Kornimate/medical-research-clean huggingface dataset:
drug utilization of boceprevir and clinical management of health outcomes of interest in chronic hepatitis c participants (p08518)

Conditions: Hepatitis C Chronic

Summary: this is an observational prospective follow-up study to assess the utilization of boceprevir and the management of pre-specified health outcomes of interest (hois) under conditions of routine clinical care in participants with chronic hepatitis c (chc) genotype 1. as an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. no individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. physician choice of the drug used to treat the participant is based on clinical judgment alone.


Eligibility criteria:
inclusion criteria: * documented chronic hepatitis c (chc) genotype-1 infection * untreated or failed previous therapy * initiated a new treatment regimen after the study implementation date at their site * agrees to participate in the study by giving written informed consent exclusion criteria: * taking part in a clinical trial or in any study where a participant is receiving care outside of normal clinical practice for hepatitis c virus (hcv)

Keywords: pegylated interferon boceprevir telaprevir
knowledges and use of cannabidiol in older adults

Conditions: Aging; Frailty

Summary: the use of non-medical cannabidiol (cbd) has been growing recently in france and in the world, in young but also older adults. few data are available on the use of cannabidiol in older adults. a better knowledge of the use of cannabidiol in older adults, and of their own knowledges of the molecule, is necessary to guide and follow the cbd uptake in this population and avoid potential adverse events.

cannabidiol may be used by patients because it may have beneficial pharmacological effects (including anxiolytic, analgesic, anti-inflammatories or antioxidant effects). older adults aged 65 years and over, are more frequently at risk of multimorbidity and loss of autonomy, and may present with several symptoms like pain, anxiety, sleep disturbances, that may potentially respond to cbd. the molecule is often marketed as devoid of adverse effects. nevertheless, with ageing, reduction in liver and kidney function, may have an impact on the metabolism and elimination of cbd and increase the risk of side-effect. as well, the risk of interaction with drugs frequently prescribed in older adults such as cyp3a4 inhibitors (verapamil, ketoconazole ...), cyp3a4 inducers (phenytoin, carbamazepine, ...) or cy92c19 inhibitors or inducers (fluoxetine ...), may increase the risk of side effects. our hypothesis is that the use of cbd has increased last years in older adults, but that they are insufficiently informed about this molecule. there is a need to assess the prevalence of cbd use in older adults in france, to assess the knowledges of cbd users about this substance, and to better characterize cbd users.

Eligibility criteria:
inclusion criteria: * admitted to the frailty clinic, in toulouse university hospital during the recruitment period. exclusion criteria: * major cognitive disorder with mini mental state examination \<20 * being under legal supervision or guardianship.

Keywords: older adults cannabidiol use frailty
diagnosis and staging of typhoid fever using surface-enhanced raman spectroscopy liquid biopsy

Conditions: Typhoid Fever

Summary: the goal of this project is to adapt the gold nanoparticle-based surface-enhanced raman spectroscopy (sers) technology to clinical application. in this exploratory study a measurement protocol will be established to subsequently investigate whether sers allows to diagnose patients infected with typhoid fever as well as to stage the disease.

this study on the clinical application of surface-enhanced raman spectroscopy (sers) is composed of two parts. first, a sers measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patients samples, maximizing raman spectroscopical signatures. given the complex composition of human blood, which encompasses numerous biological constituents, the study focuses on serum, a component obtained through centrifugation after the removal of cells and clotting factors. fifteen spectra will be recorded per sample. the raw spectra will be post-processed, including removal of the substrate signal, baseline correction, vector normalization, and smoothing steps. the sers measurement protocol established in the first section will subsequently be applied to samples of healthy and typhoid fever patients. the samples from infected patients will be confirmed with the widal test. multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and infected patients), allowing patient diagnosis, as well as the severity of the infection.

Eligibility criteria:
inclusion criteria: * patient at nishtar medical university * the age range of the patients was from 18 to 70 years * confirmed disease with the widal test (for typhoid fever groups) exclusion criteria: * patients with severe concurrent diseases were excluded from the study
study of the blood levels and effects of atl-962 on fat excretion in obese subjects

Conditions: Obesity

Summary: the purpose of this study is to investigate the amount of metabolites of atl-962 in the blood and to investigate the effect of atl-962 on the amount of fat that is excreted in the faeces in subjects who are obese

obesity is a significant and increasing clinical problem. there is a need for effective therapeutic agents to help people reduce weight. atl-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

Eligibility criteria:
inclusion criteria: * obese, otherwise-healthy subjects * body mass index 30-45kg/m2 exclusion criteria: * women who are pregnant or breast feeding * any drug treatment within 2 weeks of commencement of dosing in this study

Keywords: obesity pharmacokinetics pharmacodynamics
radicle aces: a study of commercially available cbd used in the real-world setting

Conditions: Pain; Sleep Disturbance; Anxiety

Summary: a randomized, open-label study of commercially available, orally ingestible, cannabidiol (cbd) products used in the real-world setting for pain, sleep, and anxiety.

radicle aces is a real-world evidence study that aims to determine the effect of cbd on overall well-being, anxiety, sleep, and pain over a 28-day period in treatment groups compared to a waitlist control group.

