Kornimate/medical-research-clean huggingface dataset:
a study of atezolizumab in combination with carboplatin plus (+) paclitaxel with or without bevacizumab compared with carboplatin+paclitaxel+bevacizumab in participants with stage iv non-squamous non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[pd-l1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with stage iv non-squamous nsclc. participants were randomized in a 1:1:1 ratio to arm a (atezolizumab+carboplatin+paclitaxel), arm b (atezolizumab+carboplatin+paclitaxel+bevacizumab), or arm c (carboplatin+paclitaxel+bevacizumab).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group performance status 0 or 1 * histologically or cytologically confirmed, stage iv non-squamous nsclc * participants with no prior treatment for stage iv non-squamous nsclc * known pd-l1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a 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
ascent intervention for brain tumor patients

Conditions: Malignant Brain Tumor; Glioma; Coping Skills; Distress, Emotional

Summary: the goal of this study is to test a psychosocial intervention called ascent (act-based supportive intervention for patients with central nervous system tumors). this intervention was developed to help patients after being diagnosed with a brain tumor. the main question this study aims to answer is whether this intervention is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. participants will be asked to take part in 6 coaching sessions and complete short surveys at four different time points. some participants will be asked to share feedback via interviews.

this study will examine the feasibility and acceptability of a novel, population-specific intervention designed to help patients with newly diagnosed malignant brain tumors cope with their illness. in this project, following refinement of the intervention based on stakeholder interviews and an open pilot, the investigators will evaluate the feasibility and acceptability of ascent intervention versus usual care in a pilot randomized controlled trial (n=100). the investigators will also estimate preliminary effects of ascent on psychological and behavioral outcomes.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * massachusetts general hospital cancer center patient * within 6 months of diagnosis of malignant primary central nervous system (cns) tumor * english speaking exclusion criteria: * inability to provide informed consent as assessed by the study team (e.g., due to severe cognitive impairment/dementia) * moderate to severe receptive aphasia (quick aphasia battery sentence comprehension subscale \< 8) * current or imminent hospice enrollment

Keywords: glioma supportive care brain tumor psychological distress support
microbial profiling in pockets related to chronic periodontitis patients using 16s rna metagenomics sequencing

Conditions: Periodontal Diseases

Summary: the study was developed in compliance with the helsinki declaration on medical research involving the ethics committee at ajman university (2017-a-dn-04). informed consent from all the participants was obtained before participation in the study. the participants were systemically healthy with no history of antibiotics for the past three months. patients recruited for the study were diagnosed as stage ii generalized periodontitis according to the classification from the 2017 world workshop on the "classification of periodontal and peri-implant disease and conditions". periodontal status indicating the severity of interdental clinical attachment loss of 3-4mm, radiographic bone loss between 15%-33% and with no tooth loss were included. the complexity of periodontitis with a maximum probing depth of ≤ 5mm with horizontal bone loss and having an extent and distribution with \>30% teeth involved were included in the study. a total of 80 plaque samples were collected with the clinical characteristics of the patient comprising of age between 25-39 years, 36 females and 44 males. the subgingival plaque was collected using a sterile curette from the buccal aspect of maxillary molars and lingual aspect of mandibular incisors, in a vial containing 200µl of buffer cl.

the collected plaque samples were then freshly prepared for the dna isolation using abiopure tm total dna (version 2.0) (cat no: m501dp100) according to the manufacturer's instruction. all the samples were assessed for dna quantification using spectrophotometry and further quantified using the fluorometric method. this was performed using denovix ds-11 fx (denovix). further to the dna quantification, assessment of dna integrity was resolved on a 0.8% agarose gel with ethidium bromide. for ngs library preparation, all the samples underwent pcr amplification of the 16s rrna gene in the isolated bacterial dna. the primers used had targeted in the v3-v4 region of the 16s rrna gene. the full length primer sequences, using standard iupac nucleotide nomenclature, to follow the protocol targeting this region are: 16sampliconpcrforwardprimer=5' tcgtcggcagcgtcagatgtgtataagagacagcctacgggnggcwgcag 16sampliconpcrreverseprimer=5' gtctcgtgggctcggagatgtgtataagagacaggactachvgggtatctaatcc gel electrophoresis method was used for the size selection and the bioinformatics pipeline used for processing microbiome 16s sequence data was qiime

