Kornimate/medical-research-clean huggingface dataset:
what are the determinant factors of ceasing anti-seizure medication in infants with neonatal seizures?

Conditions: Neonatal Seizure

Summary: the investigators aimed to determine the factors for ceasing anti-seizure medication in infants who experienced seizures during the neonatal period. this retrospective, single-center, descriptive study was conducted in balıkesir between december 2020 and february 2023, and 157 neonates were recruited.

this retrospective, single-center, descriptive study was conducted at the department of paediatric neurology between december 2020 and february 2023, and 157 neonates were recruited to determine the factors related to ceasing asm treatment in infants at a follow-up 2 years. according to the international league against epilepsy (ilae) classification of neonatal seizures and their etiology, patients who were diagnosed with such seizures and received anti-seizure medication within the first 28 days of life were followed until their asm was ceased after they were discharged from the neonatal intensive care unit. infants are defined as children aged younger than 12 months. during this stage of neuronal development, the central nervous system is more susceptible to the harmful effects of external factors. consequently, the investigators have planned to evaluate the study's initial 12-month follow-up results for our group. afterwards, the infants were divided into two groups: the first group consisted of infants who continued to receive asm treatment after 12 months of age (referred to as "infants still on asm after 12 months", n=69); the second group consisted of infants who had stopped asm treatment before 12 months of age (referred to as "infants who had ceased asm before 12 months", n=88).

Eligibility criteria:
inclusion criteria: * neonates with seizures diagnosed clinically or with conventional electroencephalography (ceeg) confirmation were enrolled. exclusion criteria: * with abnormal paroxysmal events that weren't determined to be seizures by ceeg, amplitude integrated eeg (aeeg) and video records, * stopped medications due to their parents' decisions, * with missing hospital records, * delivered from pregnancies by assisted reproductive techniques were not enrolled.

Keywords: neonate seizure early onset epilepsy anti-seizure medication acute provoke seizure
bioequivalence study of metformin hydrochloride extended release 750 mg tablets versus glucophage xr® 750 mg tablet in healthy volunteers under fasting conditions.

Conditions: Type 2 Diabetes

Summary: objective: to study bioequivalence of metformin hydrochloride extended release 750 mg tablets (test formulation, torrent pharmaceuticals ltd., india) versus glucophage xr® 750 mg tablet (reference formulation, bristol-myers squibb company, usa) in healthy volunteers under fasting conditions. study design: an open-label, randomized, 2-period, 2-treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: * volunteers must meet all of the following criteria in order to be included in the study: 1. sex: male. 2. age: 18 - 45 years. 3. volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. 4. healthy and willing to participate in the study. 5. volunteer willing to adhere to the protocol requirements and to provide written informed consent. 6. non-smokers or smoker who smokes less than 10 cigarettes a day. exclusion criteria: * the volunteers will be excluded from the study based on the following criteria: 1. clinically relevant abnormalities in the results of the laboratory screening evaluation. 2. clinically significant abnormal ecg or chest x-ray. 3. systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. 4. pulse rate less than 50/minute or more than 100/minute. 5. oral temperature less than 95°f or more than 98.6°f. 6. respiratory rate less than 12/minute or more than 20/minute 7. addiction to alcohol or history of any drug abuse within the past 2 years. 8. recent history of kidney or liver dysfunction. 9. history of allergy to the test drug or any drug chemically similar to the drug under investigation. 10. administration/ intake of prescription or otc medication for two weeks before the study. 11. patients suffering from any chronic illness such as arthritis, asthma etc. 12. hiv, hcv, hbsag positive volunteers. 13. opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, cocaine positive volunteers based on urine test. 14. volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. 15. administration of any investigational products in the period 0 to 3 months before entry to the study. 16. intake of barbiturates or any enzyme-inducing drug in last three months. 17. history of significant blood loss due to any reason, including blood donation in the past 12 weeks. the total blood loss in last 3 months including for this study will not exceed 350ml. 18. existence of any surgical or medical condition, which, in the judgement of the chief investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. 19. inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
intrapulmonary percussive ventilation for sputum induction in adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a small pilot study with the goal of identifying a superior sputum collection method in cystic fibrosis patients unable to produce a sputum. participants will use the volara system during clinic visit in an attempt to produce sputum.

