Kornimate/medical-research-clean huggingface dataset:
a study of atezolizumab in combination with carboplatin plus (+) nab-paclitaxel compared with carboplatin+nab-paclitaxel in participants with stage iv non-squamous non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Squamous Non-Small Cell Lung

Summary: this randomized phase iii, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[pd-l1\] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with stage iv non-squamous nsclc. participants were randomized in a 2:1 ratio to arm a (atezolizumab+nab-paclitaxel+carboplatin) or arm b (nab-paclitaxel+carboplatin).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group performance status of 0 or 1 * histologically or cytologically confirmed, stage iv non-squamous nsclc * participants with no prior treatment for stage iv non-squamous nsclc * previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening * measurable disease, as defined by recist v1.1 * adequate hematologic and end organ function exclusion criteria: cancer-specific exclusions: * active or untreated central nervous system metastases * malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome general medical exclusions: * pregnant or lactating women * history of autoimmune disease * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted * positive test for human immunodeficiency virus * active hepatitis b or hepatitis c * severe infection within 4 weeks prior to randomization * significant cardiovascular disease * illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures exclusion criteria related to medications: * prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-pd-l1 therapeutic antibodies
clinical prediction rule score in veterans

Conditions: Gout

Summary: we will study whether the health care costs and health utilities differ in patients with gout and those without gout and whether they differ between those with more severe versus less severe gout

the purpose of this project is to study the out-patient and inpatient utilization and costs associated with tophaceous gout (a classic form of treatment-failure gout), compare these costs to patients with non-tophaceous gout and evaluate health utilities associated with these gout states. the analyses will be conducted in a manner to support a burden of illness type of presentation / manuscript. study questions 1. what are the va health care costs (inpatient and outpatient) for patients with gout compared to those without gout? 2. does health utility, as calculated by sf-6d, differ in patients with gout compared to patients without gout and between tophaceous and non-tophaceous gout? 3. what are the relationships between costs and health utility? 4. how does the burden of illness differ by subgroups of gout patients (costs and utilities)? 5. what are the va health care costs for patients with tophaceous gout and are they higher than patients with non-tophaceous gout? inclusion criteria patients with and without gout from the veterans database described above will be included in the analyses for study aims 1 and 5. this is approximately 3000 gout patients and 67,000 non-gout patients patients with sf-36 data from the above cohort will be included in the analyses for study aims 2-4. this is approximately 1500 gout patients and 38,000 non-gout patients

Eligibility criteria:
inclusion criteria: * participated in the survey * have sf-36 adn utilization data exclusion criteria: * absence of utilization and/or cost data

Keywords: gout cost utilization
a phase 1 study evaluating the safety of trk-950 in patients with advanced solid tumors

Conditions: Locally Advanced or Metastatic Solid Carcinomas; Colon Cancer; Cholangiocarcinoma

Summary: 1. to determine the maximum tolerated dose (mtd) and the dose limiting toxicities (dlts) of trk-950 as single agent 2. to establish the dose of trk-950 recommended for future phase 2 studies

this study is a first-in-human study of trk-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (dlt) and maximum tolerated dose (mtd) of trk-950 administered via intravenous (iv) infusion once weekly for 3 weeks every 28 days in arm 1. once enrollment in arm 1 was completed, two dose schedules will be evaluated in arm 2 to determine the dosing schedule. up to six (6) patients will be enrolled respectively. in parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in arm 3.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed locally advanced or metastatic solid carcinomas in arm 1 * patients with histologically confirmed locally advanced or metastatic colon cancer in arm 2 * patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in arm 3 * tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment * measurable disease per recist 1.1 (primary or metastases) exclusion criteria: * new york heart association class iii or iv, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ecg * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * pregnant or nursing women * treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry * unwillingness or inability to comply with procedures required in this protocol * known active infection with hiv, hepatitis b, hepatitis c * symptomatic brain metastases * serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor * patients who are currently receiving any other investigational agent
echocardiographic measurement of myocardial work

Conditions: Cardiovascular Physiological Phenomena; Intensive Care Unit Syndrome

Summary: echocardiography is recommended for the hemodynamic management of patients with shock. recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (gwi), constructive myocardial work (gcw), lost myocardial work (gww) and effective myocardial work (gwe). echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. to date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit.


