Kornimate/medical-research-clean huggingface dataset:
pet scan in planning treatment in patients undergoing combination chemotherapy for stage ia or stage iia hodgkin lymphoma

Conditions: Lymphoma

Summary: rationale: a pet scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required. purpose: this randomized phase iii trial is studying giving a pet scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage ia or stage iia hodgkin lymphoma also need radiation therapy.

objectives: * determine whether patients with stage ia or iia hodgkin lymphoma who have a negative fludeoxyglucose f 18 positron emission tomography (fdg-pet) imaging after 3 courses of chemotherapy comprising doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (abvd) require consolidation radiotherapy (to areas of previous involvement) in order to delay or prevent disease progression. outline: patients receive doxorubicin hydrochloride iv, bleomycin sulfate iv, vinblastine iv, and dacarbazine iv (abvd) on days 1 and 15. treatment repeats every 28 days for 3 courses. on day 15 of the third course of chemotherapy, patients undergo a ct scan of the neck, thorax, abdomen and pelvis. patients with nonresponsive disease or progressive disease are removed from the study. patients who achieve response undergo fludeoxyglucose f 18 positron emission tomography (fdg-pet). patients with a positive fdg-pet scan receive an additional course of abvd and undergo involved field radiotherapy. patients with a negative fdg-pet scan are randomized to 1 of 2 treatment arms. * arm i: within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas. * arm ii: patients receive no further treatment. after completion of study therapy, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed hodgkin lymphoma * stage ia or iia disease * no stage ia hodgkin lymphoma with no clinical or ct evidence of disease after diagnostic biopsy * above the diaphragm with no mediastinal bulk, defined as maximum transverse diameter of mediastinal mass * internal thoracic diameter at level of d5/6 interspace \> 0.33 * bulky disease at other sites, defined as nodal mass with transverse diameter ≥ 10 cm allowed patient characteristics: * not pregnant or nursing * fertile patients must use effective contraception during and for ≥ 6 months * no prior malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix * no severe underlying illness considered to make the trial therapy hazardous (i.e., severe heart disease or lung fibrosis) * willing to travel to the nearest pet scan center * able to comply with protocol follow-up arrangements prior concurrent therapy: * no prior treatment for hodgkin lymphoma * no contraindications to chemotherapy or radiotherapy

Keywords: stage i adult hodgkin lymphoma stage ii adult hodgkin lymphoma
salvage: postconditioning with adenosine for stemi

Conditions: Acute ST Elevation Myocardial Infarction

Summary: investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.

prospective, single center, randomized clinical study. study design is random patient assignment to selective intracoronary administration of adenosine or control immediately before restoration of coronary artery patency in patients presenting with an acute st segment-elevation myocardial infarction (stemi). randomisation will be stratified for the duration of symptoms (\ 4 hours).

Eligibility criteria:
inclusion criteria: * myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes. * ecg-criteria: st-segment elevation of \> 0.1 mv in 2 or more limb leads or \> 0.2 mv in 2 or more contiguous precordial leads or presumed new left bundle branch block. * written informed consent prior to inclusion in the study. if this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity. * adequate vascular access seems possible (femoral pulsation palpable). exclusion criteria: * contra-indication to heparin, lmwh, clopidogrel. * anticipated difficulty with vascular access. * cardiogenic shock. * inability to give informed consent (or assent). * high grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (diamicron) or dipyridamole. * prior cabg. * participation in an investigational drug or device study within the past 30 days.

Keywords: acute myocardial infarction pci adenosine postconditioning
safety and tolerability study comparing sodium oxybate given as an oral solution to a single-blinded combination of oral tablets plus oral solution in subjects with fibromyalgia

Conditions: Fibromyalgia

Summary: to compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (fm).