since the introduction of cftr modulator therapies, most patients with cystic fibrosis (cf) have been unable to produce an adequate sputum sample for clinical monitoring. covid-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. these issues led to lack of microbiology data for clinical care. the purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. 2. currently prescribed hypertonic saline treatment as part of routine airway clearance therapy. 2. no sputum culture results in last one year or those who were unable to produce sputum from vpep method used in qi project 3771 exclusion criteria: 1. \< 18 years old 2. sputum culture results in last one year
brentuximab vedotin (recombinant) for iv infusion - special drug use surveillance (all-case surveillance) "relapsed or refractory cd30+ hodgkin's lymphoma or anaplastic large cell lymphoma"

Conditions: Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma

Summary: the purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (iv) infusion (adcetris iv infusion 50 mg) in patients with relapsed/refractory cd30+ hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.

the present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for iv infusion (adcetris iv infusion 50 mg) in patients with relapsed/refractory cd30+ hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting. the usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. the dose should be adjusted depending on the participant's condition. see the "precautions" section of the package insert.

Eligibility criteria:
inclusion criteria: * all patients treated with brentuximab vedotin iv infusion exclusion criteria: * none

Keywords: pharmacological therapy
ct coronary angiography for type 2 myocardial infarction

Conditions: Myocardial Infarction; Coronary Artery Disease

Summary: this study is to explore whether a computed tomography (ct) scan of the heart arteries might improve the care of patients that have presented with a suspected type 2 myocardial infarction (mi). the investigators hope to demonstrate that these patients may be the ideal group of patients to benefit from cardiac ct scan imaging by; 1. confirming whether they have any disease in their heart arteries 2. demonstrating the severity of the heart artery disease 3. revealing an alternative cause for their presentation 4. avoiding the need for an invasive heart artery angiogram.

an increasing number of patients present to hospital with a heart attack (myocardial infarction, mi). heart attacks can be caused by instability and narrowing in heart arteries (type 1 mi) or strain on the heart (type 2 mi). type 2 mis can be the result of other problems with the heart including inflammation and rhythm problems or other conditions such as infection or low blood count. both type 1 and type 2 mi patients have increased risk of further problems following this presentation. deciding whether a patient has suffered a type 1 mi or a type 2 mi can be very difficult leaving uncertainty for patients and health care staff. often patients with type 2 myocardial infarction are either referred for an invasive coronary angiogram (a procedure where dye is injected into the heart arteries directly) or have no further investigations. invasive angiograms carry a small risk of complications including heart attack, stroke and, rarely, death. cardiac ct scanning has emerged in the last 20 years as the first test usually performed to investigate patients that present with stable chest pain symptoms to the outpatient department. the role of cardiac ct in patients that present as an emergency with a suspected heart attack is not yet established. to date, there are no substantive data on the role of computed tomography coronary angiography (ctca) in patients with known or suspected type 2 mi. a pilot study is proposed to address the information gaps. the specific areas of uncertainty include feasibility of enrolling into an imaging trial during acute medical care, feasibility of randomisation (including compliance and cross-overs), incremental diagnostic value, safety (procedure and post-procedure) and healthcare resource utilisation. the study aims to address the gap in evidence highlighted by the recent european society of cardiology guidelines for the management of acute coronary syndromes, 'evaluating diagnostic strategies to better classify patients according to their type of mi (type 1 vs type 2)'.