Eligibility criteria:
inclusion criteria: * participants must be 21 years of age * live in the usa * endorse symptoms of anxiety, chronic pain, or sleep disturbances as a primary reason for taking a cbd product * must have regular access to a computer, mobile device, and/or the internet to complete surveys exclusion criteria: * a person pregnant, trying to become pregnant or breastfeeding * anyone diagnosed with liver disease or considered a heavy drinker * anyone taking medication that warns against grapefruit consumption
evaluation of the diagnostic value of micrornas for inflammatory bowel diseases

Conditions: Ulcerative Colitis; Crohn Disease; Healthy; Non-IBD Colitis

Summary: the purpose of this study is to assess the diagnostic value of micrornas in ibd colon (ulcerative colitis or crohn's disease) in adults as compared to healthy controls (and non-ibd colitis)

rational inflammatory bowel disease (ibd) affects more than 200,000 people in france and 1.5 million in europe. difficulties in the management of ibd are related to the need for invasive tests for the diagnosis of ibd (endoscopy), partly explaining the delay in diagnosis, and the inability to distinguish early colonic crohn's disease of ulcerative colitis (uc) in 10-30% of cases. recently, we identified real-time polymerase chain reaction (pcr), from healthy colonic mucosa of ibd patients, a molecular signature of ibd involving 10 microrna (mirna) common (mir26a, mir29a, mir29b, mir126 \* mir15a, mir127-3p, mir324 -3p, mir30c, mir185, mir196a) and 15 colic chronic disease (mc) and ulcerative colitis (rch) discriminating microrna (mir-142-3p, mir-142-5p, mir-146a, mir-146b-5p, mir150, mir-181d, mir-182, mir199a -3p, mir199a-5p, mir199b-5p, mir-203, mir223, mir-299-5p, mir320a, mir-328). type of study : multicenter diagnostic evaluation study main purpose of the study : to evaluate the diagnostic value of microrna in colonic ibd (ulcerative colitis or crohn's disease) in adults as compared to healthy controls (and non-ibd colitis) secondary objectives : * assess the ability of microrna to discriminate a colic chronic disease (mc) of ulcerative colitis (rch) in adults * evaluate the diagnostic value of microrna in inflammatory colitis child * explore the possibility of measuring mirna of interest in the stool products of the study diagnostic kit of ibd in quantitative polymerase chain reaction (qpcr) number of patients : 6 groups of 50 patients each will be included * group 1: crohn adult colic * group 2: ulcerative colitis (rch) adults * group 3: witnesses healthy adults * group 4: witnesses adults with non-ibd inflammation * group 5: children with colitis * group 6 : witnesses healthy children inclusion length 30 months duration of the study 30 months

Eligibility criteria:
inclusion criteria : * target population : patients (children and adults), man or woman, suffering from crohn's disease with colonic involvement or ulcerative colitis according to the criteria of the european consensus (ecco 2010) * control population: healthy subjects and any non-crohn's colitis or ulcerative colitis * having a colonoscopy examination indication, * who signed the consent form (for adults and signed parental consent obtained for patients minors) exclusion criteria: * no health insurance , * mental disability, * pregnancy

Keywords: micrornas ibd crohn's disease ulcerative colitis colonic polyps screening controls
failure to adjuvant therapy after pancreatic resection for pancreatic cancer

Conditions: Pancreatic Malignant Neoplasm Primary

Summary: this study aims to evaluate the rate of patients submitted to pancreatic resection for pancreatic cancer, who fail to access to adjuvant therapy or do not complete adjuvant therapy. the purpose is to give an overview concerning the most frequent conditions and/or reasons associated with failure or omission of adjuvant therapy.

this prospective observational study will evaluate all patients submitted to pancreatic resection for pancreatic cancer. the rate of omission to adjuvant therapy and rate of failure of completion of adjuvant therapy will be evaluated as primary outcomes. as secondary outcomes, survival analyses will be performed to investigate whether these factors influence prognosis, that will be evaluated through a disease free survival analysis at 18-months. epidemiological and perioperative data will be analyzed to identify conditions associated with the primary outcomes.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of pancreatic cancer exclusion criteria: * non exocrine pancreatic tumors * periampullary malignancies

Keywords: failure adjuvant therapy
skin fibrosis analysis by raman spectroscopy in systemic sclerosis

