Kornimate/medical-research-clean huggingface dataset:
standard operating procedures for cervical (pre)cancer biomarker detection in first-void urine (bm-sop study)

Conditions: Cervical Cancer

Summary: the aim of the study is to develop robust analytical protocols for first-void urine sample preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for improved diagnosis of cervical (pre)cancer lesions.

in total 100 women will be included in this trial, women diagnosed with abnormal cytology results and/or high risk hpv (human papillomavirus) infection scheduled for a colposcopy exam. these women are asked to collect a first-void urine sample with the colli-peetm device, prior to their colposcopy exam at the clinic. the collected urine samples will be used for the development and optimisation of robust analytical protocols for first-void urine sample preparation and biomarker assays. during colposcopy, the cervix will be visually inspected, whether or not combined with a biopsy for histological confirmation. colposcopy is a procedure to identify abnormalities by using a colposcope that gives an illuminated, magnified view of the cervical region. it often includes rinsing the cervicovaginal region with 50 ml acetic acid (5%). here, this fluid will be collected and serve as the intermediate step between biomarkers in cervicovaginal secretions and urine.

Eligibility criteria:
inclusion criteria: * female * 25-64 year old * women scheduled for a colposcopy exam due to abnormal cytology result according to the bethesda classification 2001 (nilm, agc (atypical glandular cells), asc-us (atypical squamous cells of undetermined significance), asc-h (atypical squamous cells - cannot exclude hsil), lsil (low-grade squamous intraepithelial lesion), hsil (high-grade squamous intraepithelial lesion), invasive carcinoma), and/or positive for hrhpv infection. nilm (negative for intraepithelial lesion or malignancy) are only included when positive for hrhpv infection. * signing informed consent form (icf). * giving consent to the research team (cev) to contact his/her general practioner and/or gynaecologist to access details of the participants hpv vaccination (schedule) and results of cervical smears/cytology, hpv tests, colposcopy, and biopsy (included in icf). exclusion criteria: * participating in another clinical study at the same time of participating in this study. * not able to understand the information brochure/what the study is about. * anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Keywords: human papillomavirus biomarker self-sampling first-void urine cervicovaginal fluid colposcopy
comparison of two group wellness interventions in tbi partner caregivers

Conditions: Traumatic Brain Injury; Partner Caregiver

Summary: the purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (tbi). the study is designed to evaluate how well these treatments can help tbi partner caregivers improve approach/avoidance behaviors.

a multi-site randomized controlled trial will be conducted to evaluate the effectiveness of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (tbi). 92 participants will be recruited. participants are randomly assigned to one of two wellness groups. each group will involve six weekly 75-minute live video conference sessions as well as independent homework assignments that will be discussed in closed social media forums with peers and facilitators. participants will complete self-report measures (approach and avoidance, anxiety, depression, caregiver appraisal, resilience, self efficacy, social integration, quality of life.) prior to intervention participation, within a week of class 6, and at 3-months post-intervention.. intervention effectiveness will be determined by improvements between baseline and follow-up on a self-report measure of approach/avoidance behaviors.

Eligibility criteria:
inclusion criteria: * at least 18 years of age. * read and speak english fluently. * have been in an intimate relationship with a person with tbi for at least one year prior to their injury. * partner was discharged from inpatient rehabilitation at least 3 months ago. * provide care to partner on a daily basis. * have access to the internet in a private location.

Keywords: spouse partner caregivers brain injuries
development of a clinical prediction rules to identify efficacy of pulsed electromagnetic therapy on burn wound healing

Conditions: Burn Wound

Summary: the purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients

it will be hypothesized that 1. age may significantly affect burn wound healing's response to pulsed electromagnetic waves. 2. tbsa may significantly affect burn wound healing's response to pulsed electromagnetic waves 3. depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves 4. wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves this study will be conducted at the in-patient burn units. there will be only one intervention group. the duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). sixty patients (male and female) will be recruited from the burn units. pulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area. pemf therapy will be as (duration: 60 minutes; frequency: 12 hz; intensity: 12 gauss)

Eligibility criteria:
inclusion criteria partial thickness burn wound depth. age ranges from 20-50 years. tbsa more than 15% sufficient understanding to perform the tests. exclusion criteria diabetic patients. patients receiving immunosuppressive drugs. associated co-morbidities, such as neurological diseases, malnutrition, and other inﬂammatory and/or infectious diseases.
food provision in centeringpregnancy prenatal care

Conditions: Pregnancy Complications; Excessive Gestational Weight Gain

Summary: the overarching research question is: "does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (soc)?" to answer this question, the investigators will conduct a cluster-randomized controlled trial with 400 pregnant women who are enrolled in centeringpregnancy classes. centeringpregnancy classes (clusters) will be randomized to either the food provision arm or the soc arm, with approximately 200 participants per arm. participants randomized to the soc arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.those randomized to the food provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\~8 weeks post-partum).