Eligibility criteria:
inclusion criteria: * patients recruited for the study were diagnosed as stage ii generalized periodontitis * medically fit exclusion criteria: * patients having gingivitis or stage iii periodontitis * medically unfit

Keywords: metagenomics 16s periodontitis, adult
carbon dioxide-laser versus harmonic scalpel in the treatment of pelvic pain due to endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to compare laser co2 ablation/excision of endometriosis (afs stages 1-3) with excision of endometriosis using the ethicon harmonic ace device. pain scores at 6 months was the primary outcome, but secondary outcomes assessed pain scores at 1, 3 and 5 years as well as psychological state and quality of life.


Eligibility criteria:
inclusion criteria: * endometriosis grade i-iii by revised american fertility society scoring * patients in whom laser treatment to the endometriosis is considered the treatment of choice. * patients having consented to participated in the trial * patient is 18 years old or greater * patients who have no contraindications to either of the treatment modalities proposed exclusion criteria: * patients who do not wish to participate/have not signed the informed consent form * pregnancy of breast feeding * patients who are unable or unwilling to discontinue hormonal treatment for 6 months * patients who have received additional treatment for their endometriosis within 6 months of surgery * patients with documented painful conditions of the gastrointestinal or urinary system

Keywords: endometriosis co2 laser vapourisation harmonic scalpel afs stage i-iii
sensory processing in subjects with painful bladder syndrome

Conditions: Painful Bladder Syndrome

Summary: the purpose of this study is to determine if clinically relevant subsets exist in patients meeting the diagnosis of painful bladder syndrome (pbs). subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to pbs.

patients with the diagnosis of painful bladder syndrome (pbs) constitute two or more phenotypes that are distinguished by differential neurophysiological processing of sensory information. further, these differing phenotypes can be predicted by the presence or absence of the co-morbidity fibromyalgia.

Eligibility criteria:
inclusion criteria: * niddk criteria for painful bladder syndrome * age 19 years or older * must be able to read and speak english since testing materials are validated in english exclusion criteria: * pbs subjects must be independent of co-existing pain disorders or use of medications * uncontrolled hypertension or significant cardiopulmonary disease * no chronic daily pain * older than 75 years of age

Keywords: painful bladder syndrome urinary bladder
magnetic resonance spectroscopy biomarkers in type 3 gaucher disease (gd3)

Conditions: Gaucher Disease, Type 3

Summary: recent studies have has shown that magnetic resonance spectroscopy (mrs) can provide validated neuronal markers in patients with type 1 gd (gd1) who are on stable therapy. however, alterations in neurometabolites in adult patients with gd3, who have established neurological involvement, are not well understood. the goal of this study is to characterize neurometabolite profiles in adult patients with gd3 using mrs to identify novel biomarkers that can demonstrate treatment response. additionally, a secondary aim is to evaluate relationships between neurometabolites and disease parameters, such as genotype, enzyme levels and gaucher disease (gd) biomarkers.


Eligibility criteria:
inclusion criteria: * all participants must be 18 years or older. * all enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent. * individuals with gd3 who are medically stable for participation in study in the opinion of the investigator. exclusion criteria: * medically unstable conditions as determined by the investigators. * concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study. * women who are pregnant or lactating or of child-bearing age that are not using acceptable forms of contraception. * patients enrolled in another interventional study. * patients who cannot or are unwilling to have blood drawn. * inability to undergo magnetic resonance imaging (mri) scanning, including but not limited to unable to remain still in an mri scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs. * unable to adhere to study protocol for whatever reason.
chronic hepatitis intervention project for drug users

Conditions: HIV; Hepatitis C

Summary: the purpose of this study is to determine if a 6-session motivational interviewing intervention is more effective than a 6-session educational intervention at reducing behaviors that may lead to infection, transmission, and progression of hiv and hepatitis c among out of treatment injecting drug users.

