Kornimate/medical-research-clean huggingface dataset:
neurologocal symptoms in chd

Conditions: Neurological Disorders

Summary: the aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment

congenital heart defects are significant structural abnormalities affecting the heart and major intrathoracic vessels. they are among the most common birth defects, constituting about one-third of all major congenital anomalies. many of these defects necessitate surgical intervention during early childhood. advances in surgical techniques have significantly improved survival rates for patients with congenital heart disease (chd). however, a variety of systemic complications have become more apparent, including issues affecting the cardiac, pulmonary, gastrointestinal, neurological, and nephrological systems (walaa el naga et al., 2022). neurological complications greatly contribute to morbidity and mortality in pediatric chd patients, significantly impacting their neurodevelopmental outcomes. various studies indicate that up to 30% of children with congenital heart disease (chd) experience neurological complications. seizures are the most frequently reported neurological complication, accounting for approximately 70% of cases with neurological sequelae (aly el kazaz et al., 2022). also neuropsychological studies of children with complex chd reveal distinct deficits in intelligence, cognitive performance, executive function, language skills, visuospatial abilities, and attention. (guo et al., 2021). recognizing the long-term consequences of accumulated brain injury underscores the importance of identifying and minimizing early insults. (le h.sterling et al., 2021) the recognized neurodevelopmental challenges faced by children with chd prompted the american heart association to recommend routine neurodevelopmental evaluations for high-risk patients with chd. according to the american heart association, the initial visit, conducted before 12 months of age, should include a neuromotor examination assessing muscle tone, primitive and deep tendon reflexes, sensory status, and gross motor skills. although many children with chd now undergo these recommended neurological examinations, the examinations and their outcomes have not been thoroughly described. additionally, factors predicting abnormal neurological examination results have not been identified. enhancing our understanding of the findings from these routinely recommended evaluations will improve the detection of abnormalities, thereby optimizing support for children with chd and their families.(le samantha butler et al., 2023).

Eligibility criteria:
inclusion criteria: - children from 3 years to 18 years with congenital heart disease exclusion criteria: * new born infants. children with normal heart. children with chromosomal or metabolic disease.
mavric vr icd registry

Conditions: Ventricular Tachycardia; Ventricular Fibrillation

Summary: the purpose of this registry is to collect information on the health status of patients receiving marquis/maximo vr implantable cardiac defibrillators (icds), how the devices are being programmed and how this correlates to clinical patient outcome.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients implanted with a new or replacement marquis vr or maximo vr icd exclusion criteria: * patients enrolled in a device study that affects treatment and/or programming

Keywords: defibrillators llecg ventricular tachycardia ventricular fibrillation
luteal phase fsh in the ivf poor responder

Conditions: Infertility

Summary: in vitro fertilization (ivf) is a common procedure used to assist couples who have difficulty conceiving a pregnancy. ivf is a process where oocytes (eggs) are retrieved from a woman's ovaries and fertilized with sperm in the laboratory. in order to maximize the number of oocytes that can be retrieved, a women undergoes ovarian stimulation with recombinant follicle stimulating hormone (fsh). typically 6-20 oocytes are retrieved, but in some cases there is a limited response to the stimulation, producing a limited number of oocytes. this is called poor ovarian response. this study is designed to objectively compare two treatment regimens currently advocated in clinical practice, but never compared directly. the purpose is to assess ovarian response to starting treatment at the end of the preceding cycle may increase the number of developing oocytes.


