Kornimate/medical-research-clean huggingface dataset:
charcot-marie-tooth disease (cmt) infant scale (inc-6611)

Conditions: Charcot-Marie-Tooth Disease

Summary: the purpose of this study is to develop and validate a clinical outcome measure to evaluate disability and disease progression of children 3 years of age and younger (infants and toddlers) with various types of charcot-marie-tooth disease (cmt).

most forms of cmt begin in childhood and progress throughout a person's lifetime. current research suggests that treatment to slow disease progression may be most effective if introduced early in a patient's life before muscle weakness and sensation loss develop, as it may be easier to slow disease progression than to reverse disability that is already in place. clinical outcome measures have been developed for adults (cmt neuropathy score) and for children 3 years of age and older (cmt pediatric scale). however, no cmt-specific clinical outcome measure currently exists to measure disease severity or progression in children from birth to 3 years of age. it is the goal of this study to develop and validate the cmt infant scale (cmtinfs) to meet this need.

Eligibility criteria:
inclusion criteria (patients with cmt): * patient is ≤4 years of age * parent(s) or guardians have agreed for the child to take part in the study and have signed an informed consent form. * patient has known or probable inherited neuropathy * patient participates in the inc natural history study (inc 6601) inclusion criteria (controls): * participant is ≤4 years of age * parent(s) or guardians have agreed for the child to take part in the study and have signed an informed consent form. * participant does not have an inherited neuropathy as determined by the investigator * participant is an unaffected friend or family member of a patient with cmt (patient does not have to be included in the study) exclusion criteria (patients with cmt): * patient has a known condition of acquired neuropathy including toxic (e.g. medication related), metabolic (e.g. diabetic), immune mediated or inflammatory (aidp or cidp) neuropathies, a neuropathy related to leukodystrophy, or a congenital muscular dystrophy. * patient has a severe general medical condition, as determined by the site principal investigator. * patient has known normal nerve conductions of upper and lower limbs. this will be considered as exclusion criteria because it documents that the child does not have a large-fibre neuropathy. however, patients will not be required to have nerve conduction studies (ncs) or electromyography (emg).
tranexamic acid in urologic surgery

Conditions: Bleeding; Prostatectomy

Summary: this prospective randomized double-blind placebo vs control study aims at verifying the efficacy of tranexamic acid administration in reducing perioperative bleeding in patients undergoing open radical prostatectomy. two recent meta-analysis confirmed that tranexamic acid administration does not increase mortality, myocardial infarction, deep venous thrombosis, pulmonary embolism, stroke and renal failure. 200 patients undergoing open radical prostatectomy will be enrolled. patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion. patients belonging to the control group will receive the same volume of saline infusions.


Eligibility criteria:
inclusion criteria: * adult patients * patients undergoing open radical prostatectomy exclusion criteria: * age \< 18 years * patients with drug eluting stent with a double antiplatelet therapy * atrial fibrillation * thrombophilic diathesis * allergy to tranexamic acid

Keywords: tranexamic acid prostatectomy surgery
clear-road trial, investigating the efficacy of the roadsaver stent

Conditions: Peripheral Arterial Disease

Summary: the objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the roadsaver (terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

it is a prospective, multi-center, physician-sponsored clinical study. the objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the roadsaver (terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

Eligibility criteria:
inclusion criteria: high risk for carotid endarterectomy due to anatomical or co-morbid conditions and either: * has neurological symptoms and ≥ 50% stenosis via angiography, or * is asymptomatic and has ≥ 80% stenosis via angiography. 1. target lesion located in the distal common carotid artery (cca), internal carotid artery (ica), or carotid bifurcation. 2. arterial segment to be stented has a diameter between 4mm and 9mm 3. age ≥ 18 years. 4. life expectancy \> 12 months from the date of the index procedure. 5. provides a signed, irb (institutional review board) / iec (institutional ethical committee) approved informed consent form prior to participation. 6. willing and able to comply with follow-up requirements. exclusion criteria: 1. contra-indication to percutaneous transluminal angioplasty (pta). 2. sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system. 3. lesions in the ostium of the common carotid artery. 4. occlusion of the target vessel. 5. evidence of intraluminal thrombus. 6. known sensitivity to nickel-titanium. 7. known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies, or is unable or unwilling to tolerate such therapies. 8. uncorrectable bleeding disorders, or will refuse block transfusion. 9. history of prior life-threatening contrast media reaction. 10. previous stent placement in the target vessel. 11. evolving stroke or intracranial haemorrhage. 12. previous intracranial haemorrhage or brain surgery within the past 12 months. 13. clinical condition that makes endovascular therapy impossible or hazardous.
psychophysiological effects of birdsongs vs music

