Kornimate/medical-research-clean huggingface dataset:
randomized crossover of nava and synchronized intermittent pressure ventilation in neonates and infants

Conditions: Respiratory Insufficiency; Infant, Newborn, Disease

Summary: this study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on neurally adjusted ventilatory assist (nava) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (simv(pc) + ps) modes. this design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (nicu) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure. it is hypothesized that neonates and infants will have improved respiratory severity score (map x fio2) utilizing nava compared to the simv (pc) + ps mode but will have increased estimated energy expenditure.

this single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the nava or simv(pc) + ps modes. this design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (nicu) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure. infants will be screened for stability criteria including: being stable on the ventilator in either simv (pc) + ps or nava mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours. after screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. after the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. data will then be collected for 12 hours afterwards in the crossover mode. data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. while in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.

Eligibility criteria:
inclusion criteria: * neonates and infants, 22 weeks gestation age or older at birth * require mechanical ventilation for respiratory support in either simv (pc) + ps or nava modes * stable on the ventilator with a fractional inspired oxygen requirement (fio2) of 0.60 or less. * stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours. exclusion criteria: * major congenital anomalies * neurologic compromise of respiratory drive * phrenic nerve palsy * sedated enough to suppress respiratory drive * respiratory support with volume mechanical ventilation * respiratory support with high frequency oscillatory ventilation
clinical and kinematic assessment for determination of botox® injection parameters in cervical dystonia

Conditions: Cervical Dystonia

Summary: this study investigates the use of a kinematic measurement device to quantify the abnormal head movements and postures in patients with cervical dystonia (cd) in order to individualize and optimize botulinum toxin type a (bont-a) injection therapy. a single sensor captures five degrees of freedom of the neck and head that distinguish which muscle(s) contribute to cd and the amount of bont-a to inject into these muscle(s). the efficacy, relief and improvements in social, occupation and function by injections will be investigated. the efficacy of bont-a therapy using either bont-a injection parameters from clinical-based assessments and kinematically-based assessments will be investigated in cd patients. individuals clinically diagnosed with cd will be randomized for two treatment conditions: a) injection parameters from a kinematic assessment only, or b) injection parameters from a clinical assessment only.


Eligibility criteria:
inclusion criteria: * consenting male and female individuals between the ages of 18 and 80 * diagnosed with idiopathic spasmodic torticollis (also called cervical dystonia) by neurologist * botulinum neurotoxin type a injection(bont a; botox®) naïve individuals will be randomized into either clinical-assessment arm or kinematic-assessment arm and the participants will be blinded to which arm they are a part of * cd individuals who are receiving suboptimal bont-a effects will be recruited to receive kinematic-based injections. these participants will have to wait a minimum of 4 months before participating in this study * able to attend all study sessions * able to provide written consent exclusion criteria: * pregnant individuals * women who are nursing * individuals with a known botox® allergy * individuals with a known or suspected traumatic cause for the torticollis, a prior thalamotomy, or peripheral (nerve or muscle) operation * individuals with cervical contractures that limit passive range of motion * motor/nerve diseases such as myasthenia gravis, other diseases of the neuromuscular junction and/or amyotrophic lateral sclerosis * myotomy or denervation surgery involving the neck or shoulder region
long-term characterization of gore® tag® conformable thoracic stent graft with active control system performance

Conditions: Vascular Disease; Dissection; Dissection Aortic Aneurysm; Dissection of Aorta; Aneurysm Thoracic; Aneurysm Dissecting; Transection Aorta; Intramural Hematoma

Summary: an observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with gore® tag® conformable thoracic stent graft with active control system as a part of routine clinical practice. this post-market registry for the gore® tag® conformable thoracic stent graft with active control system (ctag w/ac) is intended to demonstrate that thoracic endovascular aortic repair (tevar) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.


Eligibility criteria:
inclusion criteria: 1. patient or legally authorized representative (lar) provides written authorization and/or consent per institution and geographical requirements. 2. patient has been or is intended to be treated with an eligible registry device.\* 3. patient is age ≥ 18 years at time of informed consent signature. * the intent to treat a patient with a gore product must be made prior to soliciting for possible registry participation. if pre-procedure consent is not feasible, consent prior to the time of discharge for the index procedure is acceptable. exclusion criteria: 1. patient who is, at the time of consent, unlikely to be available for standard of care (soc) follow-up visits as defined by the site's guidelines and procedures. 2. patient with exclusion criteria required by local law. 3. patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study\* within 12 months of together registry enrollment. subjects cannot be enrolled in another together registry module protocol. * the term "study" does not apply to other observational registries or quality improvement projects. collection of registry device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).

