Kornimate/medical-research-clean huggingface dataset:
machine learning predicts survival and mutations in ovarian metastases of colorectal cancer

Conditions: Ovarian Metastases of Colorectal Cancer

Summary: the study aimed to develop and validate models to predict survival outcome and key mutations in patients with ovarian metastases of colorectal cancer, as well as to compare the differential gene expression between long-survival group and short-survival group.

the investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict survival outcome and key mutations from multimodality data in patients with ovarian metastases of colorectal cancer. secondly, the investigator aimed to compare the differential gene expression between long-survival group and short-survival group.

Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal cancer * unilateral or bilateral ovarian masses confirmed by peroperative imaging examination * patient requiring resection of their ovarian and/or peritoneal carcinomatosis * 18 ≤ age ≤ 85 * world health organization performance status ≤ 1 * life expectancy \> 12 weeks * adequate haematological, liver and renal function * patient information and signature of the informed consent form before the start of any treatment procedures exclusion criteria: * ovarian metastases of origin other than colorectal * primary ovarian tumor * clinical data missing

Keywords: krukenberg tumor
a study of the pharmacokinetics, safety and tolerability of single doses of vr647 inhalation suspension administered using the vr647 inhalation system in children with wheezing, reactive airway disease or mild asthma

Conditions: Wheezing; Reactive Airway Disease; Mild Asthma

Summary: the primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of vr647 inhalation suspension in children with wheezing, reactive airway disease or mild asthma using a nebulizer, the vr647 inhalation system. secondary objectives include the evaluation of the safety and tolerability of vr647 inhalation suspension administered using the vr647 inhalation system. the study consists of four visits; a screening visit (visit 1), two dosing days (visits 2 and 3) and a follow-up visit (visit 4). on each dosing day a single dose of treatment will be administered. treatment allocation at visits 2 and 3 is determined by a balanced incomplete block design.


Eligibility criteria:
key inclusion criteria: * male or pre-menarchal female subjects. * aged 4 to 8 years, inclusive. * diagnosis of wheezing, reactive airway disease or mild asthma confirmed by a physician at least 3 months prior to screening. * wheezing, reactive airway disease or mild asthma controlled by intermittent or regular non-steroidal medications commonly used for asthma, such as short-acting β2-agonists (sabas) or leukotriene receptor antagonists (ltras), for a minimum of 28 days prior to the screening visit. * body weight ≥15 kg. * subject is able to demonstrate the ability to use the vr647 inhalation system and the conventional jet nebulizer effectively during training. key exclusion criteria: * clinically relevant abnormality or medical condition (other than wheezing, reactive airway disease or mild asthma) identified at the screening assessment that, in the opinion of the investigator, could interfere with the objectives of the trial or the safety of the subject. the sponsor's medical officer should be consulted in case of any doubt. * life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episodes. * subjects currently using long-acting β2-agonists. * use of the following prescription medications within 28 days prior to the first treatment day: corticosteroids by any route and drugs that inhibit cytochrome p450 3a4.

Keywords: mild asthma budesonide nebulizer pediatric pharmacokinetics
marijuana drug discrimination and self-administration

Conditions: Marijuana Abuse

Summary: this study is designed to investigate the associations among marijuana's discriminative stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the relative ability of oral thc to block these effects.

volunteers will be asked to live on a research unit for up to twenty-six (26) consecutive nights and will participate in a total of 38 study sessions held on 19 weekdays. each session will last approximately four hours and there will be two sessions per day, therefore each study day will last approximately eight hours. in addition to these study sessions, an orientation session will be conducted on the friday prior to admission to the inpatient unit, and a lottery session will be held on the last day of the study. during each study session participants will be asked to smoke a cigarette. the cigarette may contain marijuana or it may contain placebo (a blank). participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. the capsule could contain placebo (a blank), thc (delta-9 tetrahydrocannabinol, which is the active ingredient in marijuana responsible for its mood effects), or d-amphetamine. we will have participants answer questions about how the drugs make them feel and measure their vitals signs (blood pressure, heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals monitor.

