Kornimate/medical-research-clean huggingface dataset:
a phase i study of the safety, pharmacokinetics, and anti-tumor activity of cudc-101 in patients with advanced solid tumors

Conditions: Tumors

Summary: this is a phase i, open-label, dose-escalation study of cudc-101 in patients with advanced and refractory solid tumors. cudc-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (egfr), human epidermal growth factor receptor type 2(her2) and histone deacetylase (hdac). the study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of cudc-101.


Eligibility criteria:
inclusion criteria: * subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis * subjects must have no further standard of care options or have refused standard therapy * measurable or evaluable disease * age ≥ 18 years * ecog performance \< 2 * life expectancy ≥ 3 months * if female, neither pregnant or lactating * if of child bearing potential, must use adequate birth control * absolute neutrophil count ≥ 1,500/µl; platelets ≥ 100,000/µl; * creatinine ≤ 1.5x upper limit of normal (uln) or calculated creatinine clearance ≥ 60ml/min/1.73m2 * total bilirubin ≤ 1.5x uln; ast/alt ≤ 2.5x uln. in subjects with documented liver metastases, the ast/alt may be ≤ 5x uln * prothrombin time ≤1.5x uln, unless receiving therapeutic anticoagulation * serum magnesium and potassium within normal limits (may be supplement to achieve normal values) * subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids * able to render informed consent and to follow protocol requirements. exclusion criteria: * anticancer therapy within 4 weeks of study entry. prostate cancer subjects on lhrh hormonal therapy may be enrolled and continue on this therapy. * use of investigational agent(s) within 30 days of study entry * history of cardiac disease with a new york heart association (nyha) class ii or greater congestive heart failure (chf), myocardial infarction (mi) or unstable angina in the past 6 months prior to day 1 of treatment, serious arrhythmias requiring medication for treatment. * known infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c. * the following are permitted but should be used with caution and other suitable agents used if possible: * subjects receiving concomitant medications metabolized by cyp 3a4 and cyp 2d6 * cyp3a4 inducers * cyp3a4 inhibitors * warfarin

Keywords: advanced solid tumors egfr hdac her2 open-label dose-escalation
study of an investigational product, qls-111, provided as an eyedrop, for treatment of normal tension glaucoma (ntg)

Conditions: Normal Tension Glaucoma (NTG); Low-Tension Glaucoma, Bilateral; Low-Tension Glaucoma, Unspecified Eye; Glaucoma

Summary: qlaris' phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of qls-111 in normal tension glaucoma patients.

a randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of qls-111 0.015% versus timolol maleate ophthalmic preservative free (pf) 0.5% ophthalmic solution in subjects with ntg. primary objective is to evaluate the ocular and systemic safety and tolerability of qls-111 0.015% compared to active control (timolol). secondary objective is to evaluate the ocular hypotensive efficacy of qls-111 0.015% with once daily evening (qpm) and twice daily (bid) dosing versus timolol with qpm dosing.

Eligibility criteria:
inclusion criteria: * 30 years or older * able to provide written acknowledgement of giving informed consent * best corrected visual acuity (bcva) 20/200 or better * ntg in both eyes with untreated iop \<21 mmhg at visit 2 and morning assessment of visit 3; iop at morning assessment on visits 2 and 3 doesn't differ more than 2 mmhg; has open iridocorneal angles, historic iop \<22 mmhg in either eye exclusion criteria: * history of angle closure glaucoma, narrow or occludable angle on gonioscope * all secondary glaucomas * severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications * previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (slt) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1.5 years from study) * ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye * use of other ophthalmic concomitant medications during the study * refractive surgery * uncontrolled hypertension or hypotension * significant systemic or psychiatric disease * participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with qlaris investigational product * pregnant or lactating

Keywords: ntg qlaris intraocular pressure (iop) glaucoma nightingale low-tension glaucoma
a trial investigating the effect of acute hypoglycaemia on cognitive function and brain activation patterns in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * right-handed subjects * type 1 diabetes mellitus for at least 12 months * treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening) * visual impairment or auditory impairment
exploratory study of a new urine collection device for men

