Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of ledipasvir/sofosbuvir fixed-dose combination in adults with chronic hcv and hbv coinfection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) in adults with chronic genotype 1 or 2 hcv infection who are coinfected with hbv in taiwan.


Eligibility criteria:
key inclusion criteria: * individuals ≥ 40 kg in weight with chronic genotype 1 or 2 hcv and hbv coinfection * individuals must not be taking or requiring treatment with hbv antiviral therapy at screening. for participants that are hbv treatment experienced, the most recent treatment must have been completed at least 6 months prior to day 1. * cirrhosis determination by fibroscan * screening laboratory values within defined thresholds * use of two effective contraception methods if female or male is of childbearing potential key exclusion criteria: * current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * pregnant or nursing female * infection with human immunodeficiency virus (hiv) or hepatitis delta virus (hdv) * hepatocellular carcinoma (hcc) or other malignancy * current or prior history of clinical hepatic decompensation note: other protocol defined inclusion/exclusion criteria may apply.
lipoprotein and apolipoproteins with metabolic liver diseases

Conditions: Disorders of Lipoprotein Metabolism and Other Lipidaemias

Summary: theranostic translation applications against viral, metabolic liver diseases and hepatic oncogenesis: lipoprotein and apolipoproteins at a crossroad

an intimate link between microbial infections, metabolic changes and oncogenesis has been drawn attentions increasingly, indicating a crossroad leading to pathogenesis and disease progression. globally the burden of hepatitis b and c virus infections is 450 and 185 millions, respectively and chronic hepatitis disease causes a high risk of liver cirrhosis, hepatocellular carcinoma and metabolic disorders

Eligibility criteria:
inclusion criteria: 1. above 20 years 2. nonalcoholic fatty liver disease 3. non-alcoholic steatohepatitis exclusion criteria: 1. alcohonic hepatitis 2. autoimmune liver disease 3. hiv postive -

Keywords: lipoprotein and apolipoproteins metabolism
combining advances in imaging with biomarkers for improved diagnosis of aggressive prostate cancer

Conditions: Prostate Cancer

Summary: to enable the paradigm of mp-mri before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic mri and by improving the performance of the mp-mri itself

patients will undergo an advanced diffusion-weighted mri sequence called verdict with the intention of better characterising prostate cancer. a panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive mri. objectives: * to establish a fluidic marker - prostate mri paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) mri * enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes * assess the repeatability of verdict mri * ascertain whether verdict derived quantitative parameters correlate with quantitative histological parameters * develop a database of fluidic marker and verdict characterised, mp-mri, histologically validated patients for subsequent exploratory and longitudinal outcome analysis

Eligibility criteria:
inclusion criteria: * men referred to university college london hospital (uclh) for prostate mp-mri following biopsy elsewhere and biopsy naive men presenting to uclh with a clinical suspicion of prostate cancer. exclusion criteria: * men unable to have a mri scan, or in whom artefact would reduce quality of mri * men unable to given informed consent * previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer * on-going hormonal treatment for prostate cancer * previous biopsy within 6 months of scheduled mp-mri

Keywords: mri magnetic resonance imaging biomarkers fluidics diffusion mri
a study of bms-986504 in participants with pre-treated advanced or metastatic non-small cell lung cancer (nsclc) with homozygous mtap deletion

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to evaluate the safety and efficacy of bms-986504 monotherapy in participants with advanced or metastatic non-small cell lung cancer (nsclc) with homozygous mtap deletion after progression on prior therapies.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of nsclc and homozygous mtap deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central mtap status confirmation. * advanced or metastatic nsclc not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the american joint committee on cancer, ninth edition). * at least 1 measurable lesion as per recist v1.1. * documented radiographic disease progression on or after the most recent line of treatment. * eastern cooperative oncology group (ecog) performance status of 0-1. * participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the icf. * capability to swallow tablets intact (without chewing or crushing). exclusion criteria: * active brain metastases or carcinomatous meningitis. * history of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. * prior treatment with a prmt5 or mat2a inhibitor. * known severe hypersensitivity to study treatment and/or any of its excipients. * other protocol-defined inclusion/exclusion criteria apply.
the effect of probiotic supported yogurt consumption on gastrointestinal symptoms

Conditions: Gastrointestinal Dysfunction

Summary: probiotics have beneficial effect on gastrointestinal symptoms. the aim of this study is to determine the effect of probiotic yogurt consumptions on the people who have gastrointestinal symptoms mainly constipation.

in the beginning of the study constipation severity scale and bristol stool scale was applied to the all people who accepted to participate in this study. according to the student t test analysis (α= 0.05, β=0.20 ) 102 people with gastrointestinal symtoms should be included in the study. when 102 people are found with gastrointestinal symptoms second stage of the study will begin. in this stage of the study 102 people are randomly divided into 2 homogeneous groups. 3 day food record will be taken from 102 people at the beginning and again at the end of the study. probiotic yogurt (activia probiotic yogurt without any aroma-125 g) will be given to one group for 1 month and nothing will be given to the other group (control group).

