Kornimate/medical-research-clean huggingface dataset:
mesenchymal stem cells to treat ischemic cardiomyopathy

Conditions: Ischemic Cardiomyopathy

Summary: this study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (mscs) to repair heart function in patients with myocardial ischemia.

ischemic heart disease is a major public health problem in the industrialized and developing world. current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. mesenchymal stem cells (mscs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. therefore, mscs has shown promise for heart repair. the investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (mscs) to repair heart function in patients with myocardial ischemia.

Eligibility criteria:
inclusion criteria: * chronic coronary artery disease * nyha (heart failure) class ii-iv or angina pectoris ccs class iii or iv or symptoms consistent with. * ejection fraction between 35% and 55%. * stable medical therapy for at least one month * patients clinically treated with coronary angioplasty with or without intraluminal stent. * patients with surgical revascularization and without the possibility of new invasive intervention. exclusion criteria: * human immunodeficiency virus (hiv1-2), htlv-1 and 2. * an active uncontrolled infection. * pregnancy. * mental disability. * terminal illnesses. * valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic. * life perspective by other diseases under 1 year. * history of severe arrhythmias * renal dysfunction or against medication * inability to perform cardiac catheterization.

Keywords: cardiovascular diseases myocardial ischemia coronary artery disease heart diseases coronary disease ventricular dysfunction arteriosclerosis
follow up of mothers suspected of postpartum depression

Conditions: Depression, Postpartum

Summary: postpartum depression (pd) is a serious and disabling mental health condition that affects 10-15% of women after childbirth. low-income minority women are disproportionately affected. untreated pd can lead to significant negative outcomes for both mother and child. pediatricians are being asked to routinely screen for pd and while screening rates are improving, little is known about whether mothers actually adhere to pediatrician recommendations to seek additional help after a positive pd screen. the objective of this study is to describe the rate at which mothers seek treatment for suspected pd after a positive screen at the pediatrician office. additional examination will look at factors that predict whether a mother recalls a recommendation to seek treatment.

the primary outcome of interest is whether mothers suspected of having pd seek treatment after discussion with the pediatrician. in order to evaluate whether discussion with pediatricians leads mothers to seek care, data collection efforts should focus on what information was exchanged, the level of shared decision-making about possible treatment options and whether an agreed upon plan was reached between both parties. the investigators will examine the effectiveness of these discussions by interviewing mothers who were suspected of having pd and referred for treatment. the investigators hypothesize that pediatricians who are able to engage mothers in a shared decision will result in more of those mothers seeking help and getting into appropriate treatment for pd. the specific research aims of this proposal are to: aim 1: describe the rate at which mothers suspected by pediatricians of having pd seek treatment. aim 2: explore what factors predict whether mothers suspected of pd seek treatment, including maternal sociodemographic characteristics, family centeredness of pediatrician care, and extent of shared decision-making strategy used by the pediatrician. this will be a cohort study examining the rate at which mothers suspected of having pd seek care and the relationship between shared decision-making and seeking mental health care. data for both specific aims will be collected by a single telephone interview with mothers suspected of having pd by the pediatrician and referred. for this study, investigators will be focusing recruitment efforts in the four wishard community health centers (now eskenazi health) that use chica. in 2007, these four clinics saw 8,528 patients between the ages of 0 and 3 years. these clinics serve a large proportion of families that are underserved, economically disadvantaged and are ethnically and racially diverse.

Eligibility criteria:
inclusion criteria: -mothers with a positive pd screen who brought their child to seek medical care at participating study clinics, who were present for a majority of the child's visits. exclusion criteria: -not biological mother, did not bring child to majority of clinic visits
phase ii trial of pentostatin in steroid refractory acute graft versus host disease

Conditions: Graft-Versus-Host Disease

Summary: this study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.


Eligibility criteria:
inclusion criteria: * must have biopsy proven grade ii-iv acute gvhd refractory to systemic corticosteroids * no chronic gvhd * age ≥ 18 years * evidence of myeloid engraftment (anc ≥ 0.5 x 109/l) * performance status 0-3 exclusion criteria: * patients on mechanical ventilation or who have resting o2 saturation \<90% by pulse-oximetry. * patients on renal dialysis or who have an estimated creatinine clearance of \< 30 ml/min/1.73 m2. * patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.

Keywords: corticosteroids
evaluation of maxillary posterior teeth intrusion by skeletally anchored mousetrap appliance in adult patient with anterior open bite.

