Kornimate/medical-research-clean huggingface dataset:
the neuromarker s-100b in patients with different types of intracranial injury

Conditions: Traumatic Brain Injury; Trauma

Summary: abstract: the most widely studied neuro-markers in traumatic brain injury (tbi) are s100b and neurone specific enolase (nse). s-100b is localized in astroglia. this marker is used to predict neuronal damage caused by traumatic brain injury. the investigators conduct a study to derive and validate the measurement of s-100b in serum of patients with different types traumatic brain injuries.

the neuromarker s-100b is a well established tool for decision making in patients traumatic brain injury (tbi)in europe. in many hospitals s-100b is used routinely as a part of a set of high- and medium risk factors aiding the decision to perform a cranial computed tomography (cct) in patients with minor head injury (mhi). in patients with severe head injury raabe et al. found a significant correlation between the s-100b levels and unfavourable outcome in patients with severe brain injury with serum levels higher than 0.50 μg/l measured 24h after injury. the average level of the neuromarker, compared with other studies. the study of biberthaler et al. showed highest levels in patients with epidural hematomas, followed by subdural, subarachnoidal and intracerebral hematomas. on the contrary the average s-100b levels of patients with epidural hematomas featured in a study by unden et al. published in 2005 displayed normal levels (\<0.2 μg/l). they concluded that s-100b was unreliable as a marker for epidural hematomas. aim of the study validation of s-100b in patients with intracerebral, epidural, subdural, and subarachnoidal hematoma, brain edema and concussion (group 1-6), to find evidence which kind of injury leads to which level of elevation of the neuromarker measured in peripheral blood.

Eligibility criteria:
inclusion criteria: * all patients with traumatic brain injury exclusion criteria: * patients without traumatic brain injury

Keywords: cct brain trauma injury
safety and efficacy of lyrica (regulatory post marketing commitment plan)

Conditions: Neuralgia

Summary: the objective of this investigation is to evaluate the safety and efficacy of lyrica in medical practice. also, occurrence of unknown and known adverse drug reactions (adrs) in subjects treated with lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

all the patients whom an investigator prescribes the first lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * patients need to be administered lyrica® in order to be enrolled in the surveillance. exclusion criteria: * patients not administered lyrica®.

Keywords: lyrica regulatory post marketing commitment plan safety neuropathic pain post marketing surveillance
nocturnal ptcco2 monitoring in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a neurodegenerative disease affecting motoneurons, with a prevalence around 5/100.000. respiratory muscle involvement is a major feature in als and remains the main prognostic factor. timing and rate of progression of this respiratory muscle involvement is also highly variable among individuals. respiratory manifestations justify a careful follow up including clinical evaluation, pulmonary function tests and blood gases. prognostic value of respiratory muscle assessment has been clearly demonstrated in als, although several cut off values have been published. the clinical benefit of non invasive ventilation (niv) is well established in als, but the optimal criteria for its initiation remain debated . the 1999 consensus for niv selected classical criteria to consider niv in patients with respiratory symptoms suggesting hypoventilation: daytime hypercapnia (paco2 \> 45 mmhg), nocturnal sao2 \< 89 % more than 5 consecutive minutes and for progressive neuromuscular disorders (nmd) (mainly als), a vital capacity (vc) \< 50 % pred or a pimax \< 60 cmh2o. besides daytime clinical and pft assessment, nocturnal evaluation is essential in als. the prevalence of sleep apnea ranges from 16 % to 76 %. transcutaneous pco2 (tcpco2) is an attractive technique to evaluate non invasively nocturnal hypoventilation. the technique is well validated in different settings. its use in neuromuscular disorders (nmd) is recent. in particular one study has demonstrated a high predictive value of tcpco2 for the development of daytime hypoventilation within 1 year. to our knowledge, this technique has not been specifically assessed in als. there is a potential role for nocturnal ptcco2 monitoring in the close follow up of als patients. indeed, a close respiratory follow up of als patients is essential to determine the optimal timing of niv, avoiding the occurence of unexpected acute respiratory failure.


Eligibility criteria:
inclusion criteria: * amyotrophic lateral sclerosis :definite, probable or probable with emg (airlie house criteria, 1998). * forced vital capacity \>70% pred. * daytime paco2 \<43 mmhg. * venous hco3- \<28 mmol/l exclusion criteria: * patients unable to perform pulmonary function tests or nocturnal recordings. * coexisting significant lung disease: moderate to severe asthma or copd * current niv, cpap or oxygen therapy.
relationship between biological phenotype, clinical severity of sickle cell disease, and blood coagulation

Conditions: Sickle Cell Disease (SCD)

Summary: sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. in addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. the investigators hypothesized that patients with sickle cell disease and severe hemolysis (lactate dehydrogenase level \&gt; 484 iu/l) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.


