Kornimate/medical-research-clean huggingface dataset:
clinical analysis of safety in latent tuberculosis infection prophylaxis treatment

Conditions: Adverse Reaction to Drug; 3HP

Summary: the treatment of latent tb with 3hp is an important issue for the prevention of active tb. however, significant proportion of subjects receiving 3hp had adverse reaction. the main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. clinical characteristics and biomarker will be used to predict adverse reaction.


Eligibility criteria:
inclusion criteria: * close contact with active tb patients * patients with autoimmune diseases preceding biological therapy * health-care workers * other clinical conditions, which increased the risk of ltbi. ltbi was confirmed by quantiferon-tb gold in-tube test (qft-git; qiagen, valencia, ca, usa) with a cut-off value of 0.35 iu/ml. exclusion criteria: * age less than 20 years * pregnant women * active tb or suspected active tb in the clinical evaluation * severe liver disease * esrd * organ transplantation * close contact with a multidrug-resistant tb patient * obesity (bmi\>30 kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.
efficacy of first-line gemcitabine chemotherapy in gemcore+ metastatic pancreatic adenocarcinoma patients

Conditions: Cancer Of Pancreas

Summary: the goal of this interventional study is to learn about the efficacy of first-line chemotherapy with gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the gemcore signature in their tumor. the main question it aims to answer is to assess efficacy of gemcitabine (tumor response, survival rate) in the population of patient bearing the gemcore signature. participants will start the chemotherapy with gemcitabine as usually performed in standard care of their center. they will consent to a genomic analyze of their tumor to know if it bears the gemcore signature. the center will manage the participant's follow up as usually realized in standard care.


Eligibility criteria:
inclusion criteria: * metastatic pancreatic adenocarcinoma histological proved * folfirinox chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy * tumor material allowing assessment of gemcore status (i.e. ffpe block with tumor cellularity ≥ 10%); * life expectancy \> 2 months; * measurable target according to recist 1.1 criteria; * no previous treatment in metastatic situation; * age ≥ 18 years; * patient not opposed to study participation; * affiliation to a social security system, or beneficiary of such a scheme. exclusion criteria: * contraindication to gemcitabine treatment; * ecog performance status ≥ 3; * person in emergency situation or unable to express non-opposition; * patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice); * unable to undergo medical follow-up for geographical, social or psychological reasons.
single-dose iloperidone pharmacokinetics in patients with mild or moderate liver disease, compared to healthy volunteers

Conditions: Hepatic Impairment

Summary: this study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects


Eligibility criteria:
inclusion criteria: * inclusion criteria (all subjects): * caucasian subjects * inclusion criteria (hepatic impaired subjects): * subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, magnetic resonance imaging or computed tomogram within 3 months of screening, and a creatinine clearance \> 50 ml/min (based on cockroft and gault formula). * inclusion criteria (healthy volunteers): * good general health * matched by age, gender, smoking status, body mass index, and cyp2d6 phenotype to hepatic impaired subjects. exclusion criteria: * exclusion criteria (all subjects): * subjects who report smoking a pipe, cigars or more than 20 cigarettes per day . * history of drug abuse as defined in diagnostic and statistical manual of mental disorders, diagnostic criteria for drug and alcohol abuse, within the 12 months prior to screening * history of first-dose response/syncope to alpha1-blocking agents * exclusion criteria (hepatic impaired subjects): * patients with symptoms or 6 months past history of encephalopathy. * patients with clinical evidence of moderate-severe ascites. * patients having a previous surgical porto-systemic shunt. * exclusion criteria (healthy volunteers): * history of alcohol abuse prior to dosing, or evidence of such abuse during screening. * pulse rate \> 200 msec other protocol-defined inclusion/exclusion criteria may apply

Keywords: hepatic impairment iloperidone ilo522d pharmacokinetics
electric polarization of red blood cells : a cohort study to assess the erythrocytes membrane integrity through charge conservation, following cardiac surgery.

