Kornimate/medical-research-clean huggingface dataset:
clinical signs and changes in cervical muscles activity evaluated by magnetic resonance imaging during an endurance test

Conditions: Neck Pain; Motor Activity

Summary: the aim of this present study is to compare the radio-clinic correlation between the ability to hold the head and neck (by inertial sensor) and the changes in neck muscles activity (by functional magnetic resonance imaging) during the cervical extensor endurance test between an asymptomatic population and one suffering from chronic neck pain.


Eligibility criteria:
inclusion criteria: * neck disability index score \> 8/50 for the symptomatic group or \< 4/50 for the asymptomatic group * numerical rating scale \< 7/10 for the symptomatic group * suffering from idiopathic or traumatic chronic neck pain for the neck pain group or being free of neck pain which required therapeutic, medical or medicinal treatment in the last 12 months. exclusion criteria: * fibromyalgia, cervical radiculopathy, previous cervical surgery
circulating tumor mitochondrial dna (ct-mtdna) as a biomarker for biliary tract cancer recurrence surveillance

Conditions: Biliary Tract Cancer

Summary: this is a prospective, observational, single-center study. the purpose of this study is to evaluate the efficacy of circulating tumor mitochondrial dna (ct-mtdna) in plasma as a biomarker for minimal residual disease (mrd) assessment and recurrence monitoring in patients with biliary tract cancer.

biliary tract cancer (btc) encompasses a range of malignancies including intrahepatic, perihilar, and distal cholangiocarcinomas, as well as gallbladder cancer. while relatively rare in many high-income countries, it poses a significant health challenge in certain regions, with a rising incidence of intrahepatic cholangiocarcinoma globally. despite recent therapeutic advancements, btc remains an aggressive disease with a grim prognosis, characterized by a median overall survival of less than one year and a 5-year survival rate below 5%. the primary objective of this study is to evaluate the effectiveness of plasma tumor mitochondrial mutations as a biomarker for mrd assessment and recurrence monitoring in patients with btc. the study hypothesizes that the presence and dynamics of tumor mitochondrial mutations in plasma are associated with the risk of recurrence and overall survival in btc patients. this is a prospective, observational, single-center study conducted by the chinese cooperative group of liver cancer (ccglc) under the auspices of the chinese chapter of international hepato-pancreato biliary association. the study will involve the collection and analysis of plasma samples from patients with btc to detect ct-mtdna mutations before and after treatment. the primary clinical endpoint is the impact of mrd status on progression-free survival (pfs). secondary endpoints include the influence of treatment on mrd markers, the correlation between post-treatment residual tumor molecular burden and pfs, and the ability of mrd detection to predict recurrence earlier than traditional tumor markers or imaging methods. this study seeks to contribute to the field of btc management by providing a more precise and personalized approach to mrd assessment and recurrence monitoring. the findings have the potential to improve long-term treatment outcomes and quality of life for patients with btc.

Eligibility criteria:
inclusion criteria: * histologically confirmed biliary tract cancer (btc); * expected survival time of 12 weeks or more; * signed informed consent form and ability to comply with the study visits and related procedures as stipulated in the protocol. exclusion criteria: * patients with other active tumors or severe complications; * insufficient tumor tissue for mrd detection.

Keywords: mrd ct-mtdna recurrence biliary tract cancer
mri-based clinico-radiomics predicting lymph node metastasis status of hilar cholangiocarcinoma

Conditions: Hilar Cholangiocarcinoma

Summary: this is a prospective, observational diagnostic study aiming to assess multiparametric mri-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma.

a preoperative tool capable of predicting lymph node metastasis status in hilar cholangiocarcinoma is lacking and urgently needed for clinical practice. this study proposes to establish and evaluate a machine-learning algorithms of multiparametric mri-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma. this study will investigate the relationship between radiomic depth information and tumor biological characteristics. the study includes the construction of capable mri-based clinico-radiomics prediction model and the validation of the prediction model.

Eligibility criteria:
inclusion criteria: 1. the patient must sign an informed consent form; 2. age 18-75 years old, both male and female; 3. ecog performance status score (ps score) 0-2; 4. hilar cholangiocarcinoma with resectable tumor lesions; 5. complete the upper abdomen mri examination before treatment; exclusion criteria: 1. accompanied with other primary malignant tumors; 2. patients who have neoadjuvant chemotherapy or other tumor-targeted therapies; 3. incomplete imaging or medical history data.