Eligibility criteria:
inclusion criteria: 1. infertile women planning to undergo ivf 2. poor ovarian response in most-recent previous ivf cycle within the past 18 months as defined by the following criteria: a) \<5 dominant follicles day of hcg, b) \<5 oocytes retrieved, or c) cancellation of a previous ivf cycle due to poor response to ovulation stimulation. 3. aged 20-42 (inclusive) at the time of randomization 4. presence of both ovaries 5. normal pap smear within past three years 6. at least 45 days after the last ivf cycle 7. be willing and able to comply with the protocol for the duration of the study 8. have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. exclusion criteria: 1. clinically significant systemic disease 2. current regular cigarette smoking by patient report 3. known to be positive for human immunodeficiency virus 4. any medical condition which, in the judgment of the investigator and sponsor, may interfere with the absorption, distribution, metabolism or excretion of the medications used 5. abnormal, undiagnosed gynecological bleeding 6. known allergy or hypersensitivity to human gonadotropin preparations 7. simultaneous participation in another investigational drug or device trial 8. subject fails, in 2 separate menstrual cycle attempts, to have fsh ≤12.0 and an ultrasound exam within normal limits (per standard for ivf) at the baseline visit 9. for subjects randomized to the luteal phase regimen, failure to ovulate in 2 separate menstrual cycle attempts, as evidenced by ovulation predictor kit, progesterone level, and /or visualization of corpus luteum cyst on an ovary by ultrasound exam at the luteal visit

Keywords: infertility in vitro fertilization
study to evaluate the safety and efficacy of ari0002h, for the initial treatment of patients with primary plasma cell leukaemia

Conditions: Leukemia, Plasma Cell

Summary: phase ii, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ari0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (pcl). the study population is patients between 18 and 75 years of age with newly diagnosed primary plasma cell leukemia (ppcl), with a life expectancy of more than 3 months. the primary objective is to assess the safety and efficacy of cartbcma ari0002h (cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.


Eligibility criteria:
inclusion criteria: 1. patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to international myeloma working group (imwg). 2. disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the "international myeloma working group". 3. ecog performance status from 0 to 2 4. life expectancy greater than 3 months. 5. adequate venous access and absence of contraindications for lymphoapheresis. 6. patients who, after being informed, give their consent by signing the informed consent document. 7. up to two cycles of previous treatment for symptomatic control will be allowed before inclusion. exclusion criteria: 1. no previous treatments, except for induction therapy for primary plasma cell leukemia. 2. administration of any anti-bcma therapy as part of induction 3. not having achieved at least a minimal response with induction treatment (imwg criteria) 4. absolute lymphocyte count \<0.1x109/l 5. active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent). 6. any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma. 7. active infection requiring treatment. 8. active hiv, hbv, or hcv infection. 9. uncontrolled medical illness 10. severe organ impairment that meets any of the following criteria: ef\ 3 times the upper limit of normality (unless due to gilbert syndrome) 11. previous diagnosis of symptomatic al amyloidosis, 12. pregnant or lactating women. women of childbearing potential must have a negative pregnancy test at the screening phase. 13. women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods\* from the beginning of the study to completion of the study. 14. men who are unable or unwilling to use highly effective contraceptive methods\* from the beginning of the study to completion of the study. 15. contraindication to receive lymphodepletive chemotherapy.
effectiveness of micronutrient supplementation and fish oil + micronutrient supplementation in the treatment of environmental enteropathy

Conditions: Environmental Enteropathy

Summary: the purpose of this study is to investigate the therapeutic effectiveness of micronutrients (full rda) and micronutrients + fish oil as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural malawian children at high risk for environmental enteropathy.


Eligibility criteria:
inclusion criteria: * 1-3 years of age * lives in study villages * will not move in next 6 months * caregiver willing to give intervention daily for 6 months exclusion criteria: * unable to drink 20 ml of sugar water * demonstrating evidence of severe acute malnutrition, whz \< or = -3, presence of bi-pedal pitting edema * apparent need for acute medical treatment for an illness or injury * caregiver refusal to participate and return for 3 and 6 month follow-ups
the effect of omega -3 supplements on the serum levels of ace/ace2 ratio as a potential key in cardiovascular disease and covid-19; a randomized clinical trial in the covid-19 uninfected jordanian people