Eligibility criteria:
inclusion criteria: * indication to fluid administration left to the discretion of the attending physician * indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician. exclusion criteria: * patients under protection. * patients with do not ressuscitate order. * patients with severe left-side or right-side valvulopathy. * patients with atrial fibrillation. * patients with ventricular aneuvrysm or severe regional wall motion abnormalities. * patients with a pacemaker. * patients' objections to the collection of their health data.
first-line and neoadjuvant immunotherapy for gastric cancer

Conditions: Advanced Gastric Cancer; Locally Advanced Gastric Carcinoma

Summary: this prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes


Eligibility criteria:
inclusion criteria: 1. age 18 years old or above 2. patients with advanced gastric cancer or locally advanced gastric cancer 3. have not received any previous anti-tumor therapy 4. patients expected to receive immunotherapy for first-line or neoadjuvant therapy 5. eastern cooperative oncology group (ecog) performance status of 0-1 6. adequate organ function exclusion criteria: 1. patients with contraindications to immunotherapy 2. have received anti-tumor treatments such as immunotherapy and chemotherapy 3. have a history of active immune deficiency or autoimmune diseases, including hiv positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases 4. severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment 5. history of allogeneic stem cell transplantation or organ transplantation
an effectiveness and safety study of concerta* vs. immediate release methylphenidate (ir mph) in attention deficit hyperactivity disorder children

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to determine the effectiveness and safety of oros\*methylphenidate/concerta\* vs. immediate release methylphenidate as a treatment for adhd specifically for those children who have behavioural difficulties in the afternoon/after-school and evening periods.

methylphenidate, namely immediate release methylphenidate is the primary stimulant used in the treatment of children with attention deficit hyperactivity disorder (adhd). immediate release methylphenidate has limitations related to its time course of action.as the morning dose wears off, inattention may increase during late-morning classes. similarly, when the midday dose is wearing off, the child may experience difficulty concentrating on homework. the second problem relates to compliance with midday and late afternoon dosing. children feel stigmatized or embarrassed by trips to the nurse's office for medication and may skip doses as a result. in other cases, a school nurse may not be available or policies prohibit staff from administering drugs so children may be required to self-administer drug. concerta® was developed to overcome these limitations. the purpose of this study is to see how effective and safe concerta\* is vs. immediate release methylphenidate in children with adhd. patients will take either concerta\* (18, 27, 36, or 54 mg) or immediate release methylphenidate tablets (maximum 60mg/day) orally every morning for 8 weeks.

Eligibility criteria:
inclusion criteria: * patients must be between 6 and 12 years of age inclusive, have a diagnosis of attention deficit hyperactivity disorder (adhd) as defined by the dsm-iv established through clinical interview by the investigator and corroborated by the snap-iv parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired * eligible patients will be evaluated after a minimum 3 day washout period without adhd medication * in addition, patients must also have a cgi-severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible * patients could have had no prior treatment for adhd or are presently taking something or could have had adhd medication treatment in the past exclusion criteria: * no patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of tourette's disorder, or a family history of tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing * no patient with inability to swallow the medication whole, those with any unstable medical illness were excluded

Keywords: attention deficit hyperactivity disorder oros* methylphenidate
a study of gene therapy for classic congenital adrenal hyperplasia (cah)

Conditions: Congenital Adrenal Hyperplasia

Summary: this study is designed to evaluate the safety, tolerability, and efficacy of aav5 based bbp-631 in adult participants diagnosed with classic congenital adrenal hyperplasia.

participants will receive a single dose of aav5 based intravenous (iv) bbp-631 and will be followed for safety and efficacy for at least 5 years after the date of treatment with bbp-631.

Eligibility criteria:
key inclusion criteria 1. adult male and non-pregnant females with classic cah (simple virilizing or salt-wasting) due to 21-ohd 2. screening/baseline 17-ohp levels \> 5-10 × uln and \< 40 × uln (upper limit of normal) 3. stable oral hydrocortisone (hc) regimen as the only glucocorticoid (gc) maintenance therapy 4. naïve to prior gene therapy or aav-mediated therapy key exclusion criteria 1. positive for anti-aav5 (adeno-associated virus type 5) antibodies 2. history of adrenalectomy and/or significant liver disease

Keywords: cah gene therapy aav aav5
duopact pilot intervention

Conditions: HIV/AIDS

Summary: the investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) duopact, the newly-developed couples intervention; 2) life steps, a standardized antiretroviral adherence intervention for hiv+ individuals; and 3) a treatment as usual (tau) assessment-only control condition. after randomization, intervention sessions will be delivered weekly (6 duopact sessions, or 3 life steps sessions). all couples will be assessed pre/post intervention to evaluate intervention acceptability and feasibility.


Eligibility criteria:
inclusion criteria: 1. gay male couple. 2. one or both partners must be hiv positive and on antiretroviral medications. exclusion criteria: must be able to consent to and follow study protocol.
diagnosis and comprehensive treatment of mediastinal interventional technique

Conditions: Mediastinal Diseases

Summary: the goal of this observational study is to learn abou whether patients undergoing mediastinal disease diagnosis and combined treatment with intrapacial ultrasound-guided mediastinal opening techniques have greater clinical benefit. the participants were physically ill. the main questions it aims to answer are: * whether the mediastinal ultrasound-guided mediastinal opening technique is more beneficial for the diagnosis of benign or malignant mediastinal diseases. * does the mediastinal ultrasound-guided mediastinal opening technique benefit the patient by ablating mediastinal masses using freezing, laser, or other means. mediastinal diseases were diagnosed by lymph node biopsy combined with ngs, rose and other techniques using transairway ultrasound-guided mediastinal opening technique. ablation of mediastinal malignancies is performed using techniques such as freezing or laser. researchers will compare the experimental group with mediastinal opening and the control group without mediastinal opening to see if mediastinal open technique benefits patients.