Conditions: Urinary Incontinence

Summary: the aim of the investigation is to evaluate the subjects experience of a new collection device for men. an open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. male 3. be at least 18 years of age and have full le-gal capacity 4. suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day 5. have had current incontinence issues for at least 3 months 6. able to understand patient information and able to change the product himself 7. up to 6 of the subjects can be users who are using an intermittent catheter due to re-tention, but who are also dribble inconti-nent in-between catheterizations, and hence need a product to handle the inconti-nence. 8. able to fit the test product. exclusion criteria: 1. if experiencing incontinence less than once per week 2. bedridden, using wheelchair or using a walking aids regularly
the compartmental biology of hiv in the male genital tract

Conditions: Human Immunodeficiency Virus; Virus Shedding

Summary: male participants taking tenofovir-emtricitabine (tdf/ftc) will provide semen and blood samples which will be analyzed to better understand the pharmacology of antiretroviral therapy in the male genital tract.

8 hiv positive men taking tdf/ftc and 8 hiv negative men taking tdf/ftc as pre-exposure prophylaxis will provide multiple semen and blood samples during a 48-hour inpatient visit. 8 hiv positive men taking taf (tenofovir alafenamide) will provide multiple semen and blood samples during a 48-hour inpatient visit. participants will take part in the study for approximately two months. after the screening visit, there is one 2 day overnight visit for intensive pk/pd (pharmacokinetic/pharmacodynamic) sampling. the investigators will study drug concentrations and intracellular endogenous nucleotide concentrations (datp and dctp) in seminal plasma and (where appropriate) seminal cells. samples will be analyzed through the use of novel laboratory methods to determine the seminal plasma and seminal cell concentrations of tenofovir and emtricitabine. new technologies will be used to better understand compartmental and intracellular antiretroviral pharmacology of nucleoside/tide reverse transcriptase inhibitors. pharmacokinetic modeling will be used to estimate the primary outcomes.

Eligibility criteria:
inclusion criteria: * born male between the ages of 18 and 60 * hiv positive taking tdf/ftc (and a third drug) as treatment; or hiv negative men receiving tdf/ftc as pre-exposure prophylaxis; hiv positive men taking tenofovir alafenamide * if on routine treatment must have been taking medication for at least 3 months and adherence to medication as assessed by blood plasma hiv rna less than 50 copies per ml. * documentation of at least 80% adherence to antiretroviral (art) regimen, through clinician or self-report, with no missed doses in the 3 days prior to the inpatient visit. * willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that would pose unnecessary risk or interfere with study results. * unwilling or unable to abstain from sexual activity 72 hours prior to overnight sampling visit * unlikely to remain on current drug regimen during study period * anemia that precludes blood donation * unable to provide semen specimen * current receipt of other medications that may affect endogenous nucleotide concentrations, such as additional hiv nucleoside reverse transcriptase inhibitors, ribavirin, or adefovir

Keywords: hiv tenofovir-emtricitabine antiretroviral therapy prevention tenofovir alafenamide
study of uk adults with congenital adrenal hyperplasia.

Conditions: Congenital Adrenal Hyperplasia

Summary: congenital adrenal hyperplasia (cah) is one of the commonest inherited diseases, affecting 1:14,200 live births. it is the result of a genetic defect in one of the enzymes (in most cases 21-hydroxylase) required for cortisol biosynthesis, leading to reduced levels of cortisol and aldosterone, increased acth concentrations and consequently increased adrenal androgen production. patients suffer from problems with growth and development and as adults patients may have problems with fertility, virilisation in women, testicular masses in men and both men and women have an impaired quality of life. patients have to take life-long therapy. despite its frequency knowledge surrounding the management of adults with cah remains fairly limited. there has been a lot of work describing the management of children with cah but to date there is no consensus on how to manage adults. to address this issue a number of adult endocrinologists in the uk under the auspices of the society for endocrinology have established a country wide study (cahase) to undertake research in order to set standards of care for adult patients with cah. in cah the severity of the symptoms experienced by affected individuals varies depending on the mutation and the genetic background of the individual. the ability to tailor cah therapy on an individual basis, as determined by the severity of the underlying defect and an understanding of the likely natural history of the disease, is a key goal in clinical management. correlation of phenotype (clinical status) and genotype (the underlying 21 hydroxylase gene mutation) will facilitate stratification of severity and provide an important contribution to the debate on potential mechanisms of individualised therapy. for instance it may become clear that certain cah genotypes are associated with specific long term outcomes. in time, this could lead to suggesting different treatment strategies in certain groups. moreover, genotype data are important if we are to address the relative contribution of environment (e.g. treatment) vs. genetics on long term outcomes. this multi-centre study aims to: 1. - investigate the medical health of adults with congenital adrenal hyperplasia. 2. - investigate the relationship between the genotype of the patient and the phenotype. 3. - investigate the quality of life of adults with congenital adrenal hyperplasia.


