Kornimate/medical-research-clean huggingface dataset:
addictive potential of lccs in dual users

Conditions: Tobacco Use Disorder; Dual Tobacco Use; Tobacco Dependence; Smoking; Smoking, Cigar; Smoking, Cigarette; Smoking, Tobacco

Summary: this study is about whether or not little cigars and cigarillos cause or maintain addiction, and if flavors, such as fruit, make them more addictive. the purpose of this study is to understand the addiction potential of little cigars and cigarillos compared to cigarettes in young adults who smoke both products. this study will also look at the differences between men and women. in the rest of this form, little cigars or cigarillos will be referred to as lccs.


Eligibility criteria:
inclusion criteria: * current regular dual user of little cigars/cigarillos (lccs) and cigarettes, defined as: (a) report smoking cigarettes on ≥ 8 of the past 30 days, and (b) report smoking unaltered lccs (without marijuana) on ≥ 8 of the past 30 days. * able to speak, read and understand english * age 18-34 years of age * stable residence (not planning to move during study period) * not intending to quit smoking cigarettes or lccs within the next 2 weeks * an expired carbon monoxide (co) level of at least 4 ppm of expired air to verify smoking status exclusion criteria: * pregnant for women (verified by urine pregnancy test at visits 1 and 2) * current use of (or plans to use in the next 2-3 weeks) nicotine replacement products or cessation products (e.g., bupropion) to minimize confounding effects of another product) * positive breath alcohol screen (breath alcohol level (bal) \> 0 g/ml; one re-test allowed; assessed at visits 1, 2, and 3) * illicit drug use other than marijuana (verified by positive drug toxicology test at visits 1 and 3; one re-test allowed) * met criteria for cannabis dependence assessed by the cannabis use disorders identification test-revised (cudit-r)

Keywords: dual use little cigars and cigarillos cigarettes flavored tobacco use addiction potential
a study of c-car039 (prizloncabtagene autoleucel) in patients with relapsed/refractory large b-cell lymphoma

Conditions: Relapsed/Refractory Large B-Cell Lymphoma

Summary: this is a multicenter, single arm, open-label study. the purpose of the study is to evaluate safety of prizloncabtagene autoleucel (prizlon-cel) and establish the recommended phase 2 dose (rp2d) (phase 1b) and to evaluate the efficacy of prizlon-cel (phase 2) in patients with relapsed or refractory large b-cell lymphoma (lbcl).

the purpose of the study is to evaluate the safety and efficacy of prizlon-cel. it includes two phases, phase 1b and phase 2. in phase 1b study, rp2d will be determined. the selected dose will be further evaluated in the phase 2 study. the study includes the following sequential procedures: screening, apheresis and car-t manufacturing, baseline, lymphodepletion, car-t infusion, dlt period (phase 1b) and follow-up visit. subjects will be followed for at least 2 years after prizlon-cel infusion, with up to 15 years long-term follow-up on a separate study.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * histologically confirmed cd19 or cd20 positive b-cell non-hodgkin lymphoma, including the following neoplasms as defined by the 2016 who classification of lymphoid neoplasms: 1. diffuse large b-cell lymphoma, not otherwise specified (dlbcl, nos) 2. primary mediastinal large b-cell lymphoma (pmbcl) 3. transformed follicular lymphoma (tfl) 4. high-grade b-cell lymphoma, with myc and bcl2 and/or bcl6 rearrangements (hgbl-dh/th) 5. high-grade b-cell lymphoma, nos (hgbl, nos) 6. follicular lymphoma grade 3b (fl3b) * relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (asct) * at least one measurable lesion per the lugano 2014 classification * adequate organ and marrow function exclusion criteria: * prior allogeneic hematopoietic stem cell transplantation (hsct) at anytime, or asct within 12 weeks prior to apheresis * suspected or confirmed central nervous system involvement * stroke or convulsion history within 6 months of signing informed consent form (icf) * autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment * uncontrolled active infection * positive hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab) with detectable hepatitis b virus (hbv) dna in peripheral blood; positive hepatitis c virus (hcv) antibody with positive hcv rna in peripheral blood; positive human immunodeficiency virus (hiv) antibody; positive syphilis test * severe heart, liver, renal or metabolism disease * inadequate wash-out time for previous anti-tumor treatments prior to apheresis * prior car-t therapy
sleep apnea : diagnosis and monitoring