Eligibility criteria:
inclusion criteria: * radiographic abnormalities of mediastinum * can tolerate general anesthesia * can tolerate bronchoscopy and has the condition to have mediastinal biopsy and treatment exclusion criteria: * imaging or other tests can make a definitive diagnosis * cannot tolerate general anesthesia or tracheoscopic surgery * patients cannot sign informed consent forms
retrospective study of carotid surgery in dijon

Conditions: Carotid Stenosis

Summary: the results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons. the indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices. it would be of great use to have the statistics obtained in previous years to continue improving our practices.


Eligibility criteria:
inclusion criteria: all patients operated for carotid stenosis at dijon university hospital exclusion criteria: none
effects of different remineralization agents on molar incisor hypomineralization defects: a randomized clinical study

Conditions: Molar Incisor Hypomineralization

Summary: the aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( flúor protector), clinpro™ white varnish and pastes containing cpp-acp in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with molar incisor hypomineralization (mih) in schoolchildren 6-12 years-old in mexico.

the study included 208 teeth with yellow-brown or creamy-white defects in children aged 6-12 years who were newly diagnosed with mih with no substance loss or caries or prior restorative treatment. the children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white varnish and pastes containing cpp-acp and followed up for 24 months. the evaluations will be made based on the icdas criteria and the measurements which were performed using the laser fluorescence method (diagnodent, kavo, biberach, germany) in the follow-ups.

Eligibility criteria:
inclusion criteria: * children between 6 to 12 years * they live in the selected study area * have at least one permanent incisor or molar with mild or moderate mih (creamy white and/or yellow or brown opacities) * that their parents authorize participation in the study through informed consent. * no proven or suspected allergy and/or sensitivity to milk protein, as it is a component of the cpp-acp product. exclusion criteria: * defects in enamel development related to syndromes, dental fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta. * presence of orthodontic appliances. * teeth with mih with restorations, or severe mih (affected enamel develops post-eruptive enamel breakdown), or carious lesions classified as score \>0 according to the icdas. * children who do not show cooperation in the use of remineralizing agents.

Keywords: molar incisor hypomineralization
use of benzodiazepines and z drugs in the elderly

Conditions: Chronic Benzodiazepines and Related Drugs Users

Summary: the aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in france using a questionnaire assessing substance dependence according to dsm-iv (diagnostic and statistical manual of mental disorders) international standards.

1100 patients will be recruited by pharmacists. they will answer to a standardized questionnaire assessing their benzodiazepines or related drugs usage (phone contact). pharmacists are recruited by all french centers for evaluation and information on pharmacodependence (ceip).

Eligibility criteria:
inclusion criteria: * 65 years old or more, * benzodiazepines or benzodiazepines related drugs treatment for at least three months, * written consent and without exclusion criteria. exclusion criteria: * no written consent form * difficulties to understand or speak french

Keywords: ceip pharmacodependance addictovigilance benzodiazepines and benzodiazepines related drugs elderly
abdominal functional electrical stimulation to improve bowel function in spinal cord injury

Conditions: Spinal Cord Injuries; Neurogenic Bowel

Summary: the primary objective of this study is to gather information about the effectiveness of abdominal fes to improve bowel management time (bmt) for people with chronic sci. this study will also evaluate whether abdominal fes can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. in addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device.


Eligibility criteria:
inclusion criteria: 1. chronic sci (\> 12 months since injury) above the level of t11 2. \> 18 years of age 3. a measurable and consistent start and end event is determinable for the bowel routine * start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team. * ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team. 4. portable smart device with video capabilities and internet access 5. willingness to access and/or download zoom (videoconferencing software) exclusion criteria: 1. american spinal injuries association (asia) impairment scale (ais) e 2. self-reported bowel management time (bmt) of \<30 minutes 3. current bowel conditions such as gastro-esophageal reflux, bowel obstruction, crohn's disease, or diverticulitis 4. physical obstacles that prevent afes (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices) 5. stoma or colostomy 6. no response to afes (e.g., lower motor neuron impairment) 7. history of gastrointestinal surgery within the past 3 months 8. severely obese participants (\>40 bmi) 9. primary language other than english 10. previous history of uncontrolled, recurrent episodes of ad 11. resting systolic blood pressure (bp) reported as \>140 mmhg

Keywords: spinal cord injury functional electrical stimulation (fes) neurogenic bowel
evaluation of study experiences of neuroendocrine tumor patients

Conditions: Neuroendocrine Tumors

Summary: taking part in clinical trials usually favors a particular demographic group. but there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. this research will admit a wide range of data on the clinical study experience of neuroendocrine tumor patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with neuroendocrine tumor.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * diagnosis of neuroendocrine tumor * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * enrolled in another research study * patients with psychiatric illness/social situations that would limit compliance with study requirements * pregnant or lactating woman

Keywords: neuroendocrine tumor