Kornimate/medical-research-clean huggingface dataset:
effect on xpert® bladder test of urines inflammatory milieu induced by bcg treatment of patients with nmibc

Conditions: Non Muscle Invasive Bladder Cancer; Treatment by BCG

Summary: intravesical bcg immunotherapy is used after transurethral resection (tur) for the prevention of recurrence of nmibc. bcg treatment is usually started a few weeks after tur and is given once a week for 6 weeks. it stimulates immune responses that can destroy bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes side effects. the investigators postulate that xpert® test might be used to demonstrate the presence of residual (after turb) or recurrent (during adjuvant treatment) disease at the time of intravesical treatment, which could be of very significant impact in the management of this complex situation.urines of bcg treated patients are rich in immune system elements (cytokines, lymphocytes,...), this complex inflammatory milieu of urines may interfere with urinary biomarkers. this study will allow assessing the effect of the complex inflammatory milieu induced by bcg treatment in urines of patients with nmibc on the xpert® bladder cancer assay.

1. qualification of xpert® testing: three 50 ml fresh urine samples will be collected in sterile containers according to cepheid instructions of use: * the "baseline sample" before the first bcg instillation, * the "study sample" taken during the initiation course of treatment instillations, preferably at the 4th or 5th instillation of bcg therapy, * the "follow-up sample" at the time of the first follow-up cystoscopy, approximately 3 months after the last bcg instillation of the initiation course. xpert® test results will be qualified as positive or negative, according to cepheid instructions for use. samples tested positive at baseline will not be included in the analysis and the patient's participation in the study will be discontinued. samples obtained in patients with no recurrence at follow-up cystoscopy after the initiation course will be considered for analysis. 2. threshold of detection of thexpert® bladder test: * one urine sample of a patient tumor free (negative xpert test) under bcg treatment will be spiked into 3 log dilutions of the 2 distinct tumor cell lines sw780 and be(2)-c (100, 1000, and 10000 cells per ml). * a mix of fresh and frozen cells from en bloc harvested tumors from distinct donors will be tested at the set concentration in bcg urines from distinct patients.

Eligibility criteria:
inclusion criteria: * patients presenting with high-risk transitional cell carcinoma of the bladder, according to the eau guidelines/eortc risk stratification, who are offered adjuvant bcg instillations. exclusion criteria: -
self-administered intravaginal 2% lidocaine gel prior to intrauterine device insertion in nulliparous women

Conditions: Pain

Summary: this study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

intrauterine devices (iuds) are among the most effective forms of reversible contraception. numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of iuds in this group is low. one of the major barriers to women obtaining iuds is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during iud insertion. studies evaluating various methods for pain control during iud insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during iud insertion. this study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to iud insertion. this will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during iud insertion. if this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving iuds. increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.

Eligibility criteria:
inclusion criteria: * nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age * desires insertion of either levonorgestrel-releasing iud (lng-iud) or copper t380a iud (cu-iud) * no history of pregnancy in the last 6 weeks * able to provide written informed consent in english and comply with all study procedures exclusion criteria: * known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics * prior failed iud insertion * prior iud use * use of narcotic or benzodiazepine medication within the last 24 hours * u.s. centers for disease control medical eligibility criteria (mec) category 3 or 4 classification for use of an iud * positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period

Keywords: intrauterine device pain lidocaine
safety and tolerability of hti-1066 in subjects with advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: hti-1066 is a novel adc being developed for the treatment of cancers in patients with overexpression of c-met. this 2-part, phase 1 study evaluates the safety the tolerability of hti-1066 in subjects with advanced solid tumors.

this is a 2-part dose escalation and dose expansion study. dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (mtd) or recommended phase 2 dose (rp2d) is identified. in part 2, subjects with selected tumor types will be enrolled at the mtd or rp2d.

