Kornimate/medical-research-clean huggingface dataset:
combination chemotherapy plus radiation therapy in treating patients with stage iii or stage iv endometrial cancer

Conditions: Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer

Summary: this phase i trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage iii or stage iv endometrial cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells.

objectives: i. determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage iii or iv endometrial cancer. ii. assess the time to disease progression and overall survival of patients treated with this regimen. outline: this is a dose-escalation study of paclitaxel and cisplatin. patients receive paclitaxel iv over 1 hour and cisplatin iv on days 1, 8, 15, 22, 29, and 36. patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks. cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, additional patients are treated at that dose level. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 3-48 patients will be accrued for part i and 14-20 patients will be accrued for part ii of this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed surgical stage iii or iv endometrial cancer * any stage clear or serous papillary endometrial cancer * positive para-aortic lymph nodes allowed * tumor must be surgically reduced to 2 cm or less within 8 weeks of study * must have had hysterectomy and bilateral salpingo-oophorectomy * no recurrent disease * no metastases to lung or liver parenchyma or inguinal or scalene lymph nodes * performance status - gog 0-2 * absolute neutrophil count greater than 2,000/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot no greater than 3 times uln * creatinine no greater than 1.5 times uln * no other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer * no prior chemotherapy * no prior radiotherapy * see disease characteristics * no more than 8 weeks since prior surgery * no prior anticancer therapy that would preclude study
treatment of vulvo-vaginal atrophy (vva) using vaginal dilator in addition to usual treatment

Conditions: Vulvo Vaginal Atrophy; Genitourinary Syndrome of Menopause (GSM); Vaginal Atrophy in Breast Cancer Patients; Vaginal Atrophy Patients With GSM; Treatment; Sexual Disfunction; Dyspareunia (Female)

Summary: this is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy. study population: peri- and postmenopausal women with vva, including breast cancer survivors. design: monocentric pilot rct evaluating soc (mht, lubricants, moisturizers) (control group) to soc + vaginal dilators (test group). vaginal dilator : a silicone medical device will be used for gradual stretching progression. the kit includes dilators of progressively larger sizes. procedures: assessments at baseline, at 4 \& 12 weeks measures : vulvo vaginal atrophy severity , dyspareunia, vaginal health index score, female sexual fonction index, and visual analogue scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse). statistical analysis: differences at baseline, 4 weeks, and 12 weeks will be tested using: two-sample t-test mann-whitney test statistical power: assuming a 20% improvement in group 1 and 40% in group 2, with: p \< 0.05 (type i error) 80% power (type ii error), 160 patients needed across both groups. soc = standard of care rct = randimized control trial mht = menopausal hormonal therapy


Eligibility criteria:
inclusion criteria: * peri- or postmenopausal women suffering from vulvovaginal atrophy (vva) * breast cancer survivors with vva symptoms * understand the study, be willing to participate, and sign an informed consent form. * the use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization). exclusion criteria: * undiagnosed abnormal genital bleeding. * administration of any investigational drug within 30 days prior to the screening visit. * presence of a serious medical condition, neurological disorder, or significant comorbidities. * other gynecological malignancies. * recent vaginal surgery. * clinically significant prolapse (pop-q ≤ 2). * current urinary tract or vaginal infection, or recent sexually transmitted infection. * individuals with disabilities unable to communicate. * women eligible for the study but unwilling to participate.

Keywords: vulvo vaginal atrophy vaginal dilators genitourinary syndrome of menopause treatment
safety and rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatment due to musculoskeletal disorders.


Eligibility criteria:
inclusion criteria: * postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor positive breast cancer who want to interrupt the treatment because of severe rheumatologic adverse events * polymorphonuclear neutrophils (pnn) ≥ 1200/mm3, platelets ≥ 100000/mm3, hemoglobin (hb) ≥ 10 g/dl * bilirubin ≤ 30 μmol, sgot/sgpt \< 3n * fully signed informed consent exclusion criteria: * pain due to bone fracture * metastatic disease * hormone therapy other than anastrozole * incapacitating or uncontrolled concomitant disease that could hamper patient's quality of life * hypersensitivity to letrozole or its components other protocol-defined inclusion/exclusion criteria may apply.