Conditions: Cardiovascular Risk Factor; Covid19

Summary: the renin-angiotensin-aldosterone system (raas) is involved in blood pressure regulation and electrolyte balance. angiotensin-converting enzyme (ace) is a critical regulator of raas by cleaving angiotensin (ang1) to angiotensin2 (ang2), which is the most powerful biologically active product of raas \[1\]. in the same context, angiotensin-converting enzyme 2 (ace2) converts ang2 to ang (1-7), which is a vasodilator, antithrombotic, and antihypertrophic peptide \[2\]. ace2 which is found in many tissues \[3\] has opposite effects to ace on the heart, kidneys, and lungs \[4\]. many pathological conditions, in particular cardiovascular disease (cvd), have shown a link between a disturbance in ace/ace2 ratio and the downregulation of ace2 levels \[5\]. also, ace/ace2 has been reported to be higher in moderate to severe chronic heart failure \[6\] as well as systolic blood pressure \[7\]. recently, an elevated ace/ace2 ratio is linked to coronavirus disease 2019 (covid-19). sars-cov2 enters target cells by binding of the spike protein to ace2 and a specific transmembrane serine protease 2 (tmprss2) for the spike (s) protein priming, which also leads to downregulation of ace2 \[8\]. down-regulation of ace2 caused by coronavirus may have a potential role in the pathogenesis of covid-19 infection. accordingly, people with a higher ace/ace2 ratio may be more at increased risk of worse covid-19 consequences \[9\]. on the other hand, omega-3 fatty acids could decrease cvd risk by their anti-inflammatory anti-thrombotic function \[10\]. a meta-analysis comprising 15,806 patients, showed that omega-3 fatty acids associated with a 30% reduction in fatal myocardial infarction and sudden death, in addition to a 20% reduction in overall mortality \[11\]. to the best of our knowledge, no clinical trials have evaluated the effect of omega-3 supplementation on serum ace/ace2 ratio which is recently ascribed as a potential key in 2019 covid-19 as well as cvd \[5,9\].


Eligibility criteria:
inclusion criteria: * inclusion criteria included males and females in the age range of 35-65 years without a medical diagnosis of covid-19 infection. exclusion criteria: * any subject with any chronic disease such as cvd, diabetes, or immune problems, including autoimmune diseases, chronic or severe infections was excluded. * pregnant, breastfeeding, and females using hormonal contraceptives were excluded.
phenotyping and identification of biological markers in stxbp1 encephalopathy

Conditions: STXBP1 Encephalopathy With Epilepsy

Summary: this is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the stxbp1 gene. the study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. these patients will be followed up for 3 years. the aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (eeg, mri and study of specific proteins and neurotransmitters in plasma, urine and csf).


Eligibility criteria:
inclusion criteria: * patients under 10 years of age with confirmed mutation for stxbp1. in cases where the diagnostic technique for the mutation is not optimal, a trio exome will be performed to confirm the mutation. exclusion criteria: * presence of functional disability that prevents the neuropsychological study from being carried out and absence of a reliable informant for the patient.

Keywords: stxbp1
a study to evaluate the efficacy and safety of bimekizumab compared to placebo and an active comparator in adult subjects with moderate to severe chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis

Summary: this is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (pso).


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * chronic plaque psoriasis (pso) for at least 6 months prior to the screening visit * psoriasis area severity index (pasi) \>=12 and body surface area (bsa) affected by pso \>=10% and investigator's global assessment (iga) score \>=3 on a 5-point scale * subject is a candidate for systemic pso therapy and/or phototherapy * female subject of child bearing potential must be willing to use highly effective method of contraception exclusion criteria: * subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections * subject has concurrent acute or chronic viral hepatitis b or c or human immunodeficiency virus (hiv) infection * subject has known tuberculosis (tb) infection, is at high risk of acquiring tb infection, or has current or history of nontuberculous mycobacterium (ntmb) infection * subject has any other condition, including medical or psychiatric, which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study * presence of active suicidal ideation or positive suicide behavior * presence of moderately severe major depression or severe major depression * subject has any active malignancy or history of malignancy within 5 years prior to the screening visit except treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Keywords: bimekizumab pso psoriasis
a study evaluating a urinary catheter with different activation times for the wetting solution, in healthy male volunteers.

Conditions: Urinary Catheterization

Summary: the primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting solution (using two different activation times) with a standard reference catheter. the hypothesis is that the subjects' perception of catheterization is the same or more positive when using the test catheters compared to the reference catheter.

the study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers. all subjects will first be catheterized with a reference catheter, which is proven to be well tolerated by most subjects. this catheter will be used as a reference catheter to be compared with the randomized catheters. one more reason for this first test is to withdraw subjects who cannot tolerate catheterizations. subjects will qualify for the randomized part of the study only if the first catheterization could be performed without significant discomfort. when the subject is randomized he will be catheterized with two urinary catheters in a randomized order during one day. the activation times for the wetting solution will be 5 seconds and 24 (± 2h) hours. during each catheterization, the friction at withdrawal will be measured for the catheter using a tension test system. the subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in sweden.

