Kornimate/medical-research-clean huggingface dataset:
the amager project: intervention after suicide attempt

Conditions: Suicidal Behaviour; Repetition of Suicidal Behaviour

Summary: background: repetition rate after a suicide attempt and self harm is very high, about 12-30 percent. studies, reviewed by hawton, 1999 show a lack of evidence for psychosocial interventions. compliance with aftercare is also often very poor. objective: inspired by the norwegian baerum project, the aim is to study if active, assertive outreach, seeking contact, talking about problem solution, motivate to comply to other appointments, will reduce repetition of suicidal acts in the following years. methods: the design is a prospective randomized, controlled trial. the patients (immediately after a suicide attempt or deliberate self harm)) included are randomized to intervention or standard (treatment as usual), aiming at at least 60 persons in each arm. the intervention is carried out through research nurses with about 8 home visits, phone contact, phone messaging, e-mails.included are persons 12 years of age and older, danish speaking without translator and without diagnoses of severe mental illness (schizophrenia, bipolar illness, mania and severe/psychotic depression) or severe dementia. results: outcome is measured by repetition of suicidal act (suicide attempt, self harm or completed suicide)as recorded in medical records and by the danish cause of death register. repetition measured by persons and by acts throughout 1 year, 2 and 3 years periods. additional outcome is number and character of health system contacts.


Eligibility criteria:
inclusion criteria: * suicide attempt and self harm exclusion criteria: * severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)

Keywords: suicidal behaviour attempted suicide self harm suicide health system contacts contacts with health system
interventions to reduce excess weight gain in pregnancy

Conditions: Overweight and Obesity; Pregnancy

Summary: the study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. the central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.


Eligibility criteria:
inclusion criteria: * age 18-45 years * in first trimester of pregnancy * must be willing to not join any other weight control program while in the study * bmi of 25-40 kg/m2 * willingness and ability to attend support group meetings either in person or via web * must be able to read, speak, and understand english exclusion criteria: * carrying multiple fetuses * gestational diabetes mellitus at study entry * type 2 diabetes mellitus or blood glucose \>125 mg/dl at screening * self reported current substance abuse * current smoking * alchol consumption of more than 1 drink per day * preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing * eating disorder in the past 2 years * depression or diagnosis of bipolar disorder * concurrent participation in any other research study that would impact participation in this investigation

Keywords: weight pregnancy behavioral intervention obesity
clinical trial of the combination of intravenous alvespimycin (kos-1022), trastuzumab with or without paclitaxel in patients with advanced solid tumor malignancies or her2 positive metastatic breast cancer who have previously failed trastuzumab therapy

Conditions: Solid Tumor; Breast Cancer

Summary: to determine the maximally tolerable dose (mtd) of kos-1022 when administered weekly in combination with trastuzumab or in combination with trastuzumab and paclitaxel to patients with advanced solid tumor malignancies


Eligibility criteria:
inclusion criteria: * kps performance status \>= 70% * schedule a: all patients must have a histologically confirmed solid tumor malignancy. schedule b: patients must have metastatic breast cancer with her2 amplification by fish or 3+ her2 overexpression by immunohistochemistry ("ihc"). patients are not required to have measurable disease for this investigation. disease must be assessed within 28 days prior to treatment initiation * all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to nci ctcae (v. 3.0) grade \<= 2 (except for alopecia) * the following laboratory results, within 10 days of kos-1022 administration: * hemoglobin \>= 8.5 g/dl * absolute neutrophils count \>= 1.5 x 10\*9\* /l * platelet count \>= 75 x 10\*9\*/l * serum bilirubin \<= 2 x uln * ast and alt \<= 2.5 x uln * serum creatinine \<= 2 x uln exclusion criteria: * documented hypersensitivity reaction of ctcae grade \>= 3 to prior therapy containing trastuzumab * pregnant or breast-feeding women. male patients must be surgically sterile or agree to use an acceptable method of contraception * known active cns metastases * administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. patients should be 6 weeks from last dose of nitrosourea * patients with grade 2 or higher dyspnea at rest on room air; patients with other clinically significant pulmonary co-morbidity(s) that might predispose the patient to pulmonary toxicity * moderately severe dry eye * prior pulmonary toxic chemotherapy (e.g, bleomycin or carmustine) * congestive heart failure, or a left ventricular ejection fraction (lvef) * any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient * patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin, carcinoma-in-situ of either the uterine cervix or urinary bladder
comparison of the electric plasma surgical tool "plasmablade" for replacement of the deep brain stimulation (dbs) devices with conventional surgery

