Kornimate/medical-research-clean huggingface dataset:
preoperative hormone therapy for postmenopausal women with er+ clinical stage t2-4 tumors

Conditions: Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Summary: this phase ii trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage ii-iii breast cancer. estrogen can cause the growth of breast cancer cells. hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

this study will develop preliminary data regarding the efficacy and safety of exemestane in the preoperative treatment of postmenopausal women with er+ or pr+ tumors. this trial is also designed to develop a predictive model to correlate expression of the known isoforms of er and progesterone receptor (pr) and the aromatase enzyme with response to estrogenic deprivation using exemestane.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer * er positive (+) * primary tumor 2-4 regional lymph nodes 0-2 (t2-4n0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated * clinical stage ii/iii * postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year * newly diagnosed * patients with prior non-breast malignancies are eligible if they have been disease free for \>= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (lcis) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization * serum creatinine =\< 1.5 x institutional upper limit of normal (uln) * hemoglobin within normal limits for institution * absolute granulocyte count \>= 1500 * platelet count \>= 100,000 * serum glutamic oxaloacetic transaminase (sgot), aspartate aminotransferase (ast) or serum glutamate pyruvate transaminase (sgpt), alanine aminotransferase (alt) =\< 2.5 x uln * total bilirubin \< 2 x uln for institution * alkaline phosphatase \< 2 x the uln exclusion criteria: * completely resected * prior hormone or chemotherapy * unable to take oral medication * patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy

Keywords: breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer postmenopausal exemestane tamoxifen
effect of a virtually implemented cardiac rehabilitation program

Conditions: Heart Failure

Summary: a clinical trial investigating the effects of a virtually implemented home-based cardiac rehab program with real-time, video based exercise supervision and vitals monitoring.

this study will use a randomized, controlled trial design to test the effectiveness of a virtually implemented cardiac rehabilitation (cr) program with real-time, video based supervised exercise and vitals monitoring as compared to traditional center based rehab in patients with a clinical indication for cardiac rehab. the primary outcome of effectiveness will be change in cardiorespiratory fitness as assessed by maximal vo2 achieved at the start of cr and on upon completion of cr.

Eligibility criteria:
inclusion criteria: * patients who have been prescribed cardiac rehabilitation as part of their standard of care exclusion criteria: * patients with significant exercise limitations other than cardiovascular disease * patients who are unable to exercise in home * patients with active cancer treatment * patients who do not have an email address or a cell phone
modulating the gip system in patients with acromegaly due to a pituitary tumor

Conditions: Acromegaly Due to Pituitary Adenoma

Summary: modulation of the gip system in patients with acromegaly due to a pituitary adenoma

aim: to determine the importance of the gip system in patients with acromegaly who has paradoxical growth hormone secretion during an oral glucose tolerance test (ogtt) using a gip antagonist (gip-a). thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin levels will be included in a placebo-controlled cross-over study. the study consists of two study days with concomitant infusions of a) gip-a or b) saline (placebo). a paradoxical growth hormone secretion to an ogtt is here defined as an increase in plasma growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the literature. regazzo et al. (2017) european journal of endocrinology 176, 543-553 mukai et al. (2018) the journal of clinical endocrinology and metabolism 104(5), 1637-1644 hage et al. (2019) the journal of clinical endocrinology and metabolism 104(5), 1777-1787 scaroni et al. (2019) j clin endocrinol metab 104(3), 856-862

Eligibility criteria:
inclusion criteria: * patients under clinical investigation of acromegaly disease with normal kidney function, liver function and hemoglobin levels. exclusion criteria: * medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (\>170/100 mmhg), current pregnancy
safety,tolerability,pharmacokinetics and efficacy of cfz533 in moderate to severe myasthenia gravis

Conditions: Myasthenia Gravis, Generalized

Summary: the purpose of this study is to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics and efficacy of cfz533 as an add-on therapy to standard of care in patients with moderate to severe myasthenia gravis (mg).


Eligibility criteria:
inclusion criteria: 1. diagnosis of mg class iia to iva inclusive (myasthenia gravis foundation of america clinical classification). 2. quantitative myasthenia gravis (qmg) score of 10 or greater. if the qmg score is \< 15 no more than 4 points may be derived from items 1 or 2 (ocular motility disturbance and ptosis). 3. documented history of acetylcholine receptor (achr) or muscle specific kinase (musk) antibody positive. 4. only one immunosuppressant or immunomodulatory drug at a stable dose is allowed during the study (i) azathioprine and mycophenolate mofetil must be stable for at least 4 months prior to randomization (ii) cyclosporine must be stable for at least 3 months prior to randomization. 5. if the patient is on oral corticosteroids, methotrexate or tacrolimus at screening, the dose must be stable for at least 1 month prior to randomization. 6. if the patient is on cholinesterase inhibitors at screening, the dose must be stable for at least 2 weeks prior to randomization. 7. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, may be included in the study if they are using highly effective methods of contraception during the study and for 12 weeks after study treatment. exclusion criteria: 1. mgfa grade i, ivb, or v disease. 2. documented presence of unresected thymoma. 3. patients having undergone thymectomy or thymo thymectomy (resection of thymoma) within 6 months of screening. 4. patients having received any of the following treatments prior to randomization: 1. ivig or plasma exchange within 8 weeks; 2. oral or iv cyclosphosphamide treatment within 3 months; 3. iv corticosteroid bolus (dose higher than 1 mg/kg) within 3 months; 4. belimumab within 6 months. for patients who received belimumab earlier, b cell count should be within normal range; 5. rituximab within 12 months. for patients who received rituximab earlier, b cell count should be within normal range; 6. any other biologic or an investigational drug within 1 month or five times thehalf-life, whichever is longer. 7. live vaccines within 4 weeks of study drug infusion. 5. patients who are at significant risk for te as judged by the investigator or have any one of the following: 1. history of either thrombosis or 3 or more spontaneous abortions with or without the presence of anti-cardiolipin autoantibodies; 2. presence of prolonged partial thromboplastin time (ptt).

