Kornimate/medical-research-clean huggingface dataset:
neurobehavioral consequences of sleep apnea in children

Conditions: Lung Diseases; Sleep Apnea Syndromes

Summary: to identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children.

background: the study is in response to a request for applications (rfa) on obstructive sleep apnea in children. nhlbi issued the rfa in december, 1997, with co-sponsorship from the national institute of dental and craniofacial research and the national institute of child health and human development. design narrative: this cross-sectional study recruited a population-based sample of young children from among the more than 8000 children in massachusetts enrolled in the on-going infant care practices study. stratified sampling was used to assemble a cohort of 250 children with habitual snoring (\> 3 nights/week), 100 children with occasional snoring (\<3 nights/week), and 100 non-snoring children. these children were studied within 3 months of their fourth birthday using overnight laboratory polysomnography and a detailed neurobehavioral evaluation, in order to test the hypothesis that, after adjusting for potential confounding variables, both parent-reported snoring and polysomnographic measures were associated with standardized measures of the following neurobehavioral domains: immediate attention, sustained attention, working memory, and symptoms of hyperactivity. these data also provided an opportunity to determine normal values for polysomnographic measures in 4-year-old children and to determine the prevalence of snoring and polysomnographic abnormalities among 4-year-old children. 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
treatment of anovulatory infertility in pcos patients

Conditions: Infertility; Polycystic Ovary Syndrome; Anovulation

Summary: clomiphene citrate (cc) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (pcos), even if it is still unclear which compound between them should be initially administered. the aim of the study will be to compare in a clinical setting the efficacy of cc and metformin as first-line approaches for treating anovulation in infertile pcos patients.

eighty infertile anovulatory patients with pcos will be allocated in two body mass index (bmi)- and age-matched groups (experimental and control groups). forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive cc administered using a traditional incremental-doses protocol (control group). in both groups, patients who will ovulate under treatment will continue the therapy for a total of six months. during the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.

Eligibility criteria:
inclusion criteria: * anovulatory infertility related to polycystic ovary syndrome exclusion criteria: * neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses * hypothyroidism, hyperprolactinemia, cushing's syndrome, and non-classical congenital adrenal hyperplasia * current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. * organic pelvic diseases * previous pelvic surgery * suspected peritoneal factor infertility * tubal or male factor infertility or sub-fertility

Keywords: anovulation clomiphene citrate infertility metformin pcos treatment
fractional radiofrequency for reduction of surgical scar formation

Conditions: Surgical Incision

Summary: safety and efficacy of fractional radiofrequency for the reduction of surgical scar formation

the study will evaluate up to 20 subjects scheduled to undergo breast reduction or breast mastectomy in which scar assessment can be made after pre-surgical treatment in a split-body design. the study will involve a single treatment of radiofrequency (rf) applied to one side of the surgical area(s) within 24 hours prior to the procedure. the subject will act as their own control, where one surgical area will be treated, and the other will not be and will act as the control. tissue samples will be biopsied from the rf treated skin, as well as non-treated skin, at follow up visits. the samples will be used for histological evaluation to assess tissue structure and regeneration following surgery.

Eligibility criteria:
inclusion criteria: 1. healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars. 2. able to read, understand and voluntarily provide written informed consent. 3. able and willing to comply with the treatment/follow-up schedule and requirements. 4. willing to avoid direct sunlight to the treatment area for the duration of the study. 5. women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative urine pregnancy test at baseline. exclusion criteria: 1. subjects with any implantable metal device in the treatment area 2. pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 3. permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 4. current or history of any kind of cancer, or dysplastic nevi. 5. severe concurrent conditions, such as cardiac disorders. 6. pregnancy or intending to become pregnant during the study and nursing. 7. impaired immune system due to immunosuppressive diseases, such as aids and hiv, or use of immunosuppressive medications. 8. history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime. 9. poorly controlled endocrine disorders, such as diabetes. 10. any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 11. history of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 12. history of bleeding coagulopathies, or use of anticoagulants. 13. use of isotretinoin (accutane®) within six months prior to treatment or at physician discretion. 14. treating over tattoo or permanent makeup. 15. excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
brain ultrasound in the weaning of external ventricular leads

