Kornimate/medical-research-clean huggingface dataset:
a study of ro4917838 in combination with antipsychotic treatment in patients with schizophrenia.

Conditions: Schizophrenia

Summary: this study will determine the efficacy and safety of ro4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. after a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of ro4917838 once daily, p.o., as add-on therapy. the anticipated time o n study treatment is \<3 months, and the target sample size is 100-500 individual s.


Eligibility criteria:
inclusion criteria: * adult patients, 18-60 years of age; * diagnosis of schizophrenia (based on screening tests); * outpatients, with no hospitalization for worsening of schizophrenia within 3 months; * medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months; * currently taking no more than 2 antipsychotic drugs. exclusion criteria: * began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months; * on \>1 antidepressant, or a change in dose of antidepressant within 3 months; * alcohol or substance abuse or dependence within 3 months; * has previously received ro4917838.
delirium in mechanically ventilated patients

Conditions: Delirium

Summary: the overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the icu.

this is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the icu. enrolled patients will receive a daily baseline delirium assessment using the cam-icu tool before the awakening from sedation and an assessment during the awakening from sedation. each patient will thus serve as their own controls for these interventions.

Eligibility criteria:
inclusion criteria: * \> 18 years old * intubated and mechanically ventilated * receiving sedative and/or analgesic medication * candidate for daily awakening from sedative and/or analgesic medication exclusion criteria: * primary neurologic disease (stroke, seizure, elevated icp) * post cardiac arrest * do not speak english (assessment only english language validated)

Keywords: hypnotics and sedatives respiration, artificial ventilators, mechanical critical care intensive care
a study of the safety and efficacy of a new treatment for macular edema resulting from retinal vein occlusion

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.


Eligibility criteria:
key inclusion criteria: * 18 years of age or older with macular edema resulting from retinal vein occlusion * decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) * visual acuity in other eye no worse than 20/200 key exclusion criteria: * known anticipated need for ocular surgery within next 12 months * history of glaucoma or current high eye pressure requiring more than 1 medication * diabetic retinopathy * uncontrolled systemic disease * known steroid-responder * use of systemic steroids * use of warfarin/heparin
major and macular branched retinal venous occlusion

Conditions: Macular Edema

Summary: although it is important in the clinical management to classify brvo into subtypes based on the location of the occlusion (major or macular), few studies have provided such information\[8,9\]. the aim of this study was to evaluate the outcome of patients with macular edema due to branch retinal vein occlusion who were treated with intravitreal bevacizumab injection and to determine the concentrations of cytokines in the aqueous humor according to the site of the occlusion.

branch retinal vein occlusion is the second most frequent major retinal vascular disease after diabetic retinopathy. one of the main reasons for visual loss in brvo is the development of macular edema. treatment options for brvo include grid laser treatment, intravitreal injection of steroids, surgical procedures, and off-label treatment with intravitreal anti-vascular endothelial growth factor (vegf) agents. during recent years, intravitreal anti-vegf treatment with bevacizumab has been shown to efficiently reduce macular edema and improve visual acuity in numerous case series and prospective or retrospective studies.

Eligibility criteria:
inclusion criteria: * macular edema involving the center of the fovea with a minimum central macular thickness at baseline of ≥250 μm exclusion criteria: * previous vitreoretinal surgery, intravitreal injections or laser treatment

Keywords: macular edema secondary to retinal benous occlusion
investigation of the contents and prognostic values of glucose metabolism molecules in patients with lung adenocarcinoma

Conditions: Lung Cancer; Glycolysis; Diagnosis; Survival

Summary: detect the contents of glucose metabolism molecules in the tumor and adjacent normal samples of about 100 patients with lung adenocarcinoma using mass spectroscopy. analyze the correlation between the contents and the clinicopathological characteristics and survival.


