Kornimate/medical-research-clean huggingface dataset:
maintenance treatment for abstinent smokers

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.

the goal of this study was to assess relapse prevention outcomes among individuals able to stop smoking when pharmacotherapy is extended beyond the standard duration of treatment. we hypothesized that maintenance treatment with prolonged bupropion use and/or "as needed" use of nicotine gum will reduce relapse to smoking. participants were recruited through advertisements on radio, television, newspapers, the internet, and various community outlets. respondents were pre-screened by telephone using a standard interview. the first participant entered the olt phase in february 2001; the final ntfu visit took place in october 2005. the study was multi-phased consisting of: 1) eight-week open-label treatment (olt) with bupropion and nicotine patch; 2) randomized double-blind assignment of olt successes to 16 weeks of placebo-controlled maintenance treatment (mt); and 3) 24 weeks of non-treatment follow-up (ntfu). participants received $25 compensation for completing the ntfu visits at weeks 36 and 48. the institutional review board of the new york state psychiatric institute approved the study. the study was performed at the columbia university medical center smoking cessation clinic in new york city.

Eligibility criteria:
inclusion criteria: * patients who smoke at least 10 cigarettes daily and have attempted to quit smoking at least once exclusion criteria: * seizure history * unstable blood pressure * current major depression * current alcohol/drug abuse or dependency * lifetime psychotic illness * current use of psychotropic drugs * unstable medical condition

Keywords: maintenance treatment smoking relapse bupropion nicotine replacement
study to evaluate the safety and efficacy of asc42 tablets in subjects with primary biliary cholangitis

Conditions: Primary Biliary Cholangitis

Summary: this study is a phase ii, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of asc42 matched placebo in subjects with primary biliary cholangitis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤75 years old at screening. * definite or probable pbc diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: 1. biochemical evidence of cholestasis based on alp elevation. 2. presence of ama, or other pbc-specific autoantibodies, including sp100 or gp210, if ama is negative. 3. liver biopsy consistent with pbc. * screening alp ≥ 1.67× uln * taking udca for at least 6 months (stable dose for ≥ 3 months) prior to day 0, or unable to tolerate udca (no udca for ≥ 3 months) prior to day 0. exclusion criteria: * alt or ast \> 5× uln; alp \>10× uln * history or presence of other concomitant liver diseases * child-pugh grade b or c

Keywords: asc42 primary biliary cholangitis pbc
description of immunologic, enzymatic and metabolic biomarkers associated to the severity of covid-19 (sars-cov-2) and its resolution

Conditions: Covid19

Summary: prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of coronavirus disease (covid-19)


Eligibility criteria:
inclusion criteria for patients: * adult patient * patient with covid-19 confirmed by rt-pcr, supported by poitiers hospital * patient came for rt-pcr test at the drive of the hospital, or hospitalised in one of the covid-19 departments of the poitiers hospital (geriatry, infectious and tropical diseases, medical resuscitation and continuous care unit) * informed consent signed by the patient or a trusted or immediate person after clear and loyal information on the study exclusion criteria for patients: * minor patient * patient having had syptoms for more than 8 days * patient already enrolled in another study regarding immunomodulators * patient not benefiting from a social security scheme or not benefiting from it through a third party * patient benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adult under legal protection inclusion criteria for volunteers: * adult patient * subject wishing to be vaccinated with anti-covid-19 biontech pfizer vaccine * informed consent signed by the volunteer after clear and loyal information on the study exclusion criteria for volunteers: * minor patient * subject having had covid-19 documented by a positive rt-pcr test or serology * subject already vaccinated against covid-19 (complete or partial vaccinal scheme) * patient not benefiting from a social security scheme or not benefiting from it through a third party * patient benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adult under legal protection

Keywords: sars-cov-2 immunologic biomarkers vaccine
the angel® catheter pivotal clinical trial

Conditions: Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism; Trauma

Summary: the primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the angel® catheter in subjects at high risk of pe, and with recognized contraindications to standard pharmacological therapy (anticoagulation).