Conditions: Obstructive Sleep Apnea

Summary: this prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. a new device called apneaband will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. this device will be tested in comparison with polysomnography (psg), the gold standard reference method of sleep apnea diagnosis.

the objective of this study is to dertermine the performance of the apneaband, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with psg. 40 apneic and non apneic subjects will wear the apneaband recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements). inclusion visit will be proceeded at the university hospital grenoble-alpes ; polysomnography and mesures by the apneaband will be proceeded at the patient's home by ic@dom. patients will be equiped with psg + apneaband during the first night and with apneaband only the second night.

Eligibility criteria:
inclusion criteria: * patients with moderate or severe obstructive sleep apnea (osa), diagnosed by polygraphy or psg for less than 2 years, and not treated for that. * non apneic person (berlin score = 0 or 1) * person be able to use the personal health monitoring device apneaband * be legally able to give consent * person affiliated to social security exclusion criteria: * patient already treated for osa * patient equipped with an electric medical device (non-exhaustive examples: cardiac pace maker, cochlear implant, neuro-stimulator) * being unable to understand and to follow recommendations for the study due to cognition or language problems * pregnant women, feeding and parturient * person under administrative or judicial control, or who is protected under the act * person in exclusion period for another study * person which would perceive more than 4500 euros of compensation because of its participation in other clinical studies in 12 months preceding this study

Keywords: sleep apnea diagnosis sleep apnea monitoring
role of the il33/amphiregulin pathway as a potential therapeutic target in hiv infection

Conditions: HIV I Infection

Summary: interleukin33 organize local immune reactions, especially at epithelial barriers. st2 is the il33 receptor. the sst2 rate is higher for patient living with hiv and is an independent predictable factor of mortality. interleukin33 induce tissue treg st2+ lymphocytes proliferation and amphireguline production. amphireguline is member of epithelial growth factors family, which contributes to tissue repair, and fibrose. amphireguline also helps immunosuppressives functions. targetting amphiregulin for people living with hiv who has poor restauration of ltcd4+ could be a future therapy.


Eligibility criteria:
inclusion criteria: 1. group 1: hiv-infected subjects * hiv-1 infection * age ≥ 18 years old * cd4 count≥ 100/mm3 * receiving an active antiretroviral treatment (plasma hiv viral load ≤ 50 copies/ml) * subjects needing an sti screening for routine care including rectal biopsy (independently of the current study protocol) nb : an additional inclusion criteria for the group 1 will be defined after the "phase 0" which will define two levels of fibrosis (low / high) 2. group 2: controls not infected with hiv needing a rectoscopy for an sti screening * hiv negative * age ≥ 18 years old * subjects needing an sti screening for routine care including rectal biopsy (independently of the current study protocol) 3. group 3: controls not infected with hiv needing a colonoscopy * hiv negative * age ≥ 18 years old * subjects needing a colonoscopy with colorectal biopsy as part of routine care (independently of the current study protocol) for the 3 groups: inclusion criteria * affiliated or beneficiary of a social security coverage * free, informed and written consent, signed by the participant and the investigator (at the latest on the day of pre-inclusion and before any examination carried out within the framework of the trial) exclusion criteria for the 3 groups * - hiv-2 infection or hiv-1 \& hiv-2 co-infection * active infection or cancer * contraindication to rectal biopsies (coagulation disorders, anticoagulation therapy, anorectal surgery, inflammatory bowel disease, post-radial rectitis) * subject participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit. * person under legal guardianship or deprived of liberty by a judicial or administrative decision. * pregnant or breastfeeding women * replicative hcv or hbv infection
outcome of idiopathic pulmonary fibrosis with pregnancy

Conditions: Idiopathic Pulmonary Fibrosis

Summary: case-control study was conducted between december 2018 to april 2020. to document outcome of ipf with pregnancy.


Eligibility criteria:
inclusion criteria: * patients with pulmonary diseases during pregnancy exclusion criteria: * patients with pulmonary diseases other than ipf and bronchial asthma were excluded.

