Kornimate/medical-research-clean huggingface dataset:
study of low-dose radiotherapy (ldrt) concurrent cisplatin/carboplatin plus etoposide with atezolizumab for patients with extensive-stage small cell lung cancer

Conditions: Carcinoma, Small Cell Lung

Summary: this is a phase ii, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (ldrt) concurrent cisplatin/carboplatin plus etoposide with atezolizumab in participants who have extensive-stage small cell lung cancer (es-sclc) and are chemotherapy-navïe for their extensive-stage disease.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed es-sclc * no prior treatment for es-sclc * measurable disease, as defined by recist v1.1. previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation. * ecog performance status of 0 or 1 * life expectancy \>= 3 months * adequate hematologic and end-organ function * for participants receiving therapeutic anticoagulation: stable anticoagulant regimen * negative human immunodeficiency virus (hiv) test at screening * negative hepatitis b surface antigen (hbsag) test at screening * positive hepatitis b surface antibody (hbsab) test at screening, or negative hbsab at screening accompanied by either of the following: negative total hepatitis b core antibody (hbcab), or positive total hbcab test followed by a negative hepatitis b virus (hbv) dna test. the hbv dna test must be performed for participants who have a negative hbsag test, a negative hbsab test, and a positive total hbcab test. * negative hepatitis c virus (hcv) antibody test at screening, or positive hcv antibody test followed by a negative hcv rna test at screening. the hcv rna test must be performed for participants who have a positive hcv antibody test. * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception * for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm exclusion criteria: * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * history of leptomeningeal disease * uncontrolled tumor-related pain * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * uncontrolled or symptomatic hypercalcemia * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * active tuberculosis * significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina * history of malignancy other than small cell lung cancer (sclc) within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
history of polycystic ovary syndrome in first-degree relatives

Conditions: Polycystic Ovary Syndrome

Summary: the aim of this study was to investigate the semen analysis results of male patients with first-degree relatives meeting the diagnostic criteria for pcos.

polycystic ovary syndrome (pcos) is an endocrine metabolic disorder characterised by menstrual irregularity, anovulation, clinical and/or biochemical signs of hyper androgenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities. this syndrome is clustered in family members and appears to be inherited through an oligogenic mechanism (1,2). as a result of familial clustering of the pcos phenotype, metabolic risks have been shown to increase in family members, independent of gender. the presence of a genetic background in the etiopathogenesis of pcos means that men may also have signs and symptoms equivalent to pcos. in addition, the genes responsible for pcos susceptibility in women are also transferred to male relatives of these individuals. hormonal and metabolic abnormalities have been identified in male relatives of women with pcos. these men have shown a higher prevalence of early-onset (\<35 years) androgenetic alopecia (aga), type 2 dm and cardivascular diseases. in addition, prostate cancer, benign prostatic hyperplasia (bph) and prostatitis have also been defined more frequently in this group of individuals (1,3). in addition, differences in responses to gonadotropin-releasing hormone (gnrh) and fsh and lh levels were found in the brothers of women with pcos compared to control groups. according to genome studies (gwas), fshb gene on chromosome 11p14.1 represents the pcos susceptibility focus in women (1). genetic variations in fshb affect male reproductive function. in fact, polymorphisms of the fshb promoter have been associated with lower sperm count, higher lh, lower fsh and lower testicular volume (3,4). in the light of this information, in this study, it was planned to evaluate the comparison of semen analysis results of male patients with a first-degree relative diagnosed with pcos with the control group.

Eligibility criteria:
inclusion criteria: * the study will include male partners between the ages of 18-40 who have no known disease, who give spermiogram test for the evaluation of infertile couple in our hospital and who have accepted the consent form verbally and in writing. exclusion criteria: * exclusion criteria; 1. history of any chronic disease, urinary tract or reproductive disease, neurological or psychiatric condition in the male patient and recent fever (≥38°c in the last 3 months) 2. those with a history of vasectomy, cryptorchism, radiation history, chemotherapy, infections, sexual dysfunction and endocrine hypogonadism 3. especially those with a history of finasteride and dutasteride drug use.

Keywords: male polycystic ovary syndrome infertility
investigation of hypermobility, biomarkers, and pain generators in chronic pain patients

Conditions: Low Back Pain, Mechanical; Spinal Stenosis; Nerve Root Disorder; Radiculopathy, Cervical; Benign Hypermobility Syndrome

Summary: observational study of axial spine pain and hyperflexibility. patients will receive physical exam maneuvers (traditional straight leg raise, faber, facet loading as well as beighton's hypermobility score) and blood / urine / saliva collection. they will also be separated into pain groups based on their response to injections. a correlation between exam findings and procedure group will be measured.