Keywords: letrozole breast cancer critical musculoskeletal postmenopausal rheumatologic tolerance
vascular endothelium changes after bariatric surgery (endothelial progenitor cells)

Conditions: Type 2 Diabetes

Summary: improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (epc's) after bariatric surgery.

same as above

Eligibility criteria:
inclusion criteria: * type 2 diabetes, glucose \> 200mg/dl, currently be ing treated with oral medications and hga1c . 6.5, and bmi .35. exclusion criteria: * type 1 diabetes
human papillomavirus (hpv) genotypes in genital warts in colombian population

Conditions: Genital Warts; HPV Infections

Summary: hpv infection has been recognized as the most prevalent sexual transmitted infection worldwide. burden of many hpv related diseases is well known particularly regarding the different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however, there is much less available information on the general burden of genital warts, the associated hpv types, the costs of related medical treatments and the knowledge and perceptions towards the disease and its prevention. objectives: 1. to determine the hpv genotypes distribution in genital warts in the study population. 2. to assess the knowledge about transmission \& prevention of hpv infection related diseases 3. to determine the direct medical costs of genital warts attention.

study population female and male between 18 - 45 years of age living in bogota, colombia sample frame patients attending to gynecologic or std consult in a mayor out patient clinic in bogotá (profamilia) analysis analysis of the information will be exhaustive. we will calculate prevalence of hpv genotypes in the gw in both sexes separately. analyses of the survey will include simple frequencies, percentages, and comparison of results related to hpv knowledge with sociodemographic and clinical information. explorative analysis using parametric or non parametric statistics of the items included in the questionnaire and clinical forms will be done as appropriate. we will calculate the medical cost of patients enrolled in the study. the treatment protocols used for this protocol will reflect the current clinical practice accepted for the treatment of genital warts. we will use national reference cost list (soat) to determine the cost of procedures included.

Eligibility criteria:
inclusion criteria: * age between 18-45 years. * lesions suspicious of being hpv related. * the main manifestations of anogenital warts include: * cauliflower-like condylomata acuminata lesions that usually involve moist surfaces * keratotic and smooth papular warts, usually on dry surfaces * subclinical "flat" warts, that can be found on any mucosal or cutaneous surface and, which are probably overseen in the majority of cases. * lesions other than the described above, are not to be biopsied, according to the investigator criteria. exclusion criteria: * not willing to participate * to be a participant in any hpv vaccine clinical trial study * known immune suppressive disease.

Keywords: genital warts hpv typing hpv infections condyloma acuminata
a study of td-9855 in adults with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention-Deficit/Hyperactivity Disorder; ADHD

Summary: the safety and efficacy of multiple dosages of td-9855, administered once daily, will be evaluated in adult males with adhd.


Eligibility criteria:
inclusion criteria: * subjects must meet the following adhd diagnostic and inclusion criteria: * subjects must meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for current adhd subtypes (adhd combined type, adhd predominately inattentive type, adhd predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by adult attention-deficit/hyperactivity disorder clinical diagnostic scale (acds v1.2). * subjects must have a total score of 24 or greater on the aisrs at both the screening and baseline visits and the baseline visit aisrs scores must not vary by more than 20% from screening. * subjects are required to have cgi-s score ≥4 (moderate) at both the screening and baseline visits. subjects should have at least moderate severity for adhd symptoms. * for women of childbearing potential, documentation of a negative serum pregnancy test at screening and a negative urine pregnancy test on day 0. all female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing. * a highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device \[iud\] with documented failure rate of \<1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with a barrier method. * women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. female subjects cannot be breast-feeding. exclusion criteria: any current psychiatric disorder other than adhd as defined in dsm-iv-tr as assessed by mini international neuropsychiatric interview (mini). subjects with dysthymia that does not require pharmacological treatment will not be excluded. * madrs total score \>15. * a diagnosis of adhd nos. * any diagnosis of lifetime bipolar disorder or psychotic disorder * a current diagnosis of any severe comorbid axis ii disorder * any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by dsm-iv-tr.-

Keywords: adult adhd attention-deficit/hyperactivity disorder
treatment and vaccine development of mycoplasma pneumoniae

Conditions: Atypical Pneumonia

Summary: a randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric mycoplasma pneumonia.