Eligibility criteria:
inclusion criteria: * living in izmir * individuals who are having bmi between 18.5-24.9 kg / m2 * having gastrointestinal symptoms according to constipation severity scale and bristol stool scale exclusion criteria: * having diagnosed gastrointestinal disease * regular consumption of probiotic * using of drug that affects gastrointestinal system * presence of mental illness

Keywords: probiotic, gastrointestinal symptoms, constipation
intake care: development and validation of an innovative, personalized digital health solution for medication adherence support in cardiovascular prevention

Conditions: Hypertension; Treatment Adherence and Compliance; Digital Health

Summary: inadequate medication adherence (ma) in chronic conditions, including cardiovascular prevention, represents an important risk factor. the use of new it technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of personalization and reliance on expensive ad hoc systems. this interdisciplinary project aims to verify the hypothesis that in patients on chronic antihypertensive treatment ma can be improved through the implementation of a novel digital health solution for ma monitoring and support, based on inexpensive and user-friendly, commercially available technology (voice assistant), connected with web interface for the physician. the intervention will be personalized based on the creation of personas, intended as multidisciplinary-based representations of different user types. this approach will be tested in a randomized clinical trial.


Eligibility criteria:
inclusion criteria: * adult (\>18 years old) patients * history of essential hypertension * treatment with at least one antihypertensive drug for which dedicated plasma essay is available * wireless internet connection available at patients' home * stable clinical conditions * written informed consent exclusion criteria: * insufficient technological literacy to manage vocal assistant * dementia or significant psychiatric disorders * conditions significantly limiting vocal communication (deafness, significant speech disorders, poor knowledge of italian language) * pregnancy or breastfeeding * active cancer (except basal cell skin carcinoma) * upper limb amputation

Keywords: personalized medicine
study of camtobell inj (belotecan) on weekly schedule in non-small cell lung cancer (nsclc) patients previously treated with chemotherapy

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: a phase ii study is conducted to determine the efficacy and safety of a single agent camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. the usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.


Eligibility criteria:
inclusion criteria: * 19 years and older * histologically or cytologically confirmed locally advanced or metastatic nsclc(stage iiib or iv) * ≥ one measureable or evaluable lesion, \<25% of the bone marrow had been irradiated * prior platinum based chemotherapy * ecog ps ≤ 2 * life expectancy \> 3 months * adequate organ function: * hematology: anc ≥ 1.5×109/l, platelet ≥ 100×109/l, hemoglobin ≥ 9.0g/dl * hepatic: total bilirubin ≤ 1.5×uln, ast/alt ≤ 2.0×uln, alp ≤2.0×uln * renal: serum creatinine ≤ 1.5×uln * signed a written informed consent exclusion criteria: * active infection * symptomatic brain lesion * any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix * severe concurrent diseases * prior anticancer therapy within 4 weeks before enroll * active pregnancy test

Keywords: belotecan camtobell inj nsclc
prevalence of the victimization and the perpetration of intimate partner violence among the patients from puy-de-dôme and paris consulting or being hospitalized for addiction problems and their expectations from general practitioners (via-mg)

Conditions: Addiction; Violence, Domestic

Summary: intimate partner violence and addictions are two frequent problematics with many consequences on health. a link between intimate partner violence and addictions has been found in many studies. being a drug user increases the risk to be a perpetrator and also a victim of intimate partner violence. so, it is legitimate to question ourselves about the prevalence of the victims and perpetrators of intimate partner violence among the patients consulting or being hospitalized for an addiction problem. we believe that this prevalence will be high among these patients. on the other hand, the general practitioners are in first line receiving victims and perpetrators of violence and patients with addiction problems. so it is important to know the profiles of these patients and their expectations from their general practitioners.