Eligibility criteria:
inclusion criteria: * age over 18 * clinical and genetic diagnosis of congenital adrenal hyperplasia exclusion criteria: * pregnant females * under 18

Keywords: congenital adrenal hyperplasia quality of life genotype metabolic outcomes
efficacy of a therapeutic combination of dronabinol and pea for tourette syndrome

Conditions: Tourette Syndrome

Summary: this is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of dronabinol (synthetic δ9-thc) and pea for the treatment of adults with tourette syndrome.

the investigators propose a 12-week, investigator-initiated, open-label trial of a therapeutic combination of dronabinol and pea in 18 adults with tourette syndrome. participants will receive dronabinol and pea in combination for the duration of the trial. the goal for this pilot study is to (1) provide initial safety, feasibility and tolerability data on both dronabinol and pea in a ts population and (2) provide data in order to make a more informed decision regarding the appropriate sample size and design of a larger clinical trial to prove efficacy (i.e. sample size and trial duration in large efficacy trial of the dronabinol/pea combination in ts).

Eligibility criteria:
inclusion criteria: * adult between 18-60 years of age * meet dsm-5 criteria for the diagnosis of tourette syndrome * significant current tic symptoms: ygtss total tic score greater than or equal to 22 at baseline * on stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial * accepted method of birth control exclusion criteria: * comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (iq\<70) * recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), ssris, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). medication change is defined to include dose changes or medication discontinuation. * recent change in behavioral treatment for tourette syndrome or comorbid conditions (i.e. ocd) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks. * taking any co-medications (over the counter or prescription), food supplements/additives which can have a drug interaction with dronabinol or pea. * positive pregnancy test or drug screening test * history of cannabis dependence * significant medical comorbidity * history of hypersensitivity to any cannabinoid or sesame oil

Keywords: motor tics vocal tics cannabinoids dronabinol pea palmitoylethanolamide tourettes ts
serum lncrnas as early potential biomarkers for the prediction of preeclampsia

Conditions: Preeclampsia

Summary: to identify lncrnas differentially expressed at early stages of gestation in the serum of pregnant women, who later developed severe preeclampsia (spe) in the third trimester of pregnancy compared to women with normal pregnancy .

preeclampsia (pe) is a pregnancy syndrome characterized by hypertension and proteinuria, and a leading cause of maternal and fetal morbidity and mortality, with poorly defined pathophysiological mechanisms remain. circulating lncrnas are long, noncoding rna molecules, which negatively regulate gene expression, and considered as promising biomarkers for pe. the objective of the study is to evaluate circulating lncrna signatures in women with pe compared to healthy women, and in women sub-grouped per pe severity. this study assessed lncrna expression profile in the serum at early stages of gestation of women who later developed severe preeclampsia (spe) in the third trimester of pregnancy compared to women with uncomplicated pregnancies. circulating lncrna was extracted from maternal serum. this study also assess lncrna expression profile in the placenta tissues of pe patients and healthy pregnant women.

Eligibility criteria:
inclusion criteria: * new onset hypertension (systolic blood pressure ≥140 mm hg or diastolic blood pressure ≥90 mm hg on two occasions at least 4 h apart) after 20 weeks of gestation in women who previously had normal blood pressure. * proteinuria (the excretion of 300 mg or more of protein in a 24-hour urine collection)or other signs/symptoms of preeclampsia after 20 weeks of gestation in women who previously had normal blood pressure. exclusion criteria: * maternal infections * smoking * chemical dependency * known major foetal or chromosomal anomalies * intrahepatic cholestasis during pregnancy * assisted reproductive technology (art) treatments * chronic hypertension.
impact of covid-19 infection on the incidence of ventilator-acquired infections

Conditions: SARS-CoV 2

Summary: observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between covid-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.

