Kornimate/medical-research-clean huggingface dataset:
tucidinostat, azacitidine combined with chop versus chop in patients with untreated peripheral t-cell lymphoma

Conditions: T-cell Lymphoma

Summary: this is a prospective, multicenter, phase iii study of tucidinostat, azacitidine combined with chop versus chop in patients with untreated peripheral t-cell lymphoma

tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral t-cell lymphoma in china. azacytidine is a hypomethylating agent. the aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with chop regimen and classical chop regimen in the treatment of primary ptcl

Eligibility criteria:
inclusion criteria: * patients with peripheral t-cell lymphoma confirmed by primary pathology; * age 18-70 years; * ecog performance status ≤ 2; * adequate bone marrow hematopoietic function: wbc \> 3.5 × 10\*9/l，anc\>1.5 × 10\*9/l，hgb\>90g/l，plt\>80 × 10\*9/l; * adequate organ function: cardiac function grade 0-2 (nyha); spo2 \> 88% (natural condition); alt\ 60ml/min/m2; * patients have signed the informed consent form exclusion criteria: * alk positive anaplastic t-cell lymphoma; * nk / t cell lymphoma, nasal type; * uncontrolled active infection; * acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc; * subjects who are known or suspected to be unable to comply with the study protocol; * pregnant or lactating women

Keywords: tucidinostat azacitidine chop
efficacy study of fedovapagon for nocturia in men with benign prostatic hyperplasia (bph)

Conditions: Nocturia

Summary: this study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with bph.

fedovapagon is a selective vasopressin v2 receptor (v2r) agonist that has an antidiuretic effect through stimulation of v2 receptors in the kidney and is being developed for the treatment of nocturia. nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). it has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (bph). the purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with bph.

Eligibility criteria:
inclusion criteria: * adult males ≥18 years \[no upper limit\] * benign prostatic hyperplasia * persistent nocturia despite previous lifestyle modification advice including appropriate fluid management * serum sodium not below lower limit of normal prior to randomization * provide signed and dated informed consent before any study-specific procedures are conducted. * able to comply with the requirements of the study. exclusion criteria: -

Keywords: va106483, fedovapagon, bph, nocturia, equinoc
glucose-guided eating pilot

Conditions: Postmenopausal; Prediabetes; Adolescent and Young Adult (AYA) Cancer Survivors

Summary: this is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (gge) mobile app and intervention in two populations at risk of chronic disease (postmenopausal women with prediabetes and aya cancer survivors).

the primary objectives of the study are to (1) test the feasibility and acceptability of the gge intervention and companion gge mobile app and (2) quantify the preliminary effect of gge on 12-week changes in insulin resistance (ir) and body weight. the secondary objectives of the study are to (1) collect preliminary data on hypothesized mechanisms linking gge to ir and (2) explore the durability of intervention effects on 24-week changes in body weight.

Eligibility criteria:
inclusion criteria: all: 1. self-reported height and weight that is consistent with a bmi ≥ 27 kg/m2 2. willing to use a continuous glucose monitor 3. own smartphone that is compatible with dexcom cgm. 4. willingness to commute to gumc for in-person study visits 5. no active cancer (except for nonmelanoma skin cancer) 6. less than 5 lbs. weight change in previous 3 months 7. proficient in speaking and reading english postmenopausal women with pre-diabetes: 8. age 18 years and older 9. diagnosed as having prediabetes. 10. hba1c (within 3 months) between 5.7% and 6.4% 11. postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy) aya cancer survivors: 12. current age 21-39 years 13. previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously exclusion criteria: 1. unable or unwilling to provide informed consent 2. clinical history of type 1 or type 2 diabetes 3. currently receiving anti-diabetics (e.g., insulin, glp1), oral hypoglycemic agent (e.g., metformin), oral corticosteroids, oral glucocorticoids, beta blockers, hydroxyurea, atypical antipsychotic agents (i.e., olanzapine, aripiprazole) or systemic progestin-only contraceptives 4. current or past history of an eating disorder 5. self-identify as an overnight eater (defined as eating main meals between 9pm-5am) 6. have any contraindications for cgm, including: severe allergy to surgical adhesive, being on dialysis, receiving diathermy treatment, or scheduled ct scan or mri during wear period 7. growth hormone deficiency, hypoadrenal function, or hypopituitary function
phase i study of pdr001 in patients with advanced malignancies.