the different places where the study will take place are: * 7 outpatient addiction centers: addictology consultations in chu clermont-ferrand, ch sainte-marie, ch thiers, ch ambert, anpaa (association nationale de prévention en alcoologie et en addictologie) of clermont-ferrand, thiers and ambert. * 3 hospital addiction centers: addictology hospital services of chu of clermont-ferrand, ch thiers and clémentel. this study will be based on the filling of self-answered questionnaires by the patients consulting or being hospitalized in the different recruited centers. the questionnaire will be proposed to the patient after the consultation with the practitioner. an information about the study and the anonymity will be given to the patient. the filled questionnaire will be put by the patient in a closed envelope and then in a collection box located in the waiting room. the different boxes of the different centers will be checked regularly and then the questionnaires will be analysed. the analysis of these questionnaires will allow to describe the population consulting or being hospitalized for addiction problems in the puy-de-dôme: age, gender, type of the addiction, the presence of intimate partner violence, associated factors of the violence, recourse characteristics to general practitioners and expectations of gp. we will evaluate the prevalence of victimization and perpetration of intimate partner violence among patients consulting or being hospitalized for addiction problems in the puy-de-dôme. we estimate the duration of the study at around 6 months.

Eligibility criteria:
inclusion criteria: * patient over 18, being or having been in a relationship, consulting or being hospitalized for an addiction problem * patient speaking and writing french * patient capable of giving his informed consent to take part to the study * affiliation to the social security * patient who doesn't have a tobacco addiction only exclusion criteria: * refuse to participate

Keywords: general practice intimate partner violence
ability to drive of early stage alzheimer disease

Conditions: Alzheimer Disease

Summary: the main objectives of this study are: * to evaluate the driving capacities in a population of elderly subjects with early stage alzheimer disease (ad) in a real-life situation. * define a typology of the main errors made in this population. * propose adaptive measures or technological aids that would make it possible for these patients to maintain their ability to drive a car while limiting risk.


Eligibility criteria:
inclusion criteria: the following subjects will be included and classified as " patients " : * age \> 70 years * with established diagnosis of alzheimer's disease as defined by dsm iv * with mmse score ≥ 24 (early-stage alzheimer's disease) * holder of a valid driving license * with regular driving activity (drives at least once per week) * informed consent provided. the following subjects will be included and classified as " controls " : * age \> 70 years, * absence of cognitive impaired that interferes with their daily life at initial evaluation, * holder of a valid driving license, * with regular driving activity (drives at least once per week), * informed consent provided. exclusion criteria: * dementia syndrome(s) other than alzheimer's disease, * mmse score \< 24 * informed consent not provide
the comparison of the effect of different oxytocin administrations on the blood loss during cesarean delivery

Conditions: Cesarean Section Complications; Postpartum Hemorrhage; Blood Loss, Surgical; Blood Loss, Postoperative; Postoperative Pain; Atony, Uterine

Summary: this study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section

postpartum hemorrhage (pph) is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. the average blood loss during cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery. worldwide, the most commonly used uterotonic for the prevention of pph is oxytocin. several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects. in the current study, we tested the hypothesis that initiating iv oxytocin infusion earlier before uterine incision would induce a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the same dose administered after delivery of the fetus.

Eligibility criteria:
inclusion criteria: * single fetus at term \>37 weeks of gestational age exclusion criteria: * history of previous cesarean section * history of previous uterine surgery * multiple gestation, placenta previa, polyhydramnious, fetal macrosomia * women at high risk for uterine atony such as anemia (hb \< 8 gm/dl) * uterine atony history * gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath

Keywords: oxytocin cesarean section uterine atony postpartum hemorrhage
a pilot study to assess the follow-up of prostate cancer patients who have undergone radiotherapy treatment

Conditions: Prostate Cancer

Summary: this is a pilot study assessing the role of the general practitioner in performing follow-up reviews on men who have recently completed radical radiotherapy for prostate cancer. this will be measured primarily by assessing any changes to the patient's health-related quality of life which will be evaluated by the completion of questionnaires by the participant at each review visit. the study aims to confirm that patient outcome is identical, independent of whether follow-up is performed by a specialist or the patient's general practitioner.


Eligibility criteria:
inclusion criteria: * men with a tumour t1-3 stage prostate cancer and have had radical radiotherapy with curative intent * are between six and twelve months post-treatment completion * have completed all treatment for prostate cancer (including hormonal deprivation therapy) * have no evidence of metastatic disease * ecog performance status of between 0-1 * remains willing to comply with study requirements * has maintained contact with an individual general practitioner exclusion criteria: * persistent complications resulting from treatment defined as a minimum grade 3 treatment toxicity * unable to complete self-administered questionnaires * are currently enrolled in a study that requires specialist follow-up * life expectancy of less than 6 months * surgery to remove the prostate * evidence of biochemical failure
inadequate emergence after laparoscopic surgery in trendelemburg position

Conditions: Delayed Emergence From Anesthesia; Delirium, Cause Unknown; Confusion; Disorientation on Emergence

Summary: the purpose of this study is to determinate if the patients submitted to laparoscopic surgery in trendelemburg position develope more inadequate anaesthesic emergence than patients submitted to laparoscopic surgery in other positions.


