Kornimate/medical-research-clean huggingface dataset:
biomarker discovery in lung cancer - malaysia

Conditions: Lung Cancer

Summary: this study aims to 1. identify biomarkers and signatures to differentiate between high-risk and lung cancer patients. 2. discover blood-based biomarkers that can be used as an adjunct test to imaging diagnosis to improve patient follow-up.

with existing evidence showing the utility of using liquid biopsy for early cancer detection, the investigators hypothesized that cell-free dna and/or rna expression changes during disease progression, and biomarker signature can be derived from the changes in expression levels. the investigators aim to discover and validate rna and methylated cell-free dna cancer biomarkers that can discriminate between high-risk and lung cancer patients.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 30 and above. * no previous history of any cancers. * able to provide x-ray and/or ldct results. * have either copd or pulmonary nodules measuring less than 11mm, or deemed not for biopsy by attending physician * willing to go back for a follow-up x-ray or ldct scan in the next clinical follow up as per standard of care. * willing to provide up to 30ml of blood in month-0 (first visit) and up to 21ml in the next standard of care follow up visit (second visit). exclusion criteria: * subject has received chemotherapy or radiotherapy for cancer treatment, and any other cancer-related treatment. * subject is pregnant or lactating (self-declaration). * subject is unwilling or unable to provide signed informed consent
dose response study of va106483 in males with nocturia and benign prostatic hypertrophy (bph)

Conditions: Nocturia; Benign Prostatic Hypertrophy (BPH)

Summary: the purpose of this study is to establish the dose response relationship of va106483 and nocturnal urine volumes in a population of elderly male subjects with benign prostatic hypertrophy (bph) who are likely to present with nocturia.

va106483 is a selective vasopressin v2-receptor (v2-receptor) agonist that is being developed for the treatment of nocturia. the antidiuretic effect of v2-receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and nocturia. nocturia, defined as waking to void at least once per night between periods of sleep, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). it is the most bothersome symptom of benign prostatic hypertrophy and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (nocturnal polyuria). correlation between nocturnal urine volume and nocturnal void frequency has been demonstrated in previous studies of v2-receptor agonists. the purpose of this study is to determine the dose response relationship of va106483 and nocturnal urine volumes.

Eligibility criteria:
inclusion criteria: * males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (bph) exclusion criteria: * administration of any investigational medicinal product (imp) within 10 weeks before entry to the study * any clinically significant concomitant medical disease, condition or abnormal laboratory test result * other protocol defined eligibility criteria may apply

Keywords: va106483 nocturia benign prostatic hypertrophy bph elderly males nocturnal voids anti-diuretic
impact of hepatic impairment on the pharmacokinetics of deferasirox.

Conditions: Hepatic Impairment

Summary: this study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.


Eligibility criteria:
inclusion criteria for those with hepatic impairment: * physical signs consistent with a clinical diagnosis of liver cirrhosis * child-pugh clinical assessment score consistent with degree of hepatic impairment * otherwise considered healthy inclusion criteria for healthy volunteers: • in good health. exclusion criteria for those with hepatic impairment: * clinically significant abnormal findings other than hepatic impairment * clinical evidence of severe ascites * history of surgical portosystemic shunt * any evidence of progressive liver disease within the last 4 weeks exclusion criteria for healthy controls: * clinical evidence of liver disease or liver injury * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result * use of any prescription medication within 1 month prior to dosing other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatic impairment adults deferasirox
avatrombopag in the treatment of pediatric immune thrombocytopenia

Conditions: Immune Thrombocytopenia; Treatment

Summary: to evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons.

immune thrombocytopenia (itp) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. itp is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. conventional treatment of adult itp includes first-line glucocorticoid and immunoglobulin therapy, second line tpo and tpo receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). eltrombopag is currently the only tpo receptor agonist with indications for pediatric immune thrombocytopenia. however, at present, the treatment response of pediatric itp is not good, and a considerable number of patients need to switched to other tpo receptor agonist, such as avatrombopag, because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons. therefore, the investigators designed this clinical trial to evaluate the efficacy and safety of avatrombopag in the treatment of pediatric immune thrombocytopenia in patients who who have been treated with eltrombopag before and switched to avatrobopag because of different reasons.