Conditions: Advanced Malignancies

Summary: the purpose of this study is to characterize the safety, tolerability, pharmacokinetics (pk), and antitumor activity of pdr001 administered intravenous (i.v.) as a single agent to japanese patients.


Eligibility criteria:
inclusion criteria: * patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (recist) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists * ecog performance status ≤ 2 exclusion criteria: * active autoimmune disease * active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection * prior pd-1- or pd-l1-directed therapy other protocol defined inclusion/exclusion may apply.

Keywords: advanced malignancies pdr001 japanese patients adults
ct/mri co-registration prostate cancer

Conditions: Prostatic Neoplasm

Summary: the target volume in prostate cancer radiotherapy typically consists of the entire prostate gland which is localized by contours drawn on axial computed tomography (ct) radiation planning images. compared with ct, magnetic resonance (mr) can provide better definition of the prostate gland with respect to the surrounding tissues and the use of multi-plannar reconstruction avoids the problem of partial volume averaging inherent in ct. ct has been shown to significantly overestimate the volume of the gland using the mr-defined prostate volume as the gold standard. co-registration of mr and ct datasets, matched on fixed bony landmarks, has enabled radiation planning using a mr-defined clinical target volumes, combined with ct-based electron density information necessary for radiation treatment planning. rationale and hypothesis: co-registration may allow better delineation of tumour volumes in prostate cancer. this investigation is a fesibility study designed to evaluate and optimize imaging parameters and co-registration techniques for ct planning and mri simulator.


Eligibility criteria:
inclusion criteria: * histological confirmation of prostate adenocarcinoma * undergoing rt with fiducial markers, imrt or escalated dose conformal rt exclusion criteria: * contraindication for mri
bone status on patients with genetic hemochromatosis: a 3 years descriptive and evolutionary study

Conditions: Genetic Hemochromatosis

Summary: the purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.

bone diseases have been recognized recently as complications of genetic hemochromatosis. further studies are needed to describe the role of iron in bone injuries. the purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.

Eligibility criteria:
inclusion criteria: * patients between 18 and 80 years * c282 homozygosity exclusion criteria: * corticosteroids during the last 3 months * following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene. * following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate. * cancer or evolutionary hemopathy (including monoclonal gammopathy) * pregnancy at inclusion time * treated osteoporosis * patient in wich follow up seems hard * inclusion in another study incompatible with this one

Keywords: genetic hemochromatosis iron overload c282 homozygosity
a phase iii study of bkm120 with fulvestrant in patients with hr+,her2-, ai treated, locally advanced or metastatic breast cancer who progressed on or after mtori

Conditions: Metastatic Breast Cancer

Summary: this study was a multicenter, randomized, double-blind, placebo-controlled phase iii study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant vs. placebo plus fulvestrant in postmenopausal women with hormone receptor-positive (hr-positive), human epidermal growth factor receptor 2-negative (her2-negative), aromatase inhibitor (ai)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mtori)-based treatment. patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. randomization was stratified according to visceral disease status (present or absent).

novartis decided not to pursue further development of buparlisib program. on 19 dec 2016, novartis notified the investigators about this decision; accordingly the cbkm120f2303 study was terminated.

Eligibility criteria:
key inclusion criteria * female patients age 18 years or older * histologically and/or cytologically confirmed diagnosis of breast cancer * radiologic evidence of inoperable locally advanced or metastatic breast cancer * adequate tumor tissue for the analysis of pi3k-related biomarkers * human epidermal growth factor receptor-2 (her2) negative disease, and a known positive hormone receptor status * postmenopausal women * prior treatment with aromatase inhibitors * evidence of progression to the combination of mtori and endocrine therapy given as the last therapy prior to study entry * adequate bone marrow and organ function * ecog performance status ≤ 2 key exclusion criteria * previous treatment with pi3k inhibitors, protein kinase b inhibitors or fulvestrant * more than one chemotherapy line for metastatic disease * hypersensitivity to any of the excipients of buparlisib or fulvestrant * symptomatic central nervous system metastases * concurrent malignancy or malignancy within 3 years of study enrollment * certain drugs or radiation within 2-4 weeks of enrollment * increasing or chronic treatment (\>5 days) with corticosteroids or another immunosuppressive agent * certain scores on an anxiety and depression mood questionnaire given at screening * acute viral hepatitis or a history of chronic or active hepatitis b virus or hepatitis c virus * active cardiac disease or a history of cardiac dysfunction