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age 2. subject must have an advanced solid tumor 3. ecog performance status of 0 or 1 4. life expectancy ≥12 weeks 5. adequate laboratory parameters 6. female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception. 7. willing and able to comply with clinic visits and study-related procedures 8. provide signed informed consent exclusion criteria: 1. hypersensitivity to hti-1066 or sensitivity to humanized monoclonal antibody products 2. any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor) 3. any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor) 4. any other prohibited or restricted medication as described in the study protocol. 5. investigational therapy administered \<5 half-lives before the first dose of hti-1066 6. any anticancer therapy administered \<5 half-lives before first dose of hti-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of hti-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of hti-1066. 7. active cns metastases. 8. cardiac disease (nyha classes ii-iv) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment. 9. history or presence of an abnormal ecg, echo, or muga that is clinically meaningful. 10. history of immunodeficiency including seropositivity for human immunodeficiency virus (hiv), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis b or c) 11. any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results 12. active infection or an unexplained fever \>38.5°c during screening or on the first scheduled day of dosing. 13. unresolved toxicities from previous anticancer therapy.
impact of postoperative adjuvant chemotherapy in patients with hepatocellular carcinoma after liver transplantation

Conditions: Liver Transplantation; Hepatocellular Carcinoma; Tumor Recurrence and Metastasis; Survival; Adjuvant Chemotherapy

Summary: the study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.


Eligibility criteria:
inclusion criteria: * all liver transplantation patients with hepatocellular carcinoma between dec 2008 and may 2010 are potentially eligible for enrollment. exclusion criteria: * age less than 18 years * treatment with other postoperative adjuvant chemotherapy * survival is less than 3 months after liver transplantation * inability to provide written informed consent prior to study entry
ropivacaine/dexamethasone and 10% lignocaine injection in gpn block for intractable cancer pain

Conditions: Cancer, Oropharynx; Pain, Intractable; Cancer Pain

Summary: the study will compare the efficacy and safety of ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain


Eligibility criteria:
inclusion criteria: * patients with proven carcinoma of the oropharynx and supraglottic larynx with estimated survival of 3 months or more. * pain lasting for at least 2 weeks with an average intensity of 5 or more on an 11-point numeric rating scale (nrs) refractory to a combination strong opioids and nsaids exclusion criteria: 1. local infection or skin ulceration at the puncture site 2. local anaesthetic allergy 3. psychiatric illness that affected cooperation.
espresso (epidemiology strengthened by histopathology reports in sweden)

Conditions: Gastrointestinal Diseases

Summary: the espresso study is a collection of data from all computerised gastrointestinal histopathology reports in sweden. this allows us to study risk factors for gastrointestinal disease, as well as the prognosis of gastrointestinal disease. a review of the study has been published here: https://pubmed.ncbi.nlm.nih.gov/30679926/

the espresso study constitutes a novel approach to examine the etiology and prognosis of gastrointestinal disease in which histopathology plays a prominent role. between 2015 and 2017, all pathology departments (n=28) in sweden were contacted and asked to procure histopathology record data from the gastrointestinal tract (pharynx to anus), liver, gallbladder, and pancreas. for each individual, local histopathology it personnel retrieved data on personal identity number, date of histopathology, topography (where the biopsy is taken), morphology (biopsy appearance), and where available free text. in total, between 1965 and 2017, histopathology record data were available in 2.1 million unique individuals, but the number of data entries was 6.1 million because more than one biopsy was performed in many of the study participants. index individuals with histopathology data were matched with up to five controls from the general population. the investigators also identified all first-degree relatives (parents, children, full siblings), and the index individual's first spouse. the total study population consisted of 13.0 million individuals. data from all the study participants have been linked to swedish national healthcare registers allowing research not only on such aspects as fetal and perinatal conditions and the risk of future gastrointestinal disease but also on the risk of comorbidity and complications (including cancer and death). furthermore, the espresso database allows researchers and practitioners to identify diagnoses and disease phenotypes not currently indexed in national registers (including disease precursors). the espresso database increases the sensitivity and specificity of already-recorded diseases in the national health registers. this paper is an overview of the espresso database.