Keywords: endovascular ctag post-market registry observational multi-regional real world data together registry gore together registry gore together aortic registry conformable thoracic stent graft tgr 23-02ta tgr23-02ta gore tag
study on the influence of dyadic psychoeducational intervention on patients with maintenance hemodialysis

Conditions: End Stage Renal Disease on Dialysis

Summary: this study aims explored the effectiveness of dual psychological intervention strategies in improving the quality of life of mhd patients based on the theoretical guidance of double abc-x model. to provide a scientific and effective dual psychological intervention strategy for mhd patients and their caregivers, in order to improve the quality of life of mhd patients, and to provide a reference for nurses in clinical blood purification centers to implement psychological intervention.


Eligibility criteria:
inclusion criteria: * the inclusion criteria of mhd patients were: (1) meeting the diagnostic criteria of ckd; (2) maintenance hemodialysis at the blood purification center of our hospital for more than 3 months; (3) over 18 years of age; (4) volunteer to participate in this study. * mhd caregiver inclusion criteria: (1) over 18 years of age; (2) responsible for the main care tasks of mhd patients; (3) volunteer to participate in this study. exclusion criteria: * exclusion criteria for mhd patients: (1) patients with cognitive impairment or audio-visual impairment unable to communicate normally; (2) patients diagnosed with mental illness or who are receiving medication or psychotherapy for depression. * mhd caregiver exclusion criteria: (1) caregivers with cognitive impairment or audiovisual impairment unable to communicate normally; (2) caregivers suffering from serious heart, brain, liver, kidney and other important organ diseases; (3) carers or paid carers.

Keywords: double abc-x model; mhd; quality of life; dyadic psychological intervention strategy
effect of using an object handling serious game on upper limb rehabilitation for children with neurological disorders

Conditions: Neurologic Disorder

Summary: cerebral palsy, and more broadly neurological disorders, can lead to significant motor impairments that impact individuals' daily lives. to address these limitations, the french national authority for health has issued recommendations for rehabilitative care, highlighting intensive training programs, physical activity, and interactive computer games. scientific literature has also demonstrated the benefits of therapies that incorporate repetition. in this study, the investigators aimed to train patients in producing grasp-and-release movements, and more broadly \*reach-to-grasp\* actions, in a manner intensified by movement repetition. to mitigate the boredom inherent to such repetitive tasks, the invesigators developed a device resembling a serious game, equipped with software, a modular physical platform, and two instrumented figurines designed to interact with the software. intensive therapy through repetitive movements, supported by the engaging nature of serious games, is expected to improve the manual skills of children with neurological disorders causing motor impairments. to test this hypothesis, a cohort of 5 to 10 children aged 4 to 17 years with neurological disorders causing motor impairments will be invited to participate in the protocol. participants will first undergo a baseline assessment, which will include repeated measurements of their score on the \*box and blocks test\* and the active range of motion (arom) of the wrist in extension and supination. an \*assisting hand assessment (aha)\* test will also be conducted. following this, a 4-week intervention will be implemented, consisting of three 40-minute sessions per week. during these sessions, the child will play the game and complete the \*box and blocks test\* as well as active range of motion assessments. in total, approximately 4 hours of gameplay is estimated over the course of the intervention, which will conclude with a repeat of the aha test. a follow-up assessment will take place two months after the intervention's end, with a single measurement of the three parameters (\*box and blocks test\*, arom, and aha).


Eligibility criteria:
inclusion criteria: * neurological disorder causing motor impairment * age 4 to 17 years old * macs level i to iii * ability to cooperate, understand, and follow simple instructions to play the game. * patient affiliated with the french social security system. * voluntary patient whose parents have given consent for their child to participate in the study. exclusion criteria: * a diagnosis of photosensitive epilepsy mentioned in the medical record and/or a note in the child's medical record or reported by the parents of a history of seizures triggered by video game use. * botulinum toxin treatment within the 3 months prior to the study or intensive rehabilitation of manual skills (e.g., mcimt, habit, etc.). * sensory and/or cognitive impairments that would interfere with playing the game.
thalidomide in combination with temodar in patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumor

Summary: the purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.

* patients will receive thalidomide orally once daily continuously unless they experience significant side effects. temodar is given orally once a day for one week, followed by a one week break period. this one week on/one week off schedule will continue for the duration of treatment unless there are significant side effects. * after eight weeks (2 cycles) a ct scan will be performed to see how the treatment has affected the patient's tumor. patients will continue taking the study drug unless there is evidence of tumor growth. * regular blood tests will be done weekly during the first two months to make sure that the treatment is not resulting in serious side effects. if there are no side effects during the first two months, the blood tests may decrease in frequency to every two weeks. * immediately after the patient has completed the study they will be evaluated by physical exam, blood work, and a ct scan. the follow-up will consist of clinic visits and phone calls every 3 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma * prior treatment with chemoembolization or cryotherapy is allowed * radiotherapy is allowed if completed more than 4 weeks prior to study. * measurable disease as defined by recist criteria * age greater than or equal to 18 years. * ecog performance status of less than or equal to 2 * anc \>1,500/mm3 * platelet count \> 100,000/mm3 * hemoglobin \> 9 g/dl * serum creatinine \< 1.5 x uln * total bilirubin \< 2 x uln * sgot and sgpt \< 2 x uln * alkaline phosphatase \< 2 x uln * life expectancy of greater than 12 weeks exclusion criteria: * clinically symptomatic central nervous system metastases or carcinomatous meningitis * myocardial infarction in past 6 months * major surgery in past two weeks * uncontrolled serious medical or psychiatric illness * insufficient recovery from all active toxicities of prior therapies * active nonmalignant systemic disease * frequent vomiting or medical condition that could interfere with oral medication intake * known hiv positivity or aids-related illness * pregnant or nursing women

Keywords: thalidomide temodar metastatic neuroendocrine tumor unresectable neuroendocrine tumor
yasmin 20 cycle control - yasmin 20 versus mercilon in healthy female volunteers

Conditions: Contraception

Summary: the purpose of this study is to compare bleeding pattern of contraceptive yasmin 20 to a marketed comparator.


Eligibility criteria:
inclusion criteria: * healthy female volunteer aged 18-35, * smokers 18-30 exclusion criteria: * contraindications for using hormonal contraceptives

Keywords: contraception, cycle control, bleeding pattern
follow up study of patients having participated in clinical trial 64,185-204

Conditions: Hyperbilirubinemia, Neonatal

Summary: the objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with pt used to treat hyperbilirubinemia compared with patients in the control (placebo plus pt) group in clinical trial 64,185-204.

outcomes will be based on the following variables: reported aes and saes hearing assessments developmental assessments

Eligibility criteria:
inclusion criteria: * patients who received imp (stannsoporfin or placebo) in clinical trial 64,185-204 * parents or guardians have given written informed consent to participate

Keywords: stannsoporfin
momelotinib in transfusion-dependent adults with primary myelofibrosis (pmf) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-pv/et mf)

Conditions: Primary Myelofibrosis (PMF); Post-polycythemia Vera (Post-PV) Myelofibrosis; Postessential Thrombocythemia (Post-ET) Myelofibrosis

Summary: this study will evaluate the transfusion independence response rate in transfusion-dependent adults with myelofibrosis after treatment with momelotinib (mmb).


Eligibility criteria:
key inclusion criteria: * diagnosis of pmf or post pv/et-mf * requires myelofibrosis therapy, in the opinion of the investigator * high risk or intermediate-2 risk defined by dynamic international prognostic scoring system (dipss) or intermediate-1 risk defined by dipss and associated with symptomatic splenomegaly and/or hepatomegaly * transfusion dependent at baseline, defined as ≥ 4 u red blood cell (rbc) transfusion in the 8 weeks prior to first dose of mmb * acceptable organ function as evidenced by the following: * platelet count ≥ 50 x 10\^9/l * aspartate aminotransferase (ast/sgot) and alanine aminotransferase (alt/sgpt) ≤ 3 x upper limit of normal (uln) or ast or alt ≤ 5 x uln if liver is involved by disease process as judged by the investigator * serum creatinine ≤ 2.0 mg/dl or calculated creatinine clearance of ≥ 60 ml/min * direct bilirubin ≤ 2.0 x uln * life expectancy of \> 24 weeks * males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * lactating females must agree to discontinue nursing before mmb administration * able to understand and willing to sign the informed consent form key exclusion criteria: * prior splenectomy * splenic irradiation within 3 months prior to the first dose of mmb * prior treatment with mmb * known positive status of human immunodeficiency virus (hiv) * chronic active or acute viral hepatitis a, b, or c infection (testing required for hepatitis b and c), or hepatitis b or c carrier * use of strong cytochrome p450 3a4 (cyp3a4) inducer within 2 weeks prior to the first dose of mmb * uncontrolled intercurrent illness per protocol * treatment with a janus kinase (jak) inhibitor within 21 days of the planned first dose of mmb * presence of peripheral neuropathy ≥ common terminology criteria for adverse events (ctcae) grade 2 * unwilling or unable to undergo a mri per requirements in the study protocol * unwilling to consent to genomics sampling note: other protocol defined inclusion/exclusion criteria may apply.
pioglitazone as an adjunct for moderate to severe depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine whether pioglitazone as an adjunct to citalopram is effective in treatment of moderate to severe depression

pioglitazone as a ppar-gamma agonist is an anti diabetic drug. it was also shown that, it has certain anti inflammatory and neuro-protective effects. in recent years it has been proposed that ppar-gamma agonists may have effects on mood and cognition. in animal studies and in one human case report as well as a pilot study on human subjects these drugs improved symptoms of depression. a randomized controlled and double blind design will provide further evidence for the efficacy of these drugs in major depressive disorder.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder based on dsm-iv tr criteria * age 18-50 * hamilton depression rating scale \>=22 * signing the informed consent form * citalopram be the drug of choice for the patient irrespective of other eligibility criteria exclusion criteria: * problems in other axes * pregnancy and lactation * serious or life threatening disease * taking other antidepressant in the recent month or electroconvulsive shock in the recent two months, and taking other psychotropic agents * diabetes controlled with drugs or insulin (patients with only lifestyle interventions will be included), liver disease, congestive heart failure class iii and iv * metabolic syndrome

Keywords: major depressive disorder pioglitazone double blind placebo controlled
diagnostic value of circrna-uck2 for acute myocardial infarction

Conditions: Cardiac Disease; Diagnoses Disease; Acute Myocardial Infarction

Summary: this is an observational diagnostic study that aims to evaluate the diagnostic value of circrna-uck2 in acute myocardial infarction (ami) in adults as compared to healthy and unstable angina controls. rapid and adequate diagnosis of ami is of great importance to enable a rapid start of treatment, save large tracts of dying myocardium, reduce the infarct size,and thereby decrease the risk of subsequent heart failure.

rational acute myocardial infarction (ami) is the leading cause of sudden death and heart failure worldwide. and about 10% of all emergency department consultations are with symptoms suggestive of ami, however, only 10% to 20% of them are diagnosed as experiencing an ami. rapid and accurate identification of ami is of paramount clinical importance for subsequent timely and effectively treatment and management. recently, the investigators identified microarray analysis and real-time polymerase chain reaction (pcr) from ami animal models and small samples of ami patients, a molecular signature of ami involving 5 circrnas (circrna_006877, circrna_015350, circrna_002969, circrna_013240, circrna_004682) was found significantly change in ami patients and likely serves as candidate serum biomarkers of ami. among the 5 circrnas, circrna_006877 name of circrna-uck2 (cuck2) has more close association with ami. type of study : multicenter diagnostic evaluation study main purpose of the study : to evaluate the diagnostic value of circrnas in ami in adults as compared to healthy and unstable angina controls secondary objectives : assess the ability of cuck2 to discriminate a ami disease from unstable angina patients in adults. explore the relationship between cuck2 and heart function after myocardial infarction products of the study diagnostic kit of ami in quantitative polymerase chain reaction (qpcr) number of patients : 3 groups with 169 patients will be included group 1: 66 ami adult patients group 2: 56 unstable angina adults group 3: 56 witnesses healthy adults inclusion length 36 months duration of the study 42 months

Eligibility criteria:
inclusion criteria: * health control group:pepole who have normal ecg, deny the history of cardiovascular disease can be included in the healthy control group. * acute myocardial infarction group:clinical diagnosis of acute myocardial infarction * unstable angina group:clinical diagnosis of unstable angina. * sign informed consent. exclusion criteria: * myocarditis, hypertrophic cardiomyopathy, ablation. * malignant hypertension, severe arrhythmia. * chronic muscle disorders, rhabdomyolysis. * severe liver and kidney dysfunction. * malignant tumors, acute cerebrovascular disease. * severe neurosis, psychosis. * patients who had any of the above were excluded.