Eligibility criteria:
inclusion criteria: * female and male volunteers must be in generally good health (as indicated by results from medical history, physical exam, electrocardiogram, urine and blood samples at screening and upon arrival at the laboratory (urine samples only). * psychiatric examination must meet dsm-iv criteria for cannabis dependence. * individuals must be legally and mentally competent to provide written informed consent. * those who are unable to give their voluntary informed consent will not be accepted. exclusion criteria: * current serious axis i disorder (except cannabis or nicotine dependence), neurologic, cardiovascular, pulmonary or systemic (e.g., renal, hepatic) disease; cognitive impairment; pregnancy (urine test), lactation (self-report), or not using (self-report) medically approved contraceptives. * applicants who express interest in treatment will not be accepted for study and will be provided with a treatment referral.
study evaluating the pharmacokinetics of a single microdose of acd856

Conditions: Cognition Disorder; Alzheimer Disease

Summary: this is a phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (pk) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of acd856 in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy males aged \>18 and \<65 years. * signed and dated informed consent prior to any study-mandated procedure * willing and able to comply with study requirements. * bmi \>18.0 and \<30.0 kg/m\^2 * male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the imp. * clinically normal medical history, physical findings, vital signs, ecg and laboratory values at the time of screening, as judged by the investigator. exclusion criteria: * history of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. * any planned major surgery within the duration of the study. * clinically relevant findings in laboratory parameters, ecg or vital signs at screening * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity * regular use of any prescribed or non-prescribed medication * planned treatment or treatment with another investigational drug within 3 months * current smokers or users of nicotine products. * positive screen for drugs of abuse or alcohol at screening * history of alcohol abuse or excessive intake of alcohol * presence or history of drug abuse * history of, or current use of, anabolic steroids. * excessive caffeine consumption * plasma donation within one month of screening or blood donation during the 3 months prior to screening.

Keywords: cognition disorder alzheimer's disease
immunogenicity and safety study of nbp606 in healthy infants

Conditions: Pneumococcal Infections

Summary: this study will assess the immunogenicity and safety of primary vaccination with nbp606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.


Eligibility criteria:
inclusion criteria: * healthy infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment. * the lar (legally authorized representative) who understand the requirements of the study and voluntarily consent to participate in the study. exclusion criteria: * known hypersensitivity to any components of the pneumococcal vaccine * any confirmed or suspected immunosuppressive or immunodeficient conditions * coagulation disorder contraindicating im(intramuscular) vaccination * subject has received any licensed vaccine(not including bcg and hepatitis b) * participation to another study
sorafenib concomitantly used with tace (transarterial chemoembolization) in uhcc (unresectable hepatocellular carcinoma) patients in china

Conditions: Carcinoma, Hepatocellular

Summary: this study is to obtain the characteristics and treatment pattern of the unresectable hcc patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of tace treatment course (concomitantly use no later than the 3rd tace procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uhcc patients.


Eligibility criteria:
inclusion criteria: * patients with histologically/ cytologically documented or radiographically diagnosed unresectable hcc who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. radiographic diagnosis needs typical findings of hcc by radiographic method i.e. on multi-dimensional dynamic ct, ct hepatic arteriography (ctha)/ct arterial portography (ctap) or mri; * patients receive the first dose of sorafenib no later than 1 week (\<=7days) after the 3rd tace procedure * patients did not receive other prior systemic treatment by using target therapy * patients must sign the informed consent form; * patients must have a life expectancy of at least 3 months; * the physician must be willing to complete and submit all crfs; * the physician must be willing to submit to a site audit with verification of source documents and validation of data reported; exclusion criteria: * the first dose of sorafenib 7 days after the 3nd tace procedure * exclusion criteria must follow the approved local product information

Keywords: sorafenib hepatocellular cancer tace combination treatment pattern safety effectiveness
study to evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus abacavir/dolutegravir/lamivudine in human immunodeficiency virus-1 (hiv-1) infected, antiretroviral treatment-naive adults

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the efficacy of a fixed dose combination (fdc) containing bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) versus a fdc containing abacavir/dolutegravir/lamivudine (abc/dtg/3tc) in hiv-1 infected, antiretroviral treatment naive-adults.