Keywords: hilar cholangiocarcinoma lymph node metastasis radiomics machine-learning prognosis
plants pilot trial

Conditions: Alcohol Drinking; Social Acceptance; Depressive Symptoms; Bullying

Summary: this pilot cluster-randomized controlled trial will evaluate the plants (providing lgbtq+ adolescents with nurturance, trustworthiness, and safety) course among high school staff. the primary hypotheses are that the plants course will have high acceptability, usability, appropriateness, and feasibility as reported by high school staff.

the intervention being studied, plants, is an online-delivered training program, including asynchronous and synchronous activities targeting high school staff. this intervention is informed by the information-motivation-behavior theory to target high school staffs' skills, self-efficacy, knowledge, and outcome expectations. members of the study population as well as collaborators invested in sexual and gender minority youth (sgmy) well-being provided valuable feedback on plants throughout its development. comparison schools will receive the email-based control intervention, e-learning to maximize academic inclusion of lgbtq+ students (emails). staff will receive periodic emails with publicly available resources on similar topics to those of plants. regarding the intervention's targeted behavioral outcomes, upon completion of the plants program, high school staff will: provide interpersonal support and affirmation to sgmy; provide educational resources that are inclusive of sgmy; provide safe spaces for sgmy; promote acceptance of sgmy among cisgender heterosexual youth; prevent and reduce bullying, cyberbullying, and harassment of sgmy; evaluate and advocate for sgmy inclusivity and protections in school policies; and maintain the confidentiality of sgmy. by having high school staff achieve these behavioral outcomes, the investigators hypothesize that sgmy will experience less risk factors (e.g., bullying victimization) and more protective factors (e.g., school-based adult support), which will in turn reduce sgmy's substance use and mental health problems. the primary aim of this clinical trial is to rigorously test the acceptability, usability, appropriateness, and feasibility of the plants intervention using a 2-armed cluster-randomized controlled trial. the investigators will also examine the efficacy of intervention in improving high school staff outcomes as well as implementation and safety outcomes related to the intervention and trial. results from this pilot trial will provide necessary information to conduct a fully powered trial of the efficacy of plants for reducing the ultimate health outcome of sgmy alcohol use.

Eligibility criteria:
inclusion criteria: * currently employed by an enrolled school in the metrowest region of boston, massachusetts * age 18 years old or older * consents to participate exclusion criteria: • does not interact with high school students at work

Keywords: sexual and gender minority youth
a study of hs-10518 in healthy female participants

Conditions: Endometriosis

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hs-10518 in healthy adult premenopausal females in china.

this is a double-blind, placebo-controlled, multiple-dose, single-center phase 1 study in chinese healthy premenopausal females aged 18-45 years with a regular menstrual cycle (26-32 days). the main purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hs-10518, a gonadotropin-releasing hormone antagonist. about 48 eligible female subjects will be enrolled. the study contains four cohorts. in each cohort, participants will be randomly assigned to the hs-10518 arm or the placebo arm in a 3:1 ratio. hs-10518/matching placebo will be administered from day 1 to day 7. the study duration of each participant is up to \~10 weeks.

Eligibility criteria:
inclusion criteria: * • subject is a healthy premenopausal female aged 18-45 (inclusive) at screening; * subject has a body weight ≥45kg with a body mass index (bmi) of 18-28 kg/m\^2 (inclusive); * subject has a normal menstrual cycle for no less than 2 years (cycle: 26-32 days, menstrual period: 2-7 days), and have a positive ovulation test in the cycle prior to drug administration; * subject is willing to use highly effective, non-hormone contraceptive methods from signing the consent form until 3 months after the last dose; * subject agrees to draw blood in pre-specified time points throughout the study and to attend the follow-up visit; * subject is able to understand the purpose, process and potential adverse events of the study, and is willing to sign a written informed consent form. exclusion criteria: * • subject took caffeine-rich or xanthine-rich food or drink (e.g. coffee, tea, chocolate, cola, etc.), tobacco or alcoholic products within 48 hours prior to drug administration; * subject took any grapefruit, grapefruit juice or other products within 7 days prior to first dose of study drug; * subject has a positive breath alcohol test or a history of alcohol abuse; * subject is a heavy smoker, or smokes ≥5 cigarettes per day, or is not able to cease smoking during the study (including e-cigarette); * subject has a history of drug abuse or a positive urine drug test; * subject is pregnant, breastfeeding or has a positive pregnancy test at screening
safety, tolerability, pharmacokinetics and pharmacodynamics study of mt-1303 in subjects with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of mt-1303 in subjects with inflammatory bowel disease.

this is an open-label, non-randomised, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of mt-1303 in subjects with inflammatory bowel disease (crohn's disease and ulcerative colitis).

