Kornimate/medical-research-clean huggingface dataset:
brain healthy soul food diet intervention among older african americans

Conditions: Cardiovascular Diseases; Cognitive Decline

Summary: the primary goal of this project is to evaluate feasibility and acceptability of the mind+soul diet and its implementation. secondary goals of this project are to evaluate cardiovascular risk profile, nutritional health status, and cognition in relation to the mind+soul diet intervention.

this is a single arm trial designed to pilot test an adapted brain healthy diet intervention among older aa (n=30). specifically, this study aims to evaluate the feasibility and acceptability of the brain healthy soul food diet intervention. as secondary outcomes, this study aims to assess body composition, cardiovascular risk, nutritional health status, and changes in cognition among older aa to form the basis of estimating power and sample size for a future full-scale randomized controlled clinical trial.

Eligibility criteria:
inclusion criteria: * identify as african american or black * age 55 and older * english proficient * 1 or more of the following cvd risk factors (high blood pressure, high cholesterol, overweight/obesity with a bmi of 25 or more) * cognitively normal with an ad8 \<2 (normal cognition) exclusion criteria: * no cvd risk factors * ad8 equal to or greater than 2 * existing diet plan prescribed by a clinician * non menopausal (because of dxa scan) * no internet connection * uncontrolled hypertension, by history, or as indicated by supine systolic blood pressure \>165 mmhg or diastolic blood pressure \>95 mmhg at the baseline visit. if an initial blood pressure reading is higher than this, an additional attempt (at this visit or on another day) could be used before excluding a patient for uncontrolled hypertension * neurological diseases that impact cognition * other medical conditions likely to be negatively impacted by a diet change or that could confound the study data * unable or unwilling to provide written consent * pi determination that study is unsafe or unsuitable * active depression as determined by a score of 5 or above on the phq9 and deemed to be clinically significant by the medical monitor
a study to assess the pharmacokinetics of pxl770 after 4 weeks of treatment in subjects with nafld

Conditions: Nonalcoholic Fatty Liver

Summary: this study will assess the pharmacokinetics of pxl770 after 4 weeks of treatment.

the study will be performed in subjects with nonalcoholic fatty liver disease. the primary endpoint will be the assessment of pxl770 exposure in plasma.

Eligibility criteria:
inclusion criteria: * subjects have given written informed consent * body mass index (bmi): ≥ 25 kg/m² * hepatic steatosis (cap ≥ 300) * insulin-resistant but not diabetic subjects * fasting plasma glucose \<126 mg/dl * glomerular filtration rate (egfr) ≥ 60 ml/\[min\*1.73 m²\] * alanine amino transferase (alt) \> 20 iu/l in females and \> 30 iu/l in males * effective contraception exclusion criteria: * evidence of another form of liver disease * evidence of liver cirrhosis * evidence of hepatic impairment * positive serologic evidence of current infectious liver disease * history of excessive alcohol intake * acute cardiovascular disease with 24 weeks prior to screening * uncontrolled high blood pressure * any disease which in the investigator's opinion which in the investigator's opinion would exclude the patient from the study * use of non-permitted concomitant medication * pregnancy or lactation
safety, tolerability, pharmacokinetics (pk) and preliminary efficacy of tor kinase inhibitor in liver cancer patients

Conditions: Cancer; Advanced Hepatocellular Carcinoma

Summary: the main purpose of the study is to establish a safe dose of azd8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and collecting data about how hepatocellular carcinoma responds to the drug.


Eligibility criteria:
inclusion criteria: * advanced stage hepatocellular carcinoma (hcc) confirmed by cytology or histology * advanced stage hepatocellular carcinoma (hcc) or metastatic hepatocellular carcinoma (hcc) which is inoperable and incurable with standard available treatments * relatively good overall health other than cancer (who performance status (0-2) exclusion criteria: * patients with severe heart conditions, or those who have had heart surgery such as coronary artery bypass graft within the last 6 months, or patients with uncontrolled high blood pressure despite medical management. * patients must not have received any other anti cancer therapy including tace within 21 days of entering the trial * patients must not have received a liver transplant.