Conditions: Hydrocephalus; Intracranial Hypertension

Summary: external ventricular deviation (edv) is a medical device that provides transient and controlled external drainage of cerebrospinal fluid (csf). this device can also monitor intracranial pressure (icp). sev is an emergency measure indicated for acute hydrocephalus and / or intracranial hypertension (htic). weaning from a dve should be considered as soon as possible from the moment the patient's clinical condition allows it. there is no consensus on how to wean sevs. the main objective of this study is to evaluate inter and intraobserver reproducibility of the measurement of the 3rd ventricle size by ultrasound in patients receiving a dve withdrawal test.

ultrasound assessment of the ventricular system, including the size of the 3rd ventricle, can be used in severe traumatic brain injury. ultrasound measurement of the size of the 3rd ventricle is used as a marker to monitor cerebral atrophy in neurodegenerative diseases such as multiple sclerosis (ms). there is good correlation between brain ultrasound and mri and ct brain imaging to assess the size of the 3rd ventricle. ultrasound measurement of the size of the 3rd ventricle has never been evaluated in weaning external ventricular leads. measuring the size of the 3rd ventricle by ultrasound could be an interesting monitoring technique during a sev withdrawal trial to predict success or failure. weaning is usually based on a clamp test with more or less paraclinical clinical monitoring. the recurrence of hydrocephalus and / or htic defines a withdrawal failure of the drainage device. the size of the 3rd ventricle evaluated by cerebral ct in a clamp test is found as a predictor of weaning failure of a dve.

Eligibility criteria:
inclusion criteria: * patient benefiting from a dve, whatever the indication * hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of toulouse university hospital * first dve withdrawal test initiated by the doctor in charge of the patient * major patient * affiliated person or beneficiary of a social security scheme. * expression of non-opposition by the participant or his / her confidant and the investigator (at the latest on the day of inclusion and before any examination required by the research). exclusion criteria: * absence of cerebral acoustic window * patient with a ventriculoperitoneal (dvp) diversion before the dve. * antecedent surgery in the cerebral ventricular system. * pregnant and lactating woman * person under safeguard of justice * nosocomial neuro-meningeal infection on untreated or treatment-emergent dve

Keywords: external ventricular derivation
pharmacist-led intervention for injectable hiv treatment for women with health-related social needs

Conditions: Hiv

Summary: this study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (cab/rpv la) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (cdtm+) that will be expanded for telehealth outreach to women with health-related social needs (hrsn).

the purpose of this study is to evaluate the implementation and delivery of cab/rpv la to women with hrsn by adopting a pharmacist-led cdtm. the project primarily addresses the real-world use of cab + rpv la among women who are under-represented in clinical trials and assesses the feasibility and acceptability of cdtm+, and adoption of cab/rpv la among participants receiving the cdtm+ model. investigators will enhance the existing cdtm to reduce important social and structural barriers to cab/rpv la for women with hrsn, by increasing accessibility- using telehealth to deliver cdtm outreach to clinical and community sites without a clinician referral (cdtm+), which is highly scalable. in addition to assessing engagement with the cdtm+ intervention and impact on key implementation (reach, feasibility, acceptability, uptake) and clinical outcomes (cab/rpv la initiation), investigators will also assess impact on patient engagement in non-hiv related care and psychological, sexual, and social well-being.

Eligibility criteria:
inclusion criteria: * living with diagnosed hiv * receiving hiv care-related services from yale new haven health (ynhh) * currently on oral art and virally suppressed for at least 6 months (from electronic health review). * have experienced at least one hrsn: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; or d) substance use in the past 6 months (from self-report at screening). * able to converse comfortably in english or spanish exclusion criteria: * unable or unwilling to complete informed consent (e.g., have a conservator of person) * have initiated cab/rpv oral lead-in prior to enrollment. * have a contraindication to cab/rpv la per label. * have known or suspected resistance to cab/rpv * pregnant or breast-feeding

Keywords: criminal legal involvement unstably housed; unhoused food insecurity mental health substance use/ treatment engagement women long-acting injectable antiretroviral treatment
retrospective, non-interventional, comparative clinical investigation of the safety and performance of 690ad and 690ady monofocal intraocular lens implantation with extended patient enrolment