covapid is a multicenter cohort study with two retrospective control groups. no intervention will be performed in included patients, only patient characteristics and data on va-lrti will be collected. patients with confirmed sars-cov-2 community-acquired pneumonia, admitted to the participating icus from the start of covid epidemic will be eligible for this study. those admitted before the beginning of this study will be included retrospectively, and those admitted after the beginning of the study will be included prospectively. 10-20 patients per center will be included in this group. sarscov2 infection will be confirmed by a nasopharyngeal pcr or respiratory secretions (tracheal aspirate or bronchoalveolar lavage) pcr. two retrospective groups will be constituted in order to give some insight of potential impact of sars-cov2 infection on the incidence of valrti :1) influenza group : patients with influenza (a or b) community-acquired pneumonia. all patients with influenza community acquired pneumonia and admitted in the same icu will be eligible in this group. the number of patients included in this group per center will be similar as that of patients included in the sars-cov-2 pneumonia group (10-20 patients). these consecutive patients will by identified using the files of virology lab. the first included patient will be the last of the current influenza season (2019-2020), and others will be taken consecutively back to 2019 of 2018 if necessary. pcr (nasopharyngeal or respiratory secretions) confirmation of influenza (a ou b) is required for patients in this group. 2) no viral infection group: patients with no viral community acquired pneumonia. all patients receiving invasive mechanical ventilation for more than 48h before covid epidemic, for any reason other than viral pneumonia are eligible for this group. the number of included patients in this group will be similar as that of patients included in the sars-cov-2 group in the same center (10-20 patients) these consecutive patients will be included starting at the end of january 2020 and going back to 2019 if necessary. vat and vap are defined using clinical, radiological and quantitative microbiological criteria.

Eligibility criteria:
inclusion criteria: for all three groups: * major patient * in patients in icu * patients intubated and mechanically ventilated for more than 48 hours. for the sars-cov2 group: community-acquired sars-cov2 pneumonia for the influenza group: community-acquired influenza pneumonia for the "no viral infection" group: no viral pneumonia on admission. exclusion criteria: * refusal to participate * lack of social security coverage
the metabolic impact of intermittent carbohydrate restriction in individuals with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Overweight and Obesity; Non-Alcoholic Fatty Liver Disease; Metabolic Syndrome

Summary: the primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.


Eligibility criteria:
inclusion criteria: * men or women * 35-75 years old * bmi \>27 kg/m2 * known type 2 diabetes in stable glucose lowering therapy (for three months) or with hba1c \>48 mmol/mol if no glucose lowering therapy exclusion criteria: * anemia (hemoglobin \<8 mmol/l for men and \<7 mmol/l for women) * tsh outside reference range * treatment with insulin, sulfonylurea, or sglt2-inhibitors * treatment with systemic corticosteroids * hba1c \>70 mmol/mol * egfr \<60 ml/min/1.73 m2 * contraindications for mr-scan: abdominal height exceed limitations of the mr-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia * food allergies (including lactose and gluten intolerance) * vegetarian/vegan diet or following of specific dietary plans * alcohol consumptions \>84/168 g/week (women/men) * strenuous activity level \> 120 minutes per week * weight loss (\>5 kg) within the last three months or previous bariatric surgery * high risk of fibrosis of the liver (estimated by fib4 score \> 3.25)
comparative study of fixation or fusion of calcaneal fractures

Conditions: Fractures, Comminuted; Fracture Fixation, Internal

Summary: a multicentre randomized controlled trial that will be conducted at level 1 trauma centres across canada. it will compare patients who receive open reduction, internal fixation for sanders iv calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.


Eligibility criteria:
inclusion criteria: * patients with sanders iv displaced intra-articular calcaneal fracture * males and females aged 16-59 inclusive * ability to provide informed consent * available for follow-up for at least 2 years after injury exclusion criteria: * medical contraindications to surgery * previous calcaneal pathology (infection, tumor, etc) * co-existent foot or ipsilateral lower limb injury * open calcaneal fracture * injury greater than 3 weeks old * head injured patients * inability to obtain pre-operative ct scan or accurately classify the fractures according to the sanders classification system * inability to comply with advice to diminish smoking after the injury * metal allergy * extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon * any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion

Keywords: calcaneus intra-articular fracture open reduction internal fixation primary subtalar fusion