Eligibility criteria:
inclusion criteria: * a body mass index (bmi) ranging from 16 to 34 kg/m2 * subjects who were diagnosed as crohn's disease or ulcerative colitis at least 6 months prior to screening, clinically confirmed either by radiological, endoscopic or histological examination. * subjects who have had at least one flare within 18 months prior to screening. * confirmed medical records of inflammatory lesions in intestinal tract exclusion criteria: * present or past history of clinically significant gastrointestinal surgery. * present or past history of clinically significant stenosis, stricture or fistula in small intestine or colon. * known hypersensitivity to any formulation excipients.

Keywords: crohn's disease ulcerative colitis
laser treatment of moderate to severe acne vulgaris

Conditions: Acne Vulgaris

Summary: in this study, we are enrolling subjects with moderate to severe acne vulgaris and investigating the use of a commercially available laser in treating acne.


Eligibility criteria:
inclusion criteria: 1. subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol; 2. in good general health, based on answers provided during the screening visit; 3. subject must be able to read and understand english; 4. any gender and any fitzpatrick skin type; 5. ages 18 through 40; 6. subjects must have moderate to severe nodular active facial acne vulgaris (pga 3 or 4) 7. willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment; 8. subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy). exclusion criteria: 1. participation in another investigational drug or device clinical trial in the past 30 days; 2. currently undergoing or wish to begin or continue topical treatments; 3. are pregnant or lactating; 4. history of allergic reaction to topical anesthesia; 5. subjects may not have undergone oral isotretinoin therapy within the past 12 months; 6. currently take oral antibiotic or oral therapy for acne; 7. history of keloidal or hypertrophic scarring; 8. laser treatment in past six months; 9. history of poor wound healing; 10. clinically significant abnormal findings or conditions which might, in the opinion of the investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Keywords: acne acne vulgaris laser cystic acne
do isreali infants of ethiopian origin mother regurgitate more than other infants?

Conditions: Rumination

Summary: nursing team of well baby nursery at hillel yaffe medical center in hadera, israel have noticed that infant of ethiopian-origin mothers regurgitate more than other infants. probably, these infants are breastfeed much more than other infants. some ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production. study goal is to find out if infants of ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. another goal is to find out if breastfeeding mothers of ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.

nursing team of well baby nursery at hillel yaffe medical center in hadera, israel have noticed that infant of ethiopian-origin mothers regurgitate more than other infants. probably, these infants are breastfeed much more than other infants. some ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production. study goal is to find out if infants of ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. another goal is to find out if breastfeeding mothers of ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.

Eligibility criteria:
inclusion criteria: * infants born at hillel yaffe medical center during 2009 (to ethiopian origin mother in study group, and to non-ethiopian origin mothers in control group) exclusion criteria: * infants who were transferred to nicu for any reason.

Keywords: regurgitation infants to israeli ethiopian-origin mothers
effect of risedronate on bone mass in older men receiving neoadjuvant therapy for prostate cancer

Conditions: Prostate Cancer

Summary: men treated with neoadjuvant luteinizing hormone-releasing hormone (lhrh)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. this bone loss can be prevented by treatment with 35 mg/week of risedronate.

a 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving lhrh-agonist treatment for 6 months for locally advanced prostate cancer. bone mineral density (bmd) of the lumbar spine, femoral neck, and total hip was measured every 6 months. in addition, bone turnover markers including n-telopeptide, serum c-telopeptide and procollagen peptide, and 25-oh vitamin d and intact parathyroid hormone were measured at baseline and at 6 months.

Eligibility criteria:
inclusion criteria: * non-metastatic prostate cancer * men to receive gonadotropin-releasing hormone-agonist therapy exclusion criteria: * other cancers except skin cancer * evidence of metabolic bone disease * prior use of bisphosphonates

Keywords: non-metastatic
cervical cytology - do sms reminders increase participation in the cervical screening programme?

Conditions: Cervical Carcinoma; Cervical Dysplasia

Summary: this study will pilot production and evaluate the use of reminder information in women invited for cervical screening for the first time within the ggc eligible population for cervical screening. women aged under 30 years will be identified to receive an sms text message following their cervical screening invitation using information from the chi broadcast.

cervical cancer is the commonest cancer among women aged less than 35 years. a change to the age range and frequency for cervical screening was implemented on the 6th june 2016. this increased the younger eligible age for screening from 20 to 25. uptake of cervical screening among women in the youngest eligible age range has historically been low. research by scott porter has shown that cervical screening is not on young women's radar and additionally there is scope for confusion amongst women in this cohort about the requirement to attend for cervical screening if they have been previously immunised against hpv (human papilloma virus) generally in secondary school in year 2, some 12 years earlier. the hpv vaccine was introduced in 2008 and is designed to protect against the two types of high risk hpv which cause approximately 75% of all cervical cancer. advice to all eligible women who have been vaccinated remains that participation in cervical screening is necessary to provide the most comprehensive protection against cervical cancer, as the current vaccine does not provide protection against all high risk cancer causing strains of hpv. research from other screening programmes has also shown that where individuals engage with a screening programme from the start, they are more likely to continue to participate in screening for as long as they are eligible. "intending to, but not getting round to it", is the reason most associated with non-response to cervical cancer screening invitations. ggc serves approximately 40% of the total scottish population and therefore testing the reminder in the ggc population provides an opportunity to compare the impact of the sms text reminder in this cohort with management as usual within the remainder of the scottish eligible population. this should enable us to identify whether use of a reminder sms text message is in fact likely to add value and increase participation in cervical screening.