Keywords: ipf pregnancy
rave: radial artery vascular complication and resource utilization

Conditions: Angiogram; Percutaneous Coronary Intervention

Summary: the primary objective of this study is to determine if there is a reduction in time to hemostasis in subjects treated with softseal®-stf hemostatic pad when used in conjunction with a vascular compression device after radial transcatheter procedure.

the softseal-stf hemostatic pad and compression devices (tr band® and radar easyclik) function to stop bleeding without obstructing radial artery flow, and have been shown to reduce the occurrence of radial artery occlusion. the softseal-stf hemostatic pad is an fda-approved, chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot. its mechanism of action is believed to be due to bioadhesion between the chitosan polymer chains, which are positively charged, and the negatively charged blood and tissue components, thereby stopping bleeding. in this study the radar easyclik and tr band® compression devices will be used with the softseal®-stf hemostatic pad to promote hemostasis at the puncture site. both vascular compression devices are fda approved. the vascband™ hemostat is an fda-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

Eligibility criteria:
inclusion criteria: * scheduled for an angiogram/pci * planned transradial approach exclusion criteria: * evidence of impaired dual perfusion to the hand when tested using allen's test * inaccessible radial arteries due to anatomic variations * infection or other skin disorder at the puncture site * undergoing an emergent or unplanned angiogram using the transradial approach * evidence of severe cognitive impairment or inability to understand the study procedures and answer follow-up questions * known sensitivity or allergic reaction to materials in the study devices * unwilling to participate in the study and follow all study-related procedures * participating physician deems the subject to not be a good candidate * inability to achieve radial access

Keywords: angiogram hemostatic activated clotting time quality of life
study to evaluate the safety and efficacy of am3101 to augment meniscal healing

Conditions: Meniscus Tear

Summary: the purpose of this clinical trial is to assess the safety and efficacy of am3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. this is a prospective, randomized, controlled, double-blinded, multi-center study.

primary efficacy objective: assess the efficacy of am3101 by evaluating the integrity of repaired meniscal tissue assessed via mri at 12 months following injection with am3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo). primary safety objective: assess the safety of am3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo). secondary objective: assess and compare functional outcomes in patients receiving am3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 and ≤ 40 years old at time of screening. 2. mri evidence of acl plus meniscus tear, or isolated meniscus tear. 3. body mass index (bmi) ≤ 40 kg/m2. 4. liver and kidney function panels within normal ranges at time of screening 5. willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions. 6. willing and able to sign an irb approved informed consent exclusion criteria: 1. have any concomitant ligament injury requiring surgical repair or reconstruction other than the acl. 2. have a history of previous meniscus injury that currently needs to be treated or has been treated surgically. 3. have evidence of arthritis ≥ grade iii (outerbridge classification) in the affected compartment or greater than kellgren lawrence grade 3. 4. elevated ast or alt liver enzymes at time of screening 5. pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study. 6. known drug or alcohol dependence currently or within the last year. 7. participating concurrently in another clinical study or have participated in a clinical study within the last 90 days, or intend to during the course of the study. 8. any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation. 9. any condition which, in the judgment of the investigator, would preclude adequate evaluation of the investigational product's safety and efficacy. 10. known allergic reaction to simvastatin. 11. patients currently taking simvastatin, or any other drug that is within the statin drug classification family.

Keywords: meniscal repair complications morbidities
efficacy and safety study of simeprevir in combination with sofosbuvir in participants with chronic hepatitis c virus infection without cirrhosis

Conditions: Hepatitis C Virus Infection

Summary: the purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis c virus (hcv) genotype 1 infected men and women without cirrhosis who are hcv treatment-naïve or treatment-experienced.

this is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), multicenter study. the study will consist of a screening phase up to 6 weeks, open-label treatment phase of 8 weeks or 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. approximately 300 participants will be randomly allocated in a 1:1 ratio to receive 150 mg simeprevir in combination with 400 mg sofosbuvir once daily either for 12 weeks (arm 1) or 8 weeks (arm 2). safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. the maximum study duration for each participant will be approximately 42 weeks.

