Kornimate/medical-research-clean huggingface dataset:
functional and metabolic imaging using magnetic resonance imaging and spectroscopy

Conditions: Healthy; Nervous System Disease

Summary: technical advances in magnetic resonance imaging (mri) and magnetic resonance spectroscopy (mrs) have provided researchers with the opportunity to study changes of the central nervous system (cns) and improve diagnosis and therapy of cns disease. new mri and mrs techniques specifically designed for functional mri (fmri) and mrs imaging of the cns will be evaluated in normal volunteers and in patients with cns diseases. this study will develop and evaluate new magnetic resonance pulse sequences for performing mri or mrs and compare the results to existing mr techniques. patients and volunteers age 18 and older are eligible for the study. a history will be taken in which exclusion criteria (such as having a pacemaker or cochlear implants) will be addressed, and a pregnancy test will be administered to women of childbearing age. each subject will also be asked to fill out a questionnaire. study participants will lie in the mri scanner from 20 minutes to 2 hours. a coil may be placed on the head and participants may be asked to do simple or complex tasks. a catheter will be placed in an arm vein and a contrast agent will be administered. this agent will allow structures in the brain to show up more clearly.

technical advances in magnetic resonance imaging (mri) and magnetic resonance spectroscopy (mrs) have provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (cns) in both normal individuals and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. new mri and mrs techniques specifically designed for functional magnetic resonance imaging (fmri) and magnetic resonance spectroscopic imaging of the cns will be evaluated at 1.5 and/or at 4.0 tesla on normal volunteers and in patients with cns pathology.

Eligibility criteria:
inclusion criteria: any normal volunteer age 18 and over who is capable of giving informed consent. for the purposes of evaluating new techniques for fmri, patients will be considered the same as volunteers. exclusion criteria: a subject will be excluded if he/she has a contraindication to mr scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body or implant (e.g., metal shavings, retinal clips); breast implants or insulin pump. subjects who have a history of a reaction to mr contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol. the contraindications to mri at 1.5 tesla and 4 tesla are identical.

Keywords: central nervous system technical development activation studies pulse sequences metabolites normal volunteer
validating the effect og ondansetron and mirtazapine in treating hyperemesis gravidarum

Conditions: Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy

Summary: the aim is to investigate the efficacy of mirtazapine and ondansetron as treatment for hyperemesis gravidarum(hg). the setup is a double-blind multicenter trial where patients suffering from hg will be randomized to treatment with either mirtazapine, ondansetron or placebo (1:1:1).


Eligibility criteria:
inclusion criteria: * written informed consent obtained before any trial related procedures are performed * female age \>18 years * pregnant woman with gestational age between 5+0 and 19+6 * nausea and vomiting without other obvious reason * puqe-24 score ≥13 or puqe-24 score ≥7 and 1. weight loss \>5% of pre-pregnancy weight and/or 2. hospitalisation due to nausea and vomiting of pregnancy * singleton pregnancy * the subject must be willing and able to comply with trial protocol exclusion criteria: * mola pregnancy, multiple gestation or non-vital pregnancy * nausea and vomiting of other aetiology than nvp * allergic to selective 5-ht3-receptor antagonists * ongoing treatment with antidepressant medication * pre-existing diagnosis of chronic kidney disease, diabetes type 1 or 2, significant cardiac disease (incl. long qt syndrome), epilepsy, hiv. in case of other pre-existing conditions subjects might be excluded based on individual assessment by an md * elevated liver enzymes (alat\>150 u/l) * elevated creatinine (\>100 µmol/l) * ecg showing long qt-syndrome (qtc \>460msek) * weekly alcohol intake \>2 units of alcohol * not able to take medicine orally * not able to understand spoken and/or written danish * participation in another investigational drug trial within current pregnancy

Keywords: hyperemesis gravidarum (hg) mirtazapine ondansetron pregnancy nausea and vomiting of pregnancy (nvp) randomized controlled trial (rct)
a study of kn046 in subjects with locally advanced or metastatic triple-negative breast cancer

Conditions: Triple-negative Breast Cancer

Summary: this is an open-label, phase ib/ii, multi-center study to evaluate efficacy and safety of kn046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic triple negative breast cancer (tnbc). the study is composed of dose escalation and expansion parts. every subject will subject tumor tissue used for biomarker evaluation. each subject will receive kn046 or in combination with nab-paclitaxel untill confirmed progressive disease, unacceptable toxicity or withdrawal of informed consent whichever occurs first.