Eligibility criteria:
inclusion criteria: * patients with known or suspected type 2 mi exclusion criteria: 1. unable to provide written informed consent 2. known severe coronary artery disease 3. previous pci 4. previous cabg 5. severe renal dysfunction, defined as an egfr \<30 ml/min/1.73 m2 6. tachycardia (\>75bpm) refractory to heart rate control 7. pregnancy

Keywords: computed tomography myocardial infarction coronary artery disease
a real-world study on distal aortic remodeling for stanford type b aortic dissection with fabulous thoracic aortic stent system

Conditions: Aortic Dissection

Summary: to evaluate aortic remodeling of fabulous thoracic aortic stent system in the treatment of acute and subacute stanford type b aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.

fabulous thoracic aortic stent system is specially designed for aortic dissection based on petticoat technique.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old, regardless of gender; 2. fabulous thoracic aortic stent system is suitable for the treatment of acute or subacute stanford type b dissection, and the lesions meet one of the following criteria: 1. it is necessary to treat distal lesions due to the presence of distal tears; 2. the dissection involved a wide range, and there was collapse of the distal true cavity; 3. dissection combined with poor perfusion of distal branch vessels. 3. with appropriate arterial access and suitable for endovascular aortic repair; 4. subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol. exclusion criteria: 1. patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint; 2. patients were unable or unwilling to participate in the study; 3. patients were judged by the investigator to be ineligible for participation in the trial.

Keywords: stent graft
consumer evaluation of intermittent catheter product modifications

Conditions: Urinary Incontinence

Summary: this study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.


Eligibility criteria:
a. inclusion criteria for arm 1 subject who: 1. is male and at least 18 years of age 2. has been performing unassisted, self-catheterizations, with a hollister standard with tip hydrophilic intermittent catheter, 3 or more times a day for at least 1 month b. exclusion criteria for arm 1 subject who: 1. is currently undergoing chemotherapy, radiation or steroid therapy 2. has a symptomatic urinary tract infection (uti) 3. is currently using a coude intermittent catheter product to perform catheterization 4. performs non-urethral catheterization c. inclusion criteria for arm 2 subject who: 1. is male and at least 18 years of age 2. has been performing unassisted, self-catheterizations, with a non-standard with tip hydrophilic intermittent catheter, 3 or more times a day for at least 1 month d. exclusion criteria for arm 2 subject who: 1. is currently undergoing chemotherapy, radiation or steroid therapy 2. has a symptomatic urinary tract infection (uti) 3. is currently using a coude intermittent catheter product to perform catheterization 4. performs non-urethral catheterization 5. is unable to use a hollister standard with tip hydrophilic intermittent catheter

Keywords: intermittent catheterization
postural changes in lung volumes in obesity

Conditions: Obesity

Summary: postural changes are known to affect normal lung volumes. a reduction in sitting to supine functional residual capacity (frc) is well-described in non-obese subjects adopting a supine position. however, postural changes in lung volumes in the obese require further exploration. we aimed to longitudinally address the effects of weight loss on postural changes in lung volumes and pulmonary function, in obesity. we tested the hypothesis that supine reduction in frc would be absent in morbid obesity and recovered upon weight loss.


Eligibility criteria:
inclusion criteria: * subjects scheduled for bariatric surgery (bmi over or equal to 40 kg/m2) exclusion criteria: * subjects with respiratory and cardiac history (asthma, copd, heart failure) were excluded.

Keywords: obesity, lung volumes, postural changes
early results of coronary artery reconstruction for extensive coronary disease

Conditions: Coronary Reconstruction

Summary: evaluation of early outcome obtained from coronary reconstruction with or without endarterectomy in extensive diseased coronary arteries


Eligibility criteria:
inclusion criteria: * primary elective cabg patients patch anastomosis more than 2 cm exclusion criteria: * patients with combined valvular procedure. previous open heart surgery patients with ef \<40%
topical antibiotics for prevention of intensive care unit (icu) central line infections

Conditions: Blood Stream Infections; Skin Diseases, Infectious

Summary: the purpose of the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of polysporin triple therapy ointment to the insertion site.

previous studies in the dialysis population have found a reduction in local and system central venous catheter related infections with the application of topical antibiotics to the insertion point. one such study found a mortality benefit with polysporin triple therapy ointment. we intend to determine if this preparation can reduce overall line infection rates in the icu environment through its application at the time of line insertion and twice more the following week.

Eligibility criteria:
inclusion criteria: * all patients admitted to the icu requiring a central venous catheter exclusion criteria: * previous line infection during same icu stay * cvc for hemodialysis

Keywords: blood stream infections catheter related infections central venous catheter related infections line sepsis topical antibiotics bacitracin polymixin gramicidin polysporin triple therapy intensive care unit
post covid-19 infection central sensitisation 2

Conditions: Covid19

Summary: the aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

the covid-19 pandemic is currently a serious global public health concern. this disease is caused by a novel coronavirus which was first discovered in wuhan, china in 2019 and later spread rapidly throughout the world. symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. in 17% to 67% of cases, covid-19 patients will develop acute respiratory distress syndrome (ards) and critical illness. besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system. the term central sensitivity syndrome (css) describes a group of medically nonspecific disorders, such as fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome, for which central sensitivity might be a common etiology. despite the lack of a solid outcome measurement, the central sensitization inventory (csi) was previously introduced as a screening instrument for clinicians to help identify patients with a css. furthermore, quantitative sensory testing can be used to identify and quantify sensory disfunctions by evaluating a variety of parameters including pain thresholds, temporal summation, and conditioned pain modulation (cpm). previous research in patients with chronic pain resulted in less efficacious cpm, increased nociceptive facilitation and decreased pain thresholds. in post covid-19 patients, potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. persisting symptoms are a frequently reported complaint in patients recovered from covid-19 infection with at least 1 symptom, particularly fatigue and dyspnea. fatigue is also one of the core symptoms in central sensitisation disorders, leading to the hypothesis that central sensitisation might be the underlying common etiology in chronic pain patients and patients post covid-19 infection. therefore, the aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

Eligibility criteria:
inclusion criteria: * patients with a diagnosed covid-19 infection that took place 2-8 weeks before study inclusion. * cognitive and language functioning enabling coherent communication between the researcher and the participant. * french-or dutch speaking persons. exclusion criteria: * covid-19 infection \> 8 weeks ago.
determinants of compliance with glaucoma therapy

Conditions: Open Angle Glaucoma

Summary: the purpose of this study is to determine which medical, demographic, and health belief factors are associated with glaucoma therapy compliance.


Eligibility criteria:
inclusion criteria: * open angle glaucoma * be well controlled on current medical therapy * be using a prostaglandin analogue

Keywords: open angle glaucoma compliance adherence
infant nutrition: evaluation of an educational touchscreen computer program

Conditions: Obesity

Summary: the investigators are recruiting participants for a randomized controlled trial to evaluate the usability and educational value of a nutrition education touchscreen computer program targeting spanish-speaking latina caregivers of children 2 and under. participants will be randomized to the intervention group - use the computer program and the control group - do not use the program. they will be asked basic demographic questions, nutrition knowledge questions and computer users will be asked usability questions. objectives are 1. evaluate the subjective and objective usability of the touchscreen computer. 2. determine whether health knowledge on nutrition topics is enhanced through the use of the computer modules.


Eligibility criteria:
inclusion criteria: * 1. have a child 2 and under in their care 2. consider themselves latina 3. are spanish-speaking exclusion criteria: exclude if child has major medical issues interfering with feeding
incisional negative pressure wound therapy to reduce infection and complications in high-risk fractures

Conditions: Fracture of Tibia; Wound Heal; Infected Wound; Wound Complication; Wound Dehiscence

Summary: this is a multi-center, pragmatic, parallel arm randomized controlled trial (rct) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. eligible participants will be randomized to receive either incisional negative pressure wound therapy (npwt) or a non-suction standard-of-care wound dressing for their definitive wound management. the primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. the secondary outcomes will independently assess the components of the primary outcome.


Eligibility criteria:
inclusion criteria: 1. all open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. any open gustilo type i, ii or iiia tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed. 2. we define high-risk fractures as those that are either: * closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved; * any open type i, ii or iiia fracture, regardless of timing of definitive treatment; * any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed 3. requiring incision for fixation or debridement of 3 cm or greater. 4. patients 18 years of age or older exclusion criteria: 1. the study injury is already infected at time of study enrollment. 2. patient is unable to receive incisional npwt for any reason. 3. patients who have already had definitive fixation prior to enrollment in the study. 4. severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners). 5. the study injury is a gustilo type iiib or iiic open fracture.