Conditions: Parkinson Disease; Essential Tremor; Dystonia; Epilepsy

Summary: the deep brain stimulation is surgical technique used for the parkinson's disease, essential tremor, dystonia, epilepsy, and psychiatric diseases. a pulse generator or battery (implanted pulse generator, ipg) is a need for replacement every few years. in general, electric cautery(bovie), which is commonly used in surgery, cannot be used when the deep brain stimulation machine is inserted, so conventional tools such as scissors and knives are used for replacement surgery. however, in the process, damage to the machine may be inflicted by knives, scissors, etc., and in the worst case, the machine may be unusable, resulting in financial and human consumption. plasma blade is currently used for tissue incision and coagulation in korea, and is the only insurance-recognized tool in korea for the replacement surgery of a cardiovascular implantable electronic device (cied). the deep brain stimulation machine has a structure very similar to that of the heart electronics. in addition, the plasma blade was used to replace the deep brain stimulation machine overseas.the safety is reported in the surgery, so the plasma blade deep brain stimulation machine has been replaced in korea. the investigators would like to check the safety and effectiveness for use in surgery.


Eligibility criteria:
inclusion criteria: * men and women over the age of 19 * those who voluntarily agree to participate in this clinical trial and are willing to comply with the clinical trial protocol * persons who have previously undergone deep brain stimulation for parkinson's disease, essential tremor, dystonia, epilepsy, etc. * those who need replacement of deep brain stimulation machine exclusion criteria: * those who cannot be under general anesthesia
the concomitant cryomaze procedure using nitreous oxide cryoprobe: comparison with argon based cryoprobe

Conditions: Atrial Fibrillation; Valve

Summary: the aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using argon gas. the investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with holter monitoring. atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.

the investigators have used the medtronic ats cryoprobe (argon based) since 2009 for cryomaze procedure for treatment of atrial fibrillation combined with valvular heart disease. however, sometimes, it was inconvenient due to excess flexibility, wide lesion related to excess low temperature and time-consuming detachment from atrium after cryoablation. the investigators introduced atricure cryoprobe (nitreos oxide based) in hope of overcoming these shortcomings of ats probes last year. up to date, the investigators have been satisfactory in terms of the surgical convenience. on the other hand, we have the questionability of transmural lesion of atricure probe because of the higher temperature of atricure probe compared with ats probe. the aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using argon gas. the investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with holter monitoring. atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.

Eligibility criteria:
inclusion criteria: * requiring concomitant maze operation with valve surgery (persistent atrial fibrillation) * between 18 and 75 years old exclusion criteria: * previous cardiac surgery * behcet disease * takayasu's arteritis * infective endocarditis * congenital heart disease * left atrial size over 80mm * moderate or greater functional tricuspid regurgitation

Keywords: atrial fibrillation maze operation cryoablation
alterations in the brain's connectome after severe traumatic brain injury

Conditions: Traumatic Brain Injury; Disorders of Consciousness

Summary: this study explores the changes in whole-brain connectivity that occur during recovery from severe traumatic brain injury and how these changes are related to the recovery of consciousness. multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the tbi episode.

severe traumatic brain injury (tbi) can result in a long-lasting altered state of consciousness. at present, the underlying neurological determinants of recovery in patients with disorders of consciousness (doc) after a severe tbi are not well understood, and individual prognosis is very limited. moreover, the rate of misdiagnosis between different states of altered consciousness by standard clinical scales is high, which further impacts on the clinical prognosis. in this project, multimodal neuroimaging measures will be applied and whole-brain data will be obtained from patients recovering from severe tbi in a longitudinal fashion. patients will be examined at four time points during the sub-acute stage: immediately after admission to the neurorehabilitation unit, after ten weeks of admission, at discharge, and after one year of the tbi episode. brain connectivity will be assessed with functional magnetic resonance imaging (fmri) combined with electroencephalography (eeg), structural mri, diffusion mri, high-density eeg (hdeeg) alone, and hdeeg combined with transcranial magnetic stimulation (eeg-tms), and \[18f\]-fluorodeoxyglucose positron emission tomography (fdg-pet). the overall aim of the study is to find reliable biomarkers for the recovery of consciousness based on changes in cortico-cortical and cortico-subcortical brain connectivity. in order to explore this, patients that suffered a severe tbi as well a matched healthy participants group will be included in the study.

