Kornimate/medical-research-clean huggingface dataset:
the esg integrity study: effect of proton pump inhibitors on the structural integrity of endoscopic sleeve gastroplasty

Conditions: Obesity

Summary: the study is a single center randomized, open-label, phase iv clinical trial. obese patients who have indication to endoscopic sleeve gastroplasty (esg) for clinical reasons are included and esg is performed as per clinical practice. after randomization, the patients are divided in two arms: * arm a: patients will stop proton pump inhibitors (ppi) 24h after the procedure. * arm b: patients will assume oral esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of ppis after esg- standard current treatment). the primary aim of the study is to evaluate the effect of ppi on the structural integrity of the esg


Eligibility criteria:
inclusion criteria: * age 20 to 65 years * bmi between 30 to 45 kg/m2 * willingness to participate in the study and ability to comply and understand the study protocol. exclusion criteria: * active gastric gastro-duodenal during the last 6 months * helicobacter pylori infection. * organic or motility disorder of the stomach and / or esophagus * anticoagulant treatment * previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum * ongoing or active malignancy during the last 5 years. * myocardial infarction during the past 6 months or/and heart failure class iii or iv according to the new york heart association's classification. * drug or alcohol abuse * bulimic or binge eating pattern * continuous glucocorticoid or anti-inflammatory treatment * uncontrolled thyroid disease. * pregnancy, breastfeeding * psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study. * hiatal hernia ≥ 5 cm * known allergy or hypersensitivity to the active substance or any of the other excipients * liver cirrhosis of any child-phugh stage or meld\> 15 * chronic severe renal insufficiency (egfr \< 30 ml/min/1.73 m2 based on ckd-epi equation) * currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered * any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
pharmacokinetics of levofloxacin in intensive care unit

Conditions: Intensive Care Unit Syndrome; Community-acquired Pneumonia

Summary: the aim of this study is 1. to describe levofloxacin pharmacokinetics in icu patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/minimum inhibitory concentration (mic) ratio \> 5 and area under curve (auc) /minimum inhibitory concentration(mic) ratio \> 125. no therapeutic drug monitoring will be performed in this study.


Eligibility criteria:
inclusion criteria: * severe community-acquired pneumonia due to a strain sensible to levofloxacin * age \> 18 years * informed consent * saps ii (simplified acute physiological score) \> 20 awaited duration of survival higher than 7 days exclusion criteria: * historic of allergy to levofloxacin * resistant strain to levofloxacin * pregnancy * contra-indications of levofloxacin use, renal failure

Keywords: pharmacokinetic study : open, prospective, monocentric
enhancing immune health randomized controlled trial

Conditions: Mental Disorder

Summary: this study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses.

this study is testing the efficacy of a brief intervention designed to improve immune health literacy and behaviors among adults with mental illnesses. this psychoeducational intervention supports lifestyle changes, including promotion of immunity-enhancing nutrition and immunity aids, activated intentions to receive needed inoculations and annual health screenings, better sleep, and more effective stress management. adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. they are assessed at baseline, two months post-baseline, and three months later. multivariable analysis models are used to assess the primary outcome of self-reported immune status.

Eligibility criteria:
inclusion criteria: * age 18 and older * serious mental illness * membership in a collaborating community mental health agency * access to the internet * able to provide informed consent exclusion criteria: * cognitive impairment preventing informed consent * unable to communicate in english
bd veritor™ at-home and bd veritor™ professional

Conditions: Upper Respiratory Infection

Summary: the bd veritor™ system is a rapid test that is testing for both covid-19 and for influenza this study will try to determine if the bd veritor™ system can assist in the diagnosis of someone who has upper respiratory infection symptoms. there is both an at-home self test and test completed by a health care professional that will be completed during this study.

this is a prospective, multi-country, multicenter, comparative study to assess the performance of the bd veritor™ at-home sars-cov-2 \& flu a+b test and the bd veritor™ system for rapid detection of sars-cov-2 \& flu a+b (professional use) compared to an fda approved flu a/b reference assay (rt-pcr) and fda authorized molecular sars-cov-2 comparator reference method assays.

