Kornimate/medical-research-clean huggingface dataset:
a study of tiragolumab plus atezolizumab and atezolizumab monotherapy in participants with metastatic and/or recurrent pd-l1-positive cervical cancer

Conditions: Cervical Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (pd-l1)-positive cervical cancer (metastatic and/or recurrent).


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy * radiologically-measurable disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * cervical cancer tissue for study analysis (archival or fresh biopsy specimen) * life expectancy of at least 12 weeks * adequate hematologic and organ function * female of childbearing potential must be willing to comply with adequate contraception exclusion criteria: * treatment with investigational therapy with therapeutic intent within 28 days prior to randomization * active or untreated central nervous system (cns) or brain metastases * active or history of autoimmune disease or immune deficiency * active tuberculosis * known, clinically significant liver disease * severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety * prior treatment with cd137 agonists or immune checkpoint blockade therapies, anti-ctla-4, anti-tigit, anti-pd-1, and anti-pd-l1 therapeutic antibodies * treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization * treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study * pregnant or breastfeeding woman * known hypersensitivity to any component of the tiragolumab or atezolizumab formulations
cohort multiple randomized controlled trials open-label of immune modulatory drugs and other treatments in covid-19 patients

Conditions: Corona Virus Infection

Summary: the overall objective of the study is to determine which treatments (e.g. immune modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with covid-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. the specific aims of this covid19 cohort are to collect observational data at regular intervals on an ongoing basis in order to embed a series of randomized controlled trials evaluating a various set of interventions for patients with covid-19 pneumonia. the study has a cohort multiple randomized controlled trials (cmrct) design.


Eligibility criteria:
inclusion criteria: * laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen \< 72 hours and/or ct scan prior to randomization (following typical radiological findings (ground glass abnormalities, and absence of lymphadenopathy, pleural effusion, pulmonary nodules, lung cavitation) * hospitalized patients * illness of any duration and severity (mild, moderate, severe, critical, see annexe 1), with symptoms (fever, cough, respiratory difficulties, shortness of breath), and at least one of the following: * radiographic infiltrates by imaging (ct scan) * clinical assessment (evidence of rales/crackles on exam or respiratory rate \>25/min) and spo2≤94% on room air * spo2≤97 % with o2 \> 5l/min or respiratory rate\>=30/min * requiring mechanical ventilation * with any comorbidities (tbd such as acute kidney injury, cardiovascular condition, pulmonary disease, obesity, high blood pressure, diabetes, chronic kidney diseases, haematological diseases, sickle cell diseases, autoimmune and auto-inflammatory, pregnant women, hiv infected, etc) * male or female adult ≥ 18 years of age at time of enrolment * patients must be able and willing to comply with study visits and procedures. * patient agrees to the collection of oropharyngeal and nasal swabs and venous blood per protocol written informed consent provided by the patient or alternatively by next-of-kin prior to any protocol-specific procedures. exclusion criteria: * patients with any condition that the physician judges could be detrimental to the patient participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions (active infection diseases such as severe bacterial infections, aspergillosis, tuberculosis, depending on the tested medication). * absence of health insurance * subject protected by law under guardianship or curatorship
norepinephrine to prevent hypotension after spinal anesthesia for cesarean delivery: a dose finding study

Conditions: Hypotension

Summary: spinal anesthesia is the most common anesthetic technique for elective cesarean delivery (cd), but the most frequent unwanted side effect is hypotension, which can cause nausea and vomiting, as well as effects on the fetus. prevention and treatment of maternal hypotension includes intravenous fluids and vasopressors. phenylephrine is the most common vasopressor used for this purpose. however, it has been shown to reduce maternal heart rate and cardiac output, which may be a concern in an already compromised fetus. norepinephrine is commonly used in high concentrations in intensive care and recent studies have suggested that in low concentrations it may be a better alternative to phenylephrine in elective cd, as it does not reduce the maternal heart rate or cardiac output. the optimum bolus dose of norepinephrine to prevent hypotension after spinal anesthesia in elective cd has not been elucidated. the investigators propose this study to determine the dose that would be effective in 90% of patients (ed90). a previous study by ngan kee et al, using continuous infusion of norepinephrine to prevent hypotension in elective cd, suggested a potency ratio for norepinephrine to phenylephrine of approximately 16:1. hence, the investigators hypothesise that the ed90 will be approximately 6 µg, given that the current phenylephrine bolus dose at the investigators' institution is approximately 100 µg.