Keywords: mtor kinase inhibitor phase i/ii dose escalation hepatocellular carcinoma (hcc) asia hcc safety and pharmacokinetics
identifying cancer genes in in blood and bone marrow samples from patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and identify genes related to cancer. it may also help doctors diagnose cancer and predict how patients will respond to treatment. purpose: this research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.

objectives: * to identify and validate individual genes for diagnosis of three major translocations in acute myeloid leukemia. * to correlate transcript expression data in the various translocations with age, sex, race, response to treatment, and survival and with other known mutations. outline: blood and/or bone marrow samples previously procured from patients on calgb-9665 are obtained from the calgb leukemia tissue bank from patients enrolled on calgb aml treatment studies. mononuclear cells are isolated from samples and mrna is extracted. gene expression profiles are analyzed via custom mrna microarray and confirmed by quantitative real-time pcr.

Eligibility criteria:
* enrolled on calgb acute myeloid leukemia (aml) treatment studies and concurrently enrolled on leukemia tissue bank protocol calgb-9665 * short-term or long-term survivor * bone marrow and/or peripheral blood obtained at diagnosis * leukemia is one of the following cytogenetic subtypes: * t(8;21) * t(15;17) * inv(16)

Keywords: adult acute myeloid leukemia in remission adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(8;21)(q22;q22) childhood acute myeloid leukemia in remission recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies
biodiesel exhaust, acute vascular and endothelial responses

Conditions: Healthy

Summary: exposure to particulate air pollution has been shown to increase cardiovascular mortality and morbidity, and in previous controlled exposure studies has been shown to have acute cardiovascular and respiratory effects. the last decade has seen an unprecedented drive towards finding a bioeconomical and renewable source of fuel in order to reduce our dependence on fossil fuels. although both biodiesel and bioethanol have emerged as contenders for future fuels, biodiesel remains as the strongest contender within european markets. in 2007 researchers at the epa released a commentary, which concluded that the assumed correlation between the chemical composition of biodiesel exhaust and a reduction in health effects was only hypothetical. they suggested that there was a clear need for the study of health effects in humans regarding biofuel exhaust. in this project the investigators aim to investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust exposure in healthy volunteers.


Eligibility criteria:
inclusion criteria: * 20 healthy, non-smoking subjects, age 20-55 year old, both genders. all subjects undergo a general health examination and are required to have: normal clinical examination normal ekg normal routine blood tests normal lung function exclusion criteria: * cardiovascular disease * diabetes mellitus * asthma and/or allergy * respiratory infection within 3 weeks of the study * antioxidant- and/or vitamin supplementation within 2 weeks prior to, as well as during the course of the study. (incl vitamin c, acetylcysteine) * female subjects will take a urinary pregnancy test before each exposure and will be excluded if this is positive.

Keywords: air pollution diesel exhaust biodiesel exhaust vascular function fibrinolysis acute vascular and endothelial responses
luxsol(tm) topical cream for the treatment of symptomatic bacterial vaginosis; a proof of concept study

Conditions: Bacterial Vaginosis (BV)

Summary: luxsol cream may be useful for the treatment of bacterial vaginosis. in this study, luxsol cream is compared to a control arm group using metronidazole cream. luxsol is administered intravaginally for 10 days, each evening before bedtime to treat bacterial vaginosis..

luxsol topical cream is a copper containing topical cream indicated for the treatment of bacterial vaginosis (bv). the study is an open-label, randomized, controlled study comparing luxsol cream to metrogel in patients with a diagnosis of bv. the investigational product or the comparator product will be self-administered by the patient for 10 consecutive nights. a successful patient outcome is cured bv at 30 days.

Eligibility criteria:
inclusion criteria: * subject agrees to participate and signs informed consent * female age 18 or older * subject has clinical bv with 4 of 4 amsel's criteria * off-white (milky or gray), thin, adherent, homogenous discharge with minimal or absent pruritus and inflammation of the vulva and vagina * presence of 'clue cells' \>/=20% of the total epithelial cells on microscopic examination of the saline 'wet mount.' * virginal secretion ph of \>4.5 * a fishy odor of the vaginal discharge with the addition of a drop of 10% koh (i.e. a positive 'whiff test') * subject agrees to refrain from use of douches, intravaginal products for treatment period * subject agrees to refrain from taking oral or intravaginal antibiotics or antifungal agents during entire study period * subject agrees to refrain from vaginal intercourse during treatment period. exclusion criteria: * subject has another infectious or noninfectious cause of vulvovaginitis * subject has another vaginal or vulvar condition that would confound the determination of study endpoints. * subject has received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days prior to enrollment. * subject is under treatment for cervical intra-epithelial neoplasia or cervical carcinoma * subject is known to be hiv positive * subject has a positive pregnancy test * subject has any abnormal anatomy or pathology of the vagina * subject has untreated sexually transmitted disease * subject is currently having menstrual period or may have her period during treatment days. * subject's pap smear \>/= to lsil * subjects with known sensitivity or allergic reactions to copper or metronidazole vaginal gel * subject has known wilson's disease

Keywords: bacterial vaginosis (bv) amsel's criteria pap smear
abnormal vaginal flora and vaginal lesions at delivery: is there a relationship?