Eligibility criteria:
inclusion criteria: 1. subject or legally authorized representative is willing and able to provide written informed consent, 2. subject is 18 years or older, 3. subject is expected to remain in a critical care setting for at least 72 hours, and at least one of the following inclusion criteria (4,5, and/or 6) 4. subject has recognized contraindications to standard pharmacological thromboprophylaxis including: * active bleeding or at high risk for bleeding or * hypersensitivity to pharmacological thromboprophylaxis or * history of severe heparin induced thrombocytopenia or * severe thrombocytopenia 5. subject has a confirmed acute proximal lower extremities dvt or a confirmed acute pe with recognized contraindication to anticoagulation 6. subject requires a temporary interruption (\>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure exclusion criteria: 1. subject is pregnant 2. subject is in treatment with an investigational drug or device within 30 days prior to enrollment 3. subject has a pre-existing ivc filter in place 4. bmi = \> 45 5. subject has functioning pelvic renal allograft on the only side available for device insertion 6. subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted 7. anatomic inability to place the angel® catheter 8. subject has known hypersensitivity to any of the components of the angel® catheter, specifically nitinol (nickel and/or titanium)

Keywords: pulmonary embolism pe dvt deep vein thrombosis vte venous thromboembolism prophylaxis thromboprophylaxis contraindications to thromboprophylaxis prophylactic prevention inferior vena cava filter ivc filter filter prevention of pulmonary embolism trauma critically-ill
a study to evaluate the effects of indacaterol maleate (qab149) as a new formulation in the epic test fixture

Conditions: Asthma

Summary: this study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of indacaterol maleate (qab149), administered via the epic test fixture. the study aims to determine whether the novel device has a similar clinical profile as the established concept 1 device.


Eligibility criteria:
inclusion criteria: male and female patients with asthma, aged 18 or above patients using inhaled corticosteroid (with or without long acting beta agonist) patients who demonstrate an increase in fev1 after inhaling a short acting beta agonist exclusion criteria: asthma exacerbations in previous 6 months copd or other pulmonary disease excessive use of short acting beta agonists other protocol-defined inclusion/exclusion criteria may apply

Keywords: asthma indacaterol qab149
assessing patient satisfaction and confidence after use of educational video to augment surgical consent for thyroid surgery

Conditions: Thyroid Cancer

Summary: this study looks at how a short educational video can help people better understand thyroid surgery. patients who have thyroid nodules and need surgery will be part of the study. some patients will get the usual information from their doctor, while others will also watch a video that explains the surgery in a simple and clear way. the study will check if the video helps patients feel more confident about their decision, lowers anxiety, and helps them remember important information about their surgery. patients will answer surveys before surgery, after surgery, and 3 months later.


Eligibility criteria:
inclusion criteria fluent in english * english is primary language * ≥18 years old at time of consent * eligible for thyroidectomy, lobectomy, isthmusectomy for any indication exclusion criteria: * history of prior thyroid surgery * previously consented for thyroid surgery
a study to assess safety and efficacy of vilaprisan in subjects with uterine fibroids

Conditions: Uterine Fibroids

Summary: the primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. the secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.


Eligibility criteria:
inclusion criteria: * women, 18 years or older at the time of visit 1 * diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm * heavy menstrual bleeding (hmb) \>80.00 ml documented by menstrual pictogram (mp) in a bleeding episode period during the screening period * use of an acceptable non-hormonal method of contraception * an endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology exclusion criteria: * pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * hypersensitivity to any ingredient of the study drugs * hemoglobin values ≤6 g/dl or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dl will be recommended to use iron supplementation) * any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including * abuse of alcohol, drugs, or medicines (eg: laxatives) * undiagnosed abnormal genital bleeding * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
evaluation of an automated smartphone-based digital auscultation application for detecting abnormal heart sounds using deep learning techniques

Conditions: Valvular Heart Disease

Summary: this pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (pcg) recordings using a smartphone-based auscultation device in the first step. the ability to determine valvular heart disease (vhd) (i.e., presence or absence of cardiac murmurs) using novel handheld caa-devices shall be analyzed and first data on a smartphone-based auscultation in a hospital setting shall be collected. in further studies, the data provided from this study can be used to investigate the potential diagnostic use of such devices in the ambulatory and stationary care scenarios.

cardiac auscultation is considered to be highly subjective with substantial varying sensitivities and specificities in regard of the practitioners' expertise. computer-assisted auscultation (caa) aims to provide increased objectivity. caa makes auscultation procedure less operator-dependent, approximate inter-examiner differences and may reduce uncertainties in the course of the examination. with the introduction of modern machine learning software libraries and ever-growing computational resources caa has advanced significantly and is now able to classify heart sounds and murmurs into normal and abnormal, using complex spectro-temporal signal processing techniques and neural network pathways. caa has simultaneously made the shift from the deployment on computers to consumer smartphones. a benefit of caa can be expected from the smartphone alone in terms of cost, application range, the clinical validity of such algorithms should now be measured in this pilot study. this pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (pcg) recordings using a smartphone-based auscultation device in the first step. in further studies, the data provided from this study can be used to investigate the potential diagnostic use of such devices in the ambulatory and stationary care scenarios.