this 4.5-year community-based study is a randomized field experiment that uses a two-group design. participants are randomized into either an educational intervention group or a motivational intervention group. we are comparing the effectiveness of the motivational intervention with the educational intervention. we are also estimating the costs and evaluating the cost-effectiveness of the motivational intervention relative to the educational intervention. we have the following aims and related hypotheses: aim 1: to compare the effectiveness of a 6-session personalized motivational intervention to a 6-session educational intervention in terms of injection risk, sexual behavior, alcohol use, and knowledge and perception related to hbv and hcv; h1. relative to the educational intervention group, a greater proportion of the motivational intervention group will report no injection risk at 6- and 12-month follow-up interviews. no injection risk is operationally defined as either no injections in the past 30 days, or no direct or indirect sharing of syringes and other injection equipment in the past 30 days. h2. relative to the educational intervention group, a greater proportion of the motivational intervention group will report no sexual risk at 6- and 12-month follow-up interviews. no sexual risk is operationally defined as either no sex (oral, vaginal, or anal) in the past 30 days, or no unprotected oral, vaginal, or anal sex in the past 30 days. h3. relative to the educational intervention group, the motivational intervention group will report greater decreases in frequency of alcohol consumption and quantity of alcohol consumed. frequency of alcohol consumption is defined as "number of days drank alcohol in the past 30 days," and quantity of alcohol consumed is defined as "the average number of drinks per drinking day during the past 30 days." h4. relative to the educational intervention group, participants in the motivational intervention group will report greater increases in knowledge and more accurate perceptions of severity of disease and efficacy of protective actions regarding hepatitis b and c at session 3. aim 2: to estimate the cost and cost-effectiveness of a 6-session personalized motivational intervention relative to a 6-session educational intervention. h5. the motivational intervention will cost more than the educational intervention, but will be cost-effective at eliminating injection risk behavior and sexual risk behavior and at reducing alcohol use

Eligibility criteria:
inclusion criteria: * minimum age of 18 years injected illicit drugs within last 30 days exclusion criteria: * participated in formal substance treatment in last 30 days
study of obeldesivir in participants with covid-19 who have a high risk of developing serious or severe illness

Conditions: COVID-19

Summary: the goal of this clinical study is to test how well the study drug, obeldesivir (gs-5245), works and how safe it is in treating coronavirus disease 2019 (covid-19) in participants that have a higher risk of getting a serious illness.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent. * severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection confirmed by pcr or an approved alternative assay (eg. rapid antigen test) ≤ 5 days before randomization. serologic tests will not be accepted. * initial onset of covid-19 signs/symptoms ≤ 5 days before randomization. * not currently hospitalized or requiring hospitalization. * presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease. key exclusion criteria: * anticipated use of covid-19 therapies during the current covid-19 illness. * received any direct acting antiviral drug against sars-cov-2 for the treatment of covid-19 \< 28 days or \< 5 half-lives, whichever is longer, before randomization. * anticipated need for hospitalization \< 48 hours after randomization. * new oxygen requirement \< 24 hours before randomization. * decompensated cirrhosis (child-pugh class b or c) or acute liver injury/failure. * undergoing dialysis, or history of moderate to severe renal impairment. * pregnant or breastfeeding (nursing). * unwilling to use protocol-mandated birth control. * received an approved, authorized or investigational covid-19 vaccine (including booster dose) \<120 days before randomization. note: other protocol defined inclusion/exclusion criteria may apply.
acei/arb alone versus acei/arb plus steroids in the treatment of primary iga nephropathy, a rct

Conditions: Glomerulonephritis, IGA

Summary: iga nephropathy( igan) is the most common primary glomerulonephritis worldwide. since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for igan. both acei/arb and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. however, there is no evidence from rct on the question of whether combined use of steroid with acei/arb can bring more benefit to igan patients than acei/arb alone. we therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of acei/arb plus steroid compared with acei/arb alone in the treatment of patients with igan.

iga nephropathy( igan) is the most common primary glomerulonephritis worldwide. since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for igan. in the many studies on the treatment of igan, both acei/arb and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects, and acei/arb was considered to be the first line therapy. however, there is no evidence from rct on the question of whether combined use of steroid with acei/arb can bring more benefit to igan patients than acei/arb alone. we therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of acei/arb plus steroid compared with acei/arb alone in the treatment of patients with igan.

