Kornimate/medical-research-clean huggingface dataset:
standard radiation therapy, higher-dose radiation therapy, or chemotherapy in treating older patients with glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. it is not yet known whether standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme. purpose: this randomized phase iii trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.

objectives: primary * compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs hypofractionated radiotherapy vs chemotherapy. secondary * compare the quality of life (qlq-c30) of these patients. * compare the safety, tolerance, and toxicity of these regimens. * assess the pharmacoeconomic cost of these regimens. outline: this is a multicenter study. patients are randomized to 1 of 3 treatment arms. * arm i: patients undergo standard radiotherapy 5 days a week for 6 weeks. * arm ii: patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks. * arm iii: patients receive oral temozolomide on days 1-5. treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically.

Eligibility criteria:
disease characteristics: * histologically confirmed glioblastoma multiforme * grade 4 disease (who) patient characteristics: * who performance status (ps) 0-2 (ps 3-4 allowed if secondary to a neurological physical handicap) * life expectancy ≥ 3 months * anc ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 10 g/dl * bilirubin \< 1.5 times upper limit of normal (uln) * transaminases ≤ 3 times uln * creatinine \< 1.5 times uln * able to tolerate the 3 treatment options * no other malignancy within the past 5 years except for curatively treated basal cell or squamous cell carcinoma of the skin * no acute or chronic severe illness that, in the investigator's opinion, contraindicates participation in the study prior concurrent therapy: * no prior chemotherapy, radiotherapy, or immunotherapy * concurrent corticosteroids allowed provided patient is receiving the lowest dose necessary for optimal functioning

Keywords: adult giant cell glioblastoma adult glioblastoma adult gliosarcoma
study of two oral formulations of lx4211 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of lx4211 in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 65 years of age * males and females of non-childbearing potential * diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening * fasting plasma glucose ≤240 mg/dl * body mass index \<42 kg/sq m * hba1c of 7-11% * c-peptide of ≥1.0 ng/ml * ability to provide written informed consent exclusion criteria: * history of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia * current use of any blood glucose-lowering agent other than metformin * exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening * history of hiv, hepatitis b, or hepatitis c * surgery within 6 months of screening * donation or loss of \>400 ml of blood or blood product within 8 weeks prior to start of study * use of proteins or antibodies within 12 weeks prior to screening. (flu shots are allowed.) * exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study * history of drug or alcohol abuse within 12 months prior to screening.
omphaloceles and associated malformations

Conditions: Omphalocele

Summary: major birth defects like omphalocele are diagnosed in 3-8% of all newborns in germany each year. prevention and treatment quality of congenital malformations are key concerns for child health. poor long-term outcome is more likely in the presence of associated structural or chromosomal abnormalities that occur in approximately 50-77% of these infants. furthermore, many newborns have respiratory failure and supposedly pulmonary hypertension - another reason for increased mortality. as part of the surveillance unit for rare pediatric conditions in germany (erhebungseinheit für seltene pädiatrische erkrankungen in deutschland), all neonatological departments receive over two years monthly reporting cards to notify the study centre of cases, which will be analysed based on anonymised questionnaires.

an observational study using anonymized questionnaires, enrolled over two years (01/07/2019 - 30/06/2021) via the surveillance unit for rare pediatric conditions in germany (esped - erhebungseinheit für seltene pädiatrische erkrankungen in deutschland). the nationwide epidemiological data collection contents information about the incidence of omphalocele, associated malformations and risk factors for the occurrence of omphalocele, especially for pulmonary hypertension and its treatment. we use the following inclusion criteria: preterm and term babies' ≤ 28 days of life. the aim of our study is a reliable, population-related data acquisition about prevalence of omphalocele, associated malformations and possible risk factors and characteristic early warning symptoms regarding concomitant diseases. thereby, in the future it will be possible to develop prevention strategies für early detection and treatment of omphalocele and the associated malformations/ diseases to improve outcome for these babies. a further aim is to follow-up the thriving and the psychomotor development of these babies in the age of two years.

Eligibility criteria:
inclusion criteria: * preterm and term newborns ≤ 28 days * present omphalocele exclusion criteria: * none
glabellar botulinum toxin injections for the treatment of geriatric depression

Conditions: Major Depressive Disorder; Major Depressive Episode; Treatment Resistant Depression

Summary: the effectiveness of glabellar injection of botulinum toxin type a (bta) in treating depression has not yet been investigated in elderly patients. the study aims in addressing the question if glabellar injection of bta is effective in treating geriatric depression.

feedback from facial expressions is known to influence emotional experience. treatment of muscles involved in facial expression of sadness, anger or anxiety with botulinumtoxin showed a quick, strong and sustained improvement in the symptoms of depression. as considerable proportion of patients do not sufficiently respond to existing treatment options. especially in the elderly current treatments show limited response or are associated with side effects. injections with bta are considered as a very safe treatment without lasting side effects. the aim of the study is to investigate effectiveness of bta in treating major depression in the elderly in a cross-over designed, placebo-controlled manner.

