Kornimate/medical-research-clean huggingface dataset:
study of r-acvbp regimen supported by pegfilgrastim in high-risk diffuse large b-cell lymphoma

Conditions: Untreated CD20-positive Large B-cell Lymphoma

Summary: evaluation of the efficacy of a single injection of pegfilgrastim (6mg) administered at day 3 of each cycle of r-acvbp regimen during 4 cycles in patients with cd20+ diffuse large b-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (aa-ipi).

this is a phase ii, multicentric, open-label, non-randomized study, evaluating the efficacy of a single injection of pegfilgrastim (6mg) administered at day 3 of each cycle of r-acvbp regimen during 4 cycles in patients aged 18 to 60 years with previously untreated cd20+ diffuse large b-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (aa-ipi), and eligible for transplant. it is anticipated that 60 subjects will be enrolled over 2 years (from 2004 to 2006), in a group sequential manner one planned interim analysis. the duration of the treatment period is approximately 26 weeks and patients are followed until death. the total duration of the study is expected to be 2.5 years.

Eligibility criteria:
inclusion criteria: * patient with histologically proven cd20+ diffuse large b cell lymphoma (who classification). * age \>18 and \< 61 years, eligible for transplant. * patient not previously treated. * with at least two prognostic factors of the aa-ipi. * with a minimum life expectancy of 3 months. * creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma. * neutrophils \> 1.5 g/l and platelets \> 100 g/l, unless if patient has a bone marrow infiltration. * negative hiv, hbv and hcv serologies 4 weeks (except after vaccination). * having previously signed a written informed consent. exclusion criteria: * any other histological type of lymphoma. * any history of treated or non-treated indolent lymphoma. * central nervous system or meningeal involvement by lymphoma. * contra-indication to any drug contained in the chemotherapy regimens. * any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * any serious active disease (according to the investigator's decision). * treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception. * adult patient under tutelage.

Keywords: diffuse large b cell lymphoma pegfilgrastim autotransplant
immune response in lung cancer

Conditions: Lung Cancer

Summary: this study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (nsclc) patients.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) score of 0-1 * patients with histologically documented non-small cell lung cancer * control group - patients without non-small cell lung cancer * written (signed) informed consent to participate in the study exclusion criteria: * any other malignancies within 5 years * any unstable systemic disease (including active infections, significant cardiovascular disease) * prior chemotherapy or radiotherapy * autoimmune disease * nursing or pregnant women

Keywords: immune response cancer
duration of continuous positive airway pressure and pulmonary function testing in preterm infants

Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Summary: the primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (cpap), and then randomized to two additional weeks of cpap and room air versus room air alone. we hypothesize that infants randomized to additional cpap will demonstrate an increased functional residual capacity (at the end of the two week study period and prior to discharge) compared to those randomized to room air.


Eligibility criteria:
inclusion criteria: * gestational age at birth \<33 weeks * required cpap for a minimum of 24 hours for respiratory distress * patient on cpap and room air at time of randomization exclusion criteria: * complex congenital heart disease other than patent ductus arteriosus or atrial septal defect * major malformations or chromosomal anomalies * multiple gestation greater than twins * culture proven sepsis or unstable at time of randomization

Keywords: continuous positive airway pressure prematurity respiratory distress syndrome bronchopulmonary dysplasia
asian phase ii study of inc424 in patients with primary myelofibrosis (mf), post-pv mf or post-et mf

Conditions: Primary Myelofibrosis (MF); Post-Polycythemia Vera (PV) MF; Post-Essential Thrombocythemia (ET) MF

Summary: the objective of this study was to determine the efficacy of inc424 as assessed by reduction in spleen volume in patients with primary myelofibrosis (mf), post-polycythemia vera (pv) mf, or post-essential thrombocythemia (et) mf. the safety and tolerability of inc424 and the effects of inc424 on patient reported outcomes and the duration of response as assessed by reduction in spleen volume was also assessed.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. diagnosis of primary myelofibrosis (mf), post-polycythemia vera (pv) mf, or post-essential thrombocythemia (et) mf 3. enlarged spleen, measuring 5 cm or greater from the costal margin 4. must have two or more of the following risk factors: 1. over 65 years old 2. have the following symptoms often associated with mf: loss of weight, fever, night sweats 3. have a low red blood cell count (anemia - hemoglobin \< 10 g/dl) 4. have a high white blood cell count (history of white blood cell count \> 25,000/ul) 5. have high circulating blasts (\> or = 1%) as measured by blood tests 5. should have circulating blasts \<10% (as measured by blood tests) 6. should be capable of self-care 7. should have adequate bone marrow reserve 8. should not have the option of stem cell transplantation 9. should discontinue any prior or ongoing treatment for myelofibrosis prior to entering the study 10. had no prior treatment with another jak inhibitor exclusion criteria: 1. does not have adequate liver or kidney function (as measured by blood tests) 2. has an active infection (bacterial, viral, etc.) 3. has active hepatitis a, b, or c or positive for hiv 4. has another cancer that needs active intervention 5. had a history of bleeding disorder 6. had a history of very low platelet counts (as measured by blood tests) not related to treatment of mf 7. had radiation of the spleen within 1 year of joining the study 8. does not have adequate heart function 9. sufficient time has elapsed between stopping previous treatment for mf and joining the study 10. females who are pregnant or breast-feeding 11. not able to sign informed consent 12. has any other active medical conditions that the doctor deems may compromise your safety or ability to join in the study

Keywords: primary myelofibrosis (mf) post-polycythemia vera (pv) mf post-essential thrombocythemia (et) mf post-pv mf post-et mf inc424 ruxolitinib myelofibrosis mf
surgical outcome of type ii odontoid fracture, harms technique

Conditions: Tramatic Odontoid Fracture

Summary: cervical trauma is a common cause of disability following spinal cord injury, especially in athletic populations. the biomechanics in the atlantoaxial joint carry more than 50% of the rotational movement which can be affected in transverse ligament tear associated with odontoid fracture type ii. odontoid fracture type ii considered an unstable fracture with a high rate of non-union in conservative treatment. limitation of the odontoid screws in some cases gives the chance of posterior cervical fixation to have the superior role. use of polyaxial screws in harms technique gives the best results in maintaining the majority of the biomechanics. purpose: our aim in this study to evaluate harms technique in those patients regarding pain improvement and restoration of the motor power and to report the complications. study design: a retrospective case series study. we used the frankel grading system to evaluate the postoperative neurological state.

after approval of research ethics committee, twelve patients with post-traumatic odontoid fracture type ii were scheduled in our neurosurgery department at sohag university hospital for atlantoaxial fusion using polyaxial c1 lateral mass and c2 pedicle screws between january 2015 and january 2018.

Eligibility criteria:
inclusion criteria: 1. c1-c2 displacement that needs intra-operative reduction 2. short neck not suitable for anterior odontoid screw 3. osteoporotic patients 4. odontoid fracture associated with transverse ligament tear suspected. 5. oblique line of fracture 6. failure of union after conservative treatment. exclusion criteria: * associated spinal fractures * other comorbidities
home-based tdcs for apathy in alzheimer's disease

Conditions: Alzheimer Disease and Related Dementias

Summary: the purpose of this study is to assess feasibility, acceptability, and safety of providing tdcs to alzheimer's disease and related dementias (adrd) patients with apathy and to assess the efficacy of tdcs for adrd-related symptoms, with a primary focus on apathy.


Eligibility criteria:
inclusion criteria: * diagnosis of possible or probable adrd according to the national institute of aging - alzheimer's association diagnostic criteria * mild or moderate dementia, as defined by a mmse score between 14 and 26 * clinically meaningful apathy for at least four weeks, clinically diagnosed according to 2018 apathy diagnostic criteria or defined as neuropsychiatric inventory (npi-q) apathy score equal or above 4 (i.e., severity of 'moderate' or greater and caregiver distress 'mild' or greater). * stable doses of cholinesterase inhibitors, memantine and other psychotropic medications for at least three months. exclusion criteria: * unstable medical conditions * history of epilepsy * metallic objects in the brain * diagnosis of major depression and/or a score higher than 18 on the cornell scale for depression in dementia
physical training in glioblastoma patients during cytotoxic therapy

Conditions: Glioblastoma

Summary: the aim of the present study is the prospective controlled use of physical activity in a collective of patients with glioblastoma after surgery and concomitant radiation/chemotherapy and during adjuvant cytotoxic therapy. the research question is whether physical exercise is feasible and whether patients benefit physically and mentally from the activities performed. for this purpose, specific training units under the supervision of a certified trainer and sports scientist as well as standardized sports medical test procedures are implemented. beyond the instructed training, general physical activity phases are recorded electronically using a pedometer/activity tracker, which is worn at all times. it will be examined whether the individual training program 1. improves physical fitness 2. increases quality of life/life satisfaction throughout the intervention 3. can be detected in blood due to increased concentrations of brain-derived neurotrophic factor 1 (bdnf-1) (voluntary) the measurements should be taken before and 8, 16 and 24 weeks after the start of training.

the personal trainers of the university clinics in bochum and homburg/saar receive specific training activities from münster's trainer ralf brandt in order to ensure a standardized concept. this way, a comparison of the trainings' conduction and recording is possible both quantitatively and qualitatively.

Eligibility criteria:
inclusion criteria: * newly diagnosed glioblastoma * karnofsky index ≥ 70 * eastern cooperative oncology group (ecog) ≤ 2 * ≥ 18 years * completed surgical therapy * completed radiation and chemotherapy * thrombocytes \> 50.000/µl * hb \> 8 mg/dl * ability to give consent * mother tongue german/very good german skills exclusion criteria: * diagnosed dementia (mini-mental-state-test \< 24/30 points) * pain (strong, permanent, restricting movement) * impairment of consciousness * fever * acute infection * pregnancy and lactation * insufficiently adjusted epilepsy (despite anticonvulsive therapy \> 3 focal seizures per day or \> 1 generalized seizure in the previous 3 days)

Keywords: sports glioblastoma (gbm) physical training quality of life (qol) neuro-oncology psycho-oncology fitness
comparison of the effectiveness of supervised, video-based and home-based resistance exercise program in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the aim of this study was to compare the effects of video-based application method of resistance exercise training and supervised exercise training on mobility, body composition, quality of life, fatigue, muscle strength and physical performance in patients with prostate cancer receiving androgen deprivation therapy treatment.


Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer with at least 1 year of androgen deprivation therapy treatment * 65 years of age or older * no speech and hearing problems exclusion criteria: * presence of metastatic cancer focus * carrying a pacemaker * mental and coordination problems * patients with neurological or orthopedic pathology that would prevent participation in exercise
alglucosidase alfa temporary access program

Conditions: Glycogen Storage Disease Type II (GSD-II); Pompe Disease (Late-Onset); Acid Maltase Deficiency Disease; Glycogenosis 2

Summary: pompe disease (also known as glycogen storage disease type ii) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in patients with pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. the objective of this expanded access study is to provide patients with pompe disease in the united states (us), access to alglucosidase alfa produced from a scaled up manufacturing process for a limited time until production at this scale is approved for commercial use by the food and drug administration.


Eligibility criteria:
inclusion criteria: * the patient or patient's legal guardian must provide signed, informed consent prior to performing any study-related procedures. * the patient must reside in the us. * the patient must have a confirmed diagnosis of pompe disease defined as documented acid alpha-glucosidase (gaa) enzyme deficiency from any tissue source and/or gaa gene mutations. * the patient must have/had documented clinical signs and symptoms of pompe disease. * the patient must have/had prior treatment with alglucosidase alfa produced at commercial scale or be naive to enzyme replacement therapy (ert) for the treatment of pompe disease and meet at least 1 of the following criteria: require a wheelchair or require some respiratory assistance for any number of hours (including night time) through non-invasive ventilation. * the patient must be capable of complying with the required program schedule of assessments. exclusion criteria: * females who are pregnant or lactating * the patient has a clinical condition unrelated to pompe disease that would interfere with program assessments. * the patient is currently enrolled in any clinical studies.

Keywords: gsd-ii, pompe disease, glycogen storage disease ii
effect of mbct applied to asthma patients on anxiety, depressıon and dyspnea

Conditions: Asthma; Mindfulness

Summary: in this study, short-term mbct will be applied to asthmatic patients receiving hospital treatment and its effects on anxiety, depression and dyspnea will be determined. a quasi-experimental study was planned for this purpose.

in the study, cognitive behavioral therapy will be applied to the intervention group, which is determined as the experimental group, and a group of asthma patients who did not receive any application during the same periods will be included and the dyspnea, anxiety and depression levels of the patients in these two groups will be compared.

Eligibility criteria:
inclusion criteria: over 18 years old, inpatient treatment in the chest ward volunteer participants with no communication problems exclusion criteria: under 18 years old, with communication problems, not willing to participate hospitalized with diseases other than asthma

Keywords: asthma mindfulness-based cognitive therapy anxiety depression dyspnea
prevalence and subjective impairment of quality of life (qol) due to dermatologic diseases in internal medicine patients

Conditions: Dermatologic Disease of Inpatients in Internal Medicine

Summary: this is a 3 months single centre clinical patient-oriented study to evaluate the prevalence and impairment in qol of dermatologic diseases in patients hospitalised in internal medicine. up to 200 patients hospitalised at the division of internal medicine for any reason are going to be offered participation by a patient information form given to patients at the time of admission, as well as oral information about the study. written informed consent will be obtained by the investigators after patients have had adequate time to consider their participation in the study. participating patients will be examined clinically for dermatologic pathologies at a single visit. in the case of signs of dermatologic disease, investigators are going to recommend further diagnostic procedures to the physician in charge and/or the referring physician, depending on the urgency of the suspected diagnosis. this procedure is meant to avoid giving referring physicians the impression that active patient acquisition for the department of dermatology is an aim of this study. diagnostic procedures that are performed upon suspicion of a specific dermatologic disease at the division of internal medicine are going to be performed during the hospitalisation period. all other diagnostic or operative procedures are going to be advised to the referring physician. study participants are going to be interviewed by the investigators about impairment in qol of their illnesses. two separate questionnaires are going to be filled in by each participant. for measurement of general qol, the widely used sf-12 questionnaire (8 questions) is going to be used. to measure specific impairment in qol by dermatologic disease, participants are going to be asked to fill in the dlqi (dermatology life quality index, 10 questions). photographic documentation of specific identified lesions will be made and pictures stored exclusively in the secured electronic patient file (kisim). medication and all identified diseases will be noted. all diagnostically useful information is going to be recorded in the patient file and transmitted to the referring physician in the discharge letter.


Eligibility criteria:
inclusion criteria: patients will be eligible for enrolment if they fulfil the following criteria: 1. male or female patients, age ? 18 years of age and 2. hospitalised at the division of internal medicine, university hospital zurich 3. patients must be able to give written informed consent before any trial-specific procedures are performed (see section 12.2). exclusion criteria: patients will be excluded from the study if they fulfill any of the following criteria: 1. ability to communicate orally severely impaired due to any reason, namely illness or inability to speak german. 2. terminal patients or other patients where participation in a visit with oral and physical examination would represent an unreasonable exertion. 3. pregnant women
the effect of early screening and intervention for gestational diabetes mellitus on pregnancy outcomes

Conditions: Pregnancy Complications; Gestational Diabetes Mellitus in Pregnancy

Summary: context: women with gestational diabetes have excessive fetus growth weeks earlier than the screening period recommended currently, suggesting that earlier screening and intervention may improve pregnancy outcomes and the health of the offspring. objective: to determine if early screening and intervention could alter pregnancy outcomes, the incidence of maternal diabetes after delivery, and growth and development of the offspring, compared to the standard group. design, setting, participants: we will conduct a multi-center open-label randomized controlled trial in 2068 pregnant women, who deliver a singleton and who have not been diagnosed with overt diabetes mellitus at national taiwan university hospital (ntuh) and ntuh hsinchu branch from 2018 to 2020. interventions: gestational diabetes mellitus (gdm) is diagnosed by a 75g 2-hour ogtt at 18-20 weeks of ga for the early-screening group and at 24-28 weeks for the standard-screening group. the diagnostic cutoffs are according to the iadpsg criteria. gdm is diagnosed if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during ogtt is above 92 mg/dl, 180 mg/dl, or 153 mg/dl respectively. subjects who are diagnosed with gdm receive lifestyle intervention and self-monitoring of blood glucose. pharmacological therapies are given when the target of glycemic control is not achieved within 4-6 weeks. main outcome measure: the primary outcome is a composite measure of pregnancy outcomes, including primary cs, birth weight \>90th percentile, neonatal hypoglycemia, cord serum c-peptide \>90th percentile, pregnancy-induced hypertension, preeclampsia, and birth trauma. the primary outcome is measured within the entire period of perinatal and neonatal intensive-care units (nicu) stay for infants and the entire period of gestation for pregnant women after randomization. conclusion: this study will test our hypothesis that early screening and intervention of gdm improves pregnancy outcomes as compared to standard practice.


Eligibility criteria:
inclusion criteria: 1. age ≥ 20 years old 2. first prenatal visit before 14 weeks of ga 3. deliver a singleton at medical centers, including national taiwan university hospital (ntuh), and ntuh, hsinchu branch. exclusion criteria: 1. diagnosed with preexisting diabetes 2. twin or multiple births pregnancy 3. current exposure to steroids 4. cannot tolerate an ogtt

Keywords: early screening early intervention gestational diabetes mellitus pregnancy outcomes randomized controlled trial
a randomized clinical trial of oral health promotion interventions among patients after stroke

Conditions: Acute Stroke

Summary: the main aim of this oral health intervention project is to compare the effect of providing 1) professional oral hygiene instruction alone versus 2) professional oral hygiene instruction plus adjunctive chlorhexidine mouth rinse versus 3) professional oral hygiene instruction plus adjunctive assisted tooth brushing and chlorhexidine mouth rinse, on the oral health condition, the general health condition and health-related quality of life (hrqol) of patients with stroke who are receiving hospital-based rehabilitation. an additional aim is to assess potential longer term oral intervention-related health and hrqol outcomes.


Eligibility criteria:
inclusion criteria: * aged 50 years and over * moderate to severe stroke (barthel index \>/= 70) * admitted to rehabilitation unit within 7 days exclusion criteria: * patients with naso-gastric feeding tube * edentulous patients * patients with communication difficulties

Keywords: oral health oral hygiene bacteria quality of life clinical oral health in patients following acute stroke oral opportunistic pathogens in patients following acute stroke oral health-related quality of life in patients following acute stroke