Eligibility criteria:
key inclusion criteria: * antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of hiv-1 infection) except the use for pre-exposure prophylaxis (prep) or post-exposure prophylaxis (pep), up to one month prior to screening * plasma hiv-1 ribonucleic acid (rna) levels ≥ 500 copies per milliliter (ml) at screening * adequate renal function: estimated glomerular filtration rate ≥ 50 milliliter per minute (ml/min) (≥ 0.83 milliliter per second \[ml/sec\]) according to the cockcroft-gault formula * negative screening test for human leukocyte antigen (hla) -b x 5701 allele provided by gilead sciences key exclusion criteria: * an opportunistic illness indicative of stage 3 hiv diagnosed within the 30 days prior to screening (refer to study protocol) * decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding) * current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance * females who are pregnant (as confirmed by positive serum pregnancy test) * females who are breastfeeding * chronic hepatitis b virus (hbv) infection note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hiv
androgen replacement therapy in women with hypopituitarism

Conditions: Hypopituitarism

Summary: this is a study to determine whether testosterone replacement with theraderm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism.

patients will be randomized into 2 groups to receive testosterone replacement therapy or placebo. group 1 will receive 2 testosterone patches and estrogen pills for 12 months. group 2 will receive 2 placebo patches and estrogen pills for 12 months. changes in bone density, bone metabolism markers, body composition, libido, and quality of life will be compared in the women receiving testosterone replacement therapy with that of the women receiving placebo. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * hypogonadism and/or hypoadrenalism of central origin * testosterone or free testosterone level below the median for age-matched normal controls * prior estrogen preparation for at least 6 months exclusion criteria: * any disease known to affect bone metabolism, including untreated hypothyroidism or hyperthyroidism * change in thyroid hormone dose in the last 3 months * untreated cushing's syndrome * renal failure * alcoholism * anorexia nervosa * prior use of medication known to affect bone metabolism (e.g., supraphysiologic doses of glucocorticoids, phenytoin, bisphosphonates, or calcitonin) within the past 3 months * pregnant or nursing * uncontrolled hypertension * alt greater than 3 times upper limit of normal * serum creatinine greater than 2 times the upper limit of normal * any contraindication to estrogen therapy, including history of breast cancer or undiagnosed uterine bleeding * concurrent growth hormone replacement therapy, if patient has been receiving it for less than 2 years
screening for autism in 9-month-olds by measuring social visual engagement

Conditions: Autism; Infant Development

Summary: the goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.

the purpose of this study is to see if measuring how infants look at social information can be used as a screening tool to identify developmental delays or vulnerabilities in infants as young as 9 months of age. what the 9-month-old infant looks at will be measured with eye-tracking technology, which uses a video camera to safely measure the child's eye movements while the child watches video scenes of other children at play. parents/caregivers will be asked if they would like to participate during their child's 9-month well-baby visit at their pediatrician's office. if they agree to participate, the child will have their first study visit at this time. children will undergo an eye-tracking session to measure social looking. parents/caregivers will also complete forms and questionnaires about their child's health and development. the forms will be emailed, to be completed when the child is approximately 9, 12, 15, 18, 21, and 24 months old. if a child shows signs of developmental delay (dd) or autism spectrum disorder (asd), the child will be asked to participate in a comprehensive developmental and diagnostic assessment in-person with expert clinicians when the child is between 18-26 months old, to determine the child's strengths and any vulnerabilities, and to recommend any support or treatment if needed. if the child does not show signs of developmental delay and/or autism, the investigators may still invite the child for an in-person assessment with expert clinicians when the child is between 18-26 months old. approximately 10% of children who do not show any signs of developmental delay and/or autism will be randomly selected for an in-person assessment. at the end of the assessment, parents/caregivers will be provided feedback on their child's strengths and any vulnerabilities and, if necessary, a report will be written to help them access services for their child.

Eligibility criteria:
inclusion criteria: * infants between the chronological ages of 8-10 months; * infants must be generally healthy with no acute illnesses likely to prevent successful or valid data collection (e.g., current vomiting, high fever, conjunctivitis affecting vision); * participants' parents/caregivers must be able to understand and voluntarily provide written informed consent. exclusion criteria: - children will be excluded if they have signs of acute illness likely to prevent successful or valid data collection (e.g., conjunctivitis affecting vision, current vomiting, or high fever).

Keywords: screening well-baby visits social development communicative development development disabilities autism spectrum disorders
can antioxidants affect pregnancy rate in patients with expected low number of egg retrieval in ivf cycles?