Keywords: bkm120 fulvestrant breast cancer metastatic locally advanced ai treated mtor inhibitor pi3k pik3ca pten her2- hr+
detection of idh2 mutations and monitoring molecular residual disease in patients with aml

Conditions: Acute Myeloid Leukemia

Summary: 1. detection of idh2 mutations in aml patients to define it incidence and correlation with clinical characteristics, relapse-free and overall survival. 2. identify aml patients who are potential candidates for idh2 inhibitor treatment. 3. monitoring minimal residual disease (mrd) following therapy to evaluate its possible role in the strategy of mrd-directed therapy in the future in patients carrying idh2 mutations at initial diagnosis.

isocitrate dehydrogenase 2 (idh2) was found to be one of the recurrently mutated genes in acute myeloid leukemia, indicating its critical role in leukemogenesis. idh2 mutations account for about 10%-20% of aml patients. idh2 mutation is found to be associated with production of 2-hg, which interferes with histone methylation and dna modification, results in partial block of myeloid cell differentiation. idh inhibitors have shown in preclinical model to reverse differentiation blockage in tumor cells. the assessment of idh2 inhibitors is ongoing with phase i/ii clinical trials. the analysis of idh2 mutation in aml patients will help to identify aml patients who might benefit from idh inhibitor treatment. bone marrow samples from 300 adult patients (\>20 years old) with newly diagnosed aml since 2014/1/1 and received standard chemotherapy in hospitals which has jointed ministry of health and welfare aml program will be examined. the mononuclear cells are extracted from bone marrow samples at the initial diagnosis. the mutational analysis of exon 4 of idh2 gene will be performed by pcr amplication followed by pyrosequencing to detect idh2-r140 and r172 mutations and mutant levels. follow-up samples of patients carrying idh2 mutations at the time of achieving hematologic remission, subsequent samples during different time points including at least following two post-remission chemotherapy, at the end of therapy and every 3 months thereafter in the first year and then every 6 months up to 24 months, as well as at time of relapse, will be measured by lna-quantitative real-time pcr with taqman probe assay to determine the changes of idh2 mutant levels.

Eligibility criteria:
inclusion criteria: * patients diagnosed with aml, age ≥ 20 years, and are willing to sign the informed consent exclusion criteria: * not aml patients * patients diagnosed with aml but age \< 20 years
role of post surgery ct following laparoscopic vertical sleeve gastrectomy

Conditions: Obesity

Summary: obesity is a extremely widespread condition in europe and north america, burdened by a series of complications characterized by major morbidity and morbility. in recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures, such as laparoscopic vertical sleeve gastrectomy are common. the aim of the study is to retrospectively determine the value of postoperative ct after lsg as an early tool to identify risk factors for the subsequent development of gastric fistula and enable to stratify postoperative risk in asymptomatic patients and ensure effective management of these risk factors.


Eligibility criteria:
inclusion criteria: * adult obese patients with lsg * bmi ≥ 40 kg/m2 or bmi between 35 and 40 kg/m2 * evidence of obesity related comorbidity * availability of upper abdomen ct scan with iv and oral contrast medium within 72 hours of surgery exclusion criteria: * pregnant women * allergy to contract medium * lack of venous access * patients who did not have a post-surgical upper abdomen ct

Keywords: ct scan
fish oil, metformin and heart health in pcos

Conditions: PCOS; Cardiovascular Disease; Atherosclerotic Cardiovascular Disease; Atherosclerotic Plaque; Cardiac Hypertrophy

Summary: women with polycystic ovary syndrome (pcos) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of type ii diabetes and cardiovascular disease (cvd). this study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with pcos, and those with pcos and type 2 diabetes.

objectives the objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apob- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with pcos. this study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early cvd risk in young women with pcos. specific objectives; 1. to quantify carotid intimal medical thickness (cimt) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function. 2. to determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma tg, apob48 and apob100-lipoprotein concentrations, and cardiac function variables including left ventricular (lv) posterior wall thickness, lv ejection fraction. 3. to assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.