Eligibility criteria:
inclusion criteria: * subject is able to understand the written informed consent * subject is 18 years of age or older. * subject meets the acr criteria for fibromyalgia * subject is willing to discontinue prohibited by the protocol * subject agrees to use only non-sedating over-the-counter (otc)medication * subject is willing to abstain from the ingestion of alcohol for the duration of the trial. exclusion criteria: * subject has protocol prohibited medical \& psychiatric conditions that would exclude subject * subject has a current or past history of a substance use disorder including alcohol abuse * subject has a clinically significant history of seizure disorder either past or present * female subject who is pregnant, nursing or lactating. * subject is diagnosed with sleep apnea * subject is unable to discontinue protocol prohibited medications * subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications. * subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form. * subject has an allergic reaction to ghb or sodium oxybate or any of its constituents (e.g. malic acid). * subject is on a sodium-restricted diet. * subject has abnormal liver function test or other abnormal lab values * subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed. * subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms. * subject has been randomized into a previous xyrem (sodium oxybate) clinical trial.
melatonin production delay in preterm infants

Conditions: Melatonin Production

Summary: objective: melatonin production is known to be delayed in preterm-born infants up to 6 months of age. this might be related to exposure of preterm infants to continuous lighting in the nicu during a critical period of pineal gland development. the investigators aimed to test the profile of melatonin production in these infants at 9-12 months of age. methods: twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks) were studied. the investigators tested nocturnal urinary melatonin excretion, within a repeated measures design, both at 9 and 12 months of age. nocturnal urine was extracted from diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by elisa assay.

unlike other organs which show catch up in preterm infants after one year of life, the pineal gland shows persistent delay in melatonin production. this field of research has been neglected lately although there are published recommendations for decrease of bright light in nicus which prevents melatonin development and production, and also recommendations for melatonin treatment in cases respiration recovery in hospitalized preterm infants.

Eligibility criteria:
inclusion criteria: * the investigators included healthy mothers with singleton pregnancies and documented prenatal care who were admitted before term (28-34) weeks gestation to the hospital's delivery room with early uterine contractions and entering stage 1 of an anticipated spontaneous vaginal delivery or term infants born at 38-42 weeks of gestation. exclusion criteria: * mothers who showed signs of fetal distress during labor, or required cesarean (c)c-section, or had fetuses withand estimated fetal weights \< 10th percentile for gestational age and children diagnosed with * genetic anomalies, congenital heart malformations, gastrointestinal disturbances and central nervous system dysfunction * age \ 9 months month at onset of study * considered medically unstable

Keywords: 6sulphatoxymelatonin preterm infants melatonin is low in preterm infants at least until the age of 6 months
the scripps des real world registry

Conditions: Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis

Summary: this study is a prospective, non-randomized, open-label registry of consecutive patients with cad treated by stent-assisted pci using at least one cyphertm stent. up to 1000 pts will be included in the registry. the registry is conducted for the evaluation of the impact of cyphertm sirolimus-eluting stent implantation in the "real world" of interventional cardiology. informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures. consecutive patients treated with the use of the cyphertm stent will be included in the registry. baseline and post-procedure blood samples will be used to perform platelet function analysis using the accumetrics ultegra rpfa (rapid platelet function assay). all patients will be followed from enrollment through the hospital discharge for any clinically significant event (death, myocardial infarction, tlr, tvr, major or minor bleeding). a follow-up telephone assessment of death, myocardial infarction, revascularization, and medical treatment will be conducted by experienced research personnel at 30 days, 6 months, 1 year and at least 2 years. all site reported deaths, myocardial infarctions and revascularizations will be adjudicated by an independent clinical events committee for all 1000 patients enrolled in the trial. an interim analysis of the first 750 patients will be conducted and data forwarded to fda.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. eligible for percutaneous coronary intervention 3. patient has at least one lesion ≥50% diameter stenosis requiring pci with stenting 4. reference vessel diameter 2.25-4.0 mm 5. percutaneous intervention with use of one or more of the fda approved cyphertm stents, planned not to exceed 108 mm of stent length. 6. target lesion is located within a native coronary artery or bypass graft 7. de novo and restenotic lesions, including isr, radiation failure 8. be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up 9. able to understand and grant informed consent exclusion criteria: 1. confirmed pregnancy at the time of index pci 2. has known allergies to aspirin, and to both clopidogrel (plavixtm) and ticlopidine (ticlidtm) 3. has known allergies or contraindication to heparin and bivalirudin (angiomaxtm) 4. known allergy or sensitivity to any component of a sirolimus-eluting stent 5. has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study; 6. any serious disease condition with life expectancy of less than 1 year.