Eligibility criteria:
inclusion criteria: * older or equal than 18 years of age * referred for an echocardiogram * able to provide informed consent exclusion criteria: * confirmed arrythmia * prior valvular intervention * evidence of congenital heart disease

Keywords: automated digital auscultation deep learning technique smartphone-based digital auscultation computer-assisted auscultation (caa) artificial neural networks (ann) heart sound (hs) identification medical grade audio phonocardiogram (pcg)
ergospirometry in paroxysmal atrial fibrillation prognosis

Conditions: Atrial Fibrillation; Atrial Arrhythmia

Summary: an observational, prospective, cohort study aiming to assess the potential predictive role of cardiopulmonary exercise testing in the prognosis of paroxysmal atrial fibrillation, in combination with echocardiographic indices and plasma biomarker values.

the "paroxysmal atrial fibrillation prognosis based on cardiopulmonary exercise test data and novel echocardiographic and plasma biochemical indices" (placebo) trial comprises an observational, prospective, single-center cohort study including patients with paroxysmal atrial fibrillation. all patients undergo clinical examination, detailed echocardiographic study, cardiopulmonary exercise testing (cpet) and 24-hour ambulatory echocardiographic monitoring (24-hour holter monitoring), as well as measurement of a series of plasma biochemical indices. the study will examine the potential prognostic role of cpet variables (such as peak vo2) in the future recurrences of paroxysmal atrial fibrillation.

Eligibility criteria:
inclusion criteria: 1. patients with paroxysmal atrial fibrillation (in sinus rhythm during baseline evaluation) 2. age \> 18 years 3. capability of providing written consent 4. patients able to undergo cardiopulmonary exercise testing 5. patients able to comply with the follow-up schedule of the study exclusion criteria: 1. patients with structural cardiomyopathy 2. patients with congenital heart disease 3. patients with permanent atrial fibrillation 4. patients who have undergone atrial fibrillation ablation 5. patients with implanted cardiac devices for primary or secondary prevention 6. patients with recent (within the last month) acute coronary syndrome 7. patients with heart failure with reduced ejection fraction (hfref) or end-stage renal disease 8. patients with autoimmune diseases or active malignancies 9. patients with uncontrolled thyroid disease 10. patients unable to undergo cardiopulmonary exercise testing due to disability or motility issues 11. patients who present with contraindications for cardiopulmonary exercise testing 12. patients unable to provide written consent 13. patients with poor echocardiographic images 14. patients unable to undergo spirometry 15. patients unable to comply with the follow-up schedule of the study 16. patients with uncontrolled hypertension 17. patients who have undergone recent (within the last 2 months) surgery 18. pregnancy

Keywords: atrial fibrillation cardiopulmonary exercise testing exercise capacity echocardiography holter monitoring peak oxygen uptake
real-life study of the efficacy of management of migraine patients after failure of 2 prophylactic treatments

Conditions: Migraine

Summary: this is a real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the migraine disability assessment (midas), headache impact test short-form (hit-6), patient global impression of change (pgic), hospital anxiety and depression (had) scale and work and personal activities impairment (wpai) questionnaires at each visit. data describing their care will be extracted from computerized patient records.


Eligibility criteria:
inclusion criteria: * patients with migraine \[international headache society (ihs) criteria 2013, revised 2018\] with or without aura * monthly number of attacks ≥ 8 for at least 3 months * indication for prophylactic treatment * for eptinezumab: resistance to at least 2 conventional disease-modifying therapies * agrees to use data for research purposes exclusion criteria: * vascular history: myocardial infarction (mi), unstable angina or coronary bypass surgery, stroke or transient ischemic attack (tia), peripheral arterial disease of the lower limbs (pad), uncontrolled hypertension * need for analgesics for a cause other than migraine * difficulty in understanding french language or cognitive impairment that compromises completion of self-questionnaires.