Eligibility criteria:
patient's inclusion criteria: - closed-head injury patient's exclusion criteria: * high level of consciousness after coma * ventricular shunt for hydrocephalus * large intracerebral hemorrhages or infarctions * structural lesions in the brain stem * locked-in syndrome due to motor pathway lesions * contraindications for mr * contraindications for tms healthy participant's inclusion criteria: - no prior history of neurological disorders and / or head injury healthy participant's exclusion criteria: * contraindications for mr * contraindications for tms
treating clozapine-induced sinustachycardia with bisoprolol

Conditions: Clozapine-induced Sinustachycardia

Summary: clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. this double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate variability, qtc and t-wave morphology.


Eligibility criteria:
inclusion criteria: * treated with clozapine \> 3 months and minimum 100 mg/day * fixed dose 14 days before inclusion * heart rate \> 100 (ecg) * pregnancy test negative * clozapine-induced sinustachycardia documented by ecg or case record * sexual abstinence or contraception * informed consent exclusion criteria: * substance abuse * physical diseases, contraindications for clozapine or bisoprolol * asthma or chronic obstructive lung disease * blood pressure \< 100/60 or recent history of syncopes * qtc\>500 ms, sa-block, av- block ii or iii * restrictions by danish mental act * allergic to clozapine or bisoprolol

Keywords: clozapine sinustachycardia heartrate variability cardiomyopathy
comparison of different types of resistant starch

Conditions: Postprandial Hyperglycemia

Summary: this study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.

each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. randomization using a latin square design was applied to minimize confounding issues associated with the order of administration. in the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. the volunteers will then consume the test solution assigned for that trial. ten minutes will be allowed for the test solution to be consumed. over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (ysi 2300, yellow springs, oh). analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/l. once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (graphpad v5.0, la jolla, ca).

Eligibility criteria:
inclusion criteria: * apparently healthy exclusion criteria: * diagnosis of any chronic disease * wheat allergy

Keywords: diabetes obesity hyperglycemia dietary fiber wheat grain
effect of cilostazol endothelial progenitor cells and collateral formation in peripheral occlusive artery disease (paod)

Conditions: Peripheral Arterial Diseases

Summary: 1. the number and function of circulating endothelial progenitor cells (epcs) are inversely associated with coronary risk factors and atherosclerotic diseases such as paod. 2. this double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early epcs and angiogenesis as well as the potential mechanisms of action in patients with mild-to-moderate paod.

1. titration of drugs 1. run-in period: eligible subjects are screened and baseline blood samples are obtained 2. study period: 12 weeks * 24 subjects with cilostazol and 20 subjects with dummy placebo * on the first day after the end of the study period, the follow-up data are obtained by the same procedure 3. blood sampling and measurement of serum biomarkers * obtained from peripheral veins in all study subjects at the run-in period and the end of the treatment period of the study * sent for isolation, cell culture, and assays of human epcs * also stored for enzyme-linked immunosorbent assay (stromal cell derived factor-alfa1, adiponectin, soluble thrombomodulin, vascular endothelial growth factor) 2. assays of human epcs 1. colony formation by epcs 2. quantification of epcs and apoptotic endothelial cells 3. chemotactic motility, proliferation/viability and apoptosis assays 3. collateral vessels formation and distal run-off assessed by dual-energy multi-slice computed tomography angiography 4. echocardiographic examinations to evaluate left ventricular functions

Eligibility criteria:
inclusion criteria: * ankle-brachial index (abi) less than 0.9 in one or both legs but no obvious symptoms of intermittent claudication exclusion criteria: * obvious symptoms of intermittent claudication * severe pad (fontaine grading \> 3) or critical limb ischemia in at least one leg * severe liver dysfunction (transaminases \>10 times of upper normal limit, history of liver cirrhosis, or hepatoma) * \> stage 4 chronic kidney disease (end-stage renal disease with chronic dialysis not excluded) * left ventricular ejection fraction \<50% by echocardiography * documented active malignancy * chronic inflammatory disease * planned coronary intervention or endovascular therapy or bypass surgery within 3 months * known drug allergy history for cilostazol * current use of cilostazol or any other camp-elevator * premenopausal women

Keywords: cilostazol endothelial progenitor cells vasculogenesis angiogenesis peripheral arterial disease biomarkers
vitamins and minerals for children with downs syndrome

Conditions: Trisiomy 21 (Down Syndrome)

Summary: the trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with down syndrome. 156 children with trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid or a placebo. blinded outcome assessment was carried out 18 months later.blood and urine samples were also taken around 12 months of age to examine metabolic effects of supplementation.


