Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of ada-011 for subjects with advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: this study consists of dose escalation evaluation to determine the safety and tolerability of ada-011 as a monotherapy. following dose escalation, one or more dose expansion cohorts in selected indications will be explored to further evaluate the safety, tolerability, and preliminary efficacy of ada-011.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (nonresectable) or recurrent and progressing since the last antitumor therapy and for which no recognized standard therapy exists * eastern cooperative oncology group (ecog) performance status ≤2 * measurable disease per recist v1.1 or per other criteria best suited for the specific tumor type being evaluated * adequate organ function exclusion criteria: * treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 2 weeks prior to the first dose of ada-011 * chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to the first dose of ada-011 * major trauma or major surgery within 4 weeks prior to the first dose of ada-011 * aes from prior anticancer therapy that have not resolved to grade ≤1 except for alopecia * known, central nervous system (cns) disease involvement, or prior history of nci ctcae grade ≥3 drug-related cns toxicity. * evidence of active uncontrolled viral, bacterial, or systemic fungal infection * active sars-cov-2 infection, irrespective of symptoms. * history or risk of severe, chronic, untreated, or currently active autoimmune disease * prior solid organ transplant or has had an allogenic hematopoietic stem cell transplant within the past 20 years * pregnant, lactating, or breastfeeding
carbon dye tattooing of biopsied axillary node in breast cancer

Conditions: Sentinel Lymph Node; Breast Cancer; Tattoo; Pigmentation; Axilla; Breast

Summary: the primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. the secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing alnd after nact).

pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. the need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (nact) is anticipated so that these nodes may be identified at the time of surgery. measures that improve both the accuracy of nodal evaluation after nact and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. the investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension (spot dye). the concept is based on the experience in the gastrointestinal tract wherein tattooing is widely used for marking lesions or tumours biopsied during endoscopy. india ink tattoos of colonic lesions remain identifiable over a long period of time. spot is routinely used in the uk for tattooing gastrointestinal tract lesions and is used to mark the axillary lymph nodes in breast cancer by some centres in the us and europe. the intraoperative success of identifying tattooed axillary lymph nodes and their concordance to sentinel nodes will be determined.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * male or female * patients scheduled to undergo routine fine needle aspiration (fna) or core biopsy of abnormal axillary lymph node * invasive breast cancer * written informed consent for the study exclusion criteria: * not undergoing surgery or unfit for surgery
safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia

Conditions: Hypoxic Ischemic Encephalopathy

Summary: the purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia.

neonatal hypoxic-ischemic encephalopathy, due to perinatal asphyxia, is one of the leading causes of cerebral palsy, whose incidence, despite improvements in perinatal practice and neonatal care, has remained essentially unchanged over the recent past decades. it occurs approximately in 2-3 newborns every 1000 live births with a mortality rate of 10% for mild degrees and 60% for severe degrees. about 30% of survivors with mild hypoxic-ischemic encephalopathy and 100% with severe hypoxic-ischemic encephalopathy exhibit variable degrees of neurological disability. several studies have demonstrated the therapeutic effects of whole-body or selective head cooling to treat neonates with hypoxic-ischemic encephalopathy. mild hypothermia, (rectal or esophageal temperature 33-34°c), started within 6 h after birth and protracted for 48-72 h, can significantly improve primary outcome measures such as death or disability at 18 months or improve the neurological outcome in survivors. consequently, mild hypothermia is at present recommended for the treatment of moderate degrees of encephalopathy. topiramate an anticonvulsant agent widely used in adults and children, has been demonstrated to posses neuroprotective properties against hypoxic ischemic brain damage, both in vitro and in animal models and has been included in neuroprotective strategies for ischemic stroke and neonatal hypoxic-ischemic cerebral injury. recently, topiramate treatment in asphyxiated newborns has been reported safe. aim of the present study is to confirm the safety and to evaluate whether the association of topiramate enhances the neuroprotective properties of hypothermia for the treatment of neonatal hypoxic-ischemic encephalopathy.

Eligibility criteria:
inclusion criteria: 1. gestational age \> 36 weeks and birth weigh \> 1800 g with at least 1 of the following: a) apgar score \ -16 mmol/l in umbilical cord blood or arterial, venous or capillary blood) within 60 minutes from birth; 2. moderate to severe encephalopathy, consisting of altered state of consciousness (irritability, lethargy, stupor, or coma) and \> 1 of the following sings: a) hypotonia, b) abnormal reflexes, including oculomotor or pupil abnormalities, c) absent or weak suck, d) clinical seizures. 3. abnormal aeeg exclusion criteria: congenital abnormalities, congenital viral infections or evidence encephalopathy other than hie. -

Keywords: asphyxia neonatorum, hypothermia, neuroprotection
clinical study of active intervention in high-risk hfpef patients