Eligibility criteria:
inclusion criteria: * aged 16-44 years * pregnant * enrolled in centeringpregnancy * speaks english, spanish, or marshallese
validation of the spanish version of the conceptualization of pain questionnaire

Conditions: Child Development; Pain; Adolescent Behavior

Summary: the goal of this observational study is to develop a questionnaire to assess a child's concept of pain and to evaluate its psychometric properties in schoolchildren aged 8-17 years. the main question\[s\] it aims to answer are: * validate to spanish language the conceptualization of pain questionnaire to assess a child's concept of pain. * conduct an analysis to evaluate its psychometric properties. participants will respond a questionnaire of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided.

the inclusion criteria were: to be able to read and write in spanish language and excluded if they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures. the main outcome was: the conceptualization of pain questionnaire - spanish version.

Eligibility criteria:
inclusion criteria: * were able to read and write in spanish exclusion criteria: * if they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures.

Keywords: survey children health knowledge chronic pain pain education
ibuprofen with or without dexamethasone for acute radicular low back pain.

Conditions: Radiculopathy, Lumbosacral Region; Back Pain With Radiation; Low Back Pain

Summary: this will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ed) visit for acute radicular low back pain (lbp) and followed by telephone two and seven days later. patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ed visit for acute radicular lbp. every patient will receive a 7 day supply of ibuprofen and a low back pain education session.


Eligibility criteria:
inclusion criteria: * present to ed primarily for management of acute radicular lbp, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. some patients may not have prominent lbp but a radicular symptom--we will include these patients as well. * patient is to be discharged home. * age 18-70 enrollment will be limited to adults \<70 years because of the increased risk of adverse medication effects in older adults. * pain duration \<2 week * prior to the acute attack of radicular lbp, back pain cannot occur more frequently than half of the days in the last 3 months. patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10 * non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month * functionally impairing radicular lbp: a baseline score of \> 5 on the roland-morris disability questionnaire exclusion criteria: * not available for follow-up * pregnant * chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis * allergic to or intolerant of investigational medications * chronic steroid use * contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) severe heart failure (nyha 2 or worse) 3) chronic kidney disease (gfr \<60ml/min) 4) current use of anti-coagulants 5) cirrhosis (child pugh a or worse) or hepatitis (transaminases 2x the upper limit of normal)

Keywords: ibuprofen dexamethasone radiculopathy low back pain back pain with radiation
a phase i study of ery974 in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this is a multicenter, open-label, dose-escalation study designed to determine the maximum tolerated dose (mtd) by evaluating dose-limiting toxicities (dlts) and to evaluate the safety, tolerability, pharmacokinetics, anti-tumor effect, and biomarkers of ery974 in combination with atezolizumab and bevacizumab following premedication with tocilizumab in patients with locally advanced or metastatic hcc.


Eligibility criteria:
inclusion criteria: * aged ≥18 years at time of informed consent * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * hcc that has been histologically confirmed exclusion criteria: * previous or concomitant autoimmune disease * uncontrolled diabetes mellitus and hypertension * concurrent new york heart association (nyha) class ≥ii congestive heart failure, myocardial infarction, arrhythmia, or unstable angina, or a history thereof within 6 months before enrollment. * concurrent symptomatic cerebrovascular disorder (e.g., subarachnoid hemorrhage, cerebral infarction, or transient ischemic attack), or a history thereof within 6 months before enrollment. * symptomatic, untreated, or actively progressing cns metastases
a multi-center prospective study on the oncological and reproductive outcomes and quality of life in young woman after fertility-sparing treatment of endometrial cancer and endometrial intraepithelial hyperplasia

Conditions: Endometrial Cancer; Endometrial Intraepithelial Neoplasia; Fertility-sparing Surgery

Summary: we will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia

a multi-center prospective study on the oncological and reproductive outcomes and quality of life in young woman after fertility-sparing treatment of endometrial cancer and endometrial intraepithelial hyperplasia

Eligibility criteria:
inclusion criteria: * fertility sparing treatment of ec and ein. * 18-45 years old * from start study (jan 2025 - end study jan 2028) * all centras in sweden exclusion criteria: * not english och swedish speaking
efficacy and safety study of dietary supplements in chronic smokers having mild to moderate hyperlipidemia

Conditions: Chronic Smokers; Hyperlipidemia

Summary: the purpose of this study is to investigate the efficacy and safety of dietary supplements (bioturmin, bioturmin-wd and maqxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.

in a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (bioturmin, bioturmin-wd and maqxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 60 days. the efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Eligibility criteria:
inclusion criteria: * men \> 20 years * chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (ldl ranging 160-189 mg/dl, tc \>200 mg/dl and/or hdl-c \<40 mg/dl) * being mentally competent and able to understand all study requirements and sign the informed consent form. exclusion criteria: * patients with chronic obstructive pulmonary disease (copd) * women * patients with severe liver, renal, cardiac or brain diseases. * unable to complete follow up. * subjects on any medication like diuretics. * allergic to any medication. * with a history of alcohol and/or drug abuse.