Conditions: Cataract; Pseudophakia; Intraocular Lens Complication; Intraocular Lens Opacification

Summary: medicontur hydrophilic posterior chamber monofocal intraocular lens (iols) are indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens. the intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power. the study will be performed partially as a retrospective study with patients enrolled who had been implanted with 690ad or 690ady iols mono- or binocularly between june 2022 - september 2023. data from five visits will be collected: * baseline preoperative (maximum 90 days prior to surgery)- retrospective * iol implantation day 0 - retrospective * postoperative visit at day 1 (+/- 0 days) - retrospective * postoperative visit at 1 month (+/- 2 weeks) - retrospective * postoperative visit at 12 months (+/- 3 months) - consent and prospective visit


Eligibility criteria:
inclusion criteria: * adult males or females above 18 years of age; * pseudophakic patients implanted with 690ad or 690ady monofocal iols (implanted between june 2022 - september 2023); * diagnosis of cataract and/or ametropia (hyperopia, myopia); * subject who has signed an informed consent form. * patients who have participated in all visits that are subject to retrospective data collection. exclusion criteria: * patients who are not targeted to emmetropia. * patients with the following condition(s) at the time of the baseline visit: * corneal astigmatism \> 1.0d * uncontrolled diabetic retinopathy * iris neovascularization * congenital eye abnormality * uncontrolled glaucoma * pseudoexfoliation syndrome * amblyopia * uveitis * amd (advanced amd) * retinal detachment * prior ocular surgery in personal medical history * previous laser treatment * corneal diseases * severe retinal diseases (dystrophy, degeneration) * high myopia * inadequate visualization of the fundus on preoperative examination * patients deemed by the clinical investigator because of any systemic disease * pregnancy * eye trauma in medical history * current use of systemic steroids or topical ocular medication * patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
efficacy and safety of spa100 (fixed-dose combination of aliskiren/amlodipine) in patients with essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of spa100 (fixed-dose combination of aliskiren and amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msdbp\] ≥ 95 mmhg and \< 110 mmhg and mean sitting systolic blood pressure \[mssbp\] ≥ 140 mmhg ). this study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in japan.


Eligibility criteria:
inclusion criteria: * patients with essential hypertension (msdbp ≥ 95 mmhg and \< 110 mmhg and mssbp ≥140 mmhg ) * outpatients exclusion criteria: * severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg) * history of allergy or hypersensitivity to renin inhibitors, calcium channel blockers * history or evidence of a secondary hypertension other protocol-defined inclusion/exclusion criteria applied

Keywords: aliskiren amlodipine essential hypertension
virtual reality glasses integrated with sign language on dental anxiety among children with hearing impairment during pulpotomy procedure

Conditions: Dental Anxiety

Summary: to evaluate the impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment. the study will be a randomized controlled parallel two arms clinical trial, a total of 40 healthy children aged 5-7 years with moderate to severe hearing disability, will be selected from pediatric dentistry and dental public health department, faculty of dentistry, alexandria university, egypt. children selected should have at least one primary molar indicated for pulpotomy. the eligible participants will be randomly assigned to one of two groups: the study group, which will use virtual reality glasses with sign language as a distraction method to manage children's behavior, and the control group, which will use the conventional behavior management strategies including show-tell-do, and positive reinforcement. local anesthesia will be given and pulpotomy procedure will be done on the selected tooth followed by stainless steel crown restoration. pre and post-operative assessment of child's dental anxiety will be done using three methods: physiologically using pulse oximeter for measuring the heart rate, objectively using venham clinical anxiety rating scale, and subjectively using the modified facial image scale.