Conditions: Sadness

Summary: the main goal of this study is to learn the psychophysiological effects of birdsongs on sadness. the main questions it aims to answer are: 1. can birdsongs alleviate sadness in a short term? 2. can birdsongs have greater impact on sadness than music? 3. can birdsongs alleviate sadness for both non-depressed and depressed participants? researchers will compare birdsongs to music (a active control) to see if birdsongs works to reduce sadness and also examined the psychophysiological effects of birdsongs in depressed and non-depressed participants. participants will: go through the following stages: baseline, neutral control, 1st sadness induction, 1st intervention, calculation task, 2nd sadness induction, and 2nd intervention.

during the baseline phase, participants were instructed to sit quietly and relax. for the neutral control, they viewed an informative video demonstrating the process of plastic injection molding. as for the sadness induction, they were presented with sad film clips from either hachi: a dog\&#39;s tale or my brother and sister. the order of the sad videos was randomized across participants. the intervention stages involved listening to either the cheerful cuckoo waltz music or a clip of birdsongs from laughing thrushes. the order of the interventions was randomized as well. the calculation task was employed as a distracter, enabling participants to return to a neutral state. except for the computational task, the remaining six phases each had a duration of 6 minutes.

Eligibility criteria:
inclusion criteria: * aged 18-30 years * right-handed * no recent illness or medication use * no history of neurological or psychiatric disorders * normal or corrected-to-normal visual acuity (myopic participants wore glasses) * normal hearing exclusion criteria: * incapable of giving written informed consent to this study * acute high suicide risk at baseline assessment * psychosis

Keywords: birdsongs music sadness depressive symptoms psychophysiological effects
detection of severe sepsis in patients with neurological haemorrhage (the dissipate study)

Conditions: Sepsis; Hemorrhage Brain

Summary: the research study is to explore novel early predictors and validation of laboratory parameters in the management of sepsis in critically ill patients especially with brain injuries and systemic inflammatory response syndrome (sirs).

this is a prospective observational study. 150 subjects with the admission diagnosis of neurological haemorrhage (e.g. subarachnoid haemorrhage, intracerebral haemorrhage etc), admitted to sicu of national university hospital, singapore, who are expected to stay for more than 48 hours, will be recruited and enrolled. no adverse events are expected as a result of this study as patients do not deviate from the current standard of care. frequency of blood sampling will be stipulated at day 1/2/3/4/5 to draw clinical relevance. an additional 0.5 tablespoonful (7.7ml) of blood will be taken daily from each subject as well as residual blood from routine laboratory test blood samples. in total, an additional volume of 2.5 tablespoonful (38.5ml) of blood will be collected from each subject over a period of 5 days. residual blood refers to any leftover blood samples collected for routine laboratory tests which will be shared and used to carry out additional blood tests. all icu patients will have arterial lines inserted as part of routine care, so there will not be pain from the blood sampling. in the current study, measurements will be made on the routine laboratory haematology, coagulation and immunoassay analyzers. research blood parameters that are not usually reported as indicated in the background section will be used for the correlation and association analysis to sepsis. in addition, the study team will also be collecting clinical and demographic data of recruited subjects from medical records for purposes of this study.

Eligibility criteria:
inclusion criteria: * adults 21 years and above * clinical/radiological suspicion or confirmation of neurological haemorrhage exclusion criteria: * age below 21 years * prisoners * known pregnancy * do-not-attempt resuscitation status * requirement for immediate surgery * active chemotherapy/neutropenia (neutrophil count \<1.0 x 109/l) * immuno-compromised * haematological malignancy * treating physician deems aggressive care unsuitable * unable to provide informed consent or comply with study requirements

Keywords: severe sepsis in patients with neurological haemorrhage
effects of relaxation response mind-body intervention in patients with ibs and ibd

Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Disease

Summary: in this pilot study, the investigators examined whether a relaxation response mind-body intervention could be effectively delivered to mixed groups of ibs and ibd patients and determined the effects of the intervention on quality of life, inflammatory markers, and gene expression using transcriptional profiling.