Eligibility criteria:
inclusion criteria: clinically relevant depressive symptoms ( defined as madrs \> 12) exclusion criteria: cognitive deficits that impair the participant´s ability to provide written informed consent severe depression madrs \>34 suicidality treatment with more than 3 psychotropic medications recent changes (4 weeks) in current psychotropic medication previous treatment with study drug active substance abuse bipolar disorder schizophrenia unstable medical condition usage of warfarin or noac bleeding disorder known hypersensitivity to study drog or any of the excipients of the formulation myasthenia gravis or eaton lambert syndrome presence of infection at the proposed injection sites

Keywords: botulinumtoxin botox depression geriatric depression depression in older adults depression in the elderly old age depression
randomized control trial to assess postoperative pain after sling placement

Conditions: Stress Urinary Incontinence

Summary: there are many ways to perform a suprapubic approach pubovaginal sling. some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. this study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores, lower use of postoperative narcotic medication and lower rates of urinary retention.

to evaluate if an injection in the retropubic space with a local acting anesthetic, marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative pain and decrease the use of narcotic pain medication. this study will include all female patients age 18 and older who will undergo a mid-urethral sling with or without anterior repair for the treatment of urinary stress incontinence by a member of the division of urogynecology and reconstructive pelvic surgery who consent to be in the study. once patients have consented to participate in the study they will be randomized into two groups. one group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic. the other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature. pain will be assessed with the use of a visual analog scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital. patients will be asked to record how often and what type of pain medication they use. patients will also be asked to keep a log of their urination if they are discharged home with self catheterization. they will be asked to mail in their pain medication log and voiding diary (if needed) at a two-week post-operative. outcomes will then be compared.

Eligibility criteria:
inclusion criteria: * any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the university of north carolina hospitals by a member of the division of urogynecology. exclusion criteria: * any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (nsaids) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/nsaids/opioids prior to surgery. * also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter. * patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded. * all minors, decisional impaired people, nursing mothers and non-english speaking people will be excluded.

Keywords: mid-urethral sling pubovaginal sling postoperative pain visual analog scale suprapubic approach sparc sling
effect of untact upper extremity rehabilitation using a smart board for late subacute and chronic patients with brain disorder

Conditions: Untact Upper Extremity Rehabilitation; Home Based Rehabilitation; Brain Disorder

Summary: the aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the neofect smart board by comparing the effects between a group using the home-based neofect smart board and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.


Eligibility criteria:
inclusion criteria: * patients with neurological diseases aged 19 to 85 years old * patients with hemiparesis lasting for more than 3 months due to neurological diseases (stroke, traumatic brain injury, brain tumor) and impaired upper limb function * patients with shoulder flexor and adductor muscle strength of mrc grade 2 or higher * patients with shoulder extensor and abductor spasticity of mas grade 1+ or lower * participants with sufficient cognitive function to understand the instructions from the researcher and the smart board, and to perform the tasks (k-mmse ≥21) exclusion criteria: * pre-existing significant neurogenic disorders * major psychiatric disorders such as schizophrenia, bipolar disorder, or dementia * history of diseases that caused pain or muscle atrophy in the affected upper limb before the onset of the neurological disease, which interfered with rehabilitation * severe spasticity of the affected upper limb (modified ashworth scale score ≥3) * skin disorders or open wounds on the affected upper limb * amputation, fractures, or soft tissue-related diseases or injuries on the affected upper limb * severe pain that interferes with rehabilitation of the affected upper limb (numeric rating scale \> 6) * inability to maintain a seated posture for more than 10 minutes, which is required for using the smart board * significant visual impairment to the extent that the screen cannot be recognized when using the smart board
blood pressure changes during moderate intensity strength training in aortic stent-graft patients

Conditions: Aortic Stent Graft

Summary: patients with an aortic stent graft are recommended to do muscle strengthening exercise as part of their rehabilitation. but, as excess blood pressure pose a risk to the integrity of the stent graft, high intensity muscle strengthening exercise may potentially be detrimental, and hence moderate intensity muscle strengthening is recommended. however, the blood pressure changes during moderate intensity strengthening exercises are unknown, and this study aims to quantify these among patients and compare them to those of healthy volunteers. purpose: the purpose of this study is to investigate the increase in blood pressure during quadriceps muscle strength training in patients with aortic stent graft. methods: patients with aortic stent graft will be included. the participants are investigated once. during the investigation, the blood pressure increase during a single strength training exercise (leg press) is measured. the strength training exercise is done at 60% of maximal strength (moderate intensity) corresponding to 15 repitition maximum (rm) (a load that can be lifted exactly 15 times).


Eligibility criteria:
inclusion criteria patients: * adults (+18y) with aortic stent graft following aortic dissection or aneurism * minimum 8 weeks post surgery * strengthening exercise approved by treating cardiologist * able to perform the exercise exclusion criteria patients: * lack of ability to read, speak or understand instructions in danish or english * other unspecified heart disease inclusion criteria healthy volunteers: * adults (+18y) * in good health (self report) exclusion criteria healthy volunteers: • lack of ability to read, speak or understand instructions in danish or english
treatment with synthetic acth in high risk patients with membranous nephropathy

Conditions: Idiopathic Membranous Nephropathy

Summary: the purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.