Conditions: Inflammatory Response; Erythrocyte Destruction; Red Blood Cell Disorder; Hemolysis; Cardiovascular Disorder

Summary: an immediate perioperative parameter that assess the integrity of the erythrocytes membrane and therefore their structural quality isn't available in clinical practice and medical diagnostics except through indirect clinical biochemical tests or through the scanning electron microscope. the red blood cell (rbc) membrane contains proteins and glycoproteins embedded in a fluid lipid bilayer that confers viscoelastic behavior. sialylated glycoproteins of the rbc membrane are responsible for a negatively charged surface which creates a repulsive electric zeta potential (ζ) between cells. these charges help prevent the interaction between rbcs and the other cells and especially between each other. the zeta potential is a physical property which is exhibited by all particles in suspension. the development of a net charge on any particle affects the distribution of ions in the surrounding interfacial region resulting in an increased concentration of counter ions of opposite charge to that of the particle, close to the surface. in this context we present a new parameter that studies the interactions of the erythrocytes membrane treated with positive ions and their maintenance of the charge. we compared the measured polarization values with the erythrocyte sedimentation rate (esr), expression of speed with which rbcs tend to settle inside a particular graduated capillary called westergren's tube and plasma free hemoglobin (pfhb).


Eligibility criteria:
inclusion criteria: * elective, primary cardiac surgery * minimally invasive cardiac surgery * mitral valve surgery (mvs) * conventional cardiac surgery (ccs) * coronary arterial bypass grafting (cabg). exclusion criteria: * abnormal plasma lactate levels (\>2 mmol/l) * renal * liver failure, * obesity, * uncompensated diabetes, * autoimmune disease, active infection * immunosuppressant therapy * coagulation disorder * surgery with circulatory arrest * preoperative hematocrit (hct) \<27%
image fusion pet, ct and 3d-ultrasound examinations

Conditions: Anal Cancer

Summary: ct-examinations are used in computer programs which are used in the planning of external radiation of cancers in the anal canal. in ct the structures of the anal canal are hardly visible. 3d-ultrasound examinations offer a better visualisation of normal and pathological structures of the anal canal. the description of the tumour made from the 3d-ultrasound examination is used in the planning of the external radiation. pet-ct is used to visualise tumour activity also in lymp nodes. the hypothesis of the study is that image fusion of pet, ct and 3d-ultrasound will offer better visualisation of tumour and hereby more accurate diagnostics and treatment.


Eligibility criteria:
inclusion criteria: * histologically verified cancer of the anal canal exclusion criteria: * pregnancy * unability to cooperate to radiation therapy
sentinel - triaging acute breathlessness using multi-modal biomarkers

Conditions: Breathlessness; COPD; Asthma; Asthma Chronic; Wheezing; Dyspnea; Shortness of Breath

Summary: the sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.


Eligibility criteria:
inclusion criteria: * aged 18-90 years. * has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. breathlessness does not have to be the primary presenting symptom. * deemed clinically sufficiently stable to participate according to health care practitioner. exclusion criteria: * inability to understand written local language at a year 5 level. * not being confident in use of digital technology (smartphone and/or tablet). this will become evident through an inability to use the system. * inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event. * received an investigational medical product in the context of a clinical trial during the 28 days prior to first probe administration.

Keywords: breathlessness copd asthma asthma chronic wheezing dyspnea shortness of breath
stress sensitivity and reward responsivity in depression

Conditions: Depressed

Summary: the goal of this project is to learn more about the different ways in which people process information that is stressful and rewarding, and how abnormalities in these two processes are related to depression.

participants will participate in two 3-hour sessions separated by a week at providence care, mental health services, and a third, 1.5-hour session at the queen's mri facility. at the first session participants will complete a packet of questionnaires about their mood and take part in an interview about their mood, medications, drug use, and any other symptoms, as well as an interview about their relationships with their parents and any experiences of abuse. at the second session participants will participate in a stress test, which involves giving a speech to a panel. the investigators will also collect saliva samples to look at stress hormones. participants will also complete a task on the computer that involves looking at cartoon faces and making decisions about them. at the third session, the investigators take images of of participant's brain using a magnetic resonance scanner. participants are invited to participate in a 6-month follow-up for this study, which would involve the same procedure as outline above.