Eligibility criteria:
inclusion criteria: * primary lung adenocarcinoma exclusion criteria: * other tumor histories, received radiotherapy or chemotherapy before surgery, tumor or adjacent normal tissues can't be obtained, patient rejected.
single dose escalation study of bivatuzumab mertansine in female patients with cd44v6 positive metastatic breast cancer

Conditions: Breast Neoplasms

Summary: maximum tolerated dose (mtd), safety, pharmacokinetics, efficacy of bivatuzumab mertansine


Eligibility criteria:
inclusion criteria: 1. female patients aged 18 years or older 2. patients with breast cancer positive for cd44v6 in at least 50 % of the tumour cells 3. patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments 4. measurable tumour deposits by one or more radiological techniques (mri, ct) 5. life expectancy of at least 6 months 6. eastern cooperative oncology group (ecog) performance score ≤ 2 7. patients must have given written informed consent (which must be consistent with international conference on harmonisation-good clinical practice (ich-gcp) and local legislation) exclusion criteria: 1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs 2. known secondary malignancy requiring therapy 3. active infectious disease 4. brain metastases requiring therapy 5. neuropathy common toxicity criteria (ctc) grade 2 or above 6. absolute neutrophil count less than 1,500/mm3 7. platelet count less than 100,000/mm3 8. bilirubin greater than 1.5 mg/dl (\> 26 μmol/l, système internationale (si) unit equivalent) 9. aspartate amino transferase (ast) and/or alanine amino transferase (alt) greater than 3 times the upper limit of normal 10. serum creatinine greater than 1.5 mg/dl (\> 132 μmol/l, si unit equivalent) 11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug 12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug) 13. radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial 14. women who are sexually active and unwilling to use a medically acceptable method of contraception 15. pregnancy or lactation 16. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) 17. patients unable to comply with the protocol
a study to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis in daily life

Conditions: Axial Spondyloarthritis

Summary: the primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.


Eligibility criteria:
inclusion criteria: * the patient personally signed and dated a patient data consent form (pdcf) prior to visit 2. no data can be entered into the electronic documentation form (edf) prior to signature of the pdcf. * the patient must have a clinical diagnosis of active axial spondyloarthritis (axspa), \[ankylosing spondylitis (as) or nonradiographic axial spondyloarthritis (nr-axspa)\] according to the diagnostic criteria used by the physician in routine clinical practice. * the decision to prescribe certolizumab pegol (czp) is made by the physician independent of the patient's participation in the nis. * the patient must be newly prescribed czp according to local regulations or guidelines (eg, bath ankylosing spondylitis disease activity index (basdai) \>=4). * treatment is according to instructions in the summary of product characteristics (smpc) for patients considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires). * if a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study. exclusion criteria: n/a

Keywords: axial spondyloarthritis radiographic axial spondyloarthritis non-radiographic axial spondyloarthritis ankylosing spondylitis diagnosis cimzia czp certolizumab pegol cdp870
a study of n-acetyl cysteine in children with autism

Conditions: Autistic Disorder

Summary: the purpose of the study is to test the tolerability and efficacy of n-acetyl cysteine (nac) in children with autism. nac is a compound that increases the levels of glutathione, the body's main antioxidant. glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). anti-oxidants protect the body from damage caused by internal toxins called "free radicals." it is possible that children with autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals. we hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop autism so that we can design better ways to treat individuals with this condition. this study is meant to test the safety tolerability of nac and its effectiveness in the treatment of behavioral difficulties in children with autism. it will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.


Eligibility criteria:
inclusion criteria: 1. outpatients between 3.0 and 12.11 years of age inclusive 2. males and females who are physically healthy 3. diagnosis of autism based diagnostic and statistical manual (dsm-iv-tr) criteria, the autism diagnostic interview-revised, and expert clinical evaluation 4. clinical global impression severity rating of 4 5. care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis 6. ability of subject to swallow the compound 7. stable concomitant medications for at least 2 weeks 8. no planned changes in psychosocial interventions during the open-label n-acetyl cysteine trial exclusion criteria: 1. dsm-iv-tr diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified 2. prior adequate trial of n-acetyl cysteine 3. active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology) 4. pregnancy or sexually active females 5. subjects taking antioxidant agents and glutathione prodrugs will be excluded from the study except if they have been off these compounds for at least 4 weeks
study of gene polymorphisms involved in the metabolism and action of vitamin d in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a case-control study performed on a biological collection. the polymorphisms present on a pre-defined list of genes will be studied for 400 amyotrophic lateral sclerosis (sporadic type) dna samples and 400 control dna samples.