the use of norepinephrine to prevent and treat hypotension during cesarean delivery (cd) is new and data in the literature are scarce. a recent randomised controlled trial by ngan kee et al compared continuous infusions of norepinephrine and phenylephrine to prevent hypotension during cd. they showed that norepinephrine was effective at maintaining blood pressure, with a greater cardiac output and heart rate compared to phenylephrine. however, the effective bolus dose of norepinephrine needed to prevent maternal hypotension was not determined, and since this is a relatively new arena, no dose-response studies are available in the literature either. therefore, it would be logical to establish the effective bolus dose of norepinephrine to prevent hypotension during elective cd.

Eligibility criteria:
inclusion criteria: * elective cd under spinal anesthesia * normal singleton pregnancy beyond 36 weeks gestation * asa physical status ii/iii * weight 50-100 kg, height 150-180 cm * age over 18 years * informed consent exclusion criteria: * patient refusal * allergy or hypersensitivity to norepinephrine or sulfite * preexisting or pregnancy-induced hypertension * cardiovascular or cerebrovascular disease * fetal abnormalities * history of diabetes, excluding gestational diabetes * use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants

Keywords: vasopressor blood pressure cesarean section spinal anesthesia
mt1013 injection for the treatment of patients with secondary hyperparathyroidism (shpt) undergoing maintenance dialysis

Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Summary: this is a phase ii study comprising 3 parts, which part a/part b a double-blind, randomized, placebo-controlled sad/mad study, and part c a single arm study to investigate long-term efficacy and safety of mt1013 after 52 week treatment.the treatment duration for part b mad study is 2-4 weeks and the duration for part c study is 52 weeks.


Eligibility criteria:
1. receiving hemodialysis 3 times weekly for at least 3 months, and have adequate hemodialysis with a delivered kt/v≥1.2 or urea reduction ratio (urr)≥65% within 4 weeks prior to screening; 2. dialysis prescription dialysate calcium concentration must be ≥2.25 meq/l, and stable for at least 4 weeks prior to screening, remain stable for the duration of the study; 3. diagnosed of secondary hyperparathyroidism (shpt), with averaged ipth ≥300 pg/ml (42.4pmol/l) 14 days prior to screening; 4. receiving active vitamin d sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable; 5. subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable.
long-term procedural and device related complications of pfo closure

Conditions: Patent Foramen Ovale

Summary: we aimed to explore: (1）long-term complications of pfo closure; (2) antiplate or anticoagulation use after pfo closure.


Eligibility criteria:
inclusion criteria: * all patients who underwent pfo closure exclusion criteria: * unable to complete or adhere to the study
genetic testing in upper tract urothelial carcinoma (utuc): the epicheck study

Conditions: Urologic Cancer; Urologic Neoplasms

Summary: background: upper tract urothelial carcinoma (utuc) is a rare tumor associated with bladder cancer in up to 50% of cases. its incidence is rising due to improved detection and bladder cancer survival. the diagnosis of utuc is challenging because more than 35% of the standard biopsies can result inconclusive. the grading of utuc cells, which delivers the most important data for the choice between a kidney-sparing surgery (kss) and a radical treatment, is upgraded in 30% of radical nephroureterectomies. the follow-up of utuc after kss requires an invasive procedure as a diagnostic ureteroscopy for a minimum of 5 years, and urinary cytology has low diagnostic power. objective: the aim of the study is to evaluate the accuracy (overall and stratified for grade) of a dna methylation urine biomarker test (bladder epichecktm) in utuc, and to compare it with current standard (urinary cytology). the secondary objective is to show its applicability in the specific clinical scenario of utuc surveillance after kidney-sparing surgery and related cost-effectiveness. design, setting, and participants: from february 2019 to february 2021, 80 consecutive patients candidates to ureteroscopy for suspicion of primary, recurrent or metachronous utuc in one tertiary referral centers (fundaciò puigvert) giving written informed consent will be included in the study. intervention: bladder urine samples (\> 10 ml) will be collected for cytology and for the methylation test before cystoscopy. prior to semirigid and flexible ureteroscopy, urine specimens from the upper urinary tract will be obtained via a ureteral catheter.