Eligibility criteria:
inclusion criteria: * age 6-18 years old (including both ends), male and female; * diagnosed with primary immune thrombocytopenia (itp); * patients who had previously received eltrombopag treatment and then converted to avatrombopag treatment because of ineffectiveness (platelet count \< 30×10\^9/l after eltrombopag treatment, or platelet count increased less than 2 times of the basic value, or bleeding) or large platelet fluctuation or due to patient preference, economic reasons and other reasons; * cardiac function of the new york society of cardiac function ≤ 2; * understand the study procedure and voluntarily sign the informed consent. exclusion criteria: * secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.; * subjects with primary disease of important organs (liver, kidney, heart, etc.), or with immune system diseases; * subjects who are known to be allergic to avatrombopag or any of its excipients; * subjects who had used rituximab within the last 3 months; * subjects who underwent splenectomy within the last 3 months； * subjects with a history of abnormal platelet aggregation that may affect the reliability of platelet count measurements； * any medical history or condition that the investigator deems unsuitable for participation in the study.
can work be organized to become more health promoting for employees in home care services?

Conditions: Occupational Exposure; Musculoskeletal Pain; Work-related Injury; Low Back Pain; Shoulder Pain; Neck Pain

Summary: this is a two-group, cluster randomized controlled trial designed to assess a health promoting intervention in the home care sector. the intervention aims to evenly distribute the patients requiring high levels of demanding care across all workers on the units, which may lower the working strain and thus the incidence of musculoskeletal pain. the two groups in the study will be a control group and an intervention group. the intervention will last for approximately 4 months.

this is a two-group cluster randomized controlled trial to compare an organizational intervention to control. the home care units will be treated as clusters to avoid contamination within units. control group: no intervention, their work will continue as usual without any instructions from researchers. intervention group: the intervention will consist of the operational managers distributing the physically strenuous shifts evenly between the workers in each home care unit. this will be achieved using a tool developed in microsoft excel which gives an overview over how much strain we expect each shift to have and gives a score on how well the operational manager distributes the strain between employees. the intervention will last for approximately 4 months, depending on duration of pre and post measurements.

Eligibility criteria:
inclusion criteria: * home care worker in one of the included home care units in trondheim municipality. * more than or equal to 50% working position at the home care unit. exclusion criteria: * physically incapable of performing day to day tasks. * any illness during the measurement week * pregnancy
gut microbiota dysbiosis and translocation during ibd and parkinson

Conditions: Inflammatory Bowel Diseases; Parkinson Disease

Summary: inflammatory bowel diseases (ibd) and parkinson disease (pd) are complex and multifactorial pathologies. gut microbiota seems to play an active role. indeed the digestive microbiota of patients with ibd or pd exhibits different compositions compared with asymptomatic subjects. bacterial translocation from gut to blood has been reported.

the investigators designed a case-control study to investigate the digestive microbiota and bacterial translocation during ibd and pd. the investigators want to evaluate gut microbiota bacteria involved in dysbiosis and bacterial translocation during ibd and pd. the investigators want to identify bacterial populations that can serve as biomarkers for clinical practice.

Eligibility criteria:
inclusion criteria: * pd patients : age \< or = 60 years * asymptomatic subjects : no chronic disease * asymptomatic subjects : no treatment exclusion criteria: * severe anemia (hb\<7g/l) * people who don't read french * pregnant women * people treated by antibiotic, probiotic or prebiotic during the 2 month before inclusion * people with any diagnosed or treated pathology

Keywords: gut microbiota bacterial translocation
oracle: a long-term follow-up study to evaluate the safety of gt005 in participants with geographic atrophy secondary to age-related macular degeneration treated in a gyroscope-sponsored antecedent study

Conditions: Age Related Macular Degeneration (AMD)

Summary: the purpose of this study is to evaluate the long-term safety of gt005 in participants with geographic atrophy (ga) secondary to amd who have been treated in an antecedent study.

this is a prospective, multi-centre, long-term, follow-up study for participants who have previously received gt005 in one of the antecedent clinical studies which were prematurely terminated gt005-01 (focus), gt005-02 (explore) or gt005-03 (horizon). participants from gt005-01 (focus) study with only 1 last study visit to be conducted (week 240) will remain in the study to complete their last visit. no investigational product will be administered within this study, and participants will be invited to enter oracle upon their completion or termination of the antecedent interventional study (whichever is soonest). this study will consist of up to three study visits prior to week 96, and up to five study visits thereafter, for an overall period of 5-years post-gt005 administration.

Eligibility criteria:
inclusion criteria: 1. able and willing to give written informed consent 2. received gt005 in an antecedent study, gt005-01 (focus, nct03846193), gt005-02 (explore, nct04437368) and gt005-03 (horizon, nct04566445) 3. willing to attend study visits and complete the study procedures.