Eligibility criteria:
for depressed participants: inclusion criteria: * outpatients aged 18-65 * currently suffering from unipolar depression * fluency in english, sufficient to complete the interviews and self-report questionnaires exclusion criteria: * clinical diagnosis of bipolar disorder, psychotic disorders, current alcohol/substance dependence, or significant medical comorbidity * treatment-resistant (defined as failing more than 3 trials of anti-depressant medication) * history of neurological insult (e.g., concussion), neurological disease, seizure disorder * smokers * pregnant women * endocrine disorders * high suicidal risk, defined by clinician judgement for healthy control participants: inclusion criteria: * adults aged 18-65 * no history of axis i disorders according to dsm-iv-tr criteria, as determined by the scid * no first-degree relatives diagnosed with bipolar disorder * fluency in english, sufficient to complete the interviews and self-report questionnaires exclusion criteria: * history of neurological insult (e.g., concussion), neurological disease, seizure disorder * smokers * pregnant women * endocrine disorders
phenylketonuria, oxidative stress, and bh4

Conditions: Phenylketonuria

Summary: the purpose of this study is to see how tetrahydrobiopterin therapy (bh4; also known as sapropterin dihydrochloride or kuvan) affects measures of oxidative stress and endothelial function in patients with phenylketonuria (pku).

oxidative stress will be induced by having participants eat a meal in polyunsaturated fats. the investigators will see how participants respond to the meal challenge over the course of 6 hours. * pku participants who are currently on bh4 therapy will be evaluated while taking bh4 with the meal at a single study visit. * pku participants who did not responded to bh4 therapy will be evaluated twice. at the first study visit the investigators will see how you react to the meal challenge when you are not given bh4. you will be given bh4 for two weeks, then return for a second meal challenge study visit while taking bh4. * healthy controls will be evaluated after consuming the meal only (no bh4) at a single study visit.

Eligibility criteria:
inclusion criteria: * have read, understood, and signed this consent form (and assent form, if \<18 years old) * are between the ages of 10-45 years * weigh at least 75 pounds (34 kg) * meet group-specific criteria exclusion criteria: * smoke * have any history of cardiovascular disease * have hepatic impairment, or demonstrate abnormal baseline liver function lab test results * have donated blood within 3 months prior to the study or are anemic as shown by the baseline lab results * are unwilling to discontinue dietary supplements (excluding medical food) two weeks prior to their first study visit * are currently take medications that will interfere with the interpretation of selected endpoints (such as lipid-lowering medication) * are currently pregnant or breastfeeding * excluding pku, have a chronic illness, disorder, or condition (including but not limited to diabetes, hypertension, cancer) * have taken any investigational drug (including kuvan for kuvan-unresponsive participants \& controls) within 3 months prior to the study * in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures

Keywords: phenylketonuria pku tetrahydrobiopterin sapropterin dihydrochloride bh4 kuvan oxidative stress
study on the etiology, risk factors and pathogenesis of copd based on clinical bioinformatics

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the risk factors and causes of chronic obstructive pulmonary disease（copd）are not clear, so the prevalence of copd is high and the prevention effect is not good. because the pathogenesis of copd is not completely elucidated, the diagnosis and classification of copd are inaccurate which resulting in poor efficacy of treatment. therefore, it is of great scientific and clinical significance to find out the risk factors and causes of copd, to clarify its pathogenesis, to put forward the prevention and early intervention measures of copd, to warn the occurrence of copd, to predict the deterioration of the disease, to reduce the occurrence of copd and to slow down the progress of copd. the project establishes a cohort of copd people，high-risk group and the healthy group. the project studys the risk factors, etiology and pathogenesis of copd. the project studys the interaction between genetic factors and environmental factors on copd and its effect on pathogenesis, progression and outcome of copd.

the project establishes the data base and specimen bank for copd.then clinical bioinformatics technology is uesd to analyze the clinical information and epidemiological information. in the same time, omics methods are used to study copd-related genes and biomarkers . finally, a multi-factor risk factor model for the occurrence and development of copd is established by combining clinical information, epidemiological information and biomics results.

Eligibility criteria:
inclusion criteria: ① inclusion criteria for patients with copd: * over 18 years of age. * fev1 / fvc\< 70% was the diagnostic criterion for copd after inhaling bronchodilators. ② inclusion criteria for high-risk subjects: * over 18 years of age. * physical examination and routine laboratory tests were normal. * chest ct to exclude other pulmonary diseases. * lung function does not meet the diagnostic criteria for copd. * having one of the following risk factors: a. smoking: current smokers, smoking index (number of years of smoking × number of cigarettes per day)≥ l. b. biofuel exposure: subjects frequently use charcoal, wood, and animal dung for home heating and cooking or crops are defined as having a history of exposure to biofuels. c. dust and chemical exposure: mining, quarrying, casting, grain dust, paint, chemicals and others (including non-return) in the above categories of self-reported) occupational dust or gas smoke exposure for more than 1 year. ③ inclusion criteria of healthy control subjects: * over 18 years of age. * physical examination and routine laboratory tests were normal. * chest ct to exclude other pulmonary diseases. * lung function does not meet the diagnostic criteria for copd. * no risk factors (including smoking, biofuel exposure, dust or chemical exposure). exclusion criteria: * history of other chronic lung diseases, such as bronchiectasis, pulmonary interstitial fibrosis, etc. * history of acute lung disease within 3 months. * history of malignant tumor. * pregnant and lactating women.
comparison of the effectiveness of yoga and exercise in female patients with fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: in this study, yoga, aerobic exercise, resistance exercise training in female individuals with fibromyalgia syndrome; it was aimed to compare their effectiveness on fatigue, quality of life and pain.