Keywords: cfz533, myasthenia gravis
hyperbaric oxygen therapy as a neuroprotective intervention in pediatric acquired brain injury with cognitive disability

Conditions: Hyperbaric Oxygen Therapy; Neuroprotective; Pediatric; Acquired Brain Injury; Cognitive Disability

Summary: this research aimed to investigate the effectiveness of hyperbaric oxygen therapy as a neuroprotective strategy for improving neurological outcomes in pediatric patients who have sustained acquired brain injury.

hyperbaric oxygen therapy (hbot) is a medical treatment that delivers high-concentration oxygen in a pressurized chamber. it was developed initially from diving physiology research and popularized by dutch surgeon boerema for its life-sustaining plasma oxygen diffusion under hyperbaric conditions. the fundamental mechanism of hbot operates through henry's law, enabling unprecedented increases in tissue oxygen partial pressures that surpass levels achievable in normal atmospheric conditions.

Eligibility criteria:
inclusion criteria: * pediatric patients aged 4-12 years with acquired brain injury. * confirmed neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, hypoxia) via mri/neurological exam. exclusion criteria: * positive family history of degenerative brain insults. * behavioral problems. * hyperbaric oxygen therapy contraindications: * active epilepsy. * respiratory insufficiency. * uncontrolled heart failure. * eustachian tube dysfunction. * tympanic membrane rupture. * mechanical ventilation dependency.
international childhood leukemia microbiome/metabolome cohort

Conditions: Acute Lymphoblastic Leukemia; Nutrition Aspect of Cancer; Microtia; Genetic Predisposition

Summary: nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. the proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed b- or t-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. patients receiving hematopoietic cell transplant will be excluded. institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the world bank. data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.


Eligibility criteria:
inclusion criteria: * patients must be between 3 years and 18 years of age at time of assent/consent. * patients must have newly diagnosed b- or t-cell all, or mixed phenotype acute leukemia confirmed by pathology report. * patients must be receiving treatment at one of the participating centers. exclusion criteria: - patients receiving hematopoietic cell transplant.
emdogain and straumann bone ceramic in infrabony defects

Conditions: Periodontitis

Summary: randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects

30 subjects (15 test and 15 control) diagnosed with moderate to severe periodontitis (armitage, 1999) will be enrolled in the study and randomized to either the test or the control group. the surgical procedure shall be performed within 15 days from the baseline visit of the subjects and will be the same for both groups. in both groups, the flap is replaced subsequently. in total 5 visits per patient are scheduled in this study. the total study duration for each patient should be 12 +/- 2 weeks. the study devices emdogain® and straumann bone ceramic are ce-marked, and approved by the fda. one center in france will participate.

Eligibility criteria:
inclusion criteria: * males and females must be at least 18 years and not more than 75 years of age * the patient will have to be able to understand and sign the informed consent prior to starting the study. * the patient also will have to have the ability and the willingness to comply with all study requirements. * the patients will be in good general health without any systemic diseases. * the teeth included in the study will be mandibular molars, maxillary and mandibular premolars, and canines. * the patients will have to have at least one defect with pocket depth ≥ 5 mm. * intra-bony defects will have to have 1 or 2-wall morphology (at least 2/3 of the defect). * depth of the intrabony component of at least 3 mm * the selected sites will have to have vertical intra-bony component ≥ 3 mm and an angle ≥ 30 degrees as assessed from standardized intra-oral radiographs. * oral hygiene parameters: plaque index (pi) ≤ 20 % and bleeding on probing (bop) ≤ 20% exclusion criteria: * heavy smokers: more than 20 cigarettes per day * mucosal diseases such as erosive lichen planus * history of local radiation therapy * presence of oral lesions (such as ulceration, malignancy) * teeth with untreated endodontic or cardiologic problems * physical handicap that will interfere with patient's ability to exercise good oral hygiene on a regular basis. * patients presenting antibiotic treatment within the 3 months preceding the surgical procedure. * patients using anti-inflammatory drugs on a regular basis. * intra-bony defects with a 3-wall morphology. * intra-bony defects with furcation involvement. * incisors and maxillary molars, will be excluded. * alcoholism or chronically drug abuse causing systemic compromize * medical conditions requiring prolonged use of steroids * current pregnancy at the time of recruitment and/or breastfeeding women. * conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
fontan-sprechstunde