Eligibility criteria:
inclusion criteria: * patients with documented ibs (confirmed by the rome iii diagnostic criteria for 6 months) or ibd (upper limit for harvey-bradshaw index \[hbi\] = 20, upper limit of simple clinical colitis activity index \[sccai\] = 18) by their primary care provider or gastroenterologist * 18-75 years old * fluent in english exclusion criteria: * patients with ibs were excluded if they had abdominal surgery in the past 5 years (with the exception of appendectomy, cholecystectomy) or documentation of gi motility disorder. * patients with ibd were excluded if they used nsaids chronically, were on a prednisone dose ≥20 mg/day, or if surgery was anticipated in the 10-weeks following enrollment. * current evidence of duodenal ulcer, gastric ulcer, diverticulitis, esophagitis or infectious gastroenteritis, or any acute gastrointestinal process, as well as if concurrent total parental nutrition or tube feeding were being used. * recent (within the last 4-weeks) changes in ibs/ibd medications, planned changes in diet, or current use of steroids * currently pregnant or attempting to become pregnant * currently (\>3-weeks) practicing tai chi, meditation, yoga, individual mind/body based psychotherapy or counseling, * initiated psychotherapy within the last 8-weeks * using psychotropic medications (except at stable doses for at least 12-weeks), * has an untreated psychiatric disorder

Keywords: irritable bowel syndrome inflammatory bowel disease mind body intervention group relaxation response genomic effects
effects of two doses of thylakoids on ogtt

Conditions: Glucose Intolerance

Summary: this cross-over intervention study aims to investigate the effect of two doses of thylakoids to an oral glucose tolerance test (ogtt) on glucose and insulin homeostasis as well as appetite regulating hormones in healthy volunteers.

a minimum of twenty healthy volunteers are recruited to participate in an ogtt at three different occasions separated by one week. at two of the occasions a green leaf extract, thylakoids, is added to a glucose solution; 5 gram or 10 gram in randomized order. the third occasion, without added thylakoids, serve as control. blood samples are taken fasting and 15, 30, 45, 60, 90, 120 and 180 minutes after the glucose load. blood samples are analysed for p-glucose, p-insulin, p-c-peptide, p-ghrelin, p-cck and p-glp-1.

Eligibility criteria:
inclusion criteria: * healthy * adult * normal-weight and weight stable * not pregnant or breast-feeding * no use of medication that can affect glucose- and insulin homeostasis (for example corticosteroids). exclusion criteria: * diabetes, * impaired glucose tolerance and/or insulin resistance * anaemia * use of tobacco or drugs.
12 versus 20 ml pcb for d&e cervical prep

Conditions: Pain

Summary: more research is needed to investigate methods of pain control for cervical preparation for abortion procedures. women report pain with paracervical block injection as well as with osmotic dilator placement. this study seeks to compare a 12 ml, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for dilation and evacuation (d\&e) to a 20 ml 1% lidocaine 2-site paracervical block.

this is a non-inferiority, single blinded, randomized controlled trial.this study will use a 2-site, 12 ml 1% plain lidocaine injection paracervical block (pcb) technique (2 ml for tenaculum placement, 10 ml for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 ml 1% lidocaine injection pcb (2 ml for tenaculum placement, 18 ml for paracervical block) when administered for dilation pain control during cervical preparation.

Eligibility criteria:
inclusion criteria: * women 18 and older * intrauterine pregnancy ≥16 weeks gestation * english speaking competency * willing and able to sign consent forms * agree to comply with study procedures exclusion criteria: * women less than 18 years of age * iv conscious sedation * known allergy to study medication (lidocaine) * any women not meeting inclusion criteria above will be excluded from participation

Keywords: paracervical block abortion dilation and evacuation cervical preparation
a study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics after high single ascending oral doses of azd1656 in t2dm patients

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate safety and tolerability after high single ascending oral doses of azd1656.


Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures. * male, t2dm patients aged 20-60 years * treatment with 1 to 2 oads as therapy for t2dm for at least 30 days prior to enrollment * patients should not have been treated with glitazones within 6 months prior to enrollment * male t2dm patients without known cardiovascular disease, with the exception of grade 1 hypertension without secondary organ involvement (eg. grade 1 ht is allowed if no eye, kidney disease or lvh has been documented). exclusion criteria: * history of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease. * prolonged qtcf\>450 msec or shortened qtcf\<350 msec or family history of long qt syndrome. * any clinically important abnormalities in rhythm, conduction or morphology of resting ecg that may interfere with the interpretation of qtc interval changes. * systolic bp\>159 mmhg or diastolic bp\>99 mmhg at screening and on day-1

