Kornimate/medical-research-clean huggingface dataset:
evaluation of vaginal microbiome as a biomarker for the improvement of vaginal health in women with breast cancer, arise study

Conditions: Breast Neoplasms

Summary: this study evaluates vaginal microbiome as a biomarker to improve vaginal and sexual health in women with breast cancer receiving endocrine therapy. breast cancer is the most common cancer in united states women, aside from skin cancers. endocrine therapy is standard treatment for 70% of invasive breast cancers, significantly affecting sexual health and often causing women to change their course of treatment or cease sexual activity. changes in the vaginal microbiome, which is the collection of all microorganisms, such as bacteria, fungi, and viruses, that naturally live on and inside the body, are implicated in menopausal-related sexual health symptoms, but the vaginal microbiome (and associated immune responses) has not been explored as a biomarker for sexual health changes in hormone-related sexual health symptoms in breast cancer. a biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. ribonucleic acid (rna)-sequencing is a cost-effective method to analyze both human and microbial transcripts. the rna that is sequenced from a standard biological sample such as a swab is a snapshot of the expression of many different cells and can be used to simultaneously measure the quantities of microbes, the overall expression of the human host, and the quantities of immune cells. information gathered from this study may help researchers establish the vaginal microbiome as a biomarker and therapeutic target to improve the vaginal and sexual health of women with breast cancer receiving endocrine therapy.

primary objective: i. determine whether individuals who experience vaginal dryness have a distinct microbiome prior to treatment from those who do not in a sample of breast cancer survivors initiating endocrine therapy. exploratory objective: i. explore potential mechanisms of microbiome-associated vaginal toxicity through correlation with host gene expression and deconvolved immune cell abundances. outline: this is an observational study. participants undergo vaginal specimen self-collection via vaginal swab collection kit, complete questionnaires, and have medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * women ages 18 years and older * non-metastatic, estrogen and/or progesterone positive, human epidermal growth factor (her) 2 negative breast cancer who will be receiving endocrine therapy, including tamoxifen, aromatase inhibitor, or ovarian suppression * endocrine positive women who have received chemotherapy (adriamycin and cytoxan + taxol; taxotere and cytoxan) will still be eligible but must have completed their treatment exclusion criteria: * triple negative breast cancer patients * human epidermal growth factor (her) 2 positive breast cancer patients * metastatic disease
safety, pharmacokinetics and anti-tumor activity of rp12146, in patients with solid tumors

Conditions: Solid Tumor; Extensive-stage Small-cell Lung Cancer; Locally Advanced Breast Cancer; Metastatic Breast Cancer; Platinum-sensitive Ovarian Cancer; Platinum-Sensitive Fallopian Tube Carcinoma; Platinum-Sensitive Peritoneal Cancer

Summary: an open-label, two-part phase i/ib study of rp12146 in adult patients with locally advanced or metastatic solid tumors. the first part (part 1) is a phase i dose-escalation, 3+3 design, open-label, mtd determination study and will enroll patients who have tumors known to harbour dna repair deficiencies. the second part (part 2) is a phase ib, dose-expansion at the mtd (or optimal dose) and will enroll patients with a confirmed deleterious hrr mutation in their tumor as identified by a central genomics testing laboratory.


Eligibility criteria:
inclusion criteria. 1. provision of full informed consent prior to any study-specific procedures. 2. patients must be ≥18 years of age, at the time of signing informed consent. 3. dose escalation phase, patients with histologically and/or cytologically confirmed malignant solid tumor whose disease has progressed following at least one standard therapy and who have no other acceptable standard treatment options. tumor types will include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (es-sclc), prostate, pancreatic, colorectal gastric, biliary tract, and endometrial cancer. 4. dose-expansion phase patients with histologically and/or cytologically confirmed malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (es-sclc), with one of the documented deleterious mutations of specified hrr genes and whose disease has progressed following at least one standard therapy. 5. patients with at least one measurable lesion per recist version 1.1 at baseline that can be accurately assessed by ct-scan or mri and is suitable for repeated assessment at follow up-visits. 6. ecog performance status 0 to 2. 7. use of contraception measures exclusion criteria: 1. patients with her2 positive breast cancer 2. patients receiving anticancer therapy 3. patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia. 4. prior treatment with a parp inhibitor 5. major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery. 6. patient with symptomatic uncontrolled brain metastasis. 7. pregnancy and lactation 8. patients with uncontrolled disease