Eligibility criteria:
inclusion criteria: * 1. participants symptomatic of an acute respiratory illness within 7 doso * 2. ≥2 years of age at the time of study participation * 3. symptomatic subjects with * a. any one of the following symptoms (with or without additional symptoms): * i. fever * 1. oral/temporal artery: ≥100.4 °f / ≥38.0 °c * 2. rectal/ear: ≥101.2 °f / ≥38.5 °c * ii. cough * iii. malaise (fatigue/extreme tiredness) * b. or two of the following symptoms: * i. sore throat, * ii. shortness of breath/difficult breathing * iii. rhinorrhea (runny or stuffy nose), * iv. myalgia, * v. headache, * vi. sneezing, * vii. new loss of taste or smell, * viii. one or more gi symptoms (nausea, vomiting, diarrhea) exclusion criteria: * 1. participants currently undergoing treatment and/or within the past thirty (30) days of the study, with medication to treat novel coronavirus sars-cov-2 viral infections, which may include but is not limited to remdesivir (veklury) * 2. participants receiving convalescent plasma therapy for sars-cov-2. * 3. participants who have received antiviral medications for influenza within the previous 30 days. * 4. participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit. * 5. the participant is currently receiving or has received within the past thirty (30) days of the study visit, an experimental biologic or drug including either treatment or therapy. * 6. participants who have been previously enrolled in the study. * 7. history of frequent or difficult to control nosebleeds within the last fourteen (14) days. * 8. participants who have tested positive for flu a/b or sars-cov-2 within the last 28 days (excluding the day of enrollment in the study). exclusion criteria for the participation in the at-home portion of the study would include all of the criteria previously listed and include the following * 1. participants without the ability to read or write in the english language * 2. participants with prior medical or laboratory training.

Keywords: sars cov 2 influenza
special drug use surveillance of vonoprazan for "maintenance therapy of reflux esophagitis: long-term use"

Conditions: Reflux Esophagitis

Summary: the purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.

the drug being tested in this survey is called vonoprazan. vonoprazan is being tested to treat patients who have reflux esophagitis. this survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings. the survey will enroll approximately 1000 participants. - vonoprazan 10 mg or 20 mg this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: - participants who require maintenance therapy for relapsed/recurrent reflux esophagitis exclusion criteria: * participants meeting the criteria of grade a to d according to the los angeles classification (hoshihara's modification), by means of endoscopy at the initiation of maintenance therapy with vonoprazan tablets * participants with a previous history of hypersensitivity to ingredients in vonoprazan tablets * participants taking atazanavir sulfate or rilpivirine hydrochloride
clinical study of gt719 injection for recurrent/refractory cd19 positive adult b-cell malignancies

Conditions: Hematological Malignancy (Leukemia- Lymphoma)

Summary: this study is a prospective single-arm open-labled phase i/ii clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of gt719 injection in relapsed/refractory cd19 positive adult b-cell non hodgkin lymphoma (b-nhl) and b-acute lymphoblastic leukemia (b-all) patients. a total of 34 subjects will be enrolled in this study.


Eligibility criteria:
inclusion criteria: 1. voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol. - 2. eastern collaborative oncology group (ecog) physical fitness status score of 0 or 1. - 3. cd19 positivity confirmed by flow cytometry and/or histopathology. exclusion criteria: 1. primary immunodeficiency. - 2. history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy. - 3. any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
study of the value of using a honey dressing compared to the use of a standard dressing on the toe amputation wound in the diabetic patient

Conditions: Diabete Mellitus; Amputation; Amputation Wound; Toe (Toes); Wound

Summary: numerous scientific publications in france and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey. honey is effective in the management of many infected or uninfected post-surgical wounds. this study focuses on post surgical wounds after toe amputation in diabetic patients. the main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french haute autorité de santé (has) recommendations


Eligibility criteria:
inclusion criteria: * diabetic patients * patients who have had an amputation of one or more toes within four days prior to inclusion without having the second dressing rehabilitated * written informed consent. exclusion criteria: * known hypersensitivity to honey, hyaluronic acid, guar gum, pectin and/or zinc oxide. * insipid diabètes * patient eligible for a dressing by vacuum assisted closure therapy (vac therapy) * transmetatarsal amputation * patient with sutured wound * patient already included in the study, for a previous amputation for wich the wound has not healed. * failure to comply with protocol requirements * person protect by article l1121-5 to l1121-8 of the french health public. * patient include in an other clinical study
mk-3475 and gemcitabine in non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a study for patients with previously-treated advanced non-small cell lung cancer (nsclc). the study will evaluate the safety of adding an investigational drug, mk-3475 to standard treatment with gemcitabine. the study will also try to identify the best dose of mk-3475 to give in combination with gemcitabine.