Eligibility criteria:
inclusion criteria: * biopsy-proven idiopathic membranous nephropathy. * nephrotic syndrome: proteinuria \> 3.5 g/day and serum albumine \< 30 g/l * normal or mildly impaired renal function (egfr \> 60 ml/min, mdrd formula) * high risk for renal failure: beta-2-microglobulin excretion \> 500 ng/min * relative contra-indication for cyclophosphamide treatment: * fertility and wish for (future) family expanding * high age ( \> 60 years) * former cyclophosphamide treatment * intolerance to cyclophosphamide exclusion criteria: * clinical,biochemical or histological signs of any underlying systemic disease * any infectious disease (including latent tuberculosis and/or latent amoebiasis) * active gastric or duodenal ulcers * pregnancy, lactation, inadequate contraceptives * clinical signs of renal vein thrombosis * asthma and /or any allergic conditions or hypersensitivity reactions * allergic reaction to synthetic acth in the past

Keywords: high risk for esrd immunosuppressive treatment membranous nephropathy acth
a study of imc-001 in subjects with relapsed or refractory extranodal nk/t cell lymphoma, nasal type

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type; Extranodal NK/T-cell Lymphoma

Summary: this is a phase 2, open-label, to investigate the efficacy and safety of imc-001 in patients with relapsed or refractory extranodal nk/t cell lymphoma, nasal type

imc-001 is a pd-l1 targeting, fully human monoclonal antibody. the purpose of this study is to determine and evaluate the efficacy and safety of imc-001. 20mg/kg every 2 weeks, iv infusion of imc-001 will be tested in subjects with relapsed or refractory extranodal nk/t cell lymphoma, nasal type.

Eligibility criteria:
inclusion criteria: 1. enktl diagnosis; * histologically confirmed diagnosed with extranodal nk/t-cell lymphoma, nasal type * at least 1 previous line of systemic therapy * documented disease progression of last therapy 2. adult age(as defined by respective country) 3. the nature of the study and voluntarily sign an icf 4. ecog 0 or1 5. adequate hematologic function, hepatic function, and renal function exclusion criteria: 1. previously treated with an anti-pd-l1 or anti-pd-1 antibody 2. known presence of symptomatic cns metastases 3. prior allogeneic hsct or solid organ transplantation 4. any active autoimmune disease or a documented history of autoimmune disease 5. apparent active or latent tb and known viral infection with hepatitis b virus or hepatitis c virus 6. pregnant or lactating

Keywords: imc-001 imc-001-201 distinkt
post-pregnancy cardio trial

Conditions: Preeclampsia

Summary: preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. this study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. a comparison between these two methods, where appropriate, is also envisaged.


Eligibility criteria:
inclusion criteria: * postpartal window: 0.5 - 20 years * cases: diagnosis of preeclampsia during the index pregnancy * controls: age and bmi matched exclusion criteria: * metal implants * kidney insufficiency (gfr \< 30 ml/min/) * claustrophobia * contrast medium allergy * current pregnancy/ lactation * chronic hypertension (\> 140/90) * diagnosis of previous cardiovascular disease * body weight over 120 kg * big tattoos in thorax area

Keywords: magnetic resonance imaging myocard preeclampsia
effect of soy protein and colorado diet on weight loss and maintenance

Conditions: Overweight; Obesity; Weight Loss

Summary: dietary protein is a key element of most effective weight loss regimens. this study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the colorado diet.

this is a randomized study comparing the efficacy of inducing weight loss of two treatment arms all based on the colorado diet. subjects will be randomly assigned to one of two study arms and instructed to follow the colorado diet by participating in weekly state of slim group classes. subjects will be followed in the study for one year. the colorado diet consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16). the maintenance phase lasts from months 5 - 12. body weight will be monitored at each study visit and body composition will be determined using dxa. blood lipid and lipoprotein concentrations, health \& wellness questionnaires, and fitness measures will also be assessed throughout the study.

Eligibility criteria:
inclusion criteria: * bmi between 27-40 * weight stable (have not lost or gained more than 10 pounds in the last 3 months) * generally healthy * able to exercise 70 minutes per day at moderate intensity * willing and able to participate in a state of slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period. exclusion criteria: * pregnant or trying to become pregnant. * diagnosis of type 1 or type 2 diabetes * individuals following a vegetarian only diet * food allergies (to soy, dairy, wheat/gluten, or peanut) * taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or otc weight loss agents, statins, fibrates, niacin, etc). oral contraceptives can be used as long as subject agrees to not change use of these during the study. * known renal disease * clinical hypothyroidism * current alcohol or drug abuse or dependence (subjects who have quit smoking in the last 6 months will be excluded. smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included). * any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable * ldl cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.

Keywords: soy obesity weight loss muscle cardiovascular disease colorado diet