Eligibility criteria:
inclusion criteria: * signed informed consent; * age of 18 or above; * histology confirmed locally advanced unresectable or metastatic triple-negative breaset cancer; * (kn046 monotherapy) failed at least one prior anthracycline and taxane containing systemic treatment, (kn046 plus nab-paclitaxel) systemic treatment naive; * measurable disease at baseline; * ecog 0-1; * adequate organ functions. exclusion criteria: * untreated active cns metastasis or leptomeningeal metastasis; * subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment; * has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management; * active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; history of uncontrolled intercurrent illness; known severe hypersensitivity reactions to antibody drug.
a trial assessing safety, tolerability, pharmacokinetics and pharmacodynamics of zp7570

Conditions: Safety and Tolerability

Summary: the trial is a phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in part 1 in a semi-parallel design and one cohort in part 2 in overweight and obese but otherwise healthy subjects, randomised to zp7570 or placebo within each cohort where the observational period is 18 weeks for part 1 and 28 weeks for part 2. all subjects will be dosed for 13 weeks in part 1 and for 28 weeks in part 2 with ascending weekly doses of zp7570 at dose levels with corresponding volume of placebo.

zp7570 is a dual glp-1r/glp-2r agonist in clinical development for weight management. the overall purpose of this trial is to evaluate the safety and tolerability when applying dose titration of ascending doses of zp7570 and at steady state. the trial is a phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in part 1 in a semi-parallel design and one cohort in part 2 in overweight and obese but otherwise healthy subjects, randomised to zp7570 or placebo. all subjects will be dosed with ascending weekly doses of zp7570 with corresponding volume of placebo. after informed consent has been obtained, eligibility of the subjects will be assessed during a screening visit (v1). additional tests to assess safety and pk and pd will take place during in-house visits and ambulatory visits.

Eligibility criteria:
inclusion criteria: * age between 18 and 64 years, both inclusive. * body mass index (bmi) between 27.0 and 39.9 kg/m\^2, both inclusive. * in overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening. exclusion criteria: * history of gastrointestinal (gi) diseases including functional complaints that could interfere with the pharmacokinetics of the imp or auxiliary medicinal product (acetaminophen) of the trial. * any relevant abnormal renal parameters in the following ranges: serum creatinine above unl+10% or normalised estimated glomerular filtration rate (egfr) below 60.0 l/min/1.73m2, as defined by ckd-epi.

Keywords: glp-1/glp-2 agonist, overweight, obesity
mobile technology and data analytics to identify real-time predictors of caregiver well-being

Conditions: Caregivers

Summary: the purpose of this study is to test whether personalized messages from an easy-to-use mobile app improve mood and stress among care partners and to see if care partners like using the app.


Eligibility criteria:
care partner inclusion criteria: * provide emotional, physical, and/or financial support/assistance to an individual with spinal cord injury (sci), huntington's disease (hd), or hematopoietic cell transplantation (hct) * have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the fitbit® app on their mobile device * care partners of persons with hd: be caring for an adult (18 years or older) with a clinical diagnosis of hd * care partners of persons with sci: be caring for an adult (18 years or older) that is ≥1 post-injury and sustained a medically documented sci at age 16 or older * care partners of persons with hct: be caring for an adult (18 years or older) who is receiving, has received or is scheduled to receive hct exclusion criteria: * is a professional, paid caregiver (e.g., home health aide)

Keywords: depression insomnia stress related disorders anxiety
efficacy of a clinic-based, multi- disciplinary, pediatric weight management program

Conditions: Body Weight Changes

Summary: childhood obesity has more than tripled in the past 30 years. from 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 although several pediatric weight management programs are available, access to these programs may not always be possible. the proposed study will be an ongoing research program with approximately 40 children ages 12-18 years enrolled into the study over a year. all study participants will participate in a baseline evaluation which will include body composition measures, aerobic testing, as well as nutrition and physical activity questionnaires. study participants will be assigned to the clinic-based group. the clinic- based group will participate in a 12-week multi-disciplinary weight management program. all study participants will then participate in a 12-week follow-up evaluation similar to the baseline visit. new participants will be enrolled every 12 weeks. every 12 weeks, active participants (those that have completed a minimum of 12 weeks) will have the option to continue in the program or, discontinue their active participation in the program and enroll into the maintenance phase which will consist of measures only every 12 weeks. the objective of the proposed study includes examining the efficacy of the clinic-based, multi-disciplinary, pediatric weight management program.


Eligibility criteria:
inclusion criteria: * phone screening * approval to participate in a weight management program from the child's pediatrician * children between the ages of 12 and 18 years * children overweight (\>85th-\ 95th bmi percentile) exclusion criteria: * children with evidence of significant cardiovascular disease or cardiac arrhythmias * children with liver disease * children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents * children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions * children with evidence of family and/or medical neglect or physical, mental or sexual child abuse
a study of necitumumab and chemotherapy in participants with stage iv squamous non-small cell lung cancer

Conditions: Squamous Non Small Cell Lung Cancer

Summary: the main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed squamous nsclc * stage iv disease at time of study entry based on american joint committee on cancer (ajcc) 7th edition * measurable disease at time of study entry as defined by response evaluation criteria in solid tumors, (recist) version 1.1 * archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (egfr) protein expression by immunohistochemistry (ihc) and other biomarker assessments exclusion criteria: * nonsquamous nsclc * prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the egfr, vascular endothelial growth factor (vegf), or vegf receptor * previous chemotherapy for nsclc * major surgery or received any investigational therapy in the 4 weeks prior to randomization * chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed) * brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)

Keywords: nsclc
utilizing hyperpolarized 129xe magnetic resonance imaging in children with primary ciliary dyskinesia

Conditions: Primary Ciliary Dyskinesia

Summary: this study investigates the use of hyperpolarized 129xe magnetic resonance imaging (mri) in children with primary ciliary dyskinesia (pcd) in detecting ventilation defects. the investigators will establish the feasibility and reliability of this test and how it changes compared to other pulmonary function tests.

primary ciliary dyskinesia (pcd) is an autosomal recessive inherited disorder caused by defects in ciliary structure and/or function. prevention or delaying disease progression requires medical therapies and routine lung function monitoring, with the goal of early initiation of medical therapies. of course, this is contingent on recognizing early lung disease. current investigations for monitoring lung disease include pulmonary function tests (pft), chest x rays and chest cts. but each of these modalities are either not sensitive enough or expose the patient to ionizing radiation. the investigators believe that hyperpolarized 129xe mri (hp xe-mri), new imaging modality, will be more sensitive then current tests and also avoid the need for ionizing radiation. to evaluate this, the investigators will compare hp xe-mri to pft, when the patient is well and during a pulmonary exacerbation that is being treated.

Eligibility criteria:
inclusion criteria * diagnosis of pcd as having either (i) biallelic mutations in known pcd genes or (ii) classic transmission electron microscopy structural ciliary defect * informed consent and verbal assent (as appropriate) provided by the participant's parent or legal guardian and the participant * ages 6-18 years and able to perform reproducible spirometry and achieve a breath hold duration sufficient for mri acquisition exclusion criteria * any other cardiac or respiratory disease * inability to perform a breath-hold of adequate duration for mri acquisition * medical instability that would preclude the ability to undergo the required investigations * fev1 % predicted \<40% on any pft within last 2 months at time of consent * use of supplementary oxygen * severe claustrophobia * pregnancy or lactation * presence of metal implants or other mri contraindications