Keywords: geographic atrophy retinal disease retinal degeneration macular atrophy dry age-related macular degeneration macular degeneration age-related macular degeneration (armd) retina damage dry macular degeneration amd
motor learning of stroke patients in virtual environments

Conditions: Stroke; Stroke Sequelae

Summary: the aim of this study is to assess the motor learning of patients with chronic stroke in virtual environments. half the patients will undergo conventional therapy and half virtual reality training using virtual game. the study will also include healthy individuals matched for age, sex, schooling and hand laterality.

stroke is the main cause of long-term disability in adults and motor learning is vital for recovering from motor sequelae. a number of approaches have been proposed to promote motor learning, including virtual reality, which simulates a real world environment and is based on the assumption that skills acquired in a virtual world will be transferred to the real world. virtual reality induces use-dependent plastic changes in response to stimulation of higher motor areas, recruiting the memory system containing stored motor programs. as such, these interactive interventions of virtual reality are based on the idea that stimulating the action processing system activates the cortical areas involved in movement execution. these game characteristics allow activation of the mirror neuron system during the execution or observation of actions. recent evidence suggests an important role for this neuron system in the improvement or motor recovery of patients. in this respect, observing an action in association with physical training may enhance the effects of motor training on the recovery of patients with stroke.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with the first episode of stroke, confirmed by medical imaging examination, unilateral brain injury, lesion time of at least 6 months; * right-handed and able to complete the assessment instruments; * individuals with affected upper limb movement skills, such as drinking water from a glass; * subjects able to remain in the orthostatic position, with or without gait assistive device. exclusion criteria: * unilateral neglect and uncorrected primary auditory or visual impairment.

Keywords: cerebrovascular disorders upper extremity paresis electroencephalography psychomotor performance
coxib-inhibition of duodenal polyp growth in fap

Conditions: Duodenal Polyposis

Summary: preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. the hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of fap patients.


Eligibility criteria:
inclusion criteria: * fap patient with previous colectomy and confirmed polyposis exclusion criteria: * pregnancy * malignancy * nsaid hypersensitivity
prophylactic early pn in hpt/bmt

Conditions: Hematologic Neoplasms

Summary: supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant.

a standard parenteral nutrition solution will be used. the parenteral nutrition solution will be given once daily, and infused intravenously. the standard parenteral nutrition solution will contain approximately 40 grams of amino acids/l, 40 g lipids/l and 100g dextrose/l). nutritional targets will be measured using indirect calorimetry where available, or calculated via the harris benedict or schofield equations. the dose of parenteral nutrition administered will be determined by the treating dietitian, treating physician or treating research team. the parenteral nutrition dose given will be individualised considering the patients clinical condition and body weight. the dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake. supplemental parenteral nutrition will be discontinued when a patient is well enough to be discharged from hospital or when the patients attending clinician determines a central line is no longer needed for standard care. there is no maximum duration of supplemental parenteral nutrition.. adherence to the study intervention will be monitored via medical chart reviews during site monitoring visits, and data queries on individual patient case report form documentation.

Eligibility criteria:
inclusion criteria: * patients who are about to commence conditioning chemoradiotherapy for allogeneic haematopoietic progenitor/stem cell transplantation, who have a haematological malignancy, who are not meeting 80% of their caloric needs via oral or enteral intakes, and who are not malnourished. exclusion criteria: * patients who are already receiving parenteral nutrition at time of screening. * patients with a documented licensing contraindication to parenteral nutrition.
feasibility and acceptability study of an individual-level behavioral intervention for individuals with acute and early hiv-infection

Conditions: Acute HIV Infection

Summary: the purpose of this study is to evaluate the acceptability and feasibility of an enhanced, individual-level counseling intervention for individuals in the acute and early phase of hiv infection aimed at reducing risk behaviors.