Conditions: Infertility, Female

Summary: the aim of the study is to evaluate the effect of antioxidants on ivf outcome in infertile patients undergoing ivf who are expected to produce low number of eggs compared to a control group. the investigators assumed that the conception rate is higher in those patients taking some antioxidants supplementation. the patients will be given antioxidant drug one month before starting ivf trial once daily by mouth. uniform protocol of stimulation will be done during the cycle by a type of short protocols known as the antagonist protocol. egg retrieval will be done under anesthesia. pregnancy test will be done 2 weeks after embryo transfer. the investigators will also assess the number and quality of eggs on the day of egg pick up. in addition, the researchers will assess the number of first and second grade embryos that are put on the day of embryo transfer.

the primary aim of this study is to assess the value of antioxidant intake on the pregnancy rate in ivf/icsi (invitro-fertilization/intracytoplasmic sperm injection) cycles in poor responders. when the participants fulfill the eligibility criteria, informed consent will be taken. block randomization will be done and the patients are allocated to one of two groups. the first group will take the antioxidant tablet daily orally for one month before the ivf/icsi cycle. the other group will take placebo following the same regimen as the study group. antagonist protocol will be done for all participants. ovum pick up will be done under general anesthesia when one or more oocytes reaches 17 mm. the researchers will do embryo transfer on day 2 or 3 after ovum pickup. pregnancy test will be in blood after 2 weeks of embryo transfer.

Eligibility criteria:
inclusion criteria: infertile females undergoing ivf/icsi cycles poor responders are identified with 1. a previous poor ovarian response (less than 3 oocytes with a conventional ovarian stimulation protocol) 2. an abnormal ovarian reserve test which is considered altered in case of antral follicle count less than 5 follicles or amh (anti-mullerian hormone) less than 1.5 ng/ml. 3. fsh (follicle stimulating hormone) value more than 10 iu/ml . exclusion criteria: 1. any endocrine or metabolic disorders such as diabetes and thyroid dysfunction 2. any significant uterine anomaly, uterine cavity distortion, fibroids, hydrosalpinx or advanced endometriosis of stage iii to iv 3. severe oligo-astheno-teratozoospermia or azoospermia are excluded, as well.

Keywords: infertility ivf icsi poor responders in ivf/icsi cycles antioxidant
bipolar disorder in late life

Conditions: Bipolar Disorder

Summary: the purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of bipolar disorder.

individuals with bipolar disorder or those with a history of bipolar disorder may have certain structural changes in their brain. the purpose of this study is to look at those changes, as well as the assessment of risk factors for bipolar disorders, involving both social and psychological aspects of behavior, age, education, marital relations, nutrition, physical activity, etc., compared with persons not having bipolar disorder. these changes in the brain will be measured by magnetic resonance imaging (mri).

Eligibility criteria:
inclusion criteria: 1. dsm-iv diagnosis of bipolar disorder, manic and mixed episodes. 2. 18 years of age and older, male or female, any race. 3. capacity to give informed consent and follow study procedures. exclusion criteria: 1. history of alcohol/drug dependence 2. any metal or pacemaker in the body which precludes mri 3. pregnancy 4. dementia or other primary psychiatric disorders including substance abuse/dependence, anxiety disorders, schizophrenia 5. for controls, numbers one through four above as well as any history of depression or the use of antidepressants

Keywords: bpd
treatment comparison in chronic pain

Conditions: Comparison of Different Treatment for Chronic Pain

Summary: chronic pain concernes one in four adults in belgium. because of the psychological and social repercussions, a biopsychosocial approach is necessary in order to improve the quality of life of people suffering from chronic pain. non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education are gaining more and more interest in the scientific field. indeed, several studies have shown a reduction in psychological distress and an improvement in global quality of life after having learned self-hypnosis/self-care. furthermore, other studies focusing on music as a treatment for chronic pain highlight an analgesic effect of music over pain and a reduction of common comorbidities. nevertheless, only few studies aim at comparing these techniques to each other. the aim of our study would be to compare a 7 months learning program of self-hypnosis/self-care, music-therapy/self-care, motivation to learn self-hypnosis/self-care and self-care alone in order to highlight the most efficient treatment for chronic pain.


Eligibility criteria:
inclusion criteria: * major * fluency in french * chronic pain diagnosis exclusion criteria: * neurologic disorder * psychiatric disorder * drug addiction * alcoholism

Keywords: chronic pain self-hypnosis self-care music-therapy psycho-education