Eligibility criteria:
inclusion criteria: * hepatitis c virus (hcv) genotype 1a or 1b infection confirmed before randomization * documentation of the presence or absence of a ns3 q80k polymorphism in hcv genotype 1a infected participants before randomization * documentation of the il28b genotype before randomization * hcv ribonucleic acid level greater than 10,000 iu/ml at screening * treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin * absence of cirrhosis in participants exclusion criteria: * evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy) * infection/co-infection with hcv non-genotype 1a or 1b * co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening) * co-infection with hepatitis-b virus (hepatitis-b-surface-antigen positive) * previously been treated with any direct acting anti-hcv agent (approved or investigational) for chronic hcv infection

Keywords: hepatitis c virus infection simeprevir sofosbuvir hcv cirrhosis
histocompatibility leukocyte antigen (hla)-a*2402 restricted peptide vaccine therapy in patients with gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*2402 restricted epitope peptides urlc10, koc1, vegfr1 and vegfr2 emulsified with montanide isa 51.

urlc10 and koc1 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cdna microarray technique. in a prior study, it has been shown that urlc10 and koc1 are upregulated in human gastric tumors. vegf receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. patients will be vaccinated twice a week for 8 weeks. on each vaccination day, the urlc10 peptide (1mg), koc1 peptide (1mg), vegfr1 peptide (1mg) and vegfr2 peptide (1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. the patients will also receive oral chemotherapy (s-1) simultaneously. repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. in the phase i study, we evaluate the safety and tolerability of these peptide vaccines. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * advanced or recurrent gastric cancer * resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s) * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*2402 * laboratory values as follows 2000/mm3\ 100000/mm3 bilirubin \< 3.0mg/dl asparate transaminase \< 150iu/l alanine transaminase \< 150iu/l creatinine \< 3.0mg/dl * able to receive oral ts-1 therapy * able and willing to give valid written informed consent exclusion criteria: * pregnancy (woman of childbearing potential:refusal or inability to use effective means of contraception) * breastfeeding * active or uncontrolled infection * unhealed external wound * concurrent treatment with steroids or immunosuppressing agent * prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal metastasis * history of allergy to tegaful, gimeracil and/or oteracil * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: peptide vaccine urlc10 koc1 vegfr1 vegfr2
czech aatd registry

Conditions: Alpha-1-antitrypsin Deficiency

Summary: alpha-1-antitrypsin deficiency is the most common congenital disease of the respiratory system, leading to early pulmonary emphysema or bronchiectasis. pulmonary involvement significantly accelerates active cigarette smoking. patients with alpha-1-antitrypsin deficiency may also have liver cirrhosis, vasculitis, skin or intestinal disorders. the aatd registry is a non-interventional multicenter retrospective prospective longitudinal follow-up of patients with alpha-1-antitrypsin deficiency. the aim of the aatd national registry is to collect and analyze clinical data in patients with alpha-1 antitrypsin deficiency.

alpha-1 antitrypsin deficiency is a genetic disorder that may result in lung disease or liver disease. it is assume that it affects 1 person from a cohort of 2,000-5,000 people of the general population. among patients with copd, the incidence of the disorder is significantly higher. the prognosis of these patients is incomparably worse compared to classic copd, because it affects younger patients and the rate of lung tissue loss is faster. the diagnosis is made in patients with pre-existing copd by examination of the plasma concentration of aat. in case of its reduction, genetic examination is added. the progression of the disease is rapid and has been shown to be slowed by lifelong augmentation treatment with human aat. however, in routine clinical practice, it is very difficult to assess the effectiveness of treatment, the progression of lung disease or the prognosis of the disease. the aatd registry is a non-interventional multicenter retrospective prospective longitudinal follow-up of patients with alpha-1-antitrypsin deficiency. the national registry collects data from all patients with severe or rare aat deficiency, regardless of the type of organ impairment and age, and thus provides a view of this genetic variation in the czech population. the aim of the aatd registry is to collect and analyse clinical data of patients with alpha-1 antitrypsin deficiency and increase the professional awareness of this hereditary disease.

Eligibility criteria:
inclusion criteria: * patients with alpha-1-antitrypsin deficiency exclusion criteria: * patient disagreement with inclusion in the study

Keywords: alpha-1-antitrypsin deficiency aatd national registry