Eligibility criteria:
inclusion criteria: * under 7 months of age * trisomy 21 * live in recruitment area-i.e. london inside m25, in west midlands or sw england. * one parent speaks english exclusion criteria: * no life threatening cardiac disease
transorbital ultrasound of optic nerve sheath diameter between healthy pregnant women and those with severe preeclampsia.

Conditions: Preeclampsia Severe

Summary: the neurological alterations associated with preeclampsia depend on cerebral autoregulation, a theory that outlines the mechanisms by which the nervous system controls cerebral perfusion. however, with the loss of autoregulation, increased blood flow, edema and eventually increased intracranial pressure are triggered and may be translated into neurological manifestations such as symptoms of vasospasm, one of the criteria for severity in preeclampsia. nervous system manifestations frequently found in preeclampsia are headache, blurred vision, scotomas and hyperreflexia. although uncommon, temporary blindness (lasting a few hours to a week) may also accompany severe preeclampsia and eclampsia. the optic nerve, as part of the central nervous system, is surrounded by cerebrospinal fluid and dura mater, which forms the optic nerve sheath. due to the connection with the intracranial subarachnoid space, the diameter of the optic nerve sheath is influenced by variations in cerebrospinal fluid pressure. increased intracranial pressure is transmitted to the subarachnoid space surrounding the optic nerve, causing its expansion. recent studies suggest that an optic nerve sheath diameter greater than 5 mm correlates 100% with icp (intracerebral pressure) greater than 20 mm hg. due to the simple nature of the test and the limited time required to perform it, it is an ideal non-invasive test to assess changes in mental status, severe headache, and to take the necessary measures aimed at reducing intracranial pressure. the diagnosis of elevated intracranial pressure is challenging and critical, because early recognition and treatment are essential to prevent brain damage or death since preeclampsia with severe data remains one of the most frequent complications in our institution. these values are not taken from the obstetric population, so this study proposes the description of a standard value for the pregnant population. there are few studies that describe a value to help us define cases of this pathology and correlate it with the signs and symptoms of severity in patients with preeclampsia.


Eligibility criteria:
inclusion criteria: * age between 15-44 years. * gestational age between 34-40 weeks of gestation. exclusion criteria: * eye disease (glaucoma, diabetic neuropathy, optic neuritis). * nervous disorders. * psychiatric disorders * diabetes

Keywords: severe preeclampsia optic nerve sheet intracranial pressure
volatility in paranoia (vip) trial: an rct of changes in volatility with psychotherapy

Conditions: Schizophrenia Disorders

Summary: the goal of this clinical trial is to learn whether learning and belief updating change in response to the treatment of persecutory delusions, in individuals with schizophrenia-spectrum disorders. the main questions are: 1. do prior expectations about environmental volatility reduce following effective psychotherapeutic treatment of delusions? 2. does corresponding brain activity related to volatility change with effective treatment of delusions? participants will: 1. engage in cbtp or tau + phone check-ins for 16 weeks 2. complete assessments at 4 timepoints over the course of 6 months 3. complete an mri when possible


Eligibility criteria:
inclusion criteria: * men and women age 18 - 65. * communicative in english. * premorbid iq \>79 (wtar) * provide voluntary, written informed consent. * stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication. * diagnosis of a non-affective psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder) * a persecutory delusion scoring at least a 3 on the conviction scale of the psychotic symptoms rating scale (psyrats) that had persisted for at least two months and that was not considered the direct result of substance use. exclusion criteria: * serious medical or neurological illness known to interfere with cognitive functioning (uncontrolled/unstable diabetes, uncontrolled hypothyroidism, cushing's disease, lupus, any demyelinating disease such as multiple sclerosis, hiv infection, cns infection, unstable heart disease, active hepatitis, other significant endocrine condition, any cancer involving the cns/brain, any uncorrected vision problems, tardive dyskinesia). * history of severe head trauma with loss of consciousness \>30 minutes. * primary diagnosis of alcohol or substance use disorder or personality disorder

Keywords: schizophrenia delusion paranoia psychotherapy beliefs volatility cognitive behavioral therapy cbtp psychosis