Conditions: Vaginal Lesion

Summary: the main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. for this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora. a more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.


Eligibility criteria:
inclusion criteria: * pregnant women with a gestational age \> 34 weeks delivering at the nîmes university hospital exclusion criteria: * patient under judicial protection * adult patient under any kind of guardianship * patient refuses participation

Keywords: perineal tear perineal lesion vaginal flora birth
head and neck paragangliomas: a 16-year experience of a university hospital in turkey

Conditions: Head and Neck Paraganglioma

Summary: the aim of the study is to examine the head and neck paraganglioma cases treated in pamukkale university hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.

39 patients were selected and analyzed retrospectively. demographic informations, complaints at the time of admission, radiological examinations, paraganglioma types, stages, postoperative complications, and relapsed cases were recorded.preoperative staging plays a crucial role in surgical planning and predicting potential intraoperative complications. in such cases, combination therapy alongside surgery may improve treatment outcomes.

Eligibility criteria:
inclusion criteria: * histopathological diagnosis of carotid paraganglioma * histopathological diagnosis of vagal paraganglioma * histopathological diagnosis of jugular paraganglioma * histopathological diagnosis of tympanic paraganglioma exclusion criteria: -inadequate information in files

Keywords: paraganglioma glomus
sepsis, severe sepsis and septic shock detection by breath analysis

Conditions: Sepsis

Summary: breath samples will be collected from patients suspected of sepsis/severe sepsis or septic shock according to hospital sepsis screening criteria in the emergency department.

breath samples will be collected from patients suspected of sepsis that meet the criteria in the hospital's sepsis patient management protocol for blood lactate point of care testing. the breath samples will be collected from the patient by the respiratory therapist (rt) at the time of blood sample collection for the blood lactate test. the breath samples will be analyzed via gas chromatography-surface acoustic wave spectroscopy for detection of a pattern of volatile organic compounds (vocs). multivariate analysis will be performed on breath sample data to determine feasibility of associating a unique voc pattern with septic/severe septic/septic shock patients.

Eligibility criteria:
inclusion criteria: * admitted to emergency department * suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed * age 18 or older exclusion criteria: * member of vulnerable patient population * unable to complete patient informed consent process/document
non-invasive risk stratification of cr amn/ssp

Conditions: Adenomatous Polyps

Summary: the purpose of this study is to determine the clinical utility of stool and blood methylation tests for detection of advanced mucosal neoplasia (amn) and sessile serrated polyps (ssp).

by not only diagnosing colorectal cancer (crc) at an early stage, but also removing precursor lesions (adenomas), colonoscopy with polypectomy reduces the risk of developing and dying from crc. approximately 90% of polyps are less than 10 mm and are easily removed by competent endoscopists. laterally spreading lesions (lst) and sessile lesions of the colon, also known as advanced mucosal neoplasia (amn) are underrecognised types of lesions that are more likely to progress to cancer. they include sessile serrated polyps (ssp), an emerging entity of flat polyps with malignant potential. detection of hemoglobin (a component of blood) in stool is an established validated screening tool for crc. its specific role in the prediction of amn, and particularly ssps is yet to be defined. blood tests measuring the level of tumour derived methylated deoxyribonucleic acid (dna) in blood circulating have been demonstrated to have clinical utility for detection of crc and amn. a blood based crc screening test has the potential to increase compliance. this study aims to determine the clinical utility of stool and blood methylation tests for detection of amn and ssps. stool and blood will be obtained from consenting patients referred for endoscopic removal of known anm and ssp (study arm) as well as from consenting patients scheduled for colonoscopy screening (control arm). the level of stool hemoglobin and methylated tumour derived dna in circulation will be measured in the two study groups. cutoff values will be generated to assess best predictive capability of high risk lesions based on these tests.