Eligibility criteria:
inclusion criteria: * the primary inclusion criterium is the same for that of the parent biological collection, i.e. the patients fulfill requirements for probable or definite amyotrophic lateral sclerosis as defined by revised international criteria (brooks et al 2000). * additionally, included patients were followed-up by doctors at the university hospital of montpellier, thus enabling verification of amyotrophic lateral sclerosis criteria over time. exclusion criteria: * the patient has a familial form of amyotrophic lateral sclerosis (autosomic dominant or recessive types) with or without a mutation of one of the 3 genes known to be responsible for familial forms (sod1, tardbp, fus). see bender (1998).
universal hemoglobin a1c versus risk-based screening for early gestational diabetes mellitus (early gdm): a randomized controlled trial

Conditions: Gestational Diabetes; Large for Gestational Age

Summary: the goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (a1c) and early risk-based screening with a glucose tolerance test (gtt) among pregnancies that present to prenatal care at \<16 weeks 6 days.


Eligibility criteria:
inclusion criteria: * presenting to prenatal care ≤16 6/7 weeks of gestation * intend to deliver at tjuh exclusion criteria: * multifetal gestation * pre-pregnancy diagnosis of diabetes mellitus * history of malabsorptive gastric bypass surgery * hemoglobinopathy
aprepitant versus hydroxyzine in persistent aquagenic pruritus for patients with myeloproliferative neoplasms

Conditions: Myeloproliferative Disorder; Aquagenic Pruritus

Summary: phase 3, randomized prospective study, double blind-double placebo, testing oral therapies aprepitant versus hydroxyzine in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

identification of patients with myeloproliferative neoplasms and aquagenic pruritus. evaluation of the intensity of the aquagenic pruritus. patients with value \>5/10 on the vas (visual analogue scale ) are proposed to participate to the protocole. randomization between the two treatments. duration of the treatment : 14 days. regular evaluation of efficacity of the drugs (questionnaires). evaluations will stop 2 months after the last intake. blood samples will be collected before and after the intakes to study cytokine and neuropeptide levels.

Eligibility criteria:
inclusion criteria: * major patients with myeloproliferative neoplasms (polycythemia vera, essential thrombocythaemia or myelofibrosis) * and treated with hydroxyurea, pipobroman, anagrelide, α2a pegylated interferon, ruxolitinib or bled for more than 6 months * and suffering of persistent aquagenic pruritus * and with a pruritus intensity on analogic visual scale \>5/10 * patients who gave their written consent for participation in the study exclusion criteria: * patients with a physical or psychological disability to sign the consent form * patients with myeloproliferative neoplasms and suffering of aquagenic pruritus but only treated by aspirin * patients already included in another therapeutic protocol * patients with diffuse dermatological disease where pruritus may be present (psoriasis, atopic dermatitis, prurigo * patients already on anti-anxiety and / or anti-depressant treatment * patients with absolute contraindications to the use of aprepitant or hydroxyzine * hypersensitivity to aprepitant and / or hydroxyzine or to any of their excipients * lactose intolerance * pregnant or lactating women
nutrient fortified oat drink

Conditions: Iron Deficiency Anemia

Summary: this study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin a and vitamin c will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage.


Eligibility criteria:
inclusion criteria: * 5-7 years old * children with parental consent * not suffering from diarrhea, respiratory infections and fever at time of interview and for the past two weeks * no history of blood disorder or malaria * had not participated in any feeding program for the past 4 months * children with hb \> 70 g/l to \<120 g/l (who/unicef/unu, 1998) * crp \<10 mg/l exclusion criteria: * all children aged \ 7 years old * without parental consent * undergoing treatment for any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at the time of examination or during the past two weeks. * reported current or history of blood abnormalities/hemoglobinopathies * children with all normal hb levels or very low hb \< 70 g/l * crp \>10mg/l

Keywords: iron deficiency anemia iron zinc vitamin a vitamin c oats
effects of the cross-training in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Weakness; Fatigue

