Kornimate/medical-research-clean huggingface dataset:
respiratory exacerbation plans for action and care transitions for children with severe cp

Conditions: Cerebral Palsy

Summary: this study will pilot test a just-in-time (jit) adaptive intervention to reduce severe respiratory illness, for children with severe cerebral palsy (cp). the intervention program, called re-pact, delivers timely, customized action planning and health coaching when mobile text messaging with families predicts hospitalization risk is elevated. a total of n=90 caregivers of children with severe cp will be enrolled from the university of wisconsin-madison (uw) and the university of california, los angeles (ucla) and can expect to be on study for up to 6 months.

the two-site study takes place at clinical programs at us children's hospitals: the uw and ucla pediatric complex care pro-grams were each established to deliver care to children with medical complexity. each program is comprised of primary care providers, care coordinators, and extended visit lengths, deliver comprehensive care to children with cerebral palsy. these sites have existing collaborative relationships through their participation in the cyshcnet national research network (http://cyshcnet.org) and other federally funded initiatives, and a track record of successful productive scientific collaboration. the study period will be divided into three waves: after each wave, feasibility, acceptability, and fidelity data will be reviewed against pre-defined measures of success to adjust the protocol and overcome implementation barriers. this study will be conducted through a six-month randomized pilot trial. briefly, after recruitment and baseline assessments, eligible caregiver/child dyads are randomized to intervention (i) or active control (ac). intervention subjects receive respiratory illness action plans and weekly mobile health (mhealth) confidence surveillance. at times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. ac subjects will receive usual comprehensive medical care and coordination. assessments of feasibility, acceptability and fidelity, as well as clinical outcomes, will be conducted at baseline and monthly intervals for 6 months. intervention outcomes will be evaluated at baseline (i.e., randomization) and 6 months post-enrollment, and will also include the primary clinical outcome (i.e., hospitalization for respiratory diagnosis).

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * primary caregiver to an eligible child (child criteria below) * speak english or spanish well enough to be interviewed * have a phone capable of sending/receiving text messages * has a child * age 0-17 years * with gross motor function classification system level iv or v cerebral palsy * cared for by respiratory specialist or receive daily respiratory treatments (oxygen, ventilation, airway clearance device, medications) exclusion criteria: * lack of interest in text messaging or coaching interactions during the study

Keywords: caregiver support
a new parameter derived from dsa to evaluate cerebral perfusion

Conditions: Cerebral Ischemia

Summary: this observational study focus on a new parameter of cerebral perfusion derived form digital substraction angiography.

ischemic cerebrovascular disease is an important cause of death and disability in the world. digital subtraction angiography (dsa) is the golden index for evaluating cerebral blood vessels. we introduced a new parameter derived from dsa to evaluate the perfusion to predict the outcomes in acute stroke with large vessel occlusion. to study the possible relationship between the new parameter of cerebral perfusion derived from dsa and outcomes in cerebral ischemia（modified rankin scale）, we intend to retrospectively analyze the images derived from patients who undergone the dsa and follow-up outcomes（modified rankin scale）.

Eligibility criteria:
inclusion criteria: 1. cerebral ischemia 2. patients undergone dsa exclusion criteria: 1.cerebral hemorrhage
an interaction study with digoxin and azd1305

Conditions: Atrial Fibrillation

Summary: the primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with azd1305. secondary purposes are to learn more about how azd1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how azd1305 and digoxin administered alone and in combination affect the body.


Eligibility criteria:
inclusion criteria: * a body mass index (bmi=weight/height2) of 19 to 30 kg/m2 exclusion criteria: * potassium outside normal reference values * ecg findings outside normal range

Keywords: atrial fibrillation interaction pharmacokinetic
bay81-8781, i.v. aspirin in the indication of acute coronary syndrome (acs)

Conditions: Acute Coronary Syndrome

Summary: the objective of this study is to investigate whether intravenous administration (injected into a vein) of acetylsalicylic acid (aspirin) in doses of 250 and 500 mg is superior to oral treatment of acs with tablets containing 300 mg of aspirin.

in november 2009 it was the company's decision to cancel this study as an international trial. however, to support the local ma application of aspirin i.v. for the indication "for the initial treatment in case of suspicion of acute coronary syndrome", bayer decided to perform this trial in germany as a domestic trial, with changed number of participants and study dates.