this is an observational study of patients with neck and back pain followed by a pain management clinic. patients with particular pain generators in the neck and back will be defined by a positive response to one of several targeted interventional pain procedures. each patient may undergo a physical exam to determine whether they have hypermobile joints. the study will thus evaluate the rate of hypermobility for each pain generator. in addition blood, urine, or saliva samples may be taken for biomarkers for pain or rheumatologic factors.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of axial back pain (neck, mid-back, lower back) or pain radiating to the extremity, with suspected diagnosis of a specific pain generator amenable to a pain procedure, including disorders of the nerves, joints, and muscles as listed immediately below. * clinical decision to schedule patient for a pain procedure, including procedures targeting the following disorders: * facet arthropathy: intra-articular facet joint injection, medial branch block, medial branch radiofrequency ablation * sacroiliac joint dysfunction: sacroiliac joint injection, lateral branch block, lateral branch radiofrequency ablation * myofascial pain syndrome: trigger point injection * radiculopathy, spinal stenosis, or herniated nucleus pulposus: epidural steroid injection, selective nerve root block * piriformis syndrome: piriformis injection * greater trochanteric bursitis: greater trochanteric bursa injection * able to provide hipaa authorization to share prior medical records/imaging. exclusion criteria: * previous diagnosis of cancer. * currently pregnant. * previously enrolled for the same procedure or the same pain generator site. (for example, this would exclude a patient who had an intra-articular facet joint injection at the right l5/s1 if: 1) he had the same injection 3 months ago and was enrolled at that time, or 2) the patient was already enrolled for a medial branch block at the right l5 and sacral ala, as this targets the same facet joint.) * inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state)

Keywords: facet joint sacroiliac joint myofascial trigger point pain injectables
pharmacometabolomic of trabectedin in soft tissue patients

Conditions: Sarcoma

Summary: this perspective, mono institutional study is addressed to find potential serum and urine biomarkers predictive of the pharmacokinetic and pharmacodynamic profile of soft tissue sarcomas patients treated with trabectedin.

this investigation enrolled patients with unresectable and/or metastatic soft tissue sarcoma not responsive to the first-line treatment based on anthracycline/ifosfamide. patients underwent trabectedin monotherapy that was administered intravenously at the dose of 1.3 mg/m2 every 21 days. single overnight fasting urine and blood samples were collected on day-1 of the first trabectedin administration. plasma pharmacokinetics was performed during cycle 1. blood samples, drawn from a site separate from the drug infusion site, were obtained prior to the infusion (basal) at 2, 8, 24 (end of infusion) and 0.5, 1.0, 4.0, 8.0, 24.0 after the end of the infusion. plasma concentrations of trabectedin were measured by liquid chromatography, tandem mass spectrometry assay (lc-ms/ms) and the pharmacokinetic parameters (cmax, clearance, auc and t1/2) were calculated from the concentration-time curve using a non-compartmental model. metabolomics profiles were explored by lc-ms/ms in predose urine and serum and encompassed a total of 192: a) 45 amino acid derivatives, virtually involved in a wide set of biochemical pathways; b) 40 different acylcarnitines, principally involved in the cellular energy metabolism; c) 15 lysophosphatidylcholine metabolites, 77 phosphatidylcholine derivatives, and 15 sphingomyelins, involved in fatty acid metabolism and cellular signaling. the identification of predictive metabolomics biomarkers is performed using univariate and multivariate statistical analyses.

Eligibility criteria:
inclusion criteria: * advanced soft tissues sarcoma stss (unresectable and/or metastatic disease). * one previous systemic treatment with ananthracycline ± ifosfamide. * measurable disease, as defined by recist criteria. * ecog ps ≤2. * age ≥18 years. * a minimum of 3 weeks since prior tumor directed therapy * recovery from toxic effects of prior therapies to nci ctc grade 1 or lower. * adequate haematological, renal liver function. * ability and willingness to provide informed consent exclusion criteria: * pregnant or breast-feeding women * prior exposure to trabectedin. * peripheral neuropathy, grade 2 or higher. * known cns metastases. * active viral hepatitis or chronic liver disease. * unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias. * active major infection. * other serious concomitant illnesses.

Keywords: soft tissues sarcoma
age and gender effects on the pharmacokinetics of bay85-3934

Conditions: Anemia

Summary: single dose study of bay85-3934 compared to placebo in young/elderly male and female healthy subjects. the main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of bay85-3934 is similar or not in the four subject groups. qualifying subjects will be dosed with a single tablet of bay85-3934 (or placebo) and blood will be drawn over 4 days. the safety and tolerability of bay85-3934 compared to placebo will also be evaluated over the 5 days of the study.


Eligibility criteria:
inclusion criteria: * no diagnosis of any specific disease or condition * subjects are expected to be in good general health for their respective age range * male or female gender * age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive) * racial group: caucasian exclusion criteria: * pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. this includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease. * clinically relevant findings in the physical examination

Keywords: bay85-3934 pharmacokinetics age gender
trauma-informed personalized scripts (tips) for relationship abuse

Conditions: Violence; Abuse

Summary: this pilot study will evaluate a computer-based intervention titled "trauma-informed personalized scripts" (tips). the goal of this intervention is to improve patient-provider communication about sensitive topics such as intimate partner violence (ipv) and reproductive coercion (rc). the main aim of this study is to pilot test tips in family planning clinics using a randomized study design to compare the basic version of tips (a computer-based assessment with provider scripts only) to an enhanced tips containing a tailored brief intervention for patients along with provider scripts. the investigators plan to recruit 240 female patients ages 16-29 for this study.