Summary: the purpose of this study is to determine whether, in patients with multiple sclerosis presenting with marked asymmetry of strength, training the less-affected limb with a cross-training approach may induce a meaningful transfer of strength with neurophysiological, functional and clinical correlates, to the contralateral, more-impaired limb.

muscle weakness is a major disability that is responsible for deeply reducing the overall quality of life (qol) of patients with multiple sclerosis (ms). research has shown that strength training (st) has a significant positive effect on the performance of daily living activities in people with ms, resulting in an increased qol. several st methods are currently employed for reducing strength impairment in ms but no one regimen has been portrayed as superior to others. when strength impairment is prominently lateralized to one limb, training is commonly addressed to the weaker side in order to balance the deficit. however, such st may not always be applicable to a severely weakened limb that is too compromised to sustain it. for these selected patients we hypothesize that training the less affected limb with a cross training (ct) approach may overcome the problem, also avoiding patients' frustration and potential withdrawals from rehabilitation programs. aim of this project is to investigate and compare in two groups of selected ms patients, with a marked asymmetry of strength, the effects induced on dynamometric, neurophysiological, functional and clinical outcomes by a ct of the less-impaired leg (ct group) compared to a st of the more-impaired leg (st group). in order to make comparisons with a population which is not exposed to the condition ms, a third group composed of healthy subjects will also be included in the study. the research plan will be articulated in 5 phases (recruitment, baseline assessment, 6 week-intervention phase, post-intervention assessment and follow up at 12 weeks).

Eligibility criteria:
inclusion criteria: * age: 18-65 years * expanded disability status scale (edss) ≤6 (pyramidal functional system ≥3) exclusion criteria: * clinically relevant cognitive disorders; * disability caused by other diseases; * medication with corticosteroids within three months prior to enrolment; * medication with botulinum toxin within six months prior to enrolment; * clinically or radiologically documented exacerbation within six months prior to enrolment; * variations in disease-modifying drugs (dmd) within three months prior to enrolment; * severe ataxia and postural instability (assessed with berg balance scale); * depression

Keywords: resistance training/methods contralateral strength training ipsilateral strength training isokinetic contraction adaptation, physiological/physiology electromyography/methods transcranial magnetic stimulation/methods evoked potentials, motor
azd1981 bioavailability study of intravenous (iv) and oral formulations

Conditions: Healthy; Postmenopausal; Surgically Sterile Women

Summary: the primary objective is to investigate the pharmacokinetics of azd1981 given in different formulations and to measure renal clearance


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * men or post-menopausal or surgically sterile women, aged 18 to 55 years * have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg * be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to visit 1 (pre-entry) exclusion criteria: * any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate * any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ecg at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
improved stroke outcome at 6 months

Conditions: Stroke

Summary: the investigators implemented a structured chain of acute stroke care with early integrated rehabilitation. the mortality at 6 months was lower (12%) compared to 23% in the international stroke trial (ist) and 39% (67%) of the patients were dead or dependent, which is superior compared to international data.

background/aim of the study: to further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data. methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. the intervention consists of a structured therapeutic chain of 290 collaborating gps, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (los) and the quantitative analysis of physical and psychosocial impairments. the data are directly compared with the same endpoints of the swiss subgroup of the international stroke trial (ist) and recent international data. results: at 6 months, mortality is significantly lower with 12 % (compared to 23 % in the ist trial) and only 39 % (67 %) of the patients are dead or dependent. stroke severity is similar as in other study populations. median los is 15 days in the acute clinic and 39 days in the rehabilitation institution. the psychosocial outcome compares favorably to a matched control group. conclusions: a structured chain of acute stroke treatment overlapping with an early integrated rehabilitation is superior compared to national and international ischemic stroke trial data.

Eligibility criteria:
inclusion criteria: * an acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (icb)) with the signs and symptoms of an acute stroke according to the world health organisation definition of acute stroke within the last 12 hours without the need or possibility of a neurosurgical intervention; * no thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the swiss cohort of the ist trial) * the informed consent of the patient or, if not possible, of the next of kindred * living at home before the event * lack of participation in another trial exclusion criteria: * transient ischemic attack (tia) resp. full recovery within 24 hours after the event

Keywords: stroke, stroke treatment, atrial fibrillation, medication, rehabilitation