this study is an open-label, non-randomized phase i study, followed by open-label non-randomized phase ii study. the first cohort of patients will receive 200 milligrams (mg) of mk-3475 by intravenous infusion over a 21-day period called a cycle along with gemcitabine 1250 mg/m2 given on days 1 and 8 of each 21-day cycle for up to 6 cycles. patients will be seen in the study clinic 12 times over 126 days for an evaluation of signs and symptoms that may represent drug toxicity. patients may continue to receive mk-3475 (without gemcitabine) for up to 2 years.

Eligibility criteria:
inclusion criteria: * women or men with advanced, histologically proven nsclc. * patients must have received at least one but no more than three prior systemic therapies for advanced disease. * any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with anti-pd1 therapy or gemcitabine should be resolved to less than grade 1. * eastern cooperative oncology group (ecog) performance status 0 or 1. * women of childbearing potential must have a negative pregnancy test * ability to give informed consent and comply with the protocol. * anticipated survival minimum 3 months. * prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment. * patients must have normal organ and marrow function as seen on protocol-defined blood test results * archived tumor tissue (minimum of 8 slides for paraffin-embedded tumor tissue) available * measurable disease by recist 1.1 criteria. * treated brain metastases will be allowed, provided they are asymptomatic. * radiation for symptomatic lesions outside the central nervous system (cns) must have been completed at least 2 weeks prior to study enrollment. exclusion criteria: * prior therapy with any anti-pd-1, anti-pd-l1, or anti-ctla4 antibody. * prior therapy with gemcitabine. * prior complications from radiation, such as history of radiation pneumonitis or pulmonary edema that, in the opinion of the investigator, may have risk of increasing toxicity with anti-pd1 therapy. * active autoimmune disease except vitiligo or stable hypothyroidism. * active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, cardiopulmonary disease (copd), allergic rhinitis). * active other malignancy, except for controlled basal cell skin carcinoma. * hiv positive and/or hepatitis b or c positive. * other medical or psychiatric conditions that in the opinion of the principal investigator would preclude safe participation in this protocol.

Keywords: nsclc lung cancer gemzar pembrolizumab anti-pd-1 immunotherapy
sequential, multiple assignment, double randomized preference, migraine behavioral trial

Conditions: Migraine; Headache; Chronic Migraine; Headache Disorders

Summary: this study will unpack the behavioral intervention for migraine and determine the optimum combinations. in addition, the study will test preference and self-selection effects during the trial.

after a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms - * choice arm: allowed to choose from a menu of migraine behavioral treatment options * random: randomized to migraine behavioral treatment options. after 6 weeks, all participants will be assessed for their migraine frequency. patients will be considered responders if the migraine frequency is reduced to 50%. the non-responders (nr) of the choice arm will be again given a chance to pick any of the 3 arms. the nr of the randomized arm will be randomized to any of the 3 arms. the responders will continue for 6 more weeks in their original arms. by the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. all behavioral interventions will be delivered virtually.

Eligibility criteria:
inclusion criteria: * have chronic migraine for a minimum of 1-year * aged 18 years and older exclusion criteria: * secondary headache disorders * children younger than 18 years old

Keywords: migraine headache behavioral intervention
application of endoscopic scissors cutting enbd tube in the treatment of malignant hilar biliary strictures

Conditions: Endoscopic Retrograde Cholangiopancreatography; Klatskin Tumor

Summary: the purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.

the management unresectable malignant hilar biliary strictures is still very difficult in spite of the rapid development of new endoscopic devices.the application of stent (plastic or metallic) has allowed us to achieve successful drainage. however,there are many complications related to the placement of stents,such as cholangitis,high rate of re-intervention,and so on. the application of endoscopic cutting technique is considered to reduce these complication.