Eligibility criteria:
inclusion criteria: * angina pectoris lasting for more than 20 minutes within the last 24 hours before study drug treatment (or equivalent acute symptoms such as increasing dyspnea, diaphoresis, nausea, abdominal/epigastric pain, syncope etc.) * ecg change suggestive for ischemia: * st elevation or t-wave change or st depression, new or presumed left bundle-branch block (lbbb) * elevated troponin t level \> 0.01 ng/ml, levels according to local laboratory reference values * risk factors for acs such as known coronary artery disease (cad), diabetes mellitus, impaired renal function, peripheral artery or cerebrovascular disease, current smoking. exclusion criteria: * treatment with acetylsalicylic acid (asa) within 48 hours prior to study drug treatment * treatment with glycoprotein iia/iiib inhibitors within 48 hours prior to study drug treatment and before the 20 minutes blood samples for thromboxane, prostacycline and platelet aggregation measurement have been taken * thrombolytic therapy within 24 hours before study drug treatment * obligation for tracheal intubation and mechanical ventilation * contraindications to asa treatment * known haemorrhagic diathesis * evidence of an active gastrointestinal or urogenital bleeding * stroke within 3 months prior to study drug treatment * major surgery including coronary artery bypass graft (cabg) within 6 weeks prior to study drug treatment * known severe hepatic or renal insufficiency * pregnant or breast-feeding women

Keywords: acute coronary syndrome acs aspirin
the follow up of chinese young children with melamine-related-calculus

Conditions: Calculus

Summary: the purpose of this study is to investigate the lesions, clinical features and outcome in young children with melamine-related-calculus.

1. to investigate the outcome of melamine-related-calculus. * the change of calculus. * the change of obstruction features,including hydronephrosis and ureterectasia. * the change of the urinalysis. 2. to investigate the change of renal function in children with melamine-related-calculus during the follow up. * creatinine, urea and uric acid. * α and β2 microglobulin. 3. to analysis the factors might be associated with the outcome. * the characteristics of patients: age, gender, and so on. * the characteristics of calculus: location, size, and so on.

Eligibility criteria:
inclusion criteria: * children with melamine-related-calculus: with a history of melamine contaminated products * the parents leave the detailed information for contact and willing to be recalled exclusion criteria: * children with other congenital renal abnormality * children with hypercalciuria * children have abnormality of parathyroid gland

Keywords: melamine calculus kidney child
continuous control of tracheal cuff pressure and microaspiration in critically ill patients

Conditions: Critically Ill

Summary: we hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

randomized controlled open label study, performed in a 10-bed icu. all patients intubated with a pvc-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). target cuff pressure is 25 cmh2o. in all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. in addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years * tracheal intubation using a polyvinylchloride tube * predictible duration of mechanical ventilation \> 48 h * enteral nutrition exclusion criteria: * refuse to participate to the study * no informed consent * contra-indication for semirecumbment position

Keywords: cuff pressure microaspiration pepsin vap mechanical ventilation
biobehavioral mechanisms of blood pressure regulation

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to investigate the role of biobehavioral factors in the pathogenesis of concentric left ventricular hypertrophy.