Keywords: parp
a prospective cohort of pulmonary ground glass nodules patients with family history.

Conditions: Lung Neoplasms; Family Research

Summary: the aim of the present prospective cohort study (ggn-f) is to study the family aggregation of pulmonary ground glass nodules via the questionnaire survey and to investigate the underlying genetic mechanism via the biobank.

in recent years, with the development of low-dose chest ct screening, more and more ground glass nodules have been found. meanwhile, presenting as ground-glass nodule (ggn), the early-stage lung adenocarcinoma patients with lung cancer family history have been emerging increasing in recent years in east asian. this prospective cohort study, with both a cross-sectional and a longitudinal part, will include patients with pulmonary ground glass nodule, which were proven malignant disease. all participants will be asked to complete questionnaire to build the clinical database of ggn patients with detailed family history. furthermore, blood and surgical tumor samples will be collected as a specific biobank. and the blood samples of other family members of participants will be collected, with their consent and knowledge.

Eligibility criteria:
inclusion criteria: 1. patients with informed consent; 2. patients with pulmonary ground glass nodule. 3. pathological proved early stage lung cancer. exclusion criteria: 1.not included in the inclusion criteria

Keywords: ground glass nodule family aggregation hereditary susceptibility
study evaluating the efficacy and safety of dose conversion from a long-acting erythropoiesis-stimulating agent (mircera®) to three times weekly oral vadadustat for the maintenance treatment of anemia in hemodialysis subjects

Conditions: Anemia Associated With Chronic Kidney Disease (CKD)

Summary: this study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (tiw) compared to a long-acting erythropoiesis-stimulating agent (esa) (mircera®) for the maintenance treatment of anemia in hemodialysis participants.

following randomization, there will be 2 periods during the study: * conversion and maintenance period (weeks 0 to 52): there will be a primary efficacy evaluation period (weeks 20 to 26) and a secondary efficacy evaluation period (weeks 46 to 52). * safety follow-up period (early termination \[et\] and follow-up): post-treatment safety follow-up visit (et/end of treatment \[eot\] +4 weeks) either in person or via telephone.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * receiving chronic, outpatient in-center hemodialysis three times weekly (tiw) for end-stage kidney disease for at least 12 weeks prior to screening visit 1 (sv1) * currently maintained on mircera® (≤250 μg/month) with at least 2 doses received within 8 weeks prior to screening visit 2 (sv2) * mean screening hemoglobin (hb) between 8.5 and 11.0 grams per deciliter (g/dl) (inclusive), as determined by the average of 2 hb values measured by the central laboratory at least 4 days apart between sv1 and sv2 * serum ferritin ≥100 nanograms per milliliter (ng/ml) and transferrin saturation (tsat) ≥20% during screening * folate and vitamin b12 measurements ≥ lower limit of normal during screening exclusion criteria: * anemia due to a cause other than chronic kidney disease (ckd). * clinically meaningful bleeding event within 8 weeks prior to baseline * red blood cell (rbc) transfusion within 8 weeks prior to baseline * having received any doses of darbepoetin alfa (aranesp®) within 4 weeks prior to baseline * having received any doses of epoetin alfa (epogen®) within 1 week prior to baseline. * current uncontrolled hypertension. * acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (hf) or new york heart association class iv hf, or stroke within 12 weeks prior to or during screening. * known hypersensitivity to vadadustat, mircera®, or any of their excipients.

