Kornimate/medical-research-clean huggingface dataset:
long term follow-up of autologous bone marrow mononuclear cells therapy in stemi

Conditions: Myocardial Infarction

Summary: the benefit of current reperfusion therapies for st-elevation myocardial infarction (stemi) is limited by post-infarction left ventricular (lv) dysfunction. many clinic trails showed the short term outcome of bone marrow stem cell transplantation for mi patients, but rare report of long term follow-up results. our aim was to investigate 4 years' efficacy and lv functional improvement of autologous bone marrow mononuclear cells (bmmc) transplantation in patients with st-elevation myocardial infarction.

the benefit of current reperfusion therapies for st-elevation myocardial infarction (stemi) is limited by post-infarction left ventricular (lv) dysfunction. many clinic trails showed the short term outcome of bone marrow stem cell transplantation for mi patients, but rare report of long term follow-up results. aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with st-elevation myocardial infarction (stemi), especially with regard to the left ventricular function. the cells are delivered by intracoronary infusion 7 days after the pci. outcomes including lvef, myocardial viability and coronary artery status are assessed by echocardiography, spect and coronary angiography.

Eligibility criteria:
inclusion criteria: * st segment elevation myocardial infarction, according to the who definition. * \<24 hour from the origin of symptoms. * single left anterior descending coronary artery disease. * successful revascularization of culprit lesion with pci. * age between 45 and 65 years old. * written informed consent. exclusion criteria: * previous mi. * cardiomyopathy. * atrial fibrillation or fluctuation. * previous heart surgery. * severe valvular heart disease. * disease of the hematopoetic system. * nyha functional class iv at baseline. * severe renal, lung and liver disease or cancer. * significant coronary lesion in one or more major coronary vessels, requiring revascularization. * intra-cardiac thrombus.

Keywords: bmmnc stemi stem cell intracoronary delivery
effect of hifu on sleep quality measures in obese doubled chin women

Conditions: OBESITY

Summary: this study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.

purpose: this study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women. background: high-intensity focused ultrasound (hifu) therapy is becoming more familiar in medical field because it is non-invasive technique with fewer side effects and provides promising therapeutic results. several hifu therapy applications have approved by many approval authorities of deferent countries since last decade. hifu cauterizes tissue from outside the body by focusing ultrasonic waves from a transducer with many ultrasonic sources on a single point, known as the target tumor .this modality is groundbreaking because it only causes coagulative necrosis via thermal and non-thermal energy (mainly cavitation) to the focal area, with hardly any impact on the intervening tissue outside the focal area. central obesity is significant predictor of metabolic syndrome and is associated with an increased risk of many medical conditions, including cardiovascular diseases (cvd), stroke , type 2 diabetes mellitus, hypertension , various types of cancer (e.g. colorectum, pancreas, endometrium, and breast) and all-cause mortality hypotheses of the study(null) there is no significant effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women. statement of the problem: is there any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women?

Eligibility criteria:
inclusion criteria: * all patients that will be included in this study will meet the following criteria: 1. female subjects with age ranged from 35 to 50 years old. 2. bmi will be 30-39.9. class i,ii bmi was classified into six groups: underweight (\ 40 kg/m2) 3. clinically and medically stable. 4. able to understand the requirements of the study. 5.thyroxin normal level( thyroid-stimulating hormone) (0.35 and 5.0milli-international unit( miu/l) exclusion criteria: - the potential participants will be excluded if they meet one of the following criteria: 1. neurological conditions (e.g., stroke history, parkinson's disease). 2. presence of an acute illness. 3. renal and hepatic diseases. 4. patient undergoes chemotherapy. 5. recent surgery. 6. any contraindications for using hifu such as:pregnancy ,metal prosthesis or implants,epilepsy,diabetes, autoimmune conditions,heart diseases including pacemaker,thrombosis . 8-bmi less than 30 and more than 39.9. 9-age less than 35 and more than 50. 10-male subjects.
efficacy and safety of intravitreal bevacizumab for threshold rop.

Conditions: Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.

Summary: prospective study to evaluate the efficacy and safety of intravitreal bevacizumab in retinopathy of prematurity (rop). bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ rop in zone i or zone ii.


