Kornimate/medical-research-clean huggingface dataset:
a study of tanespimycin (kos-953) in patients with relapsed-refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. study agent is tanespimycin (kos-953), at three different dose levels in combination with a fixed dose of bortezomib.

phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. prior therapy must include bortezomib and lenalidomide. primary objective is to assess the dose-response relationship of objective response rate (orr) using ebmt/ibmtr criteria of any three dose levels of tanespimycin (kos-953) in combination with bortezomib after four treatment cycles.

Eligibility criteria:
inclusion criteria: * good performance status * histologic evidence of multiple myeloma * have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide * no prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor * no known infections of hav, hbv, hcv, or hiv * no chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.

Keywords: multiple myeloma heat shock protein 90 hsp90 kos-953 17-aag bortezomib relapsed-refractory tanespimycin
the effect of exercise and nicotinamide riboside muscle health and insulin resistance in survivors of childhood cancer

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Prediabetes

Summary: this trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). nicotinamide riboside is a dietary supplement which is similar to vitamin b3. information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

primary objective: i. evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (ccs) with a history of prediabetes. exploratory objectives: i. describe the association between patient demographics and treatment exposures and subsequent hyperglycemia and skeletal muscle health in childhood cancer survivors. ii. describe the effect of exercise with or without nicotinamide riboside (nr) on hyperglycemia and skeletal muscle health in ccs with a history of prediabetes. outline: patients are randomized to 1 of 2 arms. arm i: patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks. arm ii: patients complete home exercise as in arm i. patients also receive nicotinamide riboside orally (po) daily for 6 weeks.

Eligibility criteria:
inclusion criteria: * history of childhood cancer * history of prediabetes (hba1c 5.7-6.4%) * in remission at time of enrollment * time between completion of cancer-directed therapy and study entry: \>= 6 months * at least 18 years of age at time of enrollment * able to access online exercise program at home * ability to tolerate the prescribed resistance exercise program * english-speaking * able to understand and sign the study specific informed consent form (icf) exclusion criteria: * taking a nicotinamide adenine dinucleotide (nad)+ precursor in the two weeks prior to enrollment * currently taking medication for hyperglycemia or diabetes * females who are pregnant or planning to become pregnant * currently recovering from an injury * contraindication to magnetic resonance imaging (mri) * pacemaker
episode-ps-covid: head pulse for ischemic stroke detection prehospital study during the covid-19 pandemic ( episodepscovid )

Conditions: Stroke, Acute; COVID-19

Summary: prehospital providers encounter patients with suspected stroke frequently. stroke and covid-19 are related potentially putting these healthcare workers at risk of covid-19 infection. in addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.

this observational prospective study will document covid-19 status on patients seen in the prehospital environment for suspected stroke. this will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting. additionally, patients will have a headset placed to record their headpulse during the encounter. these measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (lvo) stroke. this may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.

Eligibility criteria:
inclusion criteria: * suspected stroke in the prehospital setting * patient at risk for covid-19 exclusion criteria: * scalp laceration * patient refusal * prisoner, other vulnerable population * prehospital provider feels that the recording may interfere with care
a study to evaluate thr-317 treatment for macular telangiectasia type 1 (mactel 1)

Conditions: Retinal Telangiectasis; Idiopathic Juxtafoveal Retinal Telangiectasia

Summary: this study is conducted to evaluate the safety of thr-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (cst) and improving best-corrected visual acuity (bcva) in subjects with macular telangiectasia type 1 (mactel 1).