Keywords: anemia chronic kidney disease ckd hemodialysis vadadustat erythropoiesis-stimulating agent (esa)
implementation of rehabilitation program for post covid-19

Conditions: Post COVID-19 Syndrome; Rehabilitation

Summary: many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. the extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute, post-acute and long-term. rehabilitation is defined as "a set of interventions designed to reduce disability and optimize functioning in individuals with health conditions in interaction with their environment." rehabilitation might very well be a key strategy to reduce the impact of covid-19 on the health and function of people. a team work is needed to implement this programs which are essential in all phases to facilitate early discharge, but even more to support and empower patients.


Eligibility criteria:
inclusion criteria: * post acute covid-19 patients exclusion criteria: * acute covid-10 * non- covid-19 patients * recent myocardial infarction * recent pulmonary embolism * neurologic diseases

Keywords: nursing program health quality of life
comparison of two nn1250 formulations in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial was conducted in north america. the aim of this clinical trial was to investigate if two formulations of nn1250 (insulin degludec) have the same level of drug exposure to the body.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history, physical examination, vital signs and ecg (electrocardiogram), as judged by the investigator * body mass index 18.0-27.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
accuracy of computer guided four implants placement in completely edentulous mandible

Conditions: Implant Placement

Summary: thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (a) the implants were installed by fully guided stereolithographic stent (n = 18), and (b) the implants were installed by semi-guided stereolithographic stent. (n = 18). the accuracy analysis was performed by one experienced process engineer (db). cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. both cbct scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants.

objectives: current study aimed to assess the accuracy of fully- guided implant placement in completely lower edentulous patients compared to the semi-guided protocol. materials and methods: thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (a) the implants were installed by fully guided stereolithographic stent (n = 18), and (b) the implants were installed by semi-guided stereolithographic stent. (n = 18). the accuracy analysis was performed by one experienced process engineer (db). cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. both cbct scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants. measurements and analysis of results were performed by means of a software tool used during virtual planning (p3dental; protótipos).

Eligibility criteria:
inclusion criteria: * all patient wearing maxillary conventional denture. * all patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago. * they were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. this was achieved through medical history and clinical examination by physician. * all patients are of angel's class i maxillo-mandibular relationships. exclusion criteria: * patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients. * patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration. * long term immunosuppress and corticosteroid drug therapy. * patient with abnormal habits as clenching and bruxism. * smoking patient. * patient with problems in tmj

Keywords: fully-guided surgical stent semi-guided surgical stent accuracy analysis
redo transcatheter aortic valve replacement for transcatheter aortic valve failure

Conditions: Aortic Stenosis

Summary: the purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo transcatheter aortic valve replacement (tavr).

primary objectives: * to determine the acute and long-term outcomes of redo tavr for the treatment of bvf affecting tavs * to determine the factors which are associated with the acute and long-term outcomes of redo tavr

Eligibility criteria:
inclusion criteria: * bvf of a tav (either medtronic or edwards) requiring redo tavr exclusion criteria: * bvf due solely to paravalvular regurgitation * active endocarditis * untreated acute valve thrombosis * life-expectancy less than 1-year * subject is less than legal age of consent, legally incompetent, or otherwise vulnerable * participating in another study that may influence the outcome of this study
safety of effivia®, a bevacizumab biosimilar

Conditions: Metastatic Colorectal Cancer; Metastatic Cervical Cancer; Non Squamous Non Small Cell Lung Cancer

Summary: this is a post-marketing observational study aimed to evaluated the safety profile of effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.