Conditions: Validation of Raman Spectroscopy Usefulness in Systemic Sclerosis

Summary: systemic sclerosis (ssc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. most of patients develop skin fibrosis gradually spreading. two clinical distinct forms are described according to the extension of skin fibrosis: limited (lssc) and diffuse (dssc) ssc. it is now admitted that a spreading of skin fibrosis is associated with poor prognosis. this disease can be complicated by pulmonary arterial hypertension (pah), interstitial lung disease (ild) and scleroderma renal crisis (src) representing the main causes of death in ssc. usually, pah is associated with lssc, and ild and src are associated with dssc. prognosis is also different regarding skin phenotype with a higher mortality rate in dssc. an easy score, called modified rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. ultrasound can be used to measure skin thickness and is more reproducible than the rodnan skin score. nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics. thus, in this study we will investigate raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.

raman spectroscopy will be performed on patients with ssc, according to the acr criteria, and control patients without ssc, on 3 different areas of the skin. patients with ssc and controls will be matched by gender and age. these measures will be performed at 6 months, 12 months, 24 months and 36 months.

Eligibility criteria:
inclusion criteria : * patients with ssc, according to acr criteria * older than 18-years-old exclusion criteria : * younger than 18-years-old * patient protected by law

Keywords: systemic sclerosis raman spectroscopy
the effectiveness of distance yoga learning in improving ma-ternal pandemic-related depression and stress during pregnancy

Conditions: Pregnancy Related

Summary: the goal of this quasi-experimental study design is to explore the effects of distance yoga learning in improving depression and pregnancy stress in pregnant women during the pandemic disease. the main questions which aim to answer are: 1. hypothesis1 - distance yoga learning can decrease depression during pregnancy. 2. hypothesis2 -distance yoga learning can decrease pregnancy stress. the experimental group received a 12-week pregnancy yoga program, including one weekly 60-minute distance yoga class and followed by 2 times of dvd yoga exercise at home while the control group received only routine nursing care.

this is a quasi-experimental study design for primiparous women in the obstetrics and gynecology department of a regional hospital as the research subjects. this study received ethical approval from the hospital and all participants provided written informed consent. after the researcher took convenience samples and explained the research purpose in the prenatal parent classroom, they were assigned to the experimental group and the control group according to the wishes of the cases. pregnant women in the experimental group received routine prenatal care guidance and yoga exercises three times a week, while the control group only received routine pre-natal guidance and the differences between the two groups were compared. the sample size was estimated using g-power 3.1.9.2 software. the sample size was estimated to be 52 participants. assuming the attrition rate was 20%, there were 32 people in the experimental group and the control group making a total of 64 participants. during the study, one participant in the experimental group had premature delivery due to early water rupture, and the other one was hospitalized for tocolysis due to frequent uterine contractions and therefore withdrew from the experiment, resulting in a loss of 2 samples. for control group, one participant was admitted to the hospital for tocolysis due to prepartum hemorrhage and was withdrew from the study. therefore, a total of 61 participants completed the study .

Eligibility criteria:
inclusion criteria: * first-time mothers between 20 and 26 weeks of pregnancy. * normal fetus with a singleton. * no history of smoking, drinking, or drug abuse. * no bleeding during pregnancy. * no related high-risk complications during pregnancy (such as high blood pressure, preeclampsia, gestational diabetes, heart dis-ease, etc.). * no early abortion symptoms. * able to move normally. * able to listen, speak, read and write chinese. * able to participate in the research and cooperate in completing the questionnaire. exclusion criteria:exclusion conditions (any one) * multiparous women. * first-time mothers with pregnancy \>26 weeks. * multiple births. * symptoms of bleeding or early miscarriage. * related high-risk pregnancy complications.

Keywords: distance yoga pandemic depression and stress pregnancy
ph2 open-label study of aoc 1044 in duchenne muscular dystrophy participants with mutations amenable to exon44 skipping

Conditions: DMD; Duchenne Muscular Dystrophy; Duchenne; Exon 44

Summary: aoc 1044-cs2 (explore44-ole) is an open-label study to evaluate the long-term safety and tolerability of aoc 1044 administered intravenously to dmd participants with mutations amenable to exon 44 skipping.

aoc 1044-cs2 (explore44-ole) is an open label, extension study to part b of aoc 1044-cs1 (explore44). aoc 1044-cs2 is designed to evaluate the long-term safety, tolerability, pharmacokinetics, and exploratory efficacy of aoc 1044. all participants who enroll in aoc 1044-cs2 will receive active treatment. the treatment period is 2 years with iv dosing every 6 weeks. once participants have completed active treatment, they will be followed through a 3-month safety follow-up period. the sponsor may extend active treatment beyond 2 years at a future timepoint.