Keywords: migraine prophylactic treatment real life
ozone auto-hemotherapy for covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with covid-19 pneumonia. eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone. patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / ml with a gas volume of 200 ml. treatment will occur every 12h during 5 days. standard treatment will be the one used in each hospital participating in the trial. all analyses will be done according to the intention-to-treat principle


Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 confirmed by positive polymerase chain reaction (pcr) for severe acute respiratory syndrome (sars-cov-2) in respiratory tract sample, plus pneumonia confirmed by imaging tests and arterial oxygen saturation (spo2) \<94% with ambient air or a partial pressure of oxygen to fraction of inspired oxygen (po2/fio2) ratio \<300 mmhg or spo2/fio2 ≤ 315. * acceptance to participate in the study and signing of the informed consent. exclusion criteria: * patients who have received treatment with any form of ozone therapy 6 months before admission to the hospital. * patients who have previously been treated and have experienced some type of adverse reaction to ozone therapy. * patients aware of having a deficiency of glucose-6-phosphate dehydrogenase. * patients with clinically decompensated chronic comorbidities, independently of covid-19. * patients suffering from any psychiatric disorder specified in axis i of the diagnostic and statistical manual of mental disorders (dsm-v), other than major depression. * patients who are not able to clearly understand the objectives and methodology of the study. * pregnant or lactating patients.

Keywords: ozone therapy covid-19 sars-cov-2
infections and pregnancy loss: correlation between abortion and silent infections.

Conditions: Pregnancy Loss

Summary: correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy.

in this study we will analyse chorionic villi derived from abortion during the first trimester of pregnancy (spontaneous abortion vs voluntary pregnancy interruption), in order to correlate the presence of infective viruses/bacteria and the incidence of miscarriage. the first objective of this project will be to find the viral dna of hpv, bk and jc polyomaviruses and bacterial dna of chlamydia trachomatis, ureaplasma parvum, ureaplasma urealyticum, mycoplasma hominis in the aborted tissues collected from spontaneous abortions, and to compare the prevalence of these dnas to those derived from elective specimens. acronyms: dna: deoxyribonucleic acid hpv: human papillomavirus pcr: polymerase chain reaction hpyv: human polyomavirus pbmc: peripheral blood mononucleated cell bkv: bk polyomavirus jcv: jc polyomavirus

Eligibility criteria:
i.inclusion and exclusion criteria inclusion criteria: * age of the patients range from 18 to 42 years old; * gestational age ranging in the first 12 weeks. exclusion criteria: * medical history or laboratory tests positive for sexually transmitted diseases (hiv, hbv, hcv, lue) during the last year; * congenital or acquired immunodeficiency diseases, or immunosuppressive therapies during the last year; * therapeutic abortion (voluntary interruption of pregnancy, law 194 art 6 comma b) * well known causes responsable for spontaneous abortions such as genetic, severe uterine or hormonal abnormalities and use of teratogenic drugs.
comparison of topical latanoprost vs topical corticosteroid in treatment of localized alopecia areata

Conditions: Alopecia Areata

Summary: alopecia areata (aa) is an autoimmune disease that involves the hair follicles. topical corticosteroids are the established agents for treating this disorder. there are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. the two agents have not been compared head-to-head in the published literature. the investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

alopecia areata (aa) is an autoimmune disease that involves the hair follicles. topical corticosteroids are the established agents for treating this disorder. topical prostaglandins like latanoprost have also been used for this disorder. there are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. however, the two agents i.e. topical corticosteroids and topical latanoprost have not been compared head-to-head in the published literature. the investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

Eligibility criteria:
inclusion criteria: * • cases of aa involving scalp and beard area, having 5 or less patches in all, involving less than 40% area * stable disease without appearance of new patch or increase in size of existing patch for at least 15 days exclusion criteria: * • pregnant and lactating women * patients on topical treatment for alopecia in the past fifteen days or on systemic treatment for alopecia in the past one month * presence of any contraindication for topical corticosteroids (local skin infections, skin atrophy) or latanoprost (pregnancy, lactation and dermatitis) * any other coexisting hair disorder (viz., trichotillomania, androgenetic alopecia, telogen effluvium) * extensive disease i.e. \>5 patches of aa or area involving \>40% area / alopecia totalis/ alopecia universalis/ ophiasis

Keywords: alopecia areata betamethasone latanoprost topical steroid prostaglandin