background: hypertension is more prevalent in black than white men, and is more prevalent in men than women. furthermore, even controlling for blood pressure, concentric left ventricular hypertrophy, an early structural adaptation of hypertension, is more prevalent in black than white men, and more prevalent in men than women. concentric left ventricular hypertrophy is the strongest predictor, other than age, of the cardiovascular morbidity associated with high blood pressure. design narrative: in a biracial sample, concentric left ventricular hypertrophy and concentric remodelling were assessed by echocardiographic measures of left ventricular mass and relative wall thickness. laboratory procedures were used to: (i) assess hemodynamic and neurohumoral responses during exposure to a diverse battery of physical and psychological stressors, and; (ii) evaluate alpha and beta adrenergic receptor responsiveness, baroreceptor reflex gain and minimal forearm vascular resistance. since blood pressure during a typical workday was an established predictor of left ventricular hypertrophy, it was also assessed. a new biobehavioral model was tested that implicated the hemodynamic pattern of behaviorally-evoked pressor responses in the pathogenesis of concentric left ventricular hypertrophy. one prediction of this model was that a predisposition to exhibit increased vascular resistance during stress (characteristic of black men) would favor the development of concentric hypertrophy. thus, systemic vascular resistance responses, evaluated in the laboratory, were hypothesized to independently predict left ventricular mass and relative wall thickness, even after controlling for established risk factors, including workday blood pressure. sympathetic nervous system function was examined to test hypothesized mechanisms responsible for race and gender differences in the hemodynamic patterns of blood pressure regulation. the results of these studies emphasized the importance of race and gender in prescribing pharmacological and/or behavioral treatment for hypertensive heart disease. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a study to evaluate the safety, tolerability and pharmacodynamics of ddp733 for ibs-c

Conditions: Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome

Summary: this study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug ddp733 in treating subjects with ibs-c. a placebo control will be utilized.


Eligibility criteria:
inclusion criteria: * subjects must have a history of ibs-c for at least 3 months prior to randomization as assessed using rome criteria * must have had endoscopic/radiologic bowel evaluation within the past 10 years * must comply with completing a daily diary and be able to comply with gi transit measurements, including swallowing capsules containing small x-ray visible markers * female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding exclusion criteria: * serious underlying diseases, including psychiatric disorders * current history of conditions affecting bowel transit * recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection * clinically significant abnormal examination findings or laboratory tests * inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments * use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome * presence of a medical condition which could interfere with the interpretation of study data * significant use of nicotine or caffeine

Keywords: ibs ibs-c
clinical evaluation of a novel incisional npwt system

Conditions: Surgical Wound

Summary: a study of the first clinical use in humans of a novel npwt system (npsims) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds

the purpose of this investigation is to test the functionality of a novel, non-electric npwt device: npsims (negative pressure surgical incision management system) from aatru medical llc (ohio, usa) which uses an exothermic chemical process to extract the oxygen from the air contained within the dressing (air contains 21% o2) and hence bring and maintain the system to between -160 and -80 mmhg below atmospheric pressure (760 mmhg). the dressing and the chemical reaction pump module can be manufactured for significantly less than the cost of electromechanical npwt systems and can be profitably marketed at a discount to the cost of existing commercial devices. the aatru medical npwt system could transform the economics and increase the availability of this therapy across the world.

Eligibility criteria:
inclusion criteria: 1. participant is male or female ≥ 18 years of age 2. participant will undergo an elective sternotomy, thoracotomy, caesarean section (c-section) or skin surgery incision with closure by sutures or staples 3. participant will undergo a surgical procedure resulting in a closed approximately linear incision between 5 cm and 13 cm in length inclusive so that the npsims dressing covers the wound with a minimum of 1 cm overlap at each end 4. participant is willing and able to take part in the study and provide written informed consent. - exclusion criteria: 1. participants will undergo post-surgical radiotherapy or chemotherapy 2. participants who, in the opinion of the investigator, have an existing health condition that would compromise their participation and follow-up in this study 3. participant will undergo emergency surgery 4. participant is sensitive to or known to have allergies to silicone/acrylic adhesives 5. participant has malignancy in the wound bed or margins of the wound 6. participant has wound with confirmed and untreated osteomyelitis 7. participant has wound with non-enteric and unexplored fistulas 8. participant has wound with necrotic tissue with eschar present 9. participant has exposed arteries, veins, nerves or organs 10. participant has exposed anastomotic sites

Keywords: incisional npwt
role of the circulating procoagulants microparticles in the hypercoagulability of mnp ph1-

Conditions: Myeloproliferative Neoplasm

Summary: patients with myeloproliferative neoplasms philadelphia chromosome negative (mpnsph1-) such as essential thrombocytosis (et), polycythemia vera (pv) and primary myelofibrosis (pmf) have a higher risk of arterial or deep-vein thrombosis. this is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in et). cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment. these last years, cellular microparticles (mps) have been shown to play a major role in thrombogenesis. mps are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. they are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation dic, etc.). the working hypothesis is that platelet microparticles are involved in the hypercoagulability of mpns patients.