Eligibility criteria:
inclusion criteria: 1. patients age over 18 and able to tolerate ercp. 2. pathologically confirmed inoperable malignant hilar biliary strictures of bismuth type ii to iv. 3. no history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage. 4. no acute cholangitis before ercp. 5. informed consent. exclusion criteria: 1. the patient is very ill(septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment. 2. previous biliary drainage procedure. 3. inability to provide informed consent. 4. participating in other clinical trials.

Keywords: endoscopic retrograde cholangiopancreatography endoscopic drainage endoscopic nasobiliary drainage stent
evaluation of an information pamphlet for postpartum women that had a hypertensive pregnancy

Conditions: Hypertension, Pregnancy-Induced

Summary: it is known that preeclampsia is a risk factor for cardiovascular diseases, diabetes, chronic hypertension, nephropathy and thromboembolism. the study's aim, subsequent to these informations, is to help prevent those consequences. information tools have been known to enhance retention of information given orally. the objective of this study is to assess the knowledge and satisfaction of women after an episode of preeclampsia after reading an explanatory pamphlet on preeclampsia. the investigators also want to change their perception on cardiovascular risk, their risk of recurrence and preeclampsia's medium to long-term consequences and the ways to prevent them.

this is a randomised-controlled trial. women recruted will first answer a questionnaire assessing demographic data, knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected. then, women in the intervention group will receive the pamphlet. one month after, women in both groups will receive a questionnaire similar to the first one assessing knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected, including the pamphlet for the intervention group. the pamphlet was validated by a multidisciplany team including patients, doctors, nurses, education specialists and communication specialists. the questionnaire was also validated by the same multidisciplinary team. section on knowledge and anxiety were remodeled from previously validated questionnaires section on perception of cardiovascular risk was reproduced and translated with permission from its author. section on satisfaction was reproduced from the investigators' previous study where it was validated.

Eligibility criteria:
inclusion criteria: * 18 years and older * followed at the chus obstetrical clinic for a 4 weeks to 18 months postpartum follow up * had hypertension in her last pregnancy exclusion criteria: * not able to read and write in french.

Keywords: preeclampsia information pamphlet patient education
assessing the integration of tobacco cessation treatment into lung cancer screening (lcs)

Conditions: Smoking, Tobacco

Summary: this randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose ct (ldct) lung cancer screening. using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (nrt) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources.

evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. nicotine patch is an fda-approved cessation aid. the optimal duration of counseling and pharmacotherapy for patients undergoing low-dose ct (ldct) lung screening is not clear. in addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. this randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine ct lung cancer screening. patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.

Eligibility criteria:
inclusion criteria: * scheduled to undergo ldct-lcs at a participating mass general brigham health care system lcs site * speak english or spanish. * current smokers: smoked a cigarette, even a puff, in the last 30 days. * medicare coverage requirement (age 50-80 years, 20+ pack/years). * residing within the usa. exclusion criteria: * undergoing lung ct as part of a diagnostic or abnormal follow-up evaluation. * unable to give informed consent due to psychiatric or cognitive impairment as determined in consultation with study pi or treating clinician. * no access to a telephone or cannot communicate by telephone.

Keywords: lung screening
gene therapy for ada-scid

Conditions: Severe Combined Immunodeficiency Syndrome

Summary: this study investigated the safety and efficacy of different gene therapy approaches for severe combined immunodeficiency (scid) caused by the deficiency of adenosine deaminase (ada) enzyme. this is a severe condition that can be cured by hla-matched sibling donor bone marrow transplantation. patients were enrolled if no hla-identical sibling donor was available and the patient showed evidence of failure of enzyme replacement therapy or this treatment was not a long-term available option. the aim of the study was to evaluate the safety and efficacy of the procedure and to identify the relative role of peripheral blood lymphocytes and hematopoietic stem cells and progenitor cells in the long-term reconstitution of immune functions after retroviral vector mediated ada gene transfer.

this is mono-centric, non-randomized, non-controlled, open label, phase i-ii trial that evaluated the safety and efficacy of ada gene transfer into somatic cells for the treatment of ada-scid

Eligibility criteria:
inclusion criteria: * lack of hla-identical sibling donor and * evidence of failure of the enzyme replacement treatment after \>6 months or * peg-ada is not available as a life long option exclusion criteria: * hla identical bone marrow sibling donor * hiv infection * malignancy

Keywords: adenosine deaminase scid gene therapy retroviral vector