Conditions: Univentricular Heart

Summary: after successful fontan surgery, the risk of mortality in childhood is only low. unfortunately, some of the patients suffer from fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must be mentioned in particular, which is described in the literature with an incidence of 3-14% (1, 2) and still has a 5-year risk of death of 6-12% today (2, 3). protein loss tereopathy leads to loss of protein in the intestine and subsequently to diarrhea and edema. other problems concern the liver, which can develop cirrhosis due to chronic congestion (4-6). cardiac can lead to heart failure and arrhythmias. the registry study described in this protocol is intended to identify factors that influence the treatment outcome of patients in the fontan circulation in the long term through systematic prospective documentation of the data from our standardized and guideline-oriented treatment.

in particular, the following points will be scientifically analyzed: 1. the development of lymphatic drainage disorders (7-9) 2. the cellular changes of the immunological system and metabolome (10) in addition to the clinical routine, weight-adapted edta blood for the isolation of peripheral blood mononuclear cells (pbmcs) for the scientific investigation of immunological changes and serum for the analysis of the metabolome will be examined at three times (figure 1: times 2, 4, 7) as part of a routine blood sample (10). 3. the recording and treatment of psychological, social and developmental abnormalities with the help of standardized questionnaires. 4. the evaluation of special sonography examinations of the liver and kidney in the long-term course, as well as their treatment. 5. the assessment of the hemodynamic peculiarities and the classification with regard to cardiac function in the long-term course of patients with fontan circulation. 6. the assessment of various laboratory parameters as risk parameters for the development of complications. 7. the recording of cardiopulmonary performance in the long-term course and its ability to be influenced by education regarding sporting activity and the handing over of an individualized training plan. 8. the influence of physical activity on possible complications of fontan circulation. 9. the influence of early psychological, nutritional, or social intervention in the event of abnormalities on later complications of fontan circulation.

Eligibility criteria:
inclusion criteria: * congenital heart defect of the univentricular type that has led to fontan circulation exclusion criteria: * no exclusion criteria
health care transition readiness short-form video intervention

Conditions: Health Care Transition Readiness; Health Literacy; Self Efficacy; Emotional Wellbeing; Appointment Attendance

Summary: the goal of this clinical trial is to assess whether social-media style short-form health education videos can increase health care transition readiness, self-efficacy, emotional well-being, health literacy, and appointment attendance, compared with publicly available health education resources in adolescents with chronic illnesses. the main question it aims to answer is: -hypothesize social media intervention will increase health care transition readiness, self-efficacy, emotional well-being, health literacy, and appointment attendance compared to publicly available health education website immediately post intervention and at 6 month follow up. participants will be randomly assigned to one of the interventions and access the intervention for 20 minutes and complete 30-60 minutes of surveys.


Eligibility criteria:
inclusion criteria: * patients in subspecialty clinics * between 12 and 17 years old * with access to an internet-connected device * speaking english or spanish * with sufficient cognitive capacity to understand the study procedures, as assessed via a teach back method. exclusion criteria: * none

Keywords: mobile health health education transition readiness chronic illness adolescence health literacy social media video self efficacy emotional wellbeing
efficacy and safety of empagliflozin (bi 10773) / linagliptin (bi 1356) fixed dose combination in treatment naïve and metformin treated type 2 diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: this trial will evaluate use of bi 10773/linagliptin once daily (qd) fixed dose combination (fdc) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes mellitus prior to informed consent 2. male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. 3. glycosylated hemoglobin (hba1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at visit 1 (screening) exclusion criteria: 1. uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day). 2. any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2) 3. acute coronary syndrome (non-st elevation myocardial infarction, st elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) tia within 3 months prior to informed consent
the effect of long-acting antipsychotics on schizophrenia patients with violence risk

Conditions: Schizophrenia

Summary: this is a 49 weeks prospective, non-interventional cohort study. to observe the effect of long-acting injection antipsychotic(lai), paliperidone palmitate on prevention of recurrence and symptom control in schizophrenia patients with violence risk. this study can be extended according to the implementation of the project and extended follow-up time.

this is a 49 weeks prospective, observational cohort study. wuhan initiated a project to improve the lai treatment in schizophrenia patient with violence risk. this observational study will build the cohort of schizophrenia patient with violence risk and treated with lai paliperidone palmitate. the effect of long-acting antipsychotic, paliperidone palmitate, will be observed on prevention of recurrence and symptom control in these patients. safety information and laboratory tests result will also be collected. this study can be extended according to the implementation of the project and extended follow-up time.

Eligibility criteria:
patient who has violence risk and in the supervise of government system, and treated with paliperidone palmitate will be invited to the observational study.

Keywords: schizophrenia violence risk long-acting antipsychotics