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: based on inclusion and exclusion criteria, this experiment plans to include 924 heart failure with preserved ejection fraction(hfpef) patients with increased risk of all-cause death. the enrolled patients will divided into usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. the usual care patients will receive routine heart failure treatment. patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower n-terminal pro brain natriuretic peptide (nt-probnp), c-reactive protein(crp), new york heart association(nyha )classification, to add diuretics for patients with higher right ventricular diameters(rads),multidiscipline intervention for patients complicating chronic obstructive pulmonary disease(copd), and actively reperfusion for ischemic hfpef patients. the incidence of all-cause death will be compared after 3 years follow-up.the primary endpoint is the occurrence of all-cause mortality events during the follow-up period.

our newly finished study developed and validated a risk prediction model for all-cause mortality in patients with hfpef based on real-world data. the nomogram prediction model included factors such as nt-probnp, albumin, age, nyha class iii-iv, crp, rads, hemoglobin, copd, hyponatremia, and percutaneous coronary intervention(pci). discharged hfpef patients with scores ≥200.37 were found to be associated with increased risk of all-cause death up to 3 years. in this trial, we sought to evaluate the impact of targeted risk factors intervention post-discharge in patients with with scores ≥200.37 on all-cause death up to 3 years. based on inclusion and exclusion criteria,we will enroll 924 patients with hfpef and scores ≥200.37. the enrolled patients will divided into a usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. the usual care group patients will receive routine heart failure treatment, patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower nt-probnp, crp, nyha classification, to add diuretics for patients with higher rads, multidiscipline intervention for patients complicating copd, and actively reperfusion for ischemic hfpef patients. the primary endpoint is the occurrence of all-cause mortality events during the 3 years follow-up period.

Eligibility criteria:
inclusion criteria: * discharged hfpef patients with risk score \> or equal 200.37. exclusion criteria: * patients with a life expectancy of less than 1-year due to malignancy.

Keywords: all-cause mortality
measurement of early bone loss around a total hip arthroplasty

Conditions: Coxarthrosis

Summary: research with dxa has shown the pattern of bone remodelling around an implant. the baseline and reference value for such calculations is the first measurement after the operation. the baseline measurement is performed at different time from study to study. if there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. to evaluate dxa as a method we decided to set up a study with 3 dxa measurements within the first 2 weeks. our hypothesis is that there is a rapid bone loss the first 2 weeks after operation and that timing of the first post operative measurement will influence the later results.

dual x-ray absorptiometry (dxa) has become the most used and proven to be a precise method to investigate changes in bone mass density (bmd). research with dxa has shown the pattern of bone remodelling around an implant. results from implant studies are often presented as changes in bmd as a function of time. the baseline and reference value for such calculations is the first measurement after the operation. the most pronounced bone loss after implantation of hip prosthesis usually comes within 3 months. the baseline measurement is performed at different time from study to study. if there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. to evaluate dxa as a method we decided to set up a study with 3 dxa measurements within the first 2 weeks. we included 23 patients operated with total hip prosthesis (thp). they were measured with dxa at 1, 5 and 14 days, 3 and 12 months after the operation. results were given in percent (+/-sd) for each gruen zone. there were no changes in bone density between the first 3 measurements. in all zones, except zone 1, the lowest bmd was measured after 3 months. we concluded that dxa measurements done within 14 days after the operation can be used as reference measurements for later follow ups.

Eligibility criteria:
inclusion criteria: * degenerative hip osteoarthritis exclusion criteria: * metastasis to bone * dementia

Keywords: dxa hip arthroplasty
the safety and efficacy of ozarelix to treat men with lower urinary tract symptoms due to enlargement of the prostate

Conditions: Benign Prostatic Hypertrophy

Summary: this study is to compare the efficacy and safety of ozarelix 15 mg given intramuscular (im) 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with benign prostatic hypertrophy (bph) who are over 50 years of age.

this study is to compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from lower urinary tract symptoms (luts) secondary to benign prostatic hypertrophy (bph) following treatment with ozarelix. ozarelix is compared to placebo and injections given 14 days apart. patients are followed for 6 months and both safety and efficacy assessed at monthly visits. additionally, the impact of treatment on erectile function, if any, as well as prostate-specific antigen (psa) and testosterone levels will be monitored. the screening period of 7 days. the duration of the study is 40 weeks, including a 28-day placebo run-in phase (eligible participants entered a placebo run-in phase in which placebo is administered twice over a 2 week period \[day -28 and day -14\] and participants are assessed to establish baseline values approximately 14 days following the second placebo injection), study drug is administered on days 0 and 14 followed by 34 weeks of observation after the last dose of study drug.

Eligibility criteria:
inclusion criteria: - all of the following questions must be answered "yes" at visit 1 in order for the participant to participate in the study. * is the participant at least 50 years old? * does the participant have clinical signs and symptoms consistent with bph? * does the participant have an ipss 13 at screening (prior to placebo run in)? * does the participant have a peak urinary flow rate (qmax) of 4-15 milliliter/second (ml/sec) established on a voided volume of at least 125 ml? * is the participant willing to agree not to use any other approved or experimental pharmacologic bph treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study? exclusion criteria: all of the following questions must be answered "no" at visit 1 in order for the participant to participate in the study. * does the participant have a history of prostate cancer or a serum psa \>10 nanograms per milliliter (ng/ml)? * has the participant had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy? * does the participant have a prevoid total bladder volume assessed by ultrasound \> 550 ml? * does the participant have a residual urine volume \> 350 ml by ultrasound?