Eligibility criteria:
inclusion criteria: stage 2+ or stage 3+ retinopathy of prematurity in zone i or zone ii. informed written consent by parents or guardian. - exclusion criteria: refusal to give consent critically ill neonates. -
a feasibility trial of a web based app intervention in hormone positive breast cancer patients to improve adherence to endocrine therapy

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; HER2-Negative Breast Carcinoma; Hormone Receptor-Positive Breast Carcinoma

Summary: this clinical trial looks at the use of an internet-based application (app) intervention in improving adherence to endocrine therapy (et) among patients with early stage hormone receptor-positive her2-negative breast cancer. et can significantly reduce the return of the cancer in patients who are compliant with their treatment regimen. despite this, adherence to et is poor due to side effects, lack of social support and timely access to clinicians, and poor patient understanding of the necessity and effectiveness of the therapy. an internet-based app may help patients improve their adherence to et by providing reminders, side effect mitigation strategies available in the educational videos and from contacting providers/ nurse on the research team directly via the app.

primary objective: i. to assess the feasibility of a web-based app as an intervention to carry out functions such as weekly reminders, improving patient provider communication, improving patient education secondary objectives: i. to evaluate if high level of adherence to endocrine therapy can be maintained by using our web-based app in early-stage hormone positive breast cancer ii. to assess whether the web-based app will improve patient satisfaction, whether patients feel the app helped improve their likelihood of adhering to endocrine therapy by making them feel more confident in their side effect management. outline: this is a single arm, feasibility study. 30 patients will be enrolled. in addition to standard of care, patients will receive access to the web-based application for the study duration (3 months). the app will have the following features: weekly text reminders to continue et and prompts to report medication side effects, access to educational content explaining common side effects and symptom management strategies, prompts to patients to review this information when they report side effects, and most importantly, the patient will have access to their breast oncology providers to discuss their side effects and ask questions via the app. a feature unique to our app is the educational content readily available to patients. when a patient reports a side effect, the app will direct them to the relevant video explaining that side effect and going over strategies to mitigate them.

Eligibility criteria:
inclusion criteria: * early-stage hormone receptor positive, her2-negative breast cancer who have completed all recommended (neo)adjuvant chemotherapy, surgery and/or radiation therapy * age \>= 18 * started on an aromatase inhibitor or tamoxifen within less than or equal to six months prior to time of enrollment * access to internet from a desktop or a smartphone * ability to speak english exclusion criteria: * patients who are her2 neu positive
saliva levels of s100a12, crp, fetuin-a in periodontal disease patients

Conditions: Periodontal Inflammation

Summary: hs-crp, fetuin-a and s100a12 are acute phase proteins associated with many systemic diseases and conditions. the aim of this study was to determine the clinical parameters and salivary hs-crp, fetuin-a and s100a12 levels before and after non-surgical periodontal treatments in the patients with periodontal diseases. a total of 54 subjects were divided in to three groups; periodontally healthy (n: 18), gingivitis (n: 18), chronic periodontitis (n: 18). clinical periodontal parameters, salivary hs-crp, fetuin-a and s100a12 levels and salivary flow rates were evaluated at baseline and a month after the treatments. salivary hs-crp, fetuin-a and s100a12 levels were assayed by elisa.


Eligibility criteria:
inclusion criteria: never-smokers no history of systemic disease no patients had been under periodontal therapy and medicine for at least 6 months before the study no pregnancy or lactation no alcohol or antioxidant vitamin consumption. exclusion criteria: -

Keywords: fetuin-a s100a12 c-reactive protein chronic periodontitis
inclusion appeal videos and intent to register for pediatric clinical trials

Conditions: Patient Participation; Pediatric ALL

Summary: an informational video about joining a research notification registry is being compared with a version of the video tailored to african/ african american parents, reminding them about the importance of their being included in clinical trials. african/african american parents and caregivers of children under 13 years of age are targeted.

improving diversity in research projects and national data repositories is critical to providing safe and effective care to marginalized groups. unfortunately, certain groups such as african americans are inadequately represented in much of the available data and in current clinical trials. recently, investigators have begun employing new messaging approaches to increase diversity in clinical trial enrollment. these messages are typically designed to inform, with no appeal for specific groups to act, and no tailoring that takes into account specific groups. very little is known about the potential impact of inclusion appeals--direct appeals to historically marginalized groups calling on their need to be included in research studies. applying the science of appeals to recruitment messages may improve the effectiveness of educational videos and lead to greater participation in research. this pilot study proposes to empirically study whether an inclusion appeal increases decisions to enroll children in studies.