Keywords: xenon mri lung pulmonary exacerbation
anti-c1s, anti-hmgb1 and anti-c1q autoantibodies in systemic lupus erythematosus (dysalarm-322)

Conditions: Lupus Erythematosus, Systemic

Summary: systemic lupus erythematosus (sle) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage. dysfunction of proteins initially known to initiate the classical pathway for complement activation (c1q and c1s), and their functional interference with the multifunctional protein hmgb1 (high-mobility group box 1), appears to be associated with sle. on the other hand, c1s, hmgb1 and c1q can be targeted by anti-c1s, anti-hmgb1 and anti-c1q autoantibodies from lupus patients, whose functional impact remains to be explored, in particular for non-canonical functions, independent of the complement activation cascade. studies are needed to investigate the pathogenic role of these autoantibodies in sle, including possible interference with the inactivation of hmgb1. this project plans to investigate the role of anti-c1s, anti-hmgb1 and anti-c1q autoantibodies in the pathogenesis of systemic lupus erythematosus. this pilot study will be performed for 30 patients with active sle on serum, realized for routine patient care. the investigators will identify the molecular targets recognized by anti-c1s, anti-hmgb1 and anti-c1q autoantibodies purified from the sle patients' serum. the investigators will also explore the functional role of these purified autoantibodies.

regarding the exploration of anti-c1s autoantibodies purified from the sle patients' serum, the investigators will evaluate their effects on the formation of the c1r2c1s2 tetramer and interaction with c1q and their effects on the esterase activity of c1s. regarding the exploration of anti-hmgb1 autoantibodies purified from the sle patients' serum, the investigators will evaluate their effects on the binding of hmgb1 to its rage receptor and their effects on the binding of hmgb1 to c1q. regarding the exploration of anti-c1q autoantibodies purified from the sle patients' serum, the investigators will evaluate their effects on the binding of c1q to its receptors and to the c1r2c1s2 tetramer and their effects on the activation of the classical complement pathway.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * weight ≥ 40 kg * patients who have valid health insurance * patients with lupus diagnosis criteria (eular-acr-2019) * active lupus nephritis defined by sledai score \>5 and joint and/or kidney involvement. exclusion criteria: * patient protected by law (minors, pregnant or breastfeeding women, subject under guardianship or curatorship, deprived of liberty or enforced hospitalized, under administrative or judicial supervision). * patient on dialysis or on plasma exchange.
cannabidiol for prevention of chemotherapy-induced peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: this protocol describes a phase ii trial investigating the efficacy of cbd in paclitaxel- and oxaliplatin-induced peripheral neuropathy. the trial uses multiple assessments such as validated pro-questionnaires and multifrequency vibrometry.

chemotherapy induced peripheral neuropathy (cipn) is among the most feared side effects to cancer treatment. the development of cipn can lead to omission or even discontinuation of antineoplastic drugs, possibly affecting efficacy of cancer treatment. there is a lack of knowledge about the natural course of cipn and to this date, there are no available methods for the early detection of cipn. with no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age. * a diagnosis of cancer. * fulfill criteria for starting chemotherapy. * scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy. * if not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the ctfg\*-recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test). exclusion criteria: * unable to complete pro-measurements. * previously received taxanes or platinum-based chemotherapy. * if using any antiepileptic or antidepressant medicine (atc: n03a or n06a). treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. however, any treatment with clobazam (n05ba09) is not allowed due to major interaction with cannabidiol. * use of cannabinoids. if in use, treatment must be stopped 4 days prior to inclusion. * hypersensitivity reactions towards ascorbylpalmitat or triglycerides (medium-chain) * baseline transaminase level must not be above 3 times the upper limit of normal (uln) at study beginning. * women who are breastfeeding. * concomitant treatment with strong inducers of cyp3a4 and/or strong inducers of cyp2c19. ctfg: the heads of medicines agencies commissioned clinical trials facilitation group under the european union's clinical trials directive 2001/20.

Keywords: cipn cannabinoid cannabidiol cbd neurotoxic chemotherapy paclitaxel oxaliplatin peripheral neuropathy