Eligibility criteria:
inclusion criteria: * patients suspected for primary or recurrent upper tract urothelial cancer requiring ureteroscopy exclusion criteria: * metastatic disease with patient unfit for ureteroscopy * positive cystoscopy (concomitant presence of bladder cancer) * macroscopic hematuria not self-limiting requiring upfront nephroureterectomy

Keywords: upper tract urothelial carcinoma urinary biomarker liquid biopsy epigenetics surveillance follow-up
california prehospital and in hospital antifibrinolytic therapy via txa

Conditions: Hemorrhagic Shock; Trauma Injury

Summary: the california prehospital antifibrinolytic therapy (cal-pat) study seeks to evaluate the safety and efficacy of tranexamic acid (txa) use in the civilian prehospital and in hospital setting in cases of traumatic hemorrhagic shock.

the cal-pat study is a multi-centered, prospective, observational cohort study. from march 2015 to july 2017, patients ≥ 18-years-old who sustained blunt or penetrating trauma with signs of hemorrhagic shock identified were considered for txa treatment by first responders in the prehospital setting and physicians in hospital. a control group was formed of patients seen in the five years prior to data collection cessation (june 2012 to july 2017) at each receiving center who were not administered txa. control group patients were selected through propensity score matching based on gender, age, injury severity scores, and mechanism of injury. the primary outcome measured was mortality. secondary outcomes measured included the total blood products transfused, the hospital and intensive care unit length of stay, and the incidence of known adverse events associated with txa.

Eligibility criteria:
inclusion criteria: * blunt or penetrating trauma with signs and symptoms of hemorrhagic shock * systolic blood pressure less than 90 mmhg at scene of injury, during air and/or ground medical transport, or on arrival to designated trauma centers * any sustained blunt or penetrating injury within 3 hours * patient who are considered to be at high risk for significant hemorrhage 1. estimated blood loss of 500 milliliters int he field accompanied with hr \>120 2. bleeding not controlled by direct pressure or tourniquet 3. major amputation of any extremity above the wrists and above the ankles exclusion criteria: * any patient under 18 years of age * any patient with an active thromboembolic event (within the last 24 hours) i.e. active stroke, myocardial infarction, or pulmonary embolism * any patient with a hypersensitivity or anaphylactic reaction to txa * any patient more than 3 hours post injury * traumatic arrest with \> 5 minutes cpr without return of vital signs * penetrating cranial injury * traumatic brain injury with brain matter exposed * isolated drowning or hanging victims * documented cervical cord injury with motor deficit

Keywords: tranexamic acid txa
functional circuit training in older adults with congestive heart failure

Conditions: Heart Failure, Congestive

Summary: the goal of this study is to determine the effect of a functional circuit training program as compared to standard cardiac rehabilitation or control exercise in improving physical function and activity.

in older (65 years of age or older) patients with congestive heart failure, we propose to: 1. assess: a) peak aerobic capacity (peak vo2) during a monitored, standardized treadmill test; b) oxygen uptake kinetics and heart rate during a standardized submaximal treadmill test; c) performance on a set of functional mobility tasks; d) self-report of physical disability and difficulty in performing daily tasks, and physical activity. 2. conduct a 12-week randomized controlled trial, comparing changes in these assessed measures in patients randomized to three different groups: 1) standard cardiac rehabilitation using bicycle exercise; 2) group functional circuit training focusing on exercises that involve functional mobility tasks and a home-activities exercise component; 3) a chair-based, flexibility and "toning " (low level resistance) group control exercise. 3. reassess all groups after an additional 12 weeks in the measures identified above to identify how well the three groups maintain their function. 4. examine the mechanisms underlying change in functional mobility performance and self-reported function as a result of the interventions primary hypothesis 1: compared to chair-based exercise controls at the end of week 12, both the cardiac rehabilitation and functional circuit training groups will show improvements in measures of peak aerobic capacity, submaximal oxygen uptake kinetics, functional mobility performance, and self-reported function. primary hypothesis 2: compared to the other two groups that are given exercise instructions only, the functional circuit training group, who continue their home activities exercise program, show less decline by week 24 in measures of peak aerobic capacity, submaximal oxygen uptake kinetics, functional mobility performance, and self-reported function. secondary hypothesis: measures of submaximal oxygen uptake kinetics are better predictors of changes in functional mobility performance and self-reported function than peak aerobic capacity, muscle strength, joint range of motion, balance, and behavioral factors (such as depression).