Eligibility criteria:
inclusion criteria: * female * age 16-29 * english speaking * plans to stay in the area for next 6 months exclusion criteria: * female clients not of the specified age range. * clients who are intoxicated or otherwise not able to provide their own consent will not be eligible to participate. * clients who are not able to read english will also be excluded from this pilot study as the survey questions presented via the tablet computer have not been validated yet in any other language.

Keywords: intimate partner violence reproductive coercion women's health relationship abuse
a comparison of nefopam-propacetamol combination and propacetamol for postoperative quality of recovery after laparoscopic nephrectomy

Conditions: Renal Tumor

Summary: the multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. the multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects. non-opioid analgesics, non-steroidal anti-inflammatory drugs (nsaids), propacetamol (prodrug of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia after major surgery. nsaids, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side effects. in contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter renal function or cause hemorrhagic complications. recent study demonstrated that the antinociceptive properties of paracetamol (intravenous acetaminophen) associated with the analgesic effectiveness of nefopam could explain the observed synergy of the combination. the aim of this randomized, double-blinded study is to compare the opioid-sparing effect and analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and propacetamol in patients undergoing laparoscopic nephrectomy.


Eligibility criteria:
inclusion criteria: * asa status 1-3, * aged 20 to 65 years, * undergoing laparoscopic nephrectomy exclusion criteria: * severe cardiac disease, * hepatic insufficiency, * chronic kidney disease stage ≥3, * preoperative use of analgesics(corticosteroids, opioid), * chronic alcoholics, * hemolytic anemia, * convulsions
safety and effectiveness of evinacumab for the treatment of homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia

Summary: this is an open-label study designed to evaluate the long-term safety and efficacy of evinacumab, a fully human angptl3 antibody, in patients with homozygous familial hypercholesterolemia (hofh), in a real-life setting in canada. eligible patients for this study are male and female adult patients with hofh. evinacumab will be added on top of the patient's background lipid-modifying therapy (lmt), including statins, ezetimibe, pcsk9 inhibitors, lomitapide or other lipid lowering therapies. this study will be conducted using an hybrid (on-site, foldable sites) approach. patients will enter the current study, in an open-label treatment period, following their screening. this study will continue until reimbursement of evinacumab in canada or for a maximum of 24 months. the end of study (eos) visit will be scheduled 4 weeks after the last dose has been injected and will be followed by a 52-week follow-up.


Eligibility criteria:
inclusion criteria: * hofh patients having been previously or being currently treated with evinacumab or clinical diagnosis of hofh requiring additional lipid lowering therapy. exclusion criteria: * any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study; * pregnant or breastfeeding women; * women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug.

Keywords: angptl3 real-life study monoclonal antibody
impact of bariatric surgery on nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Summary: the purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. the investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.


Eligibility criteria:
inclusion criteria: * 20≤ age ≤80 * bmi\>35kg/m2 * men and women * fatty infiltration in liver ultrasonography exclusion criteria: * alcohol drinking \> 140g/week * presence of hepatitis b or c or hiv * known liver disease such as: 1. wilson's disease 2. hemochromatosis 3. α1-antitrypsin deficiency 4. autoimmune liver disease 5. primary biliary cirrhosis 6. primary sclerosing cholangitis)

Keywords: nonalcoholic fatty liver disease nonalcoholic steatohepatitis obesity bariatric surgery weight loss
eribulin use for the treatment of advanced breast cancer: a prospective observational registry

Conditions: Breast Cancer

Summary: the purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. additionally, this study will also assess the effectiveness of eribulin in real-life settings.


Eligibility criteria:
inclusion criteria the participants have to meet all of the following criteria to be eligible to enter into the prospective registry: 1. participants older than 18 years of age 2. willing and able to provide informed consent 3. diagnosis of locally advanced or metastatic breast cancer 4. progression after up to two previous chemotherapy regimens for advanced disease. prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable 5. adequate bone marrow, liver, and renal function 6. life expectancy greater than 12 weeks exclusion criteria participants meeting the following criteria will not be permitted to enter the study: 1. prior treatment with eribulin 2. participants who have received more than two prior chemotherapeutic regimens for advanced disease

Keywords: breast cancer
diagnostic evaluation of urine dna methylation/somatic mutation profiling for upper tract urothelial carcinoma detection

Conditions: Upper Tract Urothelial Carcinoma

Summary: clinical trial to determine the efficacy (sensitivity and specificity) of anchordx's urine dna methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.

this is a prospective study that involves 8 centers in china and 490 participants. the test analyzes the dna methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. the efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.

Eligibility criteria:
inclusion criteria: case group: * 1.any male or female patient aged 18 or older. * 2.able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * 3.diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery. * 4.able to provide legally effective informed consent. control group: * 1.any male or female patient aged 18 or older. * 2.able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * 3.diagnosed with urinary disease such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis. * 4.able to provide legally effective informed consent. exclusion criteria: * 1.patients had been diagnosed with cancer history. * 2.patients diagnosed with cancers unmatched with inclusion criteria cancers.

Keywords: upper tract urothelial carcinoma urine dna methylation somatic mutation