Eligibility criteria:
inclusion criteria: 1. underwent renal biopsy within 1 year before start fo trial; 2. 24 hour urinary protein excretion ranged between 1 to 7 g/d; 3. egfr, evaluated by mdrd formula, should be higher than 30 ml/min exclusion criteria: 1. crescentic glomerulonephritis; 2. steroid therapy subjected within 1 year before trial; 3. malignant hypertension(dbp\> 130 mmhg and/or sbp\> 220mmhg), resistant to anti-hypertensive agents; 4. urinary protein excretion decrease below 1 g/l after run-in period; 5. myocardial infarction or cerebrovascular accident in 6 months preceding the trial; 6. renovascular disease; 7. diabetes mellitus; 8. malignancy, severe liver disease, refractory infection; 9. peptic ulcer in active disease phase; 10. pregnancy; 11. other contraindication to the use of acei/ arb or corticosteroid; 12. alcohol abuse or drug addiction
identifying therapeutic factors in an 8-week (30 hour) mindfulness-based stress reduction (mbsr) program

Conditions: Cancer; Diabetes; Hypertension

Summary: since it's introduction in 1979 at the university of massachusetts medical center by dr. jon kabat-zinn, mindfulness-based stress reduction (mbsr) has become a respected adjunct to conventional treatment for patients suffering from many diverse chronic ailments. three decades of research have documented it's benefits, but few papers have focused on identifying which particular aspect of mbsr directly correlates with it's degree of therapeutic efficacy. this study will use 7 well validated questionnaires to compare participants responses prior to, and following completion of an eight-week mbsr program at the north york general hospital, as well as follow-up results at 1 month and 1 year post completion of the mbsr group.

as above

Eligibility criteria:
inclusion criteria: * over 18 years old * suffer from a chronic health problem * referred by their physician exclusion criteria: * acute illness (physical or psychiatric) * suicidal * problem use of alcohol or other substances * inability to do one hour of daily homework * inability to attend all 8 sessions

Keywords: mindfulness pain disorder (chronic physical or mental health complaints: fibromyalgia; migraines; back pain; etc) anxiety disorder/anxiety state
trial of vitamins in hiv progression and transmission

Conditions: HIV Infections; Disease Transmission, Vertical

Summary: this study tested the hypothesis that multivitamin supplementation given to hiv+ pregnant women in tanzania would slow disease progression and enhance their overall health.

in this study, we sought to examine whether the administration of multivitamins excluding vitamin a, multivitamins including vitamin a, or vitamin a alone would reduce the risk of perinatal transmission of hiv and slow the rate of disease progression in a group of pregnant hiv infected women. we also examined the efficacy of the supplements on pregnancy outcomes, and risks of maternal and child morbidity and wasting.

Eligibility criteria:
inclusion criteria: * hiv-infected women presenting to antenatal care between 12 and 27 weeks of gestation: exclusion criteria: -

Keywords: hiv multivitamins pregnancy outcomes tanzania women
endodrill vs. conventional biopsy. evaluation of diagnostic capacity in diffuse gastric cancer

Conditions: Stomach Neoplasms

Summary: endodrill is a new instrument for biopsy sampling in the gi-channel. the purpose of this study is as follows: * compare the endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis of diffuse gastric cancer based on collected biopsies from tumor tissue.

endodrill is a newly constructed biopsy tool for flexible endoscopic use. it uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. it was originally designed for sampling of tissue from submucosal lesions. the investigators´ first study of the instrument is now finished. endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps. in this study, the investigators want to compare the endodrill instrument´s ability to obtain representative tissue samples from a group of patients diagnosed with or suspected diffuse gastric cancer. 20 patients will be enrolled for this study. for each patient the investigators will collect 8 biopsies, 4 biopsies each with conventional biopsy and the endodrill instrument respectively. the order will be randomized for each patient. for each specific biopsy the investigator will choose a particular site on the suspected tumor tissue without knowing which instrument that will be used for the biopsy. this procedure will be repeated for all 8 biopsies.

Eligibility criteria:
inclusion criteria: * patients with suspected or with an established diagnosis of diffuse gastric cancer who are capable of stating a formal consent to participate in the study. exclusion criteria: * mental illness * extreme co-morbidity (asa\>3)

Keywords: diagnostics biopsy diffuse gastric cancer