular (im) injection, such as anticoagulant therapy or thrombocytopenia * female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study * male subject is planning to impregnate or provide sperm donation during the study

Keywords: aids
study of the prognostic value of musculoskeletal ultrasound in adults with chikungunya

Conditions: Infected by Chikungunya Virus

Summary: chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early joint damage. approximately 8% of patients have chronic arthropathy resembling to the rheumatoid polyarthritis. the echochik study we propose is in the context of the epidemic in martinique which began in january 2014. it should give a better understanding of arthritis and juxtaarticular of chik and look for signs that may allow ultrasound predict the evolution of chronic arthropathy of chik.


Eligibility criteria:
inclusion criteria: 1. age at onset of symptoms ≥ 45 years 2. seen in consultation at the university hospital of fort-de-france 3. suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees) 4. duration of symptoms suggestive of infection chikungunya less than or equal to 10 days 5. presence of joint pain on the day of inclusion 6. no history of inflammatory arthritis 7. absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to inclusion 8. ability to participate in the study throughout its duration (12 months) 9. patient affiliated or beneficiary of a social health care. 10. acceptance to participate in the study and monitoring proposed and signed informed consent exclusion criteria: 1. age at onset of symptoms \<45 years 2. duration of symptoms suggestive of chikungunya for more than 10 days 3. lack of joint pain on the day of inclusion 4. history of inflammatory arthritis nonsteroidal anti-inflammatory drugs or 5. taking in the two weeks preceding the inclusion 6. inability to participate in the study throughout its duration (12 months) 7. patient is not affiliated or beneficiary of a social health care. 8. refusal to participate in the study or to sign a consent
a study to evaluate the safety and efficacy of et-01 transplantation in subjects with transfusion dependent β-thalassaemia.

Conditions: Transfusion Dependent Beta-Thalassaemia

Summary: this is an open label, single site study to evaluate the safety and efficacy of et-01 transplantation in subjects with transfusion dependent β-thalassaemia.


Eligibility criteria:
key inclusion criteria: * subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms; * 6\~35 years old, all gender; * diagnosis of transfusion dependent β-thalassemia (β-tdt) as defined by protocol; * eligible for autologous stem cell transplant; * organs in good function. other protocol defined inclusion criteria may apply. key exclusion criteria: * subjects with associated α-thalassemia; * active bacterial, virus, fungal or parasitic infection, including hiv infection, hbsag and hbv dna positive, hcv dna positive, or treponema pallidum infection; * hla identical sibling or unrelated donors are available; * prior allo-hsct or gene therapy. other protocol defined exclusion criteria may apply.