Eligibility criteria:
key inclusion criteria rollover participants: * satisfactorily completed aoc 1044-cs1 (explore44) as determined by the investigator and sponsor * no significant tolerability issues with aoc 1044 de novo participants: * aged 7 to 27 years, inclusive, at the time of informed consent * clinical diagnosis of dmd or clear onset of dmd symptoms at or before the age of 6 years * confirmation of dmd gene mutation amenable to exon 44 skipping * weight ≥ 23 kg * ambulatory or non-ambulatory * ambulatory participants: lvef ≥50% and fvc≥50% * non-ambulatory participants: lvef ≥45% and fvc≥40% * pul 2.0 entry item a ≥3 * if on corticosteroids, stable dose for 30 days before screening and throughout the study key exclusion criteria rollover participants: * presence of any new condition or worsening of existing condition that could affect a participant\&#39;s safety or ability to comply with study procedures de novo participants: * serum hemoglobin \&lt; lower limit of normal * uncontrolled hypertension or diabetes * prior treatment with any cell or gene therapy * prior treatment with another exon 44 skipping agent within 6 months prior to informed consent * recently treated with an investigational drug * history of multiple drug allergies

Keywords: explore44 explore44-ole explore44 ole avidity biosciences avidity aoc 1044 aoc 1044-cs1 aoc 1044-cs2 aoc
adressing ptsd symptoms and aggressive behavior in vulnerable children in burundi

Conditions: Posttraumatic Stress Disorder; Aggressive Behavior

Summary: children either living in the streets of bujumbara or that are similarly affected by extreme poverty or violence are regularly exposed to traumatic events. additionally, they often find themselves in situations where engaging in violent behavior appears to be useful or even necessary for survival. the narrative exposure therapy for violent offenders (fornet) aims to reduce both ptsd symptoms and aggressive behavior. it helps the children to anchor fearful experiences and potential positive emotions linked to violent behaviour in the past. additionally, visions for the future are developed in order to enable reintegration into the family. the investigators want to provide evidence, that fornet effectively reduces ptsd symptoms and ongoing aggressive behavior which in change facilitates reintegration into society.


Eligibility criteria:
inclusion criteria: * high degree of symptoms of posttraumatic stress disorder according to ucla ptsd reaction index exclusion criteria: * psychotic symptoms
a multiple dose study of ly3209590 in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to measure the activity and insulin time action of ly3209590 at steady state in participants with type 2 diabetes mellitus. the total study duration is approximately 182 days.


Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes (t2dm). * participants who are insulin naive or receiving basal insulin \[nph (neutral protamine hagedorn) once or twice daily, once-daily insulin glargine u100 or u300, once-daily insulin degludec, or insulin detemir once or twice daily\] for fewer than 5 years prior to screening. * have glycated hemoglobin (hba1c) of ≥7.0 percent (%) to ≤9.5%, hba1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or sodium-glucose transport protein 2 inhibitors who require washout. * have a body mass index between 27 and 40 kilograms per meter square. * male or female participants who are willing to comply with the contraception requirements consistent with local regulations. * be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol. exclusion criteria: * have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study. * have a specific type of diabetes other than t2dm. * have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of hba1c. * participants with a history of kidney complications.

Keywords: clamp diabetes, type 2
glioblastoma evaluation for heterogeneity in radiosensitivity

Conditions: Glioblastoma

Summary: this is an observational study on gbm surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular the investigators will assess if there is a correlation between the number of the phosphorylated h2ax nuclear foci and the different dose level of radiation therapy.

standard of care for newly diagnosed glioblastoma (gbm) patients consists of surgical resection followed by radiotherapy with concurrent and adjuvant temozolomide chemotherapy. despite these treatments, the prognosis remains poor. nevertheless, preliminary data on gbm patients show variable outcomes related to a different treatment response, that could be related to the gbm intrinsic heterogeneity, but also to a different patient sensitivity to radiation therapy. the assessment of this individual radio-sensitivity may provide valuable data to define more tailored treatment schedules, that could potentially be more effective. published studies on small cohort of patients show that a possible system to investigate the tumor radiation sensitivity, is to monitor the cellular dna damage after tissue irradiation, that correlates with the survival fraction of in vitro tumor cells; the dna damage could be identified through the quantification of phosphorylated histone h2ax nuclear foci that correlate with the unrepaired dna double strand breaks (dsbs). based on this background, the investigators designed an observational study on gbm surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular they will assess if there is a correlation between the number of the phosphorylated h2ax nuclear foci and the different dose level of radiation therapy.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years * patients eligible for diagnostic or therapeutic surgical procedure * written informed consent * histopathologically confirmed newly diagnosed glioblastoma according to who 2021 * availability of fresh tissue samples exclusion criteria: * other extra-cranial cancer * non gbm glioma * previous brain radiation therapy