Eligibility criteria:
inclusion criteria: * diagnosis of pcos * overweight-obese (bmi \>25 kg/m2) * elevated fasting plasma tg (\>150 mg/dl) * and/or apob48-remnant cholesterol lipoproteins (\>20 ug/ml) * impaired insulin sensitivity (glucose 100-125 mg/dl and/or insulin \>15 (um/ml), and may be diagnosed with t2d (blood glucose \>126 mg/dl). exclusion criteria: -pregnancy, lactation
undifferentiated embryonal sarcoma of the liver: evaluation of the relapse profile according to the therapies administered

Conditions: Hepatic Sarcoma

Summary: undifferentiated embryonal sarcoma of the liver is the 3rd most common malignant liver tumor after hepatoblastoma and hepatocellular carcinoma with a peak incidence between 6 and 10 years of age. historically, it is a tumor treated only by surgery with a poor prognosis. in the last decade, the combination of more intensive chemotherapy and, more randomly, radiotherapy, has significantly improved the survival rate of these patients. due to its low incidence, there are few series reported in the literature and to date there is no specific treatment protocol for the management of these tumors. it seems appropriate to review the management of these tumors in france in order to discuss the best therapeutic strategy.


Eligibility criteria:
inclusion criteria: * any patient aged 0 to 25 on the date of inclusion in the study * treatment carried out in france (included in nrsts 2005, in the childhood cancer registry or in an sfce center) * start of treatment from 01/01/2008 to 31/12/2018 * diagnosis of undifferentiated embryonal sarcoma of the liver defined by a compatible histological analysis * adult subject who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research * minor subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research exclusion criteria: * refusal to participate in this research * diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, pnet * absence of histological and/or molecular documentation.

Keywords: embryonal sarcoma embryonic sarcoma hepatoblastoma hepatocarcinoma hepatic sarcoma undifferentiated (embryonal) sarcoma
xpert bladder cancer monitor; prospective, single, tertiary-care center implementation study

Conditions: Bladder Cancer

Summary: the primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of xpert bladder cancer monitor on the genexpert instrument systems in comparison to the methods currently used at the site for detecting recurrent bladder cancer.


Eligibility criteria:
inclusion criteria: * the patient shall meet all of the following criteria in order to be considered eligible for enrollment: * patient has been diagnosed with nmibc within 24 months of enrollment * at the time of the enrollment visit, the patient is scheduled for a cystoscopy within the next 6 weeks of enrollment exclusion criteria: * patient has had an excision procedure or bcg treatment within six weeks (42 days) before enrollment.

Keywords: non muscle invasive bladder cancer, recurrence, progression
cognitive behavioral therapy for insomnia and depression among menopausal women

Conditions: Depression; Insomnia; Cognitive Behavioral Therapy; Menopausal Depression

Summary: considering physical and psychological problems that threaten women during the menopausal period, it seems that therapies that can help women cope with these problems, especially psychological ones, will be useful. the community mental health nurse is usually the first health professional whom women rely on to relieve their menopause symptoms. it is essential for the primary health care nurse to know how to properly approach women at this stage of their life and how to provide them the best and safe treatment. because only limited interventional studies have been done to manage insomnia and depression among menopausal women in egypt, the present study focused on reducing and insomnia and depression of menopausal women by using group cognitive behavioral therapy. the current study aimed to examine the efficiency of group cognitive behavioral therapy for insomnia and depression among menopausal women.


Eligibility criteria:
inclusion criteria: * women with depression (bdi-ii score of 14-63) * women aged between 40 and 55 years old, menopausal (12 consecutive months without menses) * women are willing to provide written informed consent to participate in the study. * women who have the ability to read and write arabic language. * women who report wake after sleep onset (wakefulness in the middle of the night after falling asleep) of an hour or more on ≥ 3 nights per week and met criteria for diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) (american psychiatric association, 2013) insomnia disorder with onset or exacerbation during the peri- or postmenopausal period per clinical interview with the researcher. * women who have a total score of \>5 on the pittsburgh sleep quality index (psqi), which indicates poor sleep, and a total score of \>7 on the insomnia severity index (isi), which indicates insomnia. exclusion criteria: * women who are currently under any type of psychotherapy or have a previous experience of cognitive behavioral therapy. * women who have a history of neuropsychiatric illness, cancer, chemotherapy, and sudden stress in the previous 6 months (due to unfortunate events in the family) or have a severe or uncontrolled physical illness. * women who are clearly diagnosed as having sleep disorders or obstructive sleep apnea and had taken sleeping medications. * women who are on hormonal replacement therapy or cancer therapy or drugs such as tricyclic antidepressants, selective serotonin reuptake inhibitors, sedatives, and other hormones; and those who had undergone hysterectomy with oophorectomy.