Eligibility criteria:
inclusion criteria: * be enrolled in chavi 001 note: the inclusion and exclusion criteria for chavi 001 are provided below. the criteria will not be reassessed prior to enrollment in hptn 062. * inclusion criteria from chavi 001 * men and women aged ≥ 18 years at the time of screening. * able and willing to provide adequate information for locator purposes. * hemoglobin \> 10.0 g/dl. * willing to receive hiv test results. * not intending to relocate out of the area for the duration of study participation and does not have a job or other obligations that may require long absences from the area. * has acute hiv infection. (see section 2.3 for definition). exclusion criteria: * any prior or current use of antiretroviral therapy (art). this does not apply to individuals screening for group 1a. art use for the prevention of perinatal transmission may be waived after prior consultation with the protocol team. * previous or current participation in a hiv vaccine study. hptn 062 version 3.0 final 03 august 2010 * any condition that, in the opinion of the investigator of record, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
cohort study of respiratory illness in early childhood

Conditions: Lung Diseases

Summary: to analyze previously collected data on respiratory illness in early childhood.

background: the study built on a previous study funded by the health effects institute, a non-profit foundation jointly supported by the u.s. environmental protection agency and vehicle manufacturers. the previous study was a prospective cohort study of nitrogen dioxide (no2) exposure and respiratory symptoms and illnesses during the first 18 months of life. between january, 1988 and june, 1990, 1,315 infants were enrolled and then followed with collection of daily respiratory symptom data and serial monitoring of no2 concentrations in their homes. the full protocol was completed by 823 subjects and a total follow-up experience of over one-half million days was accumulated. follow-up ended in december, 1991 and analyses related to the study's principal focus, the health effects of no2, was completed during the fall of 1992. design narrative: the analyses were directed at the following: 1) time spent in day-care and the incidence and severity of respiratory illnesses; 2) breast-feeding and the incidence and severity of respiratory illnesses during the first six months of life; 3) determinants of wheezing and wheezing illnesses; 4) determinants of a physician-diagnosis of asthma; 5) exposure to woodsmoke and incidence and severity of respiratory illnesses; 6) household demographics, including ethnicity, and incidence and severity of respiratory illnesses; 7) determinants of the duration of respiratory illnesses; 8) the validity of retrospective parental reports of respiratory illness; 9) parental perceptions of the risks of indoor and outdoor air pollution; 10) clinical findings on assessment of ill children in the community.

Eligibility criteria:
no eligibility criteria
prevalence and burden of nausea and vomiting in pregnant women

Conditions: Nausea Gravidarum; Vomiting of Pregnancy

Summary: on february 25th, 2019, italfarmaco launched nuperal® in italy, an association of doxylamine succinate and pyridoxine hydrochloride authorized by aifa for the symptomatic treatment of nausea and vomiting in pregnancy (nvp). this drug is also recommended as first choice drug therapy by the american college of obstetricians and gynecologists (acog) guidelines and is supported by extensive international literature. numerous epidemiological researches conducted in the us and norway have highlighted the extent of vomiting and pregnant nausea. unfortunately to date, there are no information on the prevalence of this phenomenon in italy, on its impact on women's lives and on the interaction between woman and gynecologists. the research hypothesis of the present survey is that, using a representative sample of pregnant women in italy, it will be possible to identify the prevalence and weight of nausea and vomiting symptoms during pregnancy in this country. the study is an open, non-comparative, multicenter survey and the aim is to evaluate the prevalence and weight that the symptoms of nausea and vomiting have in pregnant women in italy. the study population will include 600 women found during weeks 18-22 of pregnancy who will arrive at the three sites or will contact the investigators after the ethics committee (ec) approval.


Eligibility criteria:
inclusion criteria: * caucasian women in physiological pregnancy and between the 18th and 22nd week (time of morphological ultrasound). * women able to communicate adequately with the interviewer and understand the questionnaires. * women able to understand and who can provide valid informed consent to the survey. exclusion criteria: * twin pregnancy. * medically assisted procreation (map)

Keywords: nausea of pregnancy vomiting of pregnancy survey italy nuperal®
a scalp lotion toimprove sensitive scalp syndrome

Conditions: Alopecia; Sensitive Skin

Summary: overall, 100 caucasian subjects participated in this 6-weeks lasting study, ac5+ was applied daily. all subjects had clinically confirmed mild to moderate alopecia and self-declared sensitive scalp. instrumental assessments included trans epidermal water loss (tewl), inflammation markers, clinical assessments included the severity of erythema, inflammation and greasiness. subjective/self assessments comprised the intensity of the scalp itch/pruritus and the evaluation of their head hair status (volume, abundance, strength). same assessments were provided by the investigators.


Eligibility criteria:
inclusion criteria: * \>18 years * mild alopecia: * female: ludwig type 1 * male: hamilton iii to iv type exclusion criteria: * moderate or severe alopecia * dandruff

Keywords: alopecia sensitive skin prurit