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older * macular oedema caused by mactel 1, with cst \>300µm on sd-oct * written informed consent obtained from the subject prior to screening procedures exclusion criteria: * type 1 or type 2 diabetes mellitus * concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results * previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment * any active ocular / intraocular infection or inflammation in either eye * pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
efficacy of empagliflozin or linagliptin as an alternative to metformin for treatment of polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome (PCOS)

Summary: the study aims to compare the efficacy of empagliflozin or linagliptin as an alternative to metformin for treatment of non-diabetic patients with polycystic ovary syndrome (pcos).

patients with polycystic ovary syndrome will be randomized to three arms: * metformin (standard care) * empagliflozin or linagliptin resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested

Eligibility criteria:
inclusion criteria: 1. women diagnosed with pcos according to national institute of health criteria. 2. age: \>18 \<40 years. 3. infertile women (primary or secondary infertility). exclusion criteria: 1. patients with history of diabetes mellitus (type 1 or 2). 2. patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease. 3. significantly elevated triglyceride levels (fasting triglyceride \> 400 mg/dl) 4. untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm hg). 5. use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or otc) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks. 6. patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status. 7. presence of hypersensitivity to empagliflozin or other sodium/glucose cotransporter 2 (sglt2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions). 8. known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (dpp-4) inhibitors (saxagliptin, linagliptin, sitagliptin...). 9. use of metformin, thiazolidinediones, glucagon-like peptide-1 (glp-1) receptor agonists, dpp-4 inhibitors, sglt2 inhibitors stopped for at least 4 weeks. 10. eating disorders (anorexia, bulimia) or gastrointestinal disorders. 11. having a history of bariatric surgery.

Keywords: pcos empagliflozin linagliptin metformin
a study to assess efficacy and safety of baxdrostat in participants with primary aldosteronism

Conditions: Primary Hyperaldosteronism

Summary: this is a phase iii, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of seated blood pressure (sbp) and unsuppression of plasma renin activity (pra) in approximately 180 participants ≥ 18 years of age with primary aldosteronism (pa), with or without prior treatment with mineralocorticoid receptor antagonists (mras) or potassium-sparing diuretics. baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks to based on clinical response and tolerability. the study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.


Eligibility criteria:
inclusion criteria: * male or female participants must be ≥ 18 years of age * participants with a documented diagnosis of pa that fulfils the criteria defined in the 2016 or 2025 endocrine society guidelines. * participants willing and able to cease dosing of mra orpotassium sparing diuretics per study requirement for participantstaking an mra or potassium sparing diuretic at screening. * egfr ≥ 45 ml/min/1.73m2 at screening * serum potassium level ≥ 3.0 and \< 5.0 mmol/l at screeningdetermined as per the central laboratory. * have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation * mean seated sbp on aobpm of ≥ 135 mmhg. exclusion criteria: - if not taking an mra or potassium sparing diuretic at screening: mean seated sbp \> 170 mmhg or mean seated dbp ≥110 mmhg (on aobpm). if taking an mra or potassium sparing diuretic at screening: mean seated sbp \> 160 mmhg or mean seated dbp ≥ 100 mmhg. * previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study. * has the following known secondary causes of htn: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, cushing's syndrome, aortic coarctation. * serum sodium level \< 135 mmol/l at screening, determined as per central laboratory. * new york heart association functional hf class iv at screening. * persistent atrial fibrillation. * treatment with any mra or potassium-sparing diuretic within 2weeks prior to randomisation.

Keywords: primary hyperaldosteronism primary aldosteronism pa baxdrostat cin-107 aldosterone
inflammatory bowel disease cohort in nantes

Conditions: Inflammatory Bowel Diseases

Summary: the celeste cohort will be a three-center prospective cohort associated with the creation of a biobank including inflammatory bowel diseases (ibd) patients with active disease

the celeste cohort will be a prospective cohort of ibd patients followed up at nantes university hospital, jules verne clinic (nantes) and/or confluent private hospital (nantes). the multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies. it will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age; * patients with an established diagnosis of ibd: cd, uc, unclassified ibd or refractory chronic pouchitis; * patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy; * patients who have given written consent to participate in the study and to keep biological samples for research purposes exclusion criteria: * patients refusing to participate in the cohort; * patients with chronic inflammatory bowel disease quiescent at inclusion; * patients with a contraindication to general anaesthesia; * vulnerable patients (under court protection, curators, guardians);