Eligibility criteria:
inclusion criteria for mnps patients: * age \> 18 * establish mnps phi- diagnosis (et, pv, mfp) * consent to participate inclusion criteria for healthy volunteers: * healthy volunteers matched in age, sex with the mnps patients, with a normal complete blood and platelet count * no personal thromboembolic history * no known thromboembolic risk factor : thrombophilia, cancers, and other disease associated with a thrombotic risk (atrial fibrillation, etc.) * not pregnant * non smoker * for women, no hormonal contraceptives exclusion criteria for mnps patients: * pregnancy * patient unable to give consent

Keywords: myeloproliferative neoplasms circulating procoagulants microparticles
evaluation of different colorectal cancer screening strategies

Conditions: Colorectal Neoplasms

Summary: a large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies.


Eligibility criteria:
inclusion criteria: * 50-74 years old * informed consent is available exclusion criteria: * previous colorectal cancer * previous colorectal resection * previous received cancer-related treatment (except non-melanoma skin cancer) * colonoscopy, sigmoidoscopy, ct colonoscopy, and barium enema were performed within 5 years * fecal occult blood or fecal dna was performed within one year * symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight) * suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)
cold pressor test is used in this study to assess the effect of pf-06305591 on pain intensity evoked by cold in healthy male subjects

Conditions: Healthy

Summary: this study will evaluate the pharmacological activity of pf-06305591 in healthy male volunteers by assessing the effects of two dose levels of pf-06305591 on cold pain intensity evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests. * body mass index (bmi) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * subjects unable to tolerate pre-study cpressor testing at screening. * subjects with an average pain (auc 0 to 120 sec) in the pre-study cpressor test of less than or equal to 20. * broken skin on hands or forearms
a long-term extension trial from phase ii/iii of spm 962 in early parkinson's disease patients

Conditions: Parkinson's Disease

Summary: safety of spm 962 in a once-daily repeated long-term treatment in parkinson's disease patients who are not concomitantly treated with l-dopa will be investigated with a doses.


Eligibility criteria:
inclusion criteria: * subject completed the preceding trial 243-07-001 (nct00537485) exclusion criteria: * subject discontinued from the preceding trial 243-07-001. * subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001. * subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001. * subject had persistent hallucination or delusion during trial 243-07-001. * subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline. * subject has orthostatic hypotension or a systolic blood pressure (sbp) \ = 30 mmhg at baseline. * subject has a history of epilepsy, convulsion etc. during trial 243-07-001. * subject develops serious ecg abnormality at the baseline. * subject has qtc-interval \>= 500 msec at the baseline or subject has an increase of qtc-interval \>= 60 msec from the baseline in the trial 243-07-001 and has a qtc-interval \> 470 msec in female or \> 450 msec in male at the baseline. * subject has a serum potassium level \< 3.5 meq/l at the end of the taper period in trial 243-07-001. * subject has a total bilirubin \>= 3.0 mg/dl or ast(got) or alt(gpt) greater than 2.5 times of the upper limit of the reference range (or \>= 100 iu/l) at the end of the period in trial 243-07-001. * subject has bun \>= 30 mg/dl or serum creatinine \>= 2.0 mg/dl at the end of the taper period in trial 243-07-001. * subject who plans pregnancy during the trial. * subject has dementia. * subject is unable to give consent. * subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.

Keywords: spm 962 rotigotine parkinson's disease monotherapy