Eligibility criteria:
inclusion criteria: * children with frankl behavior rating score 2 or 3. * children requiring pulpotomy in one of their primary molars. * parents who accepted to give their consent and participate in the study. exclusion criteria: * children with any medical condition other than hearing disability (asa ii, iii \& iv). * syndromic children with hearing impairment. * children with previous bad dental experience.
superficial cervical nerve block vs nsaids for the relief of shoulder pain after laparoscopic surgeries

Conditions: Relieve Shoulder Pain After Laparoscopic Surgeries

Summary: shoulder pain is frequently mentioned in recent literature following laparoscopic operations. several pain relief strategies have been proposed to decrease shoulder tip pain post laparoscopic surgeries. this study will be conducted to compare the superficial cervical nerve block vs. nsaids in terms of shoulder tip pain relief after laparoscopic surgeries.

the study will be conducted in the operating room and post anesthesia care unit (pacu) at makassed general hospital. this is a prospective double blind randomized clinical trial that will be conducted between june 2016 and june 2017 at makassed general hospital. following the institutional review board (irb) approval, written informed consent will be obtained from patients. patients will be randomly assigned using the sealed envelope technique into 2 groups. group i will receive superficial cervical nerve block and intravenous saline. group ii will receive saline superficial cervical block and intravenous nsaid (profenid). all patients will receive general anesthesia. general anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen. any hemodynamic change of 25% results in a gradual increase or decrease of the sevoflurane concentration.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic: cholecystectomy, sleeve gastrectomy, mini bypass surgery, gastric plication exclusion criteria: * patients with kidney disease (acute or chronic) * patients with allergy to any medication used throughout the research * patients with gastroesophageal reflux disease (gerd), peptic ulcer or duodenal ulcer disease * patients with shoulder neck pain or complications pre-operatively
intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for pregnant women

Conditions: Pregnancy

Summary: to determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

to determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed). to determine whether iv iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron. to evaluate the safety of iv low molecular weight iron dextran in pregnant women. to assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, er visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after iv iron supplementation groups.

Eligibility criteria:
inclusion criteria: * pregnant women intolerable to oral iron. hbg \<10.9 g/dl during second or third trimester. exclusion criteria: * known sensitivity to iv iron. hemoglobinopathies. hemolytic anemia. women who have received or will receive blood transfusions. women with significant vaginal bleeding(\>200 cc blood loss)prior to delivery. women with documented history of allergy to more than one class of drug clinically significant anemia requiring therapy in the opinion of the obstetrician, in the first trimester.

Keywords: iv iron in pregnant women second and third trimester
oral acetaminophen use for pain reduction in electrophysiology procedures

Conditions: Post Electrophysiology Procedure Pain

Summary: the investigators are purposing a study to evaluate the use of acetaminophen given prior to an electrophysiology procedure and post procedural pain control.

atrial arrhythmias are very common and widespread. recent reports suggest that 9% of patients over the age of 65 currently have atrial fibrillation. in individuals of european descent the lifetime risk of atrial fibrillation is as high as 26%. atrial fibrillation carries significant risk of complications including: a fivefold increase in risk of stroke, a threefold risk of heart failure, a twofold risk of dementia and a twofold risk of mortality. as treatment options continue to evolve, the use of catheter ablation procedures are becoming increasingly common within the united states. currently, ablation has a class 1a recommendation for patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one class i or class iii antiarrhythmic medication and a class 2b indication before initiation of antiarrhythmic drug therapy. one of the known complications of catheter ablation procedures is pain following the procedure. severe pain has been reported in up to 55% of patients undergoing ablation procedures. iv acetaminophen has been proven to be effective at controlling pain in post intra-abdominal surgery, however, its use is limited due to the cost of this medication. other studies have suggested that there is no clear indication for iv over oral acetaminophen in patients who are able to take oral. empirically the investigators have seen patients complaining of pain after all electrophysiology procedures, not limited to just ablation procedures. to the best of the knowledge of the investigational team, at this time, no studies have looked at using oral pre-procedural acetaminophen to assist with pain control following electrophysiology procedures. the investigators are looking to perform a randomized, double blind, placebo controlled study to evaluate the use of pre-procedural oral acetaminophen to help control post procedural pain.

Eligibility criteria:
inclusion criteria: * age: over 18 * weight: greater than 50kg * scheduled for an ep procedure * be able to take oral medications * provide signed written informed consent exclusion criteria: * have chronic pain requiring the use of chronic pain medications including narcotic pain medications or chronic acetaminophen use greater than seven consecutive days prior to the procedure * known hypersensitivity to acetaminophen * known or suspected history of alcohol or drug abuse/dependence within the previous 2 years * known impaired liver function * active pregnancy