Keywords: crohn's disease ulcerative colitis cohort biocollection pathophysiology
glutamine and traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system. glutamate is a non-essential amino acid with restricted passage to the brain from the blood. in the cns, glutamate is synthesised in neurons as part of the glutamate-glutamine cycle.5,6 so it plays an essential role in normal brain functioning and can improve situations related to impaired cognitive,motor and emotional functions and can be used to improve traumatic brain injury patient general health status

the term "brain injury" covers a wide range of conditions and injuries relating to the brain, skull, and scalp. a traumatic brain injury (tbi) usually results when the head or body suffers from a violent blow or jolt that results in swelling, bruising, bleeding, or tearing of the brain tissue which any damage to it has the potential to change the way your body operates. now ,(tbi) is considered one of the major causes of disability and deaths ,as it contributes more than 30% of deaths worldwide . those who survive a tbi can face effects that last a few days, or the rest of their lives. effects of tbi can include impaired motor, cognitive and emotional functioning. these issues not only affect individuals but can have lasting effects on families and communities.tbi can also cause some inflammatory mediators to be released in circulation that affect brain and systemic organs such as cortisol,il6 and tnf etc. a lot of modialities have been introduced to help in decreasing these side effects. glutamine,a non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. it is synthesized from glutamic acid and ammonia. it is the principal carrier of nitrogen in the body and is an important energy source for many cells.glutamine has a restricted passage to the brain from blood but it is synthesised in the brain as a part of the glutamate-glutamine cycle.5,6 so it present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system,maintaining normal brain function and can improve situations related to impaired cognitive,motor and emotional functions. hypothesis of this study; does glutamine therapy have a positive effect on traumatic brain injury patients ?

Eligibility criteria:
inclusion criteria: * 18 to 60 years old * mild to moderate head trauma exclusion criteria: * patients with concurrent cns dysfunction * renal failure patient * diabetic patients with neuropathy
treatment of nccl asociated with gingival recession with b.o.p.t. technique

Conditions: Abfraction

Summary: the purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (b.o.p.t.) of non-carious cervical lesions (nccl). in particular, the quantification of the cervical margin is carried out by an intraoral scanning device, both in length and width.


Eligibility criteria:
inclusion criteria: * over 18 years of age, all sex; * presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with r1 cairo dental recession; as well, the tooth must be in a healthy condition. exclusion criteria: * in the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades ii and iii; as well as presence of necrosis, fractures and prosthetic restorations; * presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day; * patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins); * presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.

Keywords: nccl b.o.p.t. gingival recession
xanthohumol as an adjuvant therapy in critically ill covid-19 patients

Conditions: COVID-19 Respiratory Infection

Summary: it has been well documented that coronavirus covid-19 disease is associated with massive inflammatory response and cytokine storm. several medications have been used to ameliorate covid-19-related inflammation. xanthohumol, a natural medication extracted from hop cones, possesses strong anti-inflammatory properties and can reduce the severity of inflammatory response. the aim of this study is to analyze the effect of xanthohumol on clinical course, inflammatory response and outcome in patients admitted to the icu due to covid-related acute respiratory failure with an oxygenation index (pao2/fio2) less than 150.

xanthohumol inhibits proinflammatory pathways in different independent mechanisms. ir inhibits farnesoid x receptor activity, and reduces the synthesis and release of different proinflammatory cytokines such as il-1β, il-6, il-8, il-12p70, tnfα and interferon γ. the pathomechanism of its anti-inflammatory activity is associated with the suppression of nuclear factor-kappa b. additionally, xanthohumol inhibits inflammatory-induced endothelial disorders, which are associated with an improvement in blood velocity and a reduction in the risk of arterial thrombosis, especially in pulmonary arteries. an increase in proinflammatory release, known as cytokine storm, as well as increased incidences of vascular thrombosis, are observed in coronavirus infection. hence, xanthohumol may reduce the severity of the clinical course in covid-19 patients.

Eligibility criteria:
inclusion criteria: clinical diagnosis of covid-19 with acute respiratory failure (pao2/fio2 below 150). exclusion criteria: history of chronic cardiovascular, liver or/and kidney diseases. history of chronic pulmonary diseases with prolonged oxygen supplementation or domestic mechanical ventilation. pregnant women, neoplastic diseases, immunologic diseases patients received immunomodulatory treatment.
impact of adrenoreceptor expressions on inflammatory pattern in refractory cardiogenic shock under va ecmo

Conditions: Shock, Cardiogenic; Extra-Corporeal-Life-Support ( ECLS); Autonomic Nervous System Diseases; Inflammation

Summary: refractory cardiogenic shock is characterized by a decreased in cardiac output with hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular ischemia. vaecmo, by restoring a circulatory flow, could be associated to a major reperfusion syndrome which may lead some patients to multiple organ failures and death. pathophysiology of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the sympathetic system and 2/ a major release of pro-inflammatory cytokines. as adrenoreceptors are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the over-activation of the sympathetic system.

nb : a repartition according to other ongoing study (hypoecmo nctnct02754193) is planned

Eligibility criteria:
inclusion criteria: * patients in icu * refractory cardiogenic shock * cardiogenic shock: systolic arterial pressure \<90mmhg, or mean arterial pressure \<65mmhg, adequate volemia, peripheral hypoperfusion symptoms, cardiac index \< 2.2 l/min/m2) * refractory state: hypo responsiveness to norepinephrine and/or persisting profound hypo perfusion clinical symptoms despite optimal resuscitation * needing an extra-corporeal-life-support * informed consent from relatives or patient * affiliation to a social security regimen * preliminary medical examination exclusion criteria: * patients under ecls for a/an : * cardiotoxic poisoning * human immunodeficient virus or viral hepatitis c * patient \< 18 yo * pregnancy * patient under protective supervision

Keywords: cardiogenic shock extra-corporeal-life-support (ecls) inflammation adrenergic system
the role of circadian factors in regulation of neuroplasticity in ischemic stroke (observational)

Conditions: Stroke, Ischemic; Sleep Disorder

Summary: the study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. it is designed as an observational cohort study with the retrospective and prospective longitudinal arms.

in the retrospective arm of the study, the routinely collected data of patients admitted to the stroke unit with acute ischemic stroke (from 2018 till 2022) will be evaluated. in the prospective longitudinal arm, about 200-250 patients admitted to the stroke unit of one participating center will undergo examination including the assessment of medical records, stroke characteristics, sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms within the first 2-3 days after admission.the assessment of stroke severity and functional deficit will be repeated at 10-14 days after stroke. the following associations will be assessed: * the association of genetic biomarkers of circadian rhythms with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke), with stroke characteristics (stroke subtype and neuroimaging stroke parameters) and with sleep characteristics. * the association of sleep characteristics with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke) and with stroke characteristics (stroke subtype and neuroimaging stroke parameters).

Eligibility criteria:
inclusion criteria: * acute (symptom onset to admission \<1 days) ischemic stroke * ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery * age 18-80 years * moderate or severe stroke (national institutes of health stroke scale, nihss\>=5) * intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable) * informed consent exclusion criteria: * secondary parenchymal hemorrhage (\>hemorrhage index -2) * clinically unstable or life-threatening conditions * known progressive neurological diseases * known psychiatric diseases * concomitant benzodiazepine medication * drug or alcohol abuse * pregnancy * disability to participate in the study * congestive heart failure with reduced ejection fraction (\<=45%) or new york heart association (nyha) classification iii-iv functional class

Keywords: neuroplasticity cognitive dysfunction disability circadian rhythm functional deficit stroke outcome sleep-disordered breathing heart rate variability