Eligibility criteria:
inclusion criteria: * male and female patients, 18 years and older. * patients with metastatic colorectal cancer,unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelial ovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (effivia®). * provide written informed consent. exclusion criteria: * history of recent surgery or wound healing complications. * history of gastrointestinal perforations or fistula. * history of renal injury and proteinuria. * recent surgical intervention. * pregnant or nursing women. * history of bevacizumab, monoclonal antibodies, or cho cells-derived products hypersensitivity. * other safety concerns or bevacizumab contraindications.
comparing raltegravir genital tract distribution in hiv-infected men and women

Conditions: HIV Infections

Summary: the purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

although we have many medications to fight the hiv virus, very little is known about how much of these medications get into the genital tract. raltegravir is a new hiv medication that blocks hiv growth and lowers the amount of virus in the blood in a way that is different than all other currently available hiv medications. raltegravir was recently approved by the food and drug administration (fda) for use in hiv infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. the purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Eligibility criteria:
inclusion criteria: * documentation of blood seropositive for hiv based on self report and confirmed by elisa and western blot or detectable hiv rna * stable anti-retroviral regimen for at least 3 weeks prior to enrollment * capable of giving informed consent * age 18 years and older exclusion criteria: * neoplasms * women who are pregnant or nursing * history or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study * current use of phenobarbital, phenytoin, or rifampin * any major surgery within 4 weeks of enrollment * blood transfusion within 4 weeks of enrollment * inability to tolerate oral medication * inability to tolerate venipuncture, venous access, or genital tract sampling * history of recent (within 6 months) drug or alcohol abuse * evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study * any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator * history of allergy to study medication or related compounds

Keywords: hiv raltegravir pharmacokinetics treatment experienced
analysis of pain management and pain perception intrapartum and postpartum in women with vaginal births in difference between physician-led and midwife-led birth

Conditions: Pain, Labor

Summary: the aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births


Eligibility criteria:
inclusion criteria: * understanding written and spoken german * declaration of consent exclusion criteria: * under 18 years * incomplete answered questionaire
assessment of nutritional and growth status in rett syndrome patients

Conditions: Rett Syndrome; Neurologic Disorder

Summary: children with rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. lack of proper nutritional support will seriously affect their growth, development and health. in view of there is a lack of relevant research in china, so the investigators would like to use this research to explore the nutritional, growth and postural status of rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in taiwan.


Eligibility criteria:
inclusion criteria: * rett syndrome patient. exclusion criteria: * not rett syndrome patient.
timing of thyroxine dose in ramadan

Conditions: Hypothyroidism

Summary: a randomized trial comparing two different timing of taking thyroxine in patients with hypothyroidism during fasting the month of ramadan.

to date there is debate regarding the best timing of l-thyroxine administration during ramadan as sufficient evidence is lacking. this study aims to compare two-time points of levothyroxine intake during ramadan focusing on change in tsh, satisfaction and compliance. a prospective, randomized, open label, multicenter study. the first group will be will be instructed to take their l-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume iftar meal. the second group (pre-fajer prayer), patients are going to be instructed to take l-thyroxin dose immediately before start of fast, i.e. alfajer (dawn) regardless of suhoor time. the values of thyroid stimulating hormone (tsh) will be measured two weeks before ramadan, and 2-4 weeks after ramadan for comparison.

Eligibility criteria:
inclusion criteria: * saudi patient (males and female) above 18 years with primary hypothyroidism on levothyroxine replacement who are willing to fast during ramadan. * patients with controlled thyroid function for last 3 months on same dose of levothyroxine. exclusion criteria: * pregnant or lactating women. * uncontrolled thyroid function test three months prior ramadan. * thyroid cancer patients who require suppressed tsh. * central hypothyroidism, patient with acute illness. * patients diagnosed with malabsorption i.e., celiac disease, short bowel, bariatric surgeries * use of certain medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, ppi, rifampicin, and antiepileptic medications * renal or hepatic disease: * creatinine clearance \<0.6 ml/s or serum creatinine ≥200 μmol/l * alanine transferase ≥2.5 times the upper limit of normal * active liver disease including jaundice, chronic hepatitis, previous liver transplant * unwillingness to be randomized or to sign informed consent * known psychiatric disorders * known uncontrolled substance abuse or alcoholism