Keywords: dietary supplements cotinine level malondialdehyde chronic smokers hyperlipidemia
early diagnosis of gdm by multiomics

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus (gdm) is prone to cause a variety of adverse pregnancy outcomes, and has potential harm to the short-term and long-term health of both mothers and infants. however, its diagnosis mainly relies on oral glucose tolerance test (ogtt) at 24-28 weeks of gestation, so it is often diagnosed in the second and third trimester, and may be too late to intervene. therefore, advancing the diagnostic window period of gdm is the key to the prevention and treatment of gdm and its complications. it is urgent to establish a new technology for the early diagnosis and screening of gdm with high detection rate and accuracy. based on literature survey and previous studies, this study found that the combined analysis of metabolomics and lipidomics may have broad clinical application prospects in the early diagnosis and screening of gdm. it is hoped that a set of new techniques based on multi-omics for early diagnosis and screening of gdm can be constructed, providing a feasible and effective tool for early detection and treatment of gdm in clinical.


Eligibility criteria:
inclusion criteria: * plan to have routine prenatal examinations and give birth in the research center * first trimester * singleton pregnancy * without pregnancy complications * willing to cooperate with the hospital to follow up exclusion criteria: * have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, aids, etc. * fetus has a known deformity or genetic defects * incomplete clinical data
radiosensitivity of hpv-related tumors: towards a genomic approach

Conditions: HPV-Related Carcinoma

Summary: the purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of human papilloma virus (hpv) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body.

the present study (icarus - genomic radiosensitivity virus) involves the collection of data (retrospective and prospective) from an extensive cohort of patients with hpv-related tumors of the oropharynx, cervix, and anus. the aim is to: 1. investigate the role of cl2 in non-oropharyngeal hpv-related tumors, and 2. compare the radiation sensitivity index (rsi) values of hpv-related tumors in patients who responded to radiotherapy (responders) with those of patients with radioresistant tumors (non-responders).

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) * diagnosis of hpv-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus * curative intent radiation therapy (exclusive, post-operative, with or without chemotherapy) * availability of pre-radiation therapy biopsy sample * no diagnosis of solid neoplasms and/or hematologic malignancies in the previous 5 years * possibility of retrospective and prospective data collection and anonymous submission to the referring center of clinical data related to the patient, pathology, and treatment characteristics (including radiation treatment plan in rt.dose format) * ability to obtain written informed consent for the use of data anonymously for research purposes exclusion criteria: * patients undergoing surgical treatment * patients with local and/or locoregional recurrence * patients with synchronous distant metastases at diagnosis * patients previously treated with oncologic therapies for tumors of the same anatomical site
predictendtb signature for individualizing treatment in multidrug-resistant tuberculosis

Conditions: Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Bacterial Infections; Mycobacterial Infection

Summary: predictendtb signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic signature-based model compared to the standardised twenty months treatment in a cohort of multidrug-resistant tuberculosis patients.

this study is a non-inferiority, prospective, parallel-group open-label randomized controlled trial. three hundred forty-two hiv-negative patients diagnosed with pulmonary tuberculosis (tb) and starting a new anti-multidrug-resistant tuberculosis (mdr-tb) treatment cycle will be included in the study. two randomized arms of 171 patients each will be recruited over the two-year period, each patient will be followed-up over the entire course of anti-tb treatment and one year after the end of therapy. regular study visits will include physical examination, collection of sputum, blood and urine and filling in the study questionnaire. on the collected specimens standard bacteriological and blood tests, as well as extended immunological analysis, will be performed. in the experimental group, an rna transcriptomic analysis using rna-seq technology will also be performed. in the control arm, the patients will receive a standardised world health organization recommended 20 months treatment while in the experimental arm the treatment duration will be guided by the transcriptomic signature-based model. treatment outcomes and level of tb relapse and survival within the follow-up period will be compared between the experimental and control arms. the efficacy of biomarker-guided treatment therapy will be assessed by a comparison of the proportions of favourable study outcome between two arms.

Eligibility criteria:
inclusion criteria: * patient starting an mdr-tb treatment or within the first 4 weeks after treatment initiation and before culture conversion. * rifampicin resistant m. tuberculosis detected in sputum using a nucleic acid amplification test. * new case of tb or re-treatment. * can give informed consent at the point of recruitment. * contactable (residing in the area covered by participating tb centres and possessing a landline or a mobile phone). * willing to participate for the entire course of the treatment and extensive follow-up. exclusion criteria: * age \<18 years old. * anti-mdr-tb therapy within 6 months prior to the start date of the current treatment cycle. * hiv infection. * non-adherent patient with frequent interruptions. * patient in custodianship or guardianship. * late exclusion criterion: no positive cultures at inclusion and within the first 3 months of treatment.

Keywords: tuberculosis multidrug resistance treatment duration