Keywords: diabetes mellitus
minding the baby home visiting: program evaluation

Conditions: Attachment; Child Maltreatment; Maternal Sensitivity; Infant Health

Summary: this is an efficacy study of an intensive home visitation intervention, "minding the baby" (mtb). this reflective parenting program (aimed at enhancing maternal reflective capacities), is focused on first-time young mothers and infants living in an urban community. the study, grounded in attachment and human ecology theories integrates advanced practice nursing and mental health care by pairing master's level nurse practitioners and social workers with at-risk young families. aims of the study are: 1) to determine the efficacy of the mtb intervention in young mothers and infants with respect to a) maternal outcome variables including the quality of the mother-infant relationship, maternal reflective capacities, maternal mastery/self-efficacy, parental competence, and maternal health and life course outcomes (educational success, employment, delaying subsequent child-bearing); and b) infant outcome variables including early attachment, infant health, and developmental outcomes; 2) to monitor fidelity and dose of the program with young mothers; 3) to describe the evolution of reflective capacities in adolescent mothers (contrasting intervention group with control group) through descriptive qualitative analyses of transcribed pregnancy interviews and parent development interviews at the last trimester of pregnancy and at 24 months; 4) to conduct cost-effectiveness analyses of the program. the longitudinal two-group study (subjects nested within randomly assigned groups), will include multi-method (self report, interview and direct observation and coding of behaviors) approaches with a cohort of first-time multi-ethnic mothers between the ages of 14-25 (and their infants). mtb home visits occur weekly for intervention families (n=69) beginning in mid pregnancy and continuing through the first year, and then bi-weekly through the second year. mothers and infants (n=69) in the control group will receive standard prenatal, postpartum and pediatric primary care in one of two community health centers (as will the intervention group) and also receive monthly educational materials about child health and development mailed to their homes. maternal and infant outcome variables will be followed over time (pregnancy, 4, 12, and 24 months) as well as compared between the 2 groups. cost analyses and analysis of the dose and sample characteristics linked to efficacy, will allow us to plan for translation of the model into clinical care and community sustainability.


Eligibility criteria:
inclusion criteria: * having a first child * speak english * obtains primary care from community health centers exclusion criteria: * no psychoses or terminal illnesses
trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma

Conditions: Ovarian Reserve; Endometriosis

Summary: randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma


Eligibility criteria:
inclusion criteria: * unilateral ovarian endometrioma ≥ 5cm or bilateral ovarian endometriomas with any size diagnosed by ultrasonography. * in patients with previous unilateral salpingo-oophorectomy (uso) * unilateral ovarian endometrioma with any size is eligible * 20 ≤ age ≤ 45 and premenopause * plan to undergo conservative surgery for endometriomas exclusion criteria: * pregnant women or women who were suspected to be pregnant * women with current venous thromboembolism or history of such diseases * women with current arterial disease or cardiovascular diseases (e.g. myocardial infarction, cerebrovascular diseases, or ischemic heart diseases) or history of such diseases * women with current diabetes with vascular lesions or history of such diseases * women with current severe liver diseases or history of severe liver diseases with abnormal liver function * women with current liver tumor or history of liver tumor * women with current or history of sex-hormone dependent malignant tumor or women who were suspected to have a sex-hormone dependent malignant tumor * women with vaginal bleeding of unknown causes * women with a history of allergic reaction to elements of dng * women with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * women whose non-compliance is expected * lactation (treatment with dng is not recommended in lactating women due to possible excretion in breast milk) * any medication that could result in an excessive accumulation, impaired metabolism, or altered excretion of the study drug or might interfere with the conduct of the study or the interpretation of the results
effect evaluation of early exercise training after myocardial infarction

Conditions: Myocardial Infarction

Summary: the aim of the study is to evaluate the effect of early onset of exercise training (et) after myocardial infarction (mi) in a randomized controlled trial. usual care is to wait 4-6 weeks after onset of mi, and our hypotheses are that early et will prevent a fall in vo2peak and contribute to better quality of life.

exercise training is well documented as effective treatment for myocardial infarction(mi) patients. however, the long time effect of early onset is more unclear, and it is needed to provide knowledge about to which extend early onset of et contribute to reduce risk factors, increase oxygen consumption and influence on quality of life. a rct is conducted, 60 persons with recently mi is invited to participate. the subjects participating is hospitalised in st. olavs hospital. the participants are randomised to either a training group or a control group. the training group will be offered hospital out-patient group exercise training of moderate intensity twice a week for four weeks. the training is leaded by a physiotherapist. the control group will wait four weeks before both groups continue et twice a week for 12 weeks (high intensity training).

Eligibility criteria:
inclusion criteria: * myocardiac infarction, 2 weeks ago * over 18 years * able to participate i exercise groups exclusion criteria: * unstable angina * heart failure * failure to reach a maximal pretest * drug abuse