Eligibility criteria:
inclusion criteria: * any person with a computerised histopathology record from the gastrointestinal tract including the liver, gallbladder and the pancreas. * matched controls to any person with the above histopathology record. * spouses and first-degree relatives to any of the above. exclusion criteria: -none (this is a registry-based study)

Keywords: cohort gallbladder gut liver pancreas population-based colon pathology endoscopy celiac inflammatory bowel disease colitis esophagus
long-term development of muscular dystrophy outcome assessments

Conditions: LGMD1B; LGMD1C; LGMD1D; LGMD1E; LGMD1F; LGMD1G; LGMD1H; LGMD2A; LGMD2B; LGMD2C; LGMD2D; LGMD2E; LGMD2F; LGMD2G; LGMD2I; LGMD2J; LGMD2K; LGMD2L; LGMD2M; LGMD2N; LGMD2O; LGMD2P; LGMD2Q; LGMD2S; LGMD2T; LGMD2U; LGMD2W; LGMD2X; LGMD2Y

Summary: this is a 24-month, observational study of up to 1000 participants with limb girdle muscular dystrophy (lgmd), myotonic dystrophy type 2 (dm2), and late onset pompe disease (lopd).

limb girdle muscular dystrophy (lgmd) comprise a group of disorders made up of over 30 mutations which share a common phenotype of progressive weakness of the shoulder and hip girdle muscles. while the individual genetic mutations are rare, as a cohort, lgmds are one of the four most common muscular dystrophies. myotonic dystrophy type 2 (dm2) is a more recently discovered, rare type of myotonic dystrophy. dm2 is inherited in an autosomal dominant pattern and is caused by an unstable cctg expansion. dm2 affects the muscles and other body systems (e.g. heart and eyes). pompe disease is a rare, multisystemic, hereditary disease which is caused by pathogenic variations in the gaa gene. late onset pompe disease (lopd) refers to cases in which hypertrophic cardiomyopathy did not manifest or was not diagnosed at or under the age of 1 year. lopd is characterized by skeletal muscle weakness which causes mobility problems and impacts the respiratory system. the overall goal of this project is to extend prior observational studies conducted within the grasp lgmd network to define the key phenotypes as measured by standard clinical outcome assessments (coas) for multiple rare types of muscular dystrophy to hasten therapeutic development.

Eligibility criteria:
inclusion criteria: 1. age between 6-50 years at enrollment 2. clinically affected (defined as weakness on bedside evaluation in a pattern consistent with proximal weakness) 3. genetic confirmation of a lgmd, dm2, or lopd 4. fvc above 30% of predicted exclusion criteria: 1. any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator 2. participation in a clinical trial receiving an investigational product

Keywords: muscular dystrophy myotonic dystrophy limb girdle muscular dystrophy lgmd lopd late onset pompe disease
safety/efficacy of zoledronic acid and alendronate on bone metabolism in postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: the aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.


Eligibility criteria:
inclusion criteria: - low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women exclusion criteria: - previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: osteoporosis bisphosphonate biomarker zoledronic acid alendronate postmenopausal
rosmalip® for cancer infections prevention

Conditions: Infections; Covid19; Cancer

Summary: this study is designed to assess the safety and efficacy of rosmalip® nutritional supplement compared to placebo in subjects with solid cancer for the prevention of infections including covid-19.

cancer patients undergoing oncologic treatments frequently have comorbidities and suffer immunosuppresion, toxicities and exposure to nosocomial pathogens. as a result, they are at increased risk of infections, including covid-19. it is of utmost importance to find therapies that can prevent infections with as less toxicity as possible. rosmalip® is a nutritional supplement developed as a molecular nutrition, composed of a rosemary supercritical extract at concentrations approved by efsa -with in vitro and in vivo antitumor effects that are independent of its antioxidant and anti-inflammatory properties- in a lipidic vehicle that has shown in preclinical and clinical studies to potentiate innate immunity without apparent toxicity. being a product of easy synthesis its effects on immunity, inflammation and cancer, could be of interest to prevent and ameliorate infections, including covid-19. in this pilot study it is hypothesized that rosmalip® could help to prevent or ameliorate infections, including covid-19, in oncologic patients under active treatment. secondarily, it is also hypothesized to have metabolic beneficial effects.