Keywords: benign prostatic hyperplasia prostatic adenoma, benign prostatic hypertrophy, benign enlarged prostate prostatism adenoma, prostatic
a feasibility study evaluating the use of a non-invasive ventilation mask

Conditions: Noninvasive Ventilation; Respiratory Insufficiency

Summary: evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.


Eligibility criteria:
inclusion criteria: * patient requiring non-invasive ventilation in an intensive care unit exclusion criteria: * patient not stable for non-invasive ventilation * patient with unprotected airway * excessive secretions * patient with facial surgery * agitated patient
effects of fenofibrate on metabolic and reproductive parameters in polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: this is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome and mild hypertriglyceridemia. the investigators primary objective will be to determine whether fenofibrate will reduce hepatic adiposity as measured using mri, and our secondary outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters for insulin resistance, cardiovascular disease, and reproductive status.


Eligibility criteria:
inclusion criteria: * premenopausal women ≥ 18 years * diagnosis of pcos based on the recent 2006 androgen excess society criteria (modified from rotterdam 2003) * waist circumference \>88 cm * fasting tg 2.0 - 5.0 mmol/l * stable on any type of oral contraceptive for a minimum of 3-months exclusion criteria: * known contraindications for mri * pregnancy, lactation, desire to become pregnant * participation in another clinical trial * fasting tf level ≥ 5.0 mmol/l * ast or alt \> 2.5 times upper limit of normal (uln) * creatinine kinase (ck) \> 6x uln * creatinine \> 115 μmol/l * fasting glucose ≥ 7.0 mmol/l and/or 2h glucose post oral glucose tolerance test (ogtt) ≥ 11.1 mmol/l or personal history of dm2 * personal history of renal disease, liver disease (except nafld), or heart disease * body mass index (bmi) \ 40 kg/m² * increased alcohol use (\>9 standard drinks per week \[standard drink = 12oz beer, 5oz wine, or 1.5oz spirits\]) or drug use * use of other hormonal contraception, growth hormone, glucocorticoids, anti-diabetic/anti-dyslipidemia medications, or anabolic steroids.

Keywords: polycystic ovary syndrome hepatic adiposity diabetes hormones cardiovascular disease
assess safety and efficacy of lacosamide in patients with partial seizures

Conditions: Epilepsy

Summary: the main purpose of this trial is to determine safety and efficacy of lacosamide under long term therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy * completion of double blind trial exclusion criteria: * taking other investigational drug than lacosamide * meeting withdrawal criteria from double blind trial
a study in patients with diabetes mellitus type ii of the effect on albuminuria of 24 week treatment with valsartan, benazepril, and valsartan+benazepril

Conditions: Hypertension; Diabetic Nephropathy

Summary: the purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria * patients with a median (of 3 samples) timed overnight uaer in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry * patients who give written, signed, informed consent. * patients with/without mild /moderate hypertension. * patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment. * patients without any accompanying systemic disease exclusion criteria: * pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception * patients with type i diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis other protocol-defined exclusion criteria may apply.

Keywords: hypertension diabetes mellitus type ii valsartan benazapril
psychological burden in icu survivors of severe covid-19 pneumonia, their relatives and their healthcare providers

Conditions: Corona Virus Infection; Post-traumatic Stress Disorder

Summary: coronavirus disease 2019 (covid-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (sars-cov-2). the infection is highly contagious requiring restrictive and stressful measures for patients, family members and icu healthcare providers. to avoid contagion, patient isolation has become the rule. for patients, these measures add stress to the icu environment and deprive them of unrestricted family visits. family members are not only left with fear but also many unanswered questions. in end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. the impact of exclusion or limited inclusion certainly needs to be explored. moreover, icu caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. the main objective of this study is to demonstrate that the covid-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (ptsd) in family members of critically ill patients. ptsd-related symptoms will be assessed in family members using the ies-r (impact of event scale revised) during a telephone interview 90 days after icu discharge. the ies-r is a 22-item self-report measure that assesses subjective distress caused by traumatic events. it will be compared across the three groups (covid-19, flu and cap).


Eligibility criteria:
inclusion criteria: * patients: * age\>18y * admission to the participating icus for any cause of acute respiratory failure during the covid-19 pandemic * having received invasive or noninvasive mechanical ventilation * non-opposition to participate to the telephone interviews. family members: * age\>18y * non-opposition to participate to the telephone interviews * one family member per patient: the family member the most implicated in the patient's care healthcare providers: * all nurses and physicians (including those in training) in the participating icus during the covid-19 pandemic exclusion criteria: * patients: * language barrier to be able to respond to the telephone interview * cognitive disorders disabling patients to respond to the telephone interview * person under legal protection (1121-8 of csp, public health code) failure to obtain the non-opposition family members: * language barrier to be able to respond to the telephone interview * person under legal protection (1121-8 of csp, public health code) * failure to obtain the non-opposition healthcare providers: failure to obtain the non-opposition