Keywords: coronary artery disease coronary restenosis coronary thrombosis drug-eluting stents angioplasty, transluminal, percutaneous coronary
health mindset as a driver of efficacy of a diabetes prevention program in the blackfeet community

Conditions: Diabetes Mellitus, Type 2

Summary: the overall goal of this project is to understand whether the established diabetes prevention program works to reduce diabetes risk by shifting mindsets about health.

the diabetes prevention program (dpp), a lifestyle intervention which aims to modify health behaviors, has reduced diabetes risk across several american indian communities. however, there were significant attrition rates, and non-completers were at the highest risk at baseline. one's mindset about health (i.e. whether it is fixed or malleable) may affect their likelihood of completing the intervention and its efficacy in reducing risk. with an existing cab, i will develop a culturally congruent adaptation of the dpp, the mindset-dpp (m-dpp). the m-dpp will include a discussion of mindset in each session and will present material focused on the plasticity of health, including evidence that one's mindset can affect outcomes that relate to risk for diabetes. the investigators will implement the dpp and the mdpp in a sample of 40 blackfeet community members at risk for diabetes and test whether the m-dpp associates with greater shifts towards a growth health mindsets (i.e. health can be changed by effort) compared to the dpp, and whether the m-dpp associates with greater increases in physical activity levels and greater reductions in waist circumference, and greater retention compared to the standard dpp.

Eligibility criteria:
inclusion criteria: * self identified as american indian * identified as high risk for diabetes based on the american diabetes association paper and pencil test * must reside on the blackfeet reservation exclusion criteria: -chronic disease diagnosis
disseminated endometrial cancer cells during sonohysterography

Conditions: Endometrial Cancer

Summary: the purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure and result in fluid dissemination and 2) evaluate functional viability of any disseminated tumor cells collected during shg


Eligibility criteria:
inclusion criteria: * stage i endometrial cancer disease * state iia endometrial cancer disease exclusion criteria: * prior tubal ligation * prior bilateral salpingectomy
pharmacological treatment of rett syndrome with glatiramer acetate (copaxone)

Conditions: Rett Syndrome

Summary: a phase 2 open label trial to test a potential drug treatment for rett syndrome, the leading known genetic cause of severe neurological impairment in girls. the drug, copaxone (generic name - glatiramer acetate) is medication fda approved for the treatment of multiple sclerosis. copaxone's high safety profile has been documented in large cohorts of patients for more than 12 years.

background/rationale for the study: in rett syndrome brain cells aren't actually lost, instead poor maturation of connections between brain cells (synapses) prevents effective neurological functioning, and is the main morphological feature of the disease. the mecp2 gene plays a major role in transcriptional regulation of other genes, one of which is the gene encoding brain-derived neurotrophic factor (bdnf). the disease progression and severity of symptoms is directly affected by the level of bdnf expression. an increase of bdnf levels (by genetic manipulations or pharmacological agents) leads to delayed onset of rett syndrome-like symptoms in experimental models; rescued gait/mobility, improved quality of life and increased survival rates. copaxone treatment by subcutaneous injection caused elevation of bdnf levels. quantitative immunofluorescence assays showed about a twofold increase in neuronal expression of bdnf following copaxone treatment. we expect that an increase in bdnf levels with copaxone administration will stimulate communication between brain cells (synaptic maturation), which will lead to amelioration of symptoms (motor functions/gait, cognitive functions, breathing, encephalopathy and improve quality of life) for girls with rett syndrome.

Eligibility criteria:
inclusion criteria: * female patients with genetically confirmed rett syndrome (rtt) * age: 10 or more years old. selection of the age is based on the available evidence of the safety of glatiramer acetate (ga) in this group, and the relative homogeneity/stability of the phenotype, which is not expected to spontaneously change within a 6 month period at this age * ambulatory (with our without support) exclusion criteria: * prolonged qtc (obtained within 30 days prior to enrollment) * presence of co morbid non-rett related disease * presence of immunodeficiency requiring intravenous immunoglobulin 3 (ivig 3) months prior to enrollment * allergy/sensitivity to ga or mannitol * inability or unwillingness of legal guardians to give written informed consent

Keywords: treatment trial, rett syndrome, glatiramer acetate
quality of life and surgical late effects of melanoma treatment

Conditions: Melanoma; Quality of Life; Lymphedema; Depression; Anxiety; Pain; Cicatrix