Eligibility criteria:
inclusion criteria: * aged 8 years or older * under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes s/s, s/beta0, or s/c * patient covered by a social security or equivalent health insurance plan * collection of the non-opposition for adults * information of the minor and collection of the non-opposition from both parents exclusion criteria: * patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion * patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator\&#39;s discretion) * patient under guardianship, curatorship, or legal protection * patient subject to a legal protection measure * person admitted to a health or social care institution for purposes other than research

Keywords: hemolysis coagulation red blood cell sickle cell disease
a 47 hour occlusive cutaneous skin patch test on adult subjects with dry/atopic skin

Conditions: Eczema

Summary: this is an open label, non-comparative investigation to determine the tolerance of eczema repair emollient on healthy subjects with dry/atopic and very dry/atopic skin. the eczema repair emollient will be applied for 47 hours under occlusion. skin tolerance will be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.

at immediate, 1, 24, 48, and 72 hours post-test patch removal (date \& time of each assessment will be recorded), each test site will be scored for erythema and oedema by the trained investigator using the iso 10993 scoring system. primary endpoint the irritation of the test product according to the cutaneous irritancy index value. the test product should be graded as 'non-irritant' and confirmed by the study dermatologist.

Eligibility criteria:
inclusion criteria: * subjects who are able to give written informed consent and from whom written informed consent has been obtained * generally healthy male and female subjects between the ages of 18 and 65 years inclusive * subjects assessed by the dermatologist as having dry/atopic and very dry/ atopic skin * subjects who are able to understand the study, co-operate with the study procedures and are able to attend for all study assessments exclusion criteria: * subjects with active psoriasis or other active skin disorders or with present skin tumours or malignant disease or a history of those * subjects taking antihistamine or corticoids, any medication for the treatment of diabetes mellitus, immuno-suppressive drugs or any other medication which in the opinion of the dermatologist may affect the test results. * subjects with active skin disorders or a history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the trainee dermatologist or sit personnel may affect the test results
ancillary study gog 158: survival analysis based on reclassification to a two-tier grading system

Conditions: Ovarian Cancer

Summary: primary objective: * to reclassify the histologic grade of the serous ovarian cancer specimens of patients enrolled on gynecologic oncology group (gog) protocol 158 using a two-tier system. secondary objective: * to determine the overall and progression-free survival of patients with serous carcinoma of the ovary treated on gog protocol 158 when reclassified according to tumor grade (low vs. high). tertiary objective: * to correlate histologic grade with other prognostic factors.

the purpose of this study is to describe the progression-free and overall survival of patients treated on gog protocol 158 when their tumors are reclassified into a two-tier grading system. although no universal grading system exists, malpica et al. have recently published data on a clinically meaningful two-tier grading system for serous ovarian carcinoma (malpica et al., american journal of surgical pathology, 2004). tumor grade has been shown to be an important prognostic factor in women with epithelial ovarian cancer, especially in early stage carcinomas. while there is less consensus regarding the prognostic significance of grade in late stage tumors, researchers have noted that patients with low-grade advanced disease may have a longer survival than those with high-grade lesions (bodurka-bevers et al., gynecologic oncology, 2000).

Eligibility criteria:
inclusion criteria: * all patients enrolled on gog protocol 158 with a diagnosis of serous carcinoma of the ovary. exclusion criteria: * none

Keywords: advanced stage serous carcinoma of the ovary serous ovarian carcinoma ovary gog protocol 158 survival analysis pathology slides two-tier grading system ancillary study
study of an fda-approved drug as additional therapy in patients with schizophrenia

Conditions: Schizophrenia

Summary: this is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an fda-approved drug or placebo in addition to the current treatment. safety will be closely monitored through vital signs, various tests, and blood and urine samples.


Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia. * exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening. * continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months and must be on a stable dose for at least 1 month prior to entering the study. * participant or a legal guardian is able to understand and sign the consent form. exclusion criteria: * panss (positive and negative syndrome score) total score increases or decreases by more than 20% between the screening and baseline visits. * predominant axis i disorder other than schizophrenia within 6 months prior to screening. * history of clinically significant or unstable medical disorder or treatment that would interfere with the study. * history of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child), or those who have suffered a traumatic head injury. * taking psychotropic or primarily centrally active medication at screening. * use of antidepressant medications or mood stabilizers within 1 month of screening.

Keywords: adjunctive atypical antipsychotics add-on schizophrenia psychosis
natalizumab high titer immunogenicity and safety

Conditions: Multiple Sclerosis

Summary: the primary objective of the study was to evaluate the immunogenicity of natalizumab (tysabri®) produced by a modified manufacturing process (natalizumab high titer; bg00002-e) administered intravenously (iv) to participants with relapsing forms of multiple sclerosis (ms). the secondary objective of this study was to evaluate the safety of natalizumab high titer.