mycoplasma pneumoniae accounts for 10-30% of community-acquired pneumonia (cap) in children. proportionally, m. pneumoniae has become the most important pathogen for childhood pneumonia after the widespread use of streptococcus pneumoniae vaccines. m. pneumoniae is routinely treated with antibiotics, and the macrolides antibiotics are the drug of choice for m. pneumonia infection. however, macrolide-resistance rates have increased to 20 and 100% in asia. in previous studies, the most common mutation point, a2063g, was detected from 23% of local strains in taiwan. the evolution and spreading of mycoplasma in taiwan and different countries are unknown. while the macrolide-resistance is increasing, the optimal therapy remains unclear. both tetracyclines and fluoroquinolones showed promises in treating macrolide-resistant m. pneumoniae in adults. however, their use in children is not recommended due to safety concerns. recently, evidence are accumulating that doxycycline, unlike other tetracyclines, does not cause staining of teeth. in the current study, the investigators are going to carry out a randomized control trial to compare the efficacy and safety of doxycycline against macrolide-resistant m. pneumoniae.

Eligibility criteria:
inclusion criteria: * children aged 0-18 years, admitted due to lower respiratory tract infections. mycoplamsa pneumonia is diagnosed. * the diagnosis is made within 72 hours after fever onset. * the patient and his/her guardians are willing to participate the study and able to follow the instruction. exclusion criteria: * none

Keywords: mycoplasma pneumoniae, macrolide-resistance, children
the initial assessment of daily insulin dose in newly diagnosed type 2 diabetes

Conditions: Type 2 Diabetes.

Summary: to investigate the daily dose of insulin in newly diagnosed chinese type 2 diabetic patients who use the continuous subcutaneous insulin infusion (csii) as the initial therapy.


Eligibility criteria:
inclusion criteria: all participants with type 2 diabetes, diagnosed by world health organization criteria, were recruited from outpatient of the endocrinology department in shanghai renji hospital. exclusion criteria: patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.
impact of vascular calcification and casr expression by monocytes in septic shock

Conditions: Septic Shock; Calcium Sensing Receptor; Calcium Phosphate Disorders; Inflammation; Monocyte

Summary: in septic shock, bacterial lps is able to activate the casr of cardiomyocytes inducing their apoptosis in vitro. casr activation in monocytes is responsible for activation of the nlrp3 inflammasome and macropinocytosis. in front of this immune axis, a variation in the monocyte expression of the casr is expected in the state of shock. this is already observed in other pathologies such as renal failure or in animal models of severe burns. if this is considered as an overall reflection of casr expression in the body, it would be consistent with the phosphocalcic disturbances associated with septic shock. the phosphocalcic balance is often modified, and not treated during the acute episode, with in particular hypocalcaemia which could be consecutive to a hyperactivation or overexpression of the casr. this study proposes to explore for the first time the expression of monocytic casr in patients in a state of shock, with possible therapeutic perspectives by the existence of calcimimetics and calcilytics. in this study, the investigators propose to explore the casr and its implication in septic shock in a three - part protocol : measurement by flow cytometry of monocyte expression of casr (primary objective) and cd33, cd14, cd163, cd16 and hla-dr), survey of clinical and biological parameters in patients with septic shock and healthy volunteers and acquisition of calcium score in patients with septic shock.


Eligibility criteria:
inclusion criteria: * male or female patients over the age of 18, * patients who have not participated in a study evaluating an investigational drug in the 30 days preceding the samples, * intensive care patients in a state of septic shock within the first 24 hours of the introduction of pressor amines, * french resident year-round, * lactate \> 2mmol/l, * patients with social security coverage. exclusion criteria: * patients in hemorrhagic shock, * history of parathyroidectomy, patient with hypersecretion of pthrp, * sarcoidosis, * genetic disturbance of casr including familial hypocalciuric hypercalcaemia, * current immunosuppressant treatment (anticalcineurin, mtor inhibitor, methotrexate, high-dose corticosteroids excluding hydrocortisone and fludrocortisone), * chronic myelomonocytic leukemia, * patients with febrile neutropenia, * patients with acquired or constitutional immune system, * pregnant or breastfeeding patient, * patients under curators, guardianship or safeguard of justice.

Keywords: septic shock calcium sensing receptor calcium phosphate disorders inflammation monocyte
central sleep apnea prevalence and impact on cognitive function in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction

Conditions: Heart Failure; Central Sleep Apnea

Summary: study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (lvef \<50%) followed by case-control study to assess the link between central sleep apnea and cognitive function

the study will be conducted in two phases: prevalence phase and cognitive phase. adult patients with hfref/hfmref will perform a home sleep apnea test (hsat). patients will be assigned to one of the following groups based on their sleep study results: csa, other sdb, or no sdb. this constitutes the prevalence phase of the study. the cognitive phase of the study is a case-control study that will assess cognitive function in 20 patients in the csa group (case) and 20 patients in the no sdb group (control).