Eligibility criteria:
inclusion criteria: * congestive heart failure exclusion criteria:

Keywords: aged congestive heart failure exercise
a study of cc-5013 plus dexamethasone versus dexamethasone alone in previously treated subjects with multiple myeloma

Conditions: Multiple Myeloma

Summary: to compare the efficacy of oral cc-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."


Eligibility criteria:
inclusion criteria: * prior or current diagnosis durie-salmon stage ii or iii multiple myeloma. * measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample). * eastern cooperative oncology group (ecog) performance status score of 0,1, or 2 * females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug exclusion criteria: * prior development of disease progression during high-dose dexamethasone containing therapy * pregnant or lactating females * the development of a desquamating rash while taking thalidomide * use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment * laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm3 * laboratory abnormalities: platelet count \< 75,000/mm3 * laboratory abnormalities: serum creatinine \> 2.5 mg/dl * laboratory abnormalities: serum serum glutamic oxaloacetic transaminase (sgot)/aspartate aminotransferase (ast) or serum glutamic pyruvic transaminase (sgpt)/alanine aminotransferase (alt) \> 3.0 x upper limit of normal * laboratory abnormalities: serum total bilirubin \> 2.0 mg/dl * prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.

Keywords: multiple myeloma celgene revlimid cc-5013
dendritic cell vaccine for head and neck cancer

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: this research study is testing a new treatment of cancer of the head and neck. purpose this research study is being done to: 1. test the safety of the experimental cancer vaccine made of dendritic cells. an experimental vaccine is one that is not approved by the food and drug administration (fda). 2. to learn what effects (good and bad) the vaccine will have on you and your head and neck cancer. 3. to learn if the vaccine will stimulate your body's white blood cells, which are part of your immune system (your body's natural defense system).

white blood cells are part of the body's defense system. sometimes when you have cancer, your body does not know that the cancer cells are making you sick. we hope to teach your white blood cells to find and destroy your cancer cells with a vaccine. the vaccine will be made from a special kind of blood cell called a dendritic cell. this is the cell that will carry the information about your cancer to your white blood cells in your body.

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of the head and neck in patients with unresectable recurrent disease or distant metastasis or patients who fail conventional radiation therapy and/or chemotherapy and refuse surgical salvage. * presence of cervical metastasis that is able to be accessed for injection * biopsy accessible tumor (metastatic or primary) * \>18 years of age. * the following laboratory values obtained ≤14 days prior to registration: * anc ≥1500 * plt ≥100,000 * hgb ≥ 9.0 g/dl * alkaline phosphatase ≤3 x unl * ast ≤3 x unl * creatinine ≤1.5 x unl * life expectancy ≥6 months. * ecog performance status 0, 1, or 2. * no chemotherapy for prior 4 weeks. exclusion criteria: * pregnant women. * nursing women. * men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device {iud}, abstinence.) * known hiv infection. * concurrent use of systemic immunosuppressants. * other immunocompromising condition that in the opinion of the physician renders the patient a poor candidate for this trial. * other active cancer requiring therapy to control the disease. * unwillingness to return for follow-up evaluations over a period of up to 2 years following completion of protocol therapy. * other intercurrent medical problems that, in the opinion of the investigator, would make participation in the study hazardous for the patient * patients in whom the otolaryngologist, radiation oncologist, and medical oncologist can not agree on a consensus node to treat. * patients with cns metastasis or involvement of sites where an inflammatory response would constitute an immediately life threatening situation.

Keywords: phase i dendritic cell vaccine intra tumoral squamous cell carcinoma
a multicentre observational study to assess long-term outcome of participants in the excellent clinical trial

Conditions: Acute Myocardial Infarction

Summary: the perfect study is an observational study designed to follow patients randomised in the excellent study (nct02669810) for 10 years. the aim is to assess the long-term clinical outcomes for patients randomised to the standard of care arm or the protheracytes arm.


Eligibility criteria:
inclusion criteria : * completion of the last visit in the excellent interventional clinical trial. * participation must be within 10 years after the randomization in the excellent trial exclusion criteria : * patients randomized to the protheracytes® group who did not receive the product of the excellent trial are excluded. * any other coexisting conditions that will preclude participation in the study or compromise ability to give informed consent