Eligibility criteria:
inclusion: 1. english speaking 2. self-identified african or african american 3. not already enrolled in any research participant registry, no history of clinical trial participation 4. at least one child in their care age newborn to 13 exclusion: 1. parents with children over the age of 13 2. non-english speakers 3. previously enrolled in children's hospital of philadelphia registry, history of clinical trial participation

Keywords: inclusion study african american study african american pediatrics appeal videos
use of stem cells cultured on a scaffold for the treatment of aneurysmal bone cysts (abc)

Conditions: Aneurysmal Bone Cyst

Summary: patients qualified for this study are those diagnosed with abcs and failed to be treated with other forms of classical therapies. in which, these patients will be engrafted with biodegradable scaffolds seeded with mesenchymal stem cells (mscs) supplemented with platelet lysate.

aneurysmal bone cysts (abc) are relatively rare, benign, tumor-like, expansile osteolytic lesions of unknown etiology which are predominantly found within the long bones and characterized by frequent idiopathic fractures. despite the large variety of bone substitutes that have been used to fill these cystic lesions, to date there is no graft material which can be regarded as completely satisfactory, with a recurrence rate that ranges from 5-40% of treated cases. autologous bone marrow derived mononuclear cells have been used previously to treat abcs. poly lactic-co-glycolic acid (plga) scaffolds have been used in bone tissue engineering due to their biodegradability and biocompatibility. human platelet lysate (pl) contains a number of mitogenic growth factors and has been demonstrated to enhance mesenchymal stem cell (msc) proliferation and expansion rate in vitro. this study is designed to assess the safety and effectiveness of using plga scaffolds seeded with autologous bone marrow mscs and supplemented with osteogenic media and platelet lysate in healing bone lesions of patients suffering from aneurysmal bone cysts. this study will be conducted at the cell therapy center (ctc), jordan. four abc cases will be included. patients qualified for this study are those diagnosed with abcs and failed to be treated with other forms of classical therapies; such as allografts or who are not candidate of autografts.

Eligibility criteria:
inclusion criteria: * bone cyst diagnosed with mri, ct-scan, or x-ray * intact cyst wall with high risk for fracture * cysts with minimum diameter of 6mm * diagnostic test performed on cyst fluid * diagnosed abc patients whom treatments with other forms of classical therapies ;such as allograft failed or who are not candidate of autografts * provided written consent form exclusion criteria: * patients with diagnosis of cancer * patients enrolled in other clinical trial

Keywords: aneurysmal bone cysts plga platelet lysate bone marrow mesenchymal stem cells
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell intravenous infusion for ckd

Conditions: Chronic Kidney Diseases

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of chronic kidney disease.

studies have shown that stem cell treatment is safe and efficacious for the treatment of chronic kidney disease (ckd). this patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of ckd. patients with ckd will receive a single intravenous infusion of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. for patients with more severe disease an autologous effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic kidney disease * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: renal failure stem cell treatment kidney disease
safety and efficacy of multiple doses of canakinumab (acz885) in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (acz885) vs. placebo when administered via intravenous infusion (iv), on pulmonary function in patients with copd