Conditions: Maxillary Molar Intrusion

Summary: aim of the study: this clinical study aims to evaluate the dental, skeletal, and soft tissue effects of the mousetrap appliance on the intrusion of maxillary posterior teeth in adult patients with anterior open bite. material and methods: an uncontrolled clinical trial will be conducted involving 20 participants aged 15 to 27 years with skeletal class i, ii, or mild class iii relationships and a measured aob of 3-8 mm. participants will receive mini-implants inserted in the anterior palate, with the mousetrap appliance designed to promote molar intrusion while maintaining vertical dimension. intraoral scans, radiographs, and clinical photographs will be recorded at baseline and post-intrusion.

aim of the study: this clinical study will evaluate the dental, skeletal and soft tissue effects of skeletally anchored mousetrap appliance on the intrusion of maxillary posterior teeth in adult patient with anterior open bite. materials and methods: trial design: this study will be uncontrolled clinical trial. intervention all patients will start the treatment by mini-implants insertion in anterior palate. application of topical and/or local anesthesia, mini-implants will be inserted in anterior palate, using a manual contra-angle driver. the implants are oriented perpendicularly to the palatal curvature. intraoral scanning for maxillary arch will be recorded before and after intrusion for each patient; at t0 (before intrusion), t1 (after intrusion) appliance construction: the principle of the mousetrap appliance. for molar intrusion, lever arms are connected to two mini-implants inserted in the anterior palate. a transpalatal arch is placed to avoid tipping of the molars during intrusion. customized intrusion appliance including upper first molar with band and occlusal rest on posterior teeth. the appliance will be digitally designed. a modified transpalatal arch with a is fitted with sufficient clearance between the palatal mucosa to avoid impingement and irritation during and after successful molar intrusion.

Eligibility criteria:
inclusion criteria: * age ranging from 15 to 27 years. * high angle patients with skeletal class i, ii or mild class iii. * patients with anterior open bite requiring maxillary posterior teeth intrusion as part of orthodontic treatment. * anterior open bite: range from 3-8 mm. * healthy adult patients. * no previous orthodontic treatment. * no evidence of either periodontal problems, gingival problems, or bruxism, at the beginning of orthodontic treatment. * no medical problems interfering with orthodontic treatment. exclusion criteria: * moderate to severe class iii skeletal relationship patients were excluded, as the molars intrusion would lead to increase the severity of class iii malocclusion. * patient with bad oral hygiene. * periodontal problems.
a trial to compare the efficacy, safety, pharmacokinetics and immunogenicity of hd204 to avastin® in advanced non-squamous non-small cell lung cancer patients

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: in the samson-2 study, the proposed biosimilar hd204 will be compared to its reference product eu-licensed avastin®. the aim of the study is to demonstrate equivalence of hd204 and eu-licensed avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.

this is a randomised, double-blind, parallel group, equivalence, multicentre phase iii study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (nsclc). standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between hd204 and bevacizumab.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * ecog performance status of 0-1 * histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer * at least one measurable lesion according to recist v1.1. * able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters exclusion criteria: * diagnosis of small cell carcinoma of the lung or squamous cell carcinoma * sensitizing egfr mutations or alk rearrangements * increased risk of bleeding determined by investigator based on radiographic / clinical findings * history of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of nsclc.
remotely monitored exercise program in pregnant women with obesity

Conditions: Pregnancy Related; Obesity, Maternal

Summary: pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored

pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored. the remote system use inertial motion trackers, digitizes pregnant women motion and provides real-time feedback on performance through a mobile app. it also includes a web-based platform that allows the clinical team to prescribe, monitor and adapt the exercise program remotely. this way, the system allows patients to perform independent exercise program at home without the need for constant therapist supervision, ensuring remote monitoring throughout the rehabilitation program. the exercise programme will be performed since the first gestational trimester until delivery. data of gestational weight gain, gestational diabetes mellitus, low back pain and quality of life will be colected.

Eligibility criteria:
inclusion criteria: * pregnant women with obesity (bmi ≥ 30 kg/m2) at first gestational trimester exclusion criteria: * pre-pregnancy bmi \< 30 kg/m2; * previous bariatric surgery; * hemodynamically significant heart disease; * restrictive lung disease; * incompetent cervix or cerclage; * multiple gestation; * persistent second- or third-trimester bleeding; * placenta previa after 26 weeks of gestation; * premature labor during the current pregnancy; * ruptured membranes; * preeclampsia or pregnancy-induced hypertension; * severe anemia; * inability to read and understand portuguese; -\>15 weeks gestation.

Keywords: obesity pregnancy exercise physical activity maternal gestational weight gain gestational diabetes mellitus
vnp40101m in treating patients with relapsed or refractory leukemia or myelodysplastic syndrome

Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of vnp40101m in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.

objectives: * determine the toxic effects of vnp40101m in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes. * determine the maximum tolerated dose of this drug in these patients. * determine the pharmacokinetics of this drug in these patients. * determine the antitumor effects of this drug in these patients. outline: patients receive vnp40101m iv over 15 minutes once every 4 weeks. projected accrual: approximately 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * relapsed or refractory leukemia for which no standard therapy is anticipated to result in a durable remission or * poor-risk myelodysplastic syndromes patient characteristics: age * 18 and over performance status * ecog 0-1 life expectancy * not specified hematopoietic * not specified hepatic * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast and alt no greater than 3 times uln renal * creatinine no greater than 2.0 mg/dl cardiovascular * no myocardial infarction within the past 3 months * no symptomatic coronary artery disease * no uncontrolled arrhythmia * no uncontrolled congestive heart failure other * no uncontrolled active infection prior concurrent therapy: biologic therapy * prior biologic therapy allowed chemotherapy * at least 2 weeks since prior myelosuppressive cytotoxic chemotherapy in the absence of rapidly progressing disease * at least 48 hours since prior hydroxyurea endocrine therapy * not specified radiotherapy * prior radiotherapy allowed surgery * not specified other * no other concurrent standard or investigational treatment for leukemia * no concurrent disulfiram

Keywords: acute undifferentiated leukemia chronic myelomonocytic leukemia previously treated myelodysplastic syndromes prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia refractory chronic lymphocytic leukemia refractory anemia with excess blasts refractory cytopenia with multilineage dysplasia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia secondary myelodysplastic syndromes atypical chronic myeloid leukemia, bcr-abl1 negative myelodysplastic/myeloproliferative neoplasm, unclassifiable
tamoxifen to treat barrett's metaplasia

Conditions: Barrett Metaplasia

Summary: treat barrett's esophagus (be) patients with tamoxifen to barrett's metaplasia as measured by changes in barrett's esophagus appearance by endoscopy and histology as well as changes in sox2 and cdx2.

treat barrett's esophagus (be) patients with tamoxifen to determine the effects on barrett's metaplasia as measured by changes in barrett's esophagus appearance by endoscopy and histology. tamoxifen treatment may induce sox2 expression, decrease cdx2 and promote esophageal stem cell activity, leading to regression of barrett's metaplasia. to test this hypothesis, we will conduct a prospective, pilot study where patients with be, without high grade dysplasia, are treated with tamoxifen and assessed for changes in the appearance of their be by endoscopy and histology as well as changes in the sox2/cdx2 ratio indicative of an improvement in be metaplasia

Eligibility criteria:
inclusion criteria: * biopsy-proven barrett's esophagus that is non-dysplastic or with low grade dysplasia. * at least 18 years of age. * ecog performance status ≤ 2 * normal bone marrow and organ function as defined below: * absolute neutrophil count ≥1,500/mcl * platelets ≥ 100,000/mcl * ast(sgot)/alt(sgpt) ≤1.5 x iuln * serum creatinine within normal institutional limits or less than the lower limit of normal institutional limits; or creatinine clearance ≥ 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * ability to understand and willingness to sign an irb approved written informed consent document. exclusion criteria: * prior history of esophageal cancer. * prior history or current use of tamoxifen or anti-estrogen therapy. * a history of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant and/or breastfeeding. female patients must have a negative urine pregnancy test within 14 days of study entry. * known hiv-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with tamoxifen. appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * taking medications known to affect drug metabolism via the cyp3a4, cyp2c9, or cyp2d6 pathways. * history of blood clots (i.e. pulmonary embolism, dvts). * concurrent use of anticoagulants (i.e. coumadin/warfarin).
a study of pcsk9 inhibitor ak102 in healthy subjects

Conditions: Hypercholesterolaemia

Summary: this is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, pk/pd and immunogenicity of ak102 administered subcutaneously in healthy subjects. subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.


Eligibility criteria:
inclusion criteria: * signed informed consent. * no clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram and routine laboratory evaluations. * low-density lipoprotein cholesterol (ldl-c) level of 70-190 mg/dl (inclusive). * body mass index (bmi) ≥18 and ≤ 28 kg/m\^2 , body weight \>= 50 kg for male or \>= 45 kg for female. exclusion criteria: * triglyceride concentration \>400 mg/dl (4.5 mmol/l). * history of hypersensitivity reactions to any substance of the investigation drug or other monoclonal antibodies. * drug or alcohol abuse within 6 months prior to dosing. * blood pressure \>140 mmhg (systolic) or \> 90 mmhg (diastolic)
lymphangioleiomyomatosis (lam) registry

Conditions: Lung Diseases; Lymphangiomyomatosis

Summary: to establish a registry of individuals with lam by forming a consortium of six clinical centers and referring physicians who treat lam patients.

background: lam is a rare multi-system disease that can affect the lungs of young women, is of uncertain cause, is usually progressive, and can cause debilitating lung disease which may be corrected with lung transplantation. several hundred women with the disease have been identified, largely through a lam foundation in cincinnati, ohio. design narrative: the data and coordinating center is located at the cleveland clinic foundation. the registry has six major clinical centers: cleveland clinic foundation, mayo clinic-rochester, national heart, lung, and blood institute, national jewish medical and research center, new england medical center, and stanford university medical center. data and lung tissue collected by the registry will be used to characterize the clinical features and natural history of the disease and to determine the efficacy of lung transplantation in this disorder. eligible patients are to be seen yearly for up to 4 years at the clinical centers or, in some cases, by individual referring physicians. tissue collected by the lam registry will be stored at a central nhlbi repository. outcome events include measures of pulmonary function (eg, spirometry and, when available, lung volumes and diffusing capacity), arterial blood gases or oximetry, walking and resting oxygen titration, cardiopulmonary stress testing, cause-specific mortality, functional status, and clinical events associated with lung transplantation. the office of research on women's health provided funding in fy 1997 in the amount of $100,000. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
ivacaftor treatment in 4 month to 2 year old cf subjects

Conditions: Cystic Fibrosis

Summary: the purpose of this research study is to determine the effects of clinically prescribed ivacaftor treatment on 4-24 month old children with cf and gating mutations on sleeping energy expenditure, growth status and gut health and function.

ivacaftor is a novel fda approved therapy for patients with cf and gating mutations who are 4 months and older. this investigator-initiated study is designed to evaluate the nutritional, growth and gi impact of ivacaftor treatment for the youngest (4-24 months) patient cohort and for whom fda approval has recently been granted. this proposal directly extends the previous highly informative nutrition and weight gain investigation of ivacaftor treatment in the older patient cohort (1). the primary aims of the study are to evaluate the impact of 12 weeks of ivacaftor treatment in 4-24 month old subjects with cf and gating mutations on sleeping energy expenditure, growth status and gut health and function in 18 children with protocol evaluations at baseline (pre-treatment) and 6 and 12 weeks after clinically prescribed ivacaftor treatment has begun. other outcomes of significant clinical interest in young subjects with cf will be explored. all subjects will be evaluated at the children's hospital of philadelphia (chop) and will be recruited both regionally and nationally to ensure timely enrollment.

Eligibility criteria:
inclusion criteria: * cystic fibrosis with at least one cftr gating mutation (e56k, g178r, s549r, s977f, f1074l, 2789+5g→a,p67l, e193k, g551d, f1052v, d1152h, 3272-26a→g, r74w, l206w, g551s, k1060t, g1244e, 3849+10kbc→t, d110e, r347h, d579g, a1067t, s1251n, d110h, r352q, 711+3a→g, g1069r, s1255p, r117c, a455e, e831x, r1070q, d1270n, r117h, s549n, s945l, r1070w, g1349d) approved for treatment * age: 4-24 months of age * in their usual state of good health * a clinical decision has been made for subject to begin ivacaftor treatment * family committed to the 4 to 6 month study protocol with visits to chop that will last 2 or 3 days for the baseline visit (visit 1) prior to ivacaftor and the 12 week visit (visit 3) after clinically prescribed ivacaftor treatment has begun, and will last 2 days for the 6 week visit (visit 2) after ivacaftor treatment has begun. exclusion criteria: * on parenteral nutrition * use of any medications which are as inhibitors or inducers of cytochrome p450 (cyp) 3a * liver function tests elevated above 3x the reference range for age and sex * other illness affecting growth or nutritional status * other contraindications described for ivacaftor therapy

Keywords: cf transmembrane conductance regulator cftr gating mutations