Summary: health-related quality of life in danish stage ib-iii cutaneous melanoma patients.

the aim of the phd-study is to evaluate, in a large cohort of danish melanoma patients: 1. health-related quality of life assessing psychological, physical and social well-being 2. physical long term side effects (lymphoedema, scarring and neuropathic pain) 3. lymphoedema assessed by clinical examination and dxa scans

Eligibility criteria:
inclusion criteria: * ajcc stage ib-iii cutaneous melanoma patients * at least one year follow-up after melanoma surgery exclusion criteria: * pregnancy * bilateral axilla or groin melanoma surgery
pars plana vitrectomy combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients

Conditions: Diabetic Retinopathy; Diabetic Cataract

Summary: pars plana vitrectomy (ppv) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world. however, as a predictable consequence of ppv surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after ppv in 6-24 months and a subsequent cataract surgery is usually required. while, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks. since the two-step surgical approach has its defects, the combination of ppv and phacoemulsification is an ideal surgical option. this study is a multi-center prospective study, aimed to evaluate the effect of ppv combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.

the prevalence of diabetes retinopathy is increasing dramatically recent years. pars plana vitrectomy (ppv) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world. however, as a predictable consequence of ppv surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after ppv in 6-24 months.generally, subsequent cataract surgeries are required for the phakic patients within 6-16 months after the ppv surgery to improve visualization. while, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks because of the deep anterior chamber, zonular dehiscence, and inflammation. since the two-step surgical approach has its defects, the combination of ppv and phacoemulsification is an ideal surgical option, which is only suggested in patients with severe lens opacities before the ppv surgery so far. for those with mild-moderate lens opacities, the benefits of combined surgery is unknown. this study is a multi-center prospective study, aimed to evaluate the effect of ppv combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.

Eligibility criteria:
inclusion criteria: 1. proliferative diabetes retinopathy ; 2. age over 45 years old; 3. mild-moderate lens opacities(locsⅲ : c3n3p3 or below); 4. recognition of at least one alphabet in etdrs chart. exclusion criteria: 1. long-standing retinal detachment (more than three months), macular affected 2. low vision or blind on the other eye; 3. macular degeneration, including age-related macular degeneration and polypoidal choroidal vasculopathy; 4. ocular trauma; 5. glaucoma; 6. hereditary retinopathy; 7. severe lens opacities before the surgery (locsⅲ : c4n4p4 or above).

Keywords: diabetic retinopathy diabetic cataract pars plana vitrectomy phacoemulsification
umbilical cord mesenchymal stem cell improve cardiac function on st-elevation myocardial infarction (stemi) patients

Conditions: ST Elevation Myocardial Infarction

Summary: the goal of this clinical trial is to learn about the effectiveness of umbilical cord mesenchymal stem cell (uc msc) therapy in patients with stemi against infarct myocardial size reduction and prevent the incidence of heart failure in the future

participants who have already done primary percutaneous coronary intervention (pci) will be informed about the procedure and risk of this clinical trial. after written consent, 60 participants will be check for their eligibility criteria and randomized into intervention (get uc msc transplantation) and control group. all participants will be check for their biochemical blood analysis: interleukin-10 (il-10), vascular endothelial growth factor (vegf), galectin-3, gata binding protein-4 (gata-4), and beclin 1 (1 day before transplantation, 7 dan 14 days after transplantation); infarct size and left ventricular ejection fraction (lvef) through cardiac mri (7-10 days after primary pci and 6 months after transplantation) and echocardiography (every month); and major adverse cardiac events/mace (every month). the result will be access after 6 months follow up.

Eligibility criteria:
inclusion criteria: * patients with stemi treated with primary pci maximum 12 hours after onset of chest pain exclusion criteria: * patients with history of coronary artery bypass grafting surgery * patients with history of heart failure before admission * patients with cardiogenic shock * patients with cancer disease * patients with malignant arrythmia * patients with chronic kidney disease * patients with haemostasis disorder * patients with infection * patients with stroke

Keywords: umbilical cord mesenchymal stem cell st elevation myocardial infarction infarct size left ventricular ejection fraction il-10 vegf galectin 3 gata-4 beclin 1 major cardiac adverse events