Eligibility criteria:
inclusion criteria: * male and/or female subjects from 40-80 years (inclusive) of age * subjects have a clinical diagnosis of copd * smokers or ex-smokers with a smoking history of at least 20 pack years * post-bronchodilator forced expiratory volume in 1 second (fev1 ) at screening ≤ 50% of the predicted normal value * post-bronchodilator fev1/fvc ratio \< 70% * history of at least one treated exacerbation during the 24 months year prior to screening or c-reactive protein (crp) ≥3.47 mg/l, * subjects should have no concomitant other lung disease or significant concomitant medical conditions that would affect the subjects' safety when participating in the study, or that would be expected to impact on the results of the study * female subjects must have been surgically sterilized at least 6 months prior to screening or must be using two forms of contraception, or postmenopausal women * able to provide written informed consent prior to study participation. * able to communicate well with the investigator and comply with the requirements of the study. exclusion criteria: * copd exacerbation(s) requiring treatment within 4 weeks prior to first dosing * history of lung reduction surgery * any undiagnosed nodule on chest x-ray * presence of certain medical conditions as specified by the protocol * subjects requiring oral or parenteral corticosteroids equivalent to \> 10 mg/day or \> 20 mg every other day of prednisone or prednisolone * documented homozygous alpha-1 antitrypsin deficiency. * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. * donation or loss of 400 ml or more of blood within 8 weeks prior to dosing. * a past medical history of clinically significant electrocardiogram (ecg) abnormalities or a family history of a prolonged qt-interval syndrome. * a known hypersensitivity to drugs similar to the study drug. * history of immunocompromise, including a positive hiv test result. * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * history of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during screening.
multidisciplinary support program in chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: adherence to antiviral treatment in chronic hepatitis c (chc) is an important factor to achieve sustained virological response (svr). the aim of our study is to evaluate the efficacy of a multidisciplinary support program (msp) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. we assessed 447 patients with chc receiving antiviral treatment distributed into 3 groups: control group (recruited 2002-2004, n= 147), msp-pilot group (recruited 2005-2006, n=131), and msp-validation group (recruited 2007-2009, n=169).

adherence to antiviral treatment in chronic hepatitis c (chc) is an important factor to achieve sustained virological response (svr). the aim of our study is to evaluate the efficacy of a multidisciplinary support program (msp) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. we assessed 447 patients with chc receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), msp-pilot group (follow-up 2005-2006, n=131), and msp-validation group (follow-up 2007-2009, n=169).a cost-effectiveness analysis was performed using a markov model.

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c eligible to receive antiviral treatment. exclusion criteria: * patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection, and individuals included in other treatment protocols.

Keywords: chronic hepatitis c virus infection (chc)
viral and antiretroviral dynamics in hiv-1 mother-to-child transmission fluids

Conditions: Human Immunodeficiency Virus Infection

Summary: more than 150,000 babies became infected with hiv in 2015 alone. when hiv drugs are started before or early in pregnancy, hiv positive women can give birth to hiv negative baby. this is possible because hiv drugs can reduce the amount of the virus in the body to the extent that they become undetectable by the time of delivery and during the breastfeeding period. however, some women do not start taking these drugs on time because they become infected during pregnancy or lactation. this leads to detectable virus at the time of delivery and puts the baby at risk of becoming infected. also, the amounts of hiv drugs in the body have to be at certain levels for them to work effectively. but findings from some research have recently showed that pregnancy increases the rate at which the body removes some hiv drugs used to prevent the transfer of hiv from mother to child. while this may not cause any problem in women with no detectable virus before pregnancy, it may affect the rate at which the hiv virus is removed from the body in those starting treatment late and may put the baby at risk. this project will investigate whether the changes in drug exposure caused by pregnancy or other factors have any effect on the rate at which the hiv virus is removed from the body. hiv positive pregnant women and those who recently delivered will be recruited from different hospitals and follow up will be until breastfeeding ends. the investigators will not be involved in treatment decisions and the primary care provider will be responsible for prescribing antiretroviral regimen based on current guidelines. samples will be collected to measure levels of the virus and the drugs in three fluids that transfer the virus to the baby: blood, genital fluid, and breastmilk. the hiv status of the babies will be monitored until they stop breastfeeding.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * planned exclusive breastfeeding until 6 months of age * able to understand study information and comply with follow-up schedule exclusion criteria: * severe maternal or infant illness * planned exclusive formula feeding * taking medication with known or uncertain interaction with study drugs
phase 2 study of ngm282 in patients with type 2 diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine the safety, tolerability, and activity of ngm282 in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * males or females, between 18 and 70 years of age, inclusive * bmi range of 24-40 kg/m2, inclusive * no active coronary artery disease * resting heart rate in the range of 40-100 bpm exclusion criteria: * diagnosis of type 1 diabetes * history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance