Kornimate/medical-research-clean huggingface dataset:
effect evaluation of the work rehabilitation effort "best ilag"

Conditions: Musculoskeletal Pain; Work Related Illnesses; Burnout, Professional

Summary: the study compares the effect of a group-based activity with an individual work-out activity on work participation.

the study is an rct comparing the effect of a group-based intervention with an individual work-out intervention on work participation. the target group is persons who are at risk of leaving the work force due to health issues, and people currently outside the work force. the interventions have a time-span of 3 months. survey data will be collected at baseline, after three months (after intervention has ended), and after 15 months. survey data include information on lifestyle, self-reported health, subjective health complaints and readiness for work. register data on employment and welfare benefits will be collected from two years in advance of inclusion, and five years after inclusion. according to power calculations, the study will need 322 participants. in addition to the effect evaluation, a process evaluation will also be performed. the process evaluation will examine content quality and adherence to guidelines, as well as feasibility of the group intervention. the process evaluation will consist of some survey data as well as interviews with service providers and participants.

Eligibility criteria:
inclusion criteria: * desire to work * understand norwegian sufficiently to complete surveys exclusion criteria: * not able to participate in the interventions due to personal or health-related constraints.

Keywords: return to work work rehabilitation sick-leave
antineoplaston therapy in treating patients with stage iv non-small cell lung cancer

Conditions: Stage IV Non-small Cell Lung Cancer

Summary: current therapies for stage iv non-small cell lung cancer provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of stage iv lung cancer purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with stage iv lung cancer.

stage iv non-small cell lung cancers receive antineoplaston a10 and as2-1 capsules orally six to seven times a day. treatment continues in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with stage iv non-small cell lung cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with stage iv non-small cell lung cancer. * to determine objective response, tumor size is measured utilizing mri scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iv non-small cell lung cancer that cannot be cured with existing therapeutic regimens * measurable disease by ct scan or mri * tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas patient characteristics: age: * 18 and over performance status * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc at least 2,000/mm\^3 * platelet count at least 50,000/mm\^3 hepatic: * no hepatic insufficiency * bilirubin no greater than 2.5 mg/dl * sgot and sgpt no greater than 5 times upper limit of normal renal: * no renal insufficiency * creatinine no greater than 2.5 mg/dl cardiovascular: * no chronic heart failure * no uncontrolled hypertension pulmonary: * no serious lung disease (e.g., severe chronic obstructive pulmonary disease) other: * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * no other serious medical or psychiatric conditions * no active infection * no serious malabsorption syndromes prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy and recovered chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy (less than 8 weeks if multiple tumors are involved) and recovered surgery: * no prior extensive stomach or intestinal surgery * recovered from any prior surgery other: * prior cytodifferentiating agents allowed * no prior antineoplaston treatment * no other concurrent treatment for metastatic lung cancer

Keywords: recurrent non-small cell lung cancer
pharmacokinetic, efficacy, and safety study of recombinant factor viii single chain (rviii-singlechain) in children with severe hemophilia a

Conditions: Congenital Hemophilia A

Summary: this is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (pk) profile of rviii-singlechain in pediatric patients with severe hemophilia a. a minimum of 25 previously treated subjects ≥ 6 to \ 50 exposure days (eds) with a previous factor viii (fviii) product are planned to be enrolled. subjects will be assigned to either an on-demand or prophylaxis treatment regimen and will receive rviii-singlechain at a dose to be determined by the investigator. hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.


Eligibility criteria:
inclusion criteria: * diagnosis of severe hemophilia a defined as \< 1% factor viii (fviii) concentration (fviii:c) documented in medical records, * males \< 12 years of age, * subjects who have received \> 50 eds with a fviii product, * prior pk data (at least incremental recovery and half-life) from previous fviii exposure for subjects participating in the pk part * investigator believes that the subject is willing and able to adhere to all protocol requirements. investigator believes that the subject's parent(s) or legally acceptable representative(s) is / are willing and able to adhere to all protocol requirements. exclusion criteria: * any history of or current fviii inhibitors * use of an investigational medical product (imp) within 30 days prior to the first rviii-singlechain administration, * administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rviii-singlechain, * known hypersensitivity (allergic reaction or anaphylaxis) to any fviii product or hamster protein, * subject currently receiving iv immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment, * subject with serum aspartate aminotransferase (ast) or serum alanine aminotransferase (alt) values \>5 times (x) the upper limit of normal (uln) at screening, * subjects with serum creatinine values \>2 x uln at screening, * evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months before day 1, * experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months before rviii-singlechain administration.
preventability of infections in residents of french nursing homes

Conditions: Infection Control

Summary: study hypothesis : an infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes. study design : the proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.


Eligibility criteria:
inclusion criteria: * nursing homes which contain a medical coordinator and at least one nurse and/or nursing auxiliary. * nursing homes located in france (north-west) * all the residents present or entering the facility during the study period exclusion criteria: * nursing homes where a prevention program has already been implemented

Keywords: infection control urinary tract infections respiratory tract infections
therapy adherence of apap therapy initiation in sleep-lab versus at home

Conditions: Patient Compliance

Summary: primary hypothesis: the objective compliance ( # of hours per night of apap therapy) is higher in patients who get the apap treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions. secondary hypothesis: based on the higher support at the home apap initiation the following parameters will be better in comparison to the standard supply in laboratory: objective measures: * mask leakage * pressure * apnea-hypopnea-index (ahi) subjective measures: * quality of life * sleepiness


Eligibility criteria:
inclusion criteria: * written informed consent from patients after verbally and written informing * age between 18 and 80 years * obstructive sleep apnea syndrome (osas) with an ahi \> 15/h and without previous therapy exclusion criteria: * intolerance to wear the pap therapy mask * sleep breathing disorders (sbd) with central apneas \> 20% and other sleep disorders * disabilities who prevents the wear of a therapy mask * initiated pap therapy * pre-treatment of osas incl. uppp (uvulo palato pharyngo plasty) * modified mallampati score t3 and t4 * participation on clinical studies 4 weeks before start of the study * known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study. * chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease) * acute internistic disease * neuromuscular disease * condition after apoplexy * oncological disease in recent 5 years * drug/alcohol consumption * consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle
study of prognostic factors in adult lymphoblastic lymphoma

Conditions: Lymphoblastic Lymphoma

Summary: retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (ipi, ecog, early response to chemotherapy, overall response to chemotherapy), biological (strain b or t, infiltration of the nervous system central \[cns\], bone marrow \[mo\], lactate dehydrogenase (ldh) level at the time of diagnosis, as well as genetic patients included in the study, as well as the pethema protocol used in the treatment of same patients the study will review the pethema protocols from 2003 to the present

retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (ipi, ecog, early response to chemotherapy, overall response to chemotherapy), biological (strain b or t, infiltration of the nervous system central \[cns\], bone marrow \[mo\], lactate dehydrogenase (ldh) level at the time of diagnosis, as well as genetic patients included in the study, as well as the pethema protocol used in the treatment of same patients the study will review the pethema protocols from 2003 to the present. analysis of the main clinical-biological variables as independent risk factors in adult patients (\> 15 years) diagnosed with all

Eligibility criteria:
inclusion criteria: patients \>15 years old diagnosed with all and treated with the pethema protocols for all exclusion criteria: none
reducing 30-day readmissions in patients with heart failure through pharmacist discharge medication services

Conditions: Heart Failure; Patient Readmission

Summary: patients admitted for heart failure that are provided discharge medication services by a pharmacist are less likely to be readmitted within 30 days of primary admission.


Eligibility criteria:
inclusion criteria: * diagnosis of heart failure, discharged from any medical service exclusion criteria: * unwilling to participate, discharged to nursing/rehab facility, non-english speaking, resident unavailable
dose escalation/de-escalation study of pre-operative stereotactic radiosurgery for brain metastases(rad 1002)

Conditions: Brain Metastases

Summary: this study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. the investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.

this study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (srs) in the treatment of brain metastases. patients will be placed in one of two dose groups based on index tumor size, and dose will be adjusted according to presence or absence of dose limiting toxicity (dlt). group a: index tumor \> 2 cm and up to 4 cm in maximum diameter group b: index tumor \> 4 cm and up to 6 cm in maximum diameter dose escalation or de-escalation will be conducted via a modified 3+3 method at the following levels. group a will start at dose level ii. group b will start at dose level i. dose level i: 12 gy dose level ii: 15 gy

Eligibility criteria:
inclusion criteria: * all subjects must have history of histologically confirmed malignancy. brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician. * newly diagnosed brain metastases (four or fewer by post-contrast mri obtained within six weeks of study entry) * at least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon. * karnofsky performance status (kps) of greater than or equal to 60 * age greater than 19 * life expectancy greater than 12 weeks * subjects given written informed consent exclusion criteria: * patients with small cell lung cancer and lymphoma are ineligible. * more than four metastases by baseline post-contrast mri * prior whole brain radiation therapy * insufficient recovery from all active toxicities of prior therapies * subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities * pregnant or nursing women * women of childbearing potential who are not using an effective method of contraception are excluded. women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of srs.

Keywords: brain metastases
long-limb or distal gastric bypass for superobesity - randomized study

Conditions: Obesity

Summary: the main study objective: to evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (bmi 50-60 kg/m2). the main study hypothesis: distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.

technical data will later be published in detail

Eligibility criteria:
inclusion criteria: * bmi 50 - 60 kg/m2 at admission for evaluation for bariatric surgery * bmi 48 - 62 kg/m2 at study inclusion * informed consent * scheduled for bariatric surgery exclusion criteria: * previous bariatric surgery * previous major abdominal surgery * previous history or established urolithiasis * viral hepatitis, liver cirrhosis of any kind * factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)

Keywords: obesity laparoscopy bariatric super obesity
mt2013-37r: voriconazole monitoring in pediatric stem cell transplant patients

Conditions: Fungal Infection

Summary: the primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. an optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.


Eligibility criteria:
inclusion criteria: * any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent) * age ≤ 21 years * adequate organ function within 14 days of enrollment, i.e. creatinine: \< 1.5 x uln and hepatic: alt, ast and total bilirubin \< 3 x uln * requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation exclusion criteria: * has received voriconazole within 5 days prior to starting study therapy * history of hypersensitivity or severe intolerance to azoles * history, or current evidence, of cardiac arrhythmias defined as qtc ≥ 480 mm/sec * receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids. * received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates. * received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism * receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure

Keywords: stem cell transplant hematopoietic stem cell transplant fungal infection voriconazole pediatric
registry of acute stroke under new oral anticoagulants -pilot (rasunoa-pilot)

Conditions: Ischemic Stroke; Intracranial Hemorrhage

Summary: the registry of acute stroke under new oral anticoagulants (rasunoa) is a german multicenter, prospective, observational registry performed at about 50 study centers covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per year. study enrollment will be consecutive. the rasunoa registry study center is the university medical center of the principal investigator (heidelberg, germany). the registry will focus on treatment decisions and concepts in patients being under treatment with a new oral anticoagulant and suffering from acute ischemic or hemorrhagic stroke.

the main purpose of the study is to collect information from a large, prospectively enrolling multicentre stroke database regarding the optimal management of ischemic and hemorrhagic stroke during anticoagulation with noac. specifically, we aim to obtain critical information regarding the epidemiology, natural history, laboratory and neuroradiological aspects, clinical consequences, and the effects of treatment (i.e. thrombolysis/interventional recanalisation in ischemic stroke and hemostatic therapy in ich, respectively) in stroke during noac. the registry is not limited to a specific new oac but intends to examine stroke during use of any of the approved noac. the study is not designed to perform comparisons among the different noac.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * informed consent * acute stroke or intracranial bleeding * therapy with a new oral anticoagulant (dabigatran®, rivaroxaban®, apixaban®, edoxaban®) exclusion criteria: * missing informed consent

Keywords: oral anticoagulants ischemic stroke blood thinner intracranial hemorrhage
phase i, placebo-controlled, blinded pilot study of ipratropium in children admitted to the icu with status asthmaticus

Conditions: Status Asthmaticus

Summary: this study is a phase i study to investigate the addition of inhaled ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the pediatric intensive care unit. half of the subjects will receive inhaled ipratropium, and half will receive an inhaled placebo.

status asthmaticus is an acute exacerbation of asthma that often requires treatment in a pediatric intensive care unit (picu). standard therapies for status asthmaticus include corticosteroids and bronchodilators, typically albuterol. ipratropium bromide is also a bronchodilator, but has a different mechanism of action than albuterol. the addition of ipraropium to children in the emergency room with severe asthma exacerbations improves outcomes, so many picu doctors treat patients with status asthmaticus with ipratropium. however, two studies of children hospitalized in the general wards of the hospital (not the picu) show that the addition of ipratropium to standard care does not effect clinical outcomes. this study is a first step towards determining in ipratropium is helpful in picu patients (like it is in er patients) or if it not helpful (like it is in general ward patients).

Eligibility criteria:
inclusion criteria: * admission to the picu * treatment with continuous albuterol via the asthma carepath * enrollment occurred within 4 hours of starting continuous albuterol in the picu * treatment with systemic corticosteroids by the clinical team exclusion criteria: * first episode of wheezing that prompted treatment with bronchodilators by medical personnel * prior enrollment in this study * patients with chronic lung disease requiring routine home oxygen use * allergy to inhaled ipratropium or inhaled saline * positive pressure ventilation (via an endotracheal tube or a non-invasive mask \[e.g. cpap (continuous positive airway pressure) or bipap\]) * pregnancy * tracheostomy * age \< 2 years * age \> 17 years * patient with pulmonary hypertension requiring daily therapy * patient with cyanotic congenital heart disease * cystic fibrosis
sleep and depression in induction of labour

Conditions: Prolonged Pregnancy; Sleep Disturbance; Depression

Summary: randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. the investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.

participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. participants are randomised to two groups: one hundred are randomised to the inpatient and one hundred to the outpatient group. the main outcome measure is the pain evaluated by vas at one, five , nine and 13 hours after the placement of double balloon induction catheter. the investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour. the total hospital stay and induction to delivery interval time is measured. also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.

Eligibility criteria:
inclusion criteria: * uncomplicated pregnancy * singleton pregnancy * pregnancy weeks ≥ 37 - ≤ 41+5 * the patient is living in1/2 hour away from hospital exclusion criteria: * patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis * the patient has medical treatment of diabetes * baby is not growing normally * multiple pregnancy * preterm rupture of membranes * earlier caesarean section * the patient is living more than 1/2 hour away from hospital

Keywords: induction of labor double balloon catheter mechanical ripening