Eligibility criteria:
inclusion criteria: * patients with a solid cancer under active anticancer treatment (including chemotherapy, immunotherapy, hormone therapy, targeted therapy) * informed consent signature exclusion criteria: * allergies to fish * vitamin, antioxidants consumers and who would no accept to stop taking them 1 week before and during the study * disphagia * bilirrubin higher than 1.5 upper normal limit (unl)/ creatinin \> 1.5 unl * severe organic dysfunction * cardiac dysfunction * cholangitis/ biliary tract obstruction * immunodeficiency or immflamatory disease (hiv, inflammatory bowel disease, collagenosis) * dementia or psychiatric severe disease * pregnancy or breastfeeding * previous diseases that interfere lipid carrier absorption
radiation therapy following surgery to remove brain metastases

Conditions: Metastatic Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases. purpose: pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.

objectives: i. assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. ii. measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. iii. measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients. outline: all patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. patients are given up to 5 weeks following surgery to recover and reach the required performance status. radiotherapy must commence within 6 weeks of surgery. patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5. projected accrual: there will be 20-40 patients accrued into this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed cerebral metastases post surgical resection * no greater than 3 cerebral metastases postresection * gross resection at operation as documented in operation note and postoperative mri patients must have current surgical sites that have not been previously irradiated * no other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease) * age: 18 and over * karnofsky 60-100% * life expectancy: at least 3 months * prior or concurrent required steroids allowed * prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites * prior surgery of cerebral metastases allowed exclusion criteria: * severe asthma requiring therapy * allergy to iodine or contrast media * pregnant * concurrent chemotherapy * prior whole brain irradiation or focal irradiation to current sites of disease

Keywords: tumors metastatic to brain
effects of intracoronary prourokinase on the coronary flow during primary percutaneous coronary intervention for acute myocardial infarction

Conditions: Myocardial Infarction; Percutaneous Coronary Intervention; Thrombolytic Therapy

Summary: the purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * st-segment elevation ami within 12 hours of symptom onset exclusion criteria: * contraindications to thrombolysis or pci * patients administered a fibrinolytic agent before pci * patients enrolled in clinical trials

Keywords: no-reflow phenomenon
a study of sacituzumab govitecan given at an alternative dose and schedule in participants with advanced triple-negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: the goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (sg) given at an alternative dose and schedule, in participants with triple-negative breast cancer (tnbc). the primary objectives of this study are to assess the safety and tolerability of sg given at alternate dose and schedule, to assess the effect on objective response rate (orr) and progression-free survival (pfs).

phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (pk), and efficacy of sg. phase 2 expansion of this study will further evaluate the safety, efficacy, and pk of sg.

Eligibility criteria:
key inclusion criteria: * individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent. * histologically or cytologically locally confirmed tnbc. * phase 1: individuals with unresectable, locally advanced or metastatic tnbc who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease. * phase 2: individuals with unresectable, locally advanced or metastatic tnbc who have not received previous systemic therapy for advanced disease. * phase 2: tumors must be pd-l1 negative, defined as tumor pd-l1 combined positive score (cps) \< 10 using the pd-l1 immunohistochemistry (ihc) 22c3 assay. alternatively, individuals with tumor cps ≥ 10 will be eligible if they received an anti-pd-(l)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-pd-(l)1 agent. due to a comorbidity. * uridine diphosphate glucuronosyltransferase 1a1 (ugt1a1) genotype status. during phase 1 safety run-in, individuals must be ugt1a1 wild-type. after phase 1 safety run-in, individuals with any ugt1a1 genotype may be eligible. * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) according to recist version 1.1 criteria. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * adequate hematologic counts within 2 weeks prior to enrollment. * adequate hepatic and renal function. key exclusion criteria: * prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (adc) containing a topoisomerase inhibitor. * prior treatment with a trophoblast cell-surface antigen 2 (trop-2)-directed adc. note: other protocol defined inclusion/exclusion criteria will apply.