Eligibility criteria:
inclusion criteria: * laparoscopic surgery * general anaesthesia * trendelemburg positioning * extubated in the operatory theater exclusion criteria: * unable of communicate * dementia * psychiatric history * neurosurgery * alchohol and drugs addictions

Keywords: agitation anaesthesia laparoscopy surgery delirium sedation emergence steep trendelemburg position delayed confusion disorientation
cerebral dysfunction in chronic itpwith high risk of serious bleeding excluding intracranial hemorrhage.

Conditions: Chronic Thrombocytopenia

Summary: intracranial hemorrhage despite being rare, several chronic itp patients experience moderate to severe behavioral problems including learning difficulties, memory affection .these changes could be due to the presence of minute capillary dysfunction

* first identify the presence of cognitive, behavioral and/or minimal neurological deficit in patients with chronic itp and correlate these changes with radiological evidence of minimal cns bleeding. * second investigate the correlation between these behavioral and/or minimal neurological deficits and duration, site and severity of bleeding (a total of 200 patient of persistently low platelet count \< 20x 10 9 for at least more than one month duration). * the aim is to assess the behavioral changes in chronic itp patients, and to assess the possible relation of such changes to duration and recurrence of very low platelet count as well as pattern of bleeding excluding frank intracranial hemorrhage.

Eligibility criteria:
inclusion criteria: 1. chronic itp patients with persistent platelet count \< 20 x 109/l for a period more than one month. 2. chronic itp with more than one attack of wet purpura and or internal bleeding. exclusion criteria: 1. patients' with platelet count persistently more than 40 x 109/l. 2. past history of intracranial hemorrhage. 3. past history of known neurological or psychological deficit diagnosed before onset of itp diagnosis

Keywords: chronic itp, cerebral dysfunction
multimodal assessment of sensory processing and brain features in patients with chronic orofacial pain

Conditions: Toothache; Temporomandibular Joint Disorders

Summary: this proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple mri modalities in persistent dentoalveolar pain disorder (pdap) patients with and without temporomandibular disorders (tmd). all measures from patients will be compared to painfree controls.

chronic orofacial pain disorders may present localized in the mouth such as with persistent dentoalveolar pain disorder (pdap) or widespread in the head/face/jaw such as with temporomandibular disorders (tmd). pdap pain manifests in a tooth that usually underwent root canal treatment or in the site formally occupied by such tooth, while tmd pain is usually reported over the preauricular area, jaws and temples. these commonly comorbid disorders have a significant impact on the individual and society. their mechanisms are poorly understood with evidence suggesting deficient pain modulation and abnormal brain features. pdap and tmd patients, when compared to controls, have abnormal sensory/pain processing as well as brain structural and functional differences. this proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple mri modalities in pdap patients with and without tmd. all measures from patients will be compared to painfree controls. this knowledge will support better understanding of mechanisms involved in pdap and will support development of mechanistic-based clinical treatments for the patients the investigators serve. findings from these investigations will likely contribute to our understanding of other chronic pain conditions.

Eligibility criteria:
inclusion criteria: 1. age- and handedness-matched painfree controls using frequency matching to maintain similar group averages: * no self-report of persistent pain conditions for the last 6 months; * no diagnosis of pdap or tmd; 2. pdap only: * fulfilling diagnostic criteria per nixdorf et al., 20122 * characteristic dentoalveolar pdap pain cannot be increased by pressure provocation from jaw muscle trigger points (referred pain) 3. pdap with tmd: * fulfilling diagnostic criteria for pdap2 and chronic tmd myalgia per schiffman et al. 20143 exclusion criteria: self-report: 1. chronic widespread pain 2. current use of opioids or other pain medications (e.g., ibuprofen/acetaminophen) that cannot be stopped \<3 days prior to testing 3. conditions/diseases associated with altered pain perception: neurological (e.g., multiple sclerosis, trigeminal neuralgia) psychiatric disorders, diabetes, neoplasm and cardiovascular disorders 4. injury to hands 5. substance abuse 6. mri contraindications including pregnancy