the study was planned as a randomized controlled study. participants will be divided into 3 groups by simple randomization method. groups will be named as aerobic, yoga and resistance exercise groups. 12-week exercise protocols will be applied to all participants. participants before and after treatment; the fibromyalgia impact questionnaire, the mcgill pain questionnaire for pain assessment, the chalder fatigue scale to assess their fatigue level, will be filled in by the participants before and after the study. the data obtained will be statistically analyzed.

Eligibility criteria:
inclusion criteria: * between the ages of 18-45 * be woman * being diagnosed with fibromyalgia exclusion criteria: * receiving pharmacological treatment * having had a surgical operation in the last 6 months * being pregnant * having a musculoskeletal injury

Keywords: women sleep tiredness
long-term benefits of cpap or mad treatment on the sleep of osas patients

Conditions: OSA

Summary: the remap study aims to follow a cohort of 400 patients in around ten sleep centers in france and to collect clinical routine data. the objectives of this study are to investigate the effects of one-year management of osa by cpap or mad on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. the study will also allow us to define predictive factors for improving sleep quality during osa treatment.


Eligibility criteria:
inclusion criteria: * patient already included in the sunsas study (no. id/rcb: 2021-a01827-34) or patient who has undergone polygraphy or polysomnography eligible for treatment with cpap or mad in the context of osa. * patient with a sleep test performed with the sunrise device * men or women from 18 to 80 years old * patient with osas eligible for cpap or mad therapy * affiliated patient or beneficiary of a social security scheme * signed informed consent exclusion criteria: * patient previously treated for osas by cpap or mad during the last five years * patient with copd or other respiratory diseases. * patient with contraindications to ppc or mad therapy * patient with unstable heart disease or new york heart association class iii or iv heart failure * patient unable to complete the study
international clinical trial to evaluate efficacy and safety of multiple subcutaneous injections of bcd-085 in various doses in patients with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: bcd-085-2 is a next step in clinical investigation of bcd-085. bcd-085 is a monoclonal antibody to interleukin 17. during bcd-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous treatment including uv-therapy and biologic drugs was registered, will receive 40, 80 or 120 mg of bcd-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. efficacy and safety parameters will be evaluated.


Eligibility criteria:
inclusion criteria: * written informed consent * age between 18 and 65 years * diagnosis of plaque psoriasis with stable course of the disease during last 6 months prior to enrollment in the study. * patient have had at least 1 course of phototherapy or systemic therapy of psoriasis or are candidates for such treatment. * bsa affected by psoriasis ≥ 10%, pasi score ≥ 12, spga score ≥ 3. * if patient have had biologic therapy for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. this therapy must be discontinued at least 12 weeks before enrollment in the study. * female patients have negative urine pregnancy test. * patient has no history of tuberculosis. * patients have negative results of diaskintest. * patient has no history of alcohol or drug abuse. * patients are able to perform all procedures planed by protocol. * patients are ready for contraception with reliable methods starting 2 weeks before entering the study, and up to 4 weeks after the last dose of study drug. exclusion criteria: * subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis. * previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs. * prior use of two or more biologics to tumor necrosis factor alfa. * prior use of two or more biologics to other targets. * previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent. * patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable. * prior use of disease-modifying drugs including methotrexate, sulfasalazin and cyclosporin for up to 4 weeks before signing informed consent, if their dose was not stable for up to 4 weeks before signing informed consent and during screening prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent. * prior use of phototherapy including selective phototherapy and photochemotherapy for up to 4 weeks before signing informed consent.

Keywords: interleukin 17 monoclonal antibody psoriasis