Eligibility criteria:
inclusion criteria: * diagnosis of a relapsing form of ms * must fall within the therapeutic indications stated in the locally approved label for natalizumab * other protocol-defined inclusion criteria may apply exclusion criteria: * prior treatment with natalizumab * considered by investigator to be immunocompromised * other protocol-defined exclusion criteria may apply

Keywords: natalizumab tysabri multiple sclerosis relapsing forms of multiple sclerosis
palliative care in improving quality of life and symptoms in patients with stage iii-iv pancreatic or ovarian cancer

Conditions: Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Ovarian Germ Cell Tumor; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Ovarian Germ Cell Tumor; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Ovarian Germ Cell Tumor; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IV Pancreatic Cancer

Summary: this randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage iii-iv pancreatic or ovarian cancer. palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.

primary objectives: i. test the effects of a concurrent palliative care planning intervention (pcpi) on overall quality of life (qol) and symptom burden. ii. test the effects of a concurrent pcpi on anxiety and depression. iii. test the effects of a concurrent pcpi on overall survival. iv. test the effects of a concurrent pcpi on health care resource use. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions. arm ii: patients receive standard care plus attention comprising two telephone contacts. after completion of study, patients are followed up at 1, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of pancreatic or ovarian cancer * confirmed stage iii or iv disease * patients who are within one year from initial diagnosis * able to read or understand english-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations * ability to read and/or understand the study protocol requirements, and provide written informed consent
sequential compression device (scd) for stabilizing hemodynamics in the beach chair position

Conditions: Hypotension

Summary: this study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (scd) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to ted stockings or a control group without any stockings.

this study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (scd) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to ted stockings or a control group without any stockings.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective shoulder surgery exclusion criteria: * untreated hypertension * no pulse in a. dorsalis pedis or a.tibialis posterior * leg ulcers * failed scalenous blockade
bibw 2992 (afatinib) vs gemcitabine-cisplatin in 1st line non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Summary: to investigate the efficacy and safety of bibw 2992 compared to standard first-line chemotherapy in patients with stage iiib or iv adenocarcinoma of the lung harbouring an egfr activating mutation


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed diagnosis of stage iiib or stage iv adenocarcinoma of the lung 2. egfr(epidermal growth factor receptor) mutation detected by central laboratory analysis of tumor biopsy material 3. measurable disease according to response evaluation criteria in solid tumours (recist)1.1 4. eastern cooperative oncology group (ecog) score of 0 or 1. 5. age\>=18 years 6. life expectancy of at least three months 7. written informed consent that is consistent with international conference on harmonisation-good clinical practice (ich-gcp) guidelines. exclusion criteria: 1. prior chemotherapy for relapsed and/or metastatic nsclc. 2. prior treatment with egfr targeting small molecules or antibodies. 3. radiotherapy or surgery(other than biopsy) within 4 weeks prior to randomization 4. active brain metastases 5. any other current malignancy or malignancy diagnosed within the past 5 years 6. known pre-existing interstitial lung disease 7. significant or recent acute gastrointestinal disorders with diarrhoea as a a major symptoms. 8. history or presence of clinically relevant cardiovascular abnormalities 9. cardiac left ventricular function with resting ejection fraction of less than 50%. 10. any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug. 11. absolute neutrophil count(anc)\<1500/mm3 12. platelet count\<100,000/mm3 13. creatinine clearance\ 1.5 times upper limit of normal (uln). 14. bilirubin\>1.5 times uln 15. aspartate amino transferase (ast) or alanine amino transferase (alt) \> 3 times uln 16. women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial 17. pregnancy of breast-feeding 18. patients unable to comply with the protocol 19. active hepatitis b infection, active hepatitis c infection or known hiv(human immunodeficiency virus) carrier. 20. known or suspected active drug or alcohol abuse. 21. requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2 22. any contraindications for therapy with gemcitabine/cisplatin 23. known hypersensitivity to bibw2992 or the excipient of any of the trial drugs 24. use of any investigational drug within 4 weeks of randomization.
qolicol - quality of life in colon cancer

Conditions: Colonic Neoplasm

Summary: all patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. they will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the swedish colorectal cancer registry (scrcr)

qolicol is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. all patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. patients will be followed for 3 years. they will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in denmark and sweden. as these registries differ in some areas between the countries, additional data will be collected through short crf:s.

Eligibility criteria:
inclusion criteria: * colon cancer newly diagnosed. * planned treatment presented exclusion criteria: * no colon cancer diagnosis, * below 18 years of age, * no informed consent or withdrawn informed consent.
adamts,proteoglycan and oxidant / antioxidant enzyme levels of placenta previa totalis (accreta, increta, percreta).

Conditions: Placenta Previa

Summary: placenta previa totalis (accreta, increta, percreta); adamts and proteoglycans and the oxidant / antioxidant enzyme levels.

placenta previa totalis (accreta, increta, percreta) of pregnant women in the maternal serum, fetal membranes (placenta) and hysterectomy of women with myometrial strips measured the adamts and proteoglycans expression levels, and the oxidant / antioxidant enzyme levels.

Eligibility criteria:
inclusion criteria: * pregnant women diagnosed with placenta previa by obstetric ultrasound and doppler exclusion criteria: * pregnant women with comorbid diseases other than previa totalis .