Eligibility criteria:
inclusion criteria: * provision of written informed consent * healthy volunteer * male aged 18 years or over exclusion criteria: * known or suspected, current impairment of and/or decreased urethral sensibility * history of urethral morbidity * history of urinary tract infection within three months, or ongoing symptomatic urinary tract infection * use of medications that may affect the urethra´s dryness (anti-cholinergic drugs or cortisone) * current drug, alcohol or other substance abuse * other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation * allergy to antibiotics suspected poor compliance with the protocol during the complete study period
cognitive training to improve cognitive function following chemotherapy

Conditions: Cognitive Dysfunction

Summary: the purpose of this study is to improve cognitive dysfunction following chemotherapy, the investigators investigated to see whether a cognitive training for memory and concentration skills can improve cognitive performance in patients following cancer treatment.

patients following chemotherapy invited for a cognitive training. before and after cognitive function will evaluate.

Eligibility criteria:
inclusion criteria: * patients with cancer 6 weeks after chemotherapy exclusion criteria: * patients with neurological or psychiatric disorders * patients without compliance

Keywords: cognitive dysfunction chemotherapy
dailies total1® lens centration in a japanese population

Conditions: Myopia; Refractive Error

Summary: the purpose of this study is to compare the lens centration of dailies total1® (dt1) contact lenses to 1-day acuvue® tru-eye® (1davte) contact lenses in a japanese population after 7 ± 2 days of wearing of each product.


Eligibility criteria:
inclusion criteria: * sign informed consent document. * habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis. * symptoms of contact lens discomfort as defined by protocol. * require contact lenses within the power range of -0.50 diopter (d) to -10.00 d. * cylinder, if present, less or equal to 0.75d in either eyes at visit 1. * vision correctable to 20/25 or 0.1 (logmar) or better in each eye at distance with pre-study lenses at visit 1. * acceptable contact lens fit with both study contact lenses. * willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits. * other protocol-defined inclusion criteria may apply. exclusion criteria: * currently wearing dt1 or 1davte. * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. * use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator. * eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. * any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit. * history of herpetic keratitis, ocular surgery or irregular cornea. * prior refractive surgery (e.g. lasik, prk, etc). * monocular subjects (only one eye with functional vision) or subjects fit with only one lens. * judged ineligible as a patient in this clinical study by the investigator. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses myopia
methods of computed tomography screening and management of lung cancer

Conditions: Lung Neoplasms; Computed Tomography; Mass Screening; Lung Nodules

Summary: european lung cancer screening studies using computed tomography (ct) have shown that a management protocol based on measuring lung nodule volume and volume doubling time (vdt) is more specific for early lung cancer detection than a diameter-based protocol. however, whether this also applies to a chinese population is unclear. the aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a chinese population.

in this population-based study, participants will undergo a low-dose chest ct scan for two rounds. at baseline, the first ct scan will be performed in all participants and their data will be collected. one-year after the baseline, a second ct scan will be performed and data will be collected again. ct images of each participant will be read twice independently by two groups of readers after the baseline and 1-year follow-up scans. in the first reading, the detected lung nodules are evaluated for diameter and managed according to a routine diameter-based protocol. the clinical management of participants are based on the first reading. in the second reading, each scan will be interpreted again by radiologists, blinded to the first reading. semi-automated volumetry software will be used. the lung nodules will be evaluated for volume and management will be simulated according to a european volume-based protocol. participants will be followed up and any diagnosis of lung cancer and related information will be collected at the fourth year through the hospital information system and by contacting the participants or their relatives.

Eligibility criteria:
inclusion criteria: * aged 40-74 years; * resident in the hexi district of tianjin city for at least 3 years; * having no self-reported history of any malignant tumor. exclusion criteria: * pregnant woman will be excluded.