Eligibility criteria:
inclusion criteria: * all women aged under 30 years who are eligible for cervical screening with a chi number and registered with a gp in the nhs greater glasgow and clyde area. exclusion criteria: * women have do not have a cervix

Keywords: population screening
a study to learn how the study medicine danuglipron is taken up into the blood and if danuglipron changes how the body processes other study medicines (atorvastatin and rosuvastatin) in healthy adults who are overweight or obese

Conditions: Obesity

Summary: the purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese: * how the study medicine, danuglipron, is taken up into the blood * if the study medicine, danuglipron, changes how the body processes other study medicines (atorvastatin and rosuvastatin) * about the safety and tolerability of danuglipron the study will take place in 4 cohorts (groups). the total number of weeks of the study is about 23 (about 6 months) for cohort 1 and 22 weeks (about 5.5 months) for cohort 2, 21 weeks (about 5 months) for cohort 3 and 20 weeks (about 5 months) for cohort 4.


Eligibility criteria:
key inclusion criteria: * 18 to \< 65 years of age * body mass index (bmi) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb) key exclusion criteria: * evidence or history of any clinically significant medical conditions or laboratory abnormality * any condition possibly affecting drug absorption * known intolerance/hypersensitivity to a glp-1r agonist and/or known hypersensitivity or contraindication to atorvastatin (cohort 1 and 3 participants) or rosuvastatin (cohort 2 and 4 participants)

Keywords: overweight obesity danuglipron glp-1 drug-drug interaction overtly healthy atorvastatin rosuvastatin
a multi-domain approach for the characterization and early diagnosis of neurodevelopmental disorders

Conditions: Neurodevelopmental Disorders

Summary: diagnosis and characterization of neurodevelopmental disorders are considered challenging processes because of their complexity, multi-factoriality and heterogeneity. the present project will consider two of the most common neurodevelopmental disorders (i.e. autism spectrum disorders (asd) and language disorders (ld)), with the aim to overcome these difficulties, by: a) deeply investigating their neuronal correlates; b) identifying multi-domain biomarkers (electrophysiological, genetic, environmental and clinical); c) developing a machine learning algorithm for early diagnosis. to achieve the above mentioned aims a multi-domain dataset will be used, comprising data collected from typically developing infants, infants at high risk for asd and infants at high risk for ld. the data that will be used have been already collected within other trials performed at the scientific institute e. medea.


Eligibility criteria:
inclusion criteria: * apgar scores at birth at 1' and 5' \> 7; * newborn screening otoacoustic emissions in the norm; * absence of neurological disorders; * italian as the language mainly spoken in the family nucleus. exclusion criteria: * apgar scores at birth at 1' and 5' \<= 7; * newborn screening otoacoustic emissions not in the norm; * presence of neurological disorders; * non-italian native speaker

Keywords: neurodevelopmental disorder eeg multi-domain data machine learning
genetic polymorphism and oros-methylphenidate treatment in attention deficit hyperactivity disorder(adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to examine whether genetic polymorphisms in drug transporters were associated with the side effects of oros-methylphenidate medication in attention deficit/hyperactivity disorder(adhd).

20 to 30% of children with attention deficit/hyperactivity disorder(adhd) do not respond or could not tolerate methylphenidate treatment. drug transporters such as multidrug resistant proteins(mdr) plays important role in the clearance of psychotropic drugs and their metabolites from brain tissue. it suggested that methylphenidate was a p-glycoprotein(encoded by mdr1 gene)substrate and showed inhibitory effects on the p-glycoprotein efflux function. single nucleotide polymorphisms(snp)in the mdr1 gene were analyzed in children and adolescents with oros-methylphenidate treatment. the hypothesis is that mdr1(abcb1) polymorphisms are associated with the side effects of oros-methylphenidate.

Eligibility criteria:
inclusion criteria: * adhd * must be able to swallow a capsule exclusion criteria: * pervasive developmental disorder * mental retardation * psychotic disorder * bipolar disorder * suicidality * neurological disorder * concurrent psychiatric treatment

Keywords: methylphenidate adhd multidrug resistance(mdr)polymorphism oros methylphenidate