Eligibility criteria:
prevalence phase inclusion criteria: 1. diagnosed with heart failure with reduced or mildly reduced left ventricular ejection fraction (lvef \<50%) at least 3 months prior to enrollment 2. new york heart association (nyha) functional class ii-iv 3. treated and optimized on heart failure guideline directed medical therapy as indicated for at least 4 weeks, including angiotensin receptor-neprilysin inhibitors (arni) (or angiotensin converting enzyme inhibitors (acei) or angiotensin receptor blocker (arb)), aldosterone receptor antagonists, beta-blockers and/or sodium glucose co-transporter 2 (sglt-2) antagonists 4. age 50 years or older 5. signed institutional review board (irb) or ethics committee (ec) approved informed consent 6. in the opinion of the investigator, subject is willing and able to comply with the protocol, including the cognitive function assessment prevalence phase exclusion criteria: 1. hospitalized for heart failure-related complications in the last 4 weeks 2. history of sdb and/or prior or ongoing treatment for sdb or tested for sdb within the prior year cognitive phase inclusion criteria: 1. ahi ≥ 15 events per hour and cahi ≥ 50% of total ahi (case group) or ahi \< 5 events per hour (control group) based on the baseline hsat 2. per the patient and investigator, willing and able to postpone csa treatment until completion of the study assessment visit (visit 3) cognitive phase exclusion criteria: 1. color blindness 2. currently taking opioids 3. has taken medications for memory/cognition within the last 3 months (including but not limited to cholinesterase inhibitors and/or glutamate regulators) 4. cerebrovascular accident (stroke or transient ischemic attack) in the last 12 months 5. diagnosed with neurological disease including but not limited to history of seizures, meningitis, traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, attention-deficit/hyperactivity disorder (adhd) or autism.
safety and efficacy trial with zoledronic acid for the treatment of paget's disease of bone, including an extended observation period

Conditions: Paget's Disease of Bone

Summary: the primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. the extended observation period included participants of the core study who responded to treatment.


Eligibility criteria:
inclusion criteria: * 30 years or older * sap 2 times uln * confirmed diagnosis of paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.). * 90 days washout calcitonin * 180 day washout bisphosphonate exclusion criteria: * allergic reaction to bisphosphonates * history of upper gi disorders * history of iritis, uveitis * calculated creatinine clearance \< 30 ml/min at baseline * evidence of vitamin d deficiency other protocol-defined inclusion/exclusion criteria may apply.

Keywords: zoledronic acid, risedronate, paget's disease of bone
adult outcomes of children with caps

Conditions: Cryopyrin Associated Periodic Syndrome

Summary: the patients included in this study were followed up in the internal medicine and paediatrics departments of the lille chu, the paediatric rheumatology and immunology department of the necker enfant malade hospital in paris and the paediatric rheumatology department and internal medicine of the bicêtre hospital in paris. all patients selected presented one of the 3 caps clinical phenotypes (cinca/nomid, muckle-wells or cold urticaria). the mutation and the determination of the variant had to be confirmed by genetic analysis. patient data were collected from their medical records, retrospectively. data collected concern childhood period from appearance of symptoms, adulthood period, in the last year and patients' way of life and quality of life upon the assessment. in addition, we collected demographic data related to the patients' lifestyle (intoxications, living arrangements, level of education) and we conducted individual telephone interviews lasting 15 minutes to complete a quality of life questionnaire including the sf36 questionnaire. the study aimed to describe the clinical symptoms of patients in adulthood and to assess quality of life. we also wanted to compare the clinical phenotypes of patients according to their genetic variant.


Eligibility criteria:
inclusion criteria: * diagnosis of fcas, muckle-wells or nomid/cinca; * age \< 16 years at the apparition of the first symptoms of the disease; * age ≥ 16 years old at inclusion * follow-up in a ceremaia reference or competence center. exclusion criteria: * age \< 16 years at inclusion; * non-consenting patient

Keywords: caps cryopyrin associated periodic syndromes mws muckle-wells syndrome cinca chronic infantile neurological cutaneous and articular syndrome ; fcas familial cold auto-inflammatory syndrome phenotype ; quality of life quality of life