Eligibility criteria:
inclusion criteria: * individuals capable and willing of proving satisfactory informed consent * individuals with colonic lesions larger than 20mm * individuals diagnosed with laterally spreading or sessile polyp morphology * individuals schedules for screening colonoscopy and with no prior history of crc * ability and willingness to collect stool sample at home * ability and willingness to undergo venepuncture procedure exclusion criteria: * individuals not able or unwilling to provide informed consent * individuals less than 18 year of age * individuals who undergo an incomplete colonoscopy or resection, which raises doubt as to the status of the colon (post-hoc exclusion) * individuals with a prior history of crc * individuals with a history of irritable bowel disease (ibd), hereditary nonpolyposis colorectal cancer (hnpcc) or familial adenomatous polyposis (fap) * individuals with bleeding diathesis * pregnancy

Keywords: sessile serrated polyps advanced mucosal neoplasia
yondelis (trabectedin) single patient compassionate use / expanded access

Conditions: Soft Tissue Sarcoma

Summary: the yondelis (trabectedin) single patient compassionate use /expanded access program provides patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials with yondelis (trabectedin), access to this investigational treatment.

the single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. the patient will be treated with yondelis® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on day 1 every 21 days, provided that he/she fulfills all eligibility criteria. the patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. safety will be evaluated and serious adverse events will be reported. disease assessments will occur according to institutional practice.

Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. 18 years-of-age or older. 3. unresectable, advanced or metastatic, histologically proven soft tissue sarcoma. 4. recovery from toxic effects of prior therapies to nci ctc grade 1 or better. 5. hematologic variables: * hemoglobin ≥9 g/dl * anc ≥1,500/μl * platelet count ≥100,000/μl 6. serum creatinine ≤ upper limit of normal (uln) 7. hepatic function variables: * total bilirubin ≤ uln * total alkaline phosphatase ≤ uln, or if \> uln, then alkaline phosphatase liver fraction or 5'-nucleotidase must be ≤ uln. * ast (serum aspartate transaminase \[sgot\]) and alt (serum alanine transaminase \[sgpt\]) must be ≤ 2.5xuln * albumin ≥2.5 g/dl exclusion criteria: 1. pregnant or breast-feeding women, or patients (male or female) not employing adequate contraception. acceptable means of birth control include iud, oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository. 2. less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent 3. active viral hepatitis or chronic liver disease 4. unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias 5. active infection
a study to evaluate time in range in type 2 diabetics using afrezza® plus basal insulin compared to multiple daily injections

Conditions: Type 2 Diabetes Treated With Insulin

Summary: the purpose of this study is to collect cgm, a1c and quality of life data in subjects with type 2 diabetes before and after transitioning from multiple daily injections to basal plus bolus with afrezza® inhaled insulin. the primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. additional objectives include evaluation of a1c and quality of life data. the expected outcomes are improvement of time in range, no change or improvement in a1c and favorable quality of life data


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. diagnosed with type 2 diabetes mellitus treated with multiple daily injections 3. screening a1c 7.5 % - 11.5% inclusive 4. willing and able to wear cgm system during the study 5. willing to use only inhaled insulin (afrezza®) at meals and for correction 6. able to understand, speak, read and write english 7. female of child-bearing potential willing to use contraceptive measures to prevent pregnancy exclusion criteria: 1. diagnosed with copd 2. is an active smoker , or has smoked in the past 6 months 3. diagnosed with asthma 4. pregnancy, breast-feeding or planning to become pregnant during study period 5. have a disease or condition that, in the opinion of the investigator, could affect subject safety or interfere with their participation in the study 6. use of oral or injected corticosteroid within 6 weeks of study enrollment 7. enrollment in another investigational trial at the time of screening
impact of recombinant humanized type iii collagen on the immediate and long-term effects of breast tumor surgery

Conditions: Breast Cancer; Collagen Protein

Summary: breast tumors, particularly breast cancer, are increasingly prevalent in china, with a noticeable trend towards younger ages. preliminary research indicates that type iii collagen (col3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. however, there are no clinical studies related to col3 in breast tumors. this project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized type iii collagen (rhcol3) to patients undergoing breast tumor surgery. the study will observe the incidence of perioperative complications after rhcol3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhcol3 injection. the goal is to establish a targeted rhcol3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.


Eligibility criteria:
inclusion criteria: 1. females aged 18 years or older but not exceeding 80 years; 2. clinical and imaging diagnosis of breast tumor, planned for needle biopsy; 3. planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy; 4. no systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening; 5. ecog performance status (ps) - 0 or 1; 6. subjects voluntarily join this study and sign the informed consent form. exclusion criteria: a.tumor-related symptoms and treatments 1）bilateral, multiple lesions; 2) skin damage and ulceration on the affected side of the breast; b. history of allergy to collagen products or their excipients or severe allergic constitution; c. history of breast cancer or other malignant tumors; d. positive serum pregnancy test or lactation; e. use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. with severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.