Kornimate/medical-research-clean huggingface dataset:
ocular function in autism spectrum disorder

Conditions: Autism; Ocular Surface Disease

Summary: this study will investigate the visual function in individuals with asd, with a particular focus on the ocular surface condition and visual function assessment.

anomalies in visual information processing can have a major effect on the life quality of individuals with autism spectrum disorders (asd), including eye gaze abnormality, higher frequency of refractive errors (e.g., astigmatism, hypermetropia, and anisometropia), strabismus, abnormal blinking rate, disturbed eye movements that may be associated with or aggravated social communication deficits of asd. however, little is known about the ocular surface conditions. this study will investigate the visual function in individuals with asd, with a particular focus on the ocular surface condition. we plan to recruit 50 adults with asd and 50 age-/sex-matched typically developing controls in this project, and perform visual function assessment.

Eligibility criteria:
asd group: inclusion criteria: 1. having a clinical diagnosis of autism spectrum disorder 2. aged over 20 years; able to read and sign an informed consent form. 3. clear conscious and can follow the instruction of opening eyes and movement toward all direction. exclusion criteria: 1. unable to cooperate with the examinations. 2. younger than 20 years old. td group: inclusion criteria: 1. aged over 20 years; able to read and sign an informed consent form. 2. clear conscious and can follow the instruction of opening eyes and movement toward all direction. exclusion criteria: 1. unable to cooperate with the examinations. 2. younger than 20 years old. 3. having a clinical diagnosis of autism spectrum disorder
a randomized trial to study combined pulsed dye laser and rapamycin treatment of port wine stain birthmarks.

Conditions: Port Wine Stain

Summary: the purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. the researchers want to determine whether the combined use of pulsed dye laser therapy and rapamycin will improve pws therapeutic outcome.

the researchers want to combined use of pulsed dye laser to induce port wine stain blood vessel injury, and rapamycin directly inhibits the proliferation of vascular endothelial cells driven by vascular endothelial growth factor which preventing port wine stain angiogenesis and recanalization, to improve port wine stain lesion blanching.

Eligibility criteria:
inclusion criteria: * port wine stain birthmarks suitable for comparison testing. exclusion criteria: * pregnancy. * abnormal blood hematology or chemistry blood tests or urine analysis. * history of cancer, history of high cholesterol, lipids or liver disease * allergy to macrolide drugs (e.g., erythromycin). * any therapy within the previous two months to the proposed pws treatment sites. * concurrent use of known photosensitizing drugs,immunosuppressive drugs or systemic steroids,antifungals, antiepileptics, hiv protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil.

Keywords: hypervascular anomalies
effect of patient education on functions in patients with non-specific and/or degenerative low back pain

Conditions: Low Back Pain

Summary: the aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain. the patients will be recruited to four group based patient education lessons during a two months period. the study is a randomized controlled trial and the patients will be randomized to standard treatment or standard treatment and patient education. the patient education will be led by physiotherapists, nurses and physicians. the outcomes are functions, pain, quality of life, self-efficacy, and depression. the data are reported in questionnaires.

design: randomized controlled trial; intervention study. patients: patients with low back pain; referred to nordsjaellands hospital, denmark. inclusion criteria: adults, low back pain minimum scored 4 on numeric rating scale, able to conduct exercise training. exclusion criteria: unable to understand danish, psychiatric disorder, dementia, approaching operation, current or approaching settlement regarding working ability or compensation as a result of low back pain. intervention: randomization to usual care or usual care and four times two hours group based patient education with an interdisciplinary focus on self-management of low back pain. the patient education will be delivered by physiotherapists, nurses and physicians. outcome: functions, pain, quality of life, self-efficacy, and depression. the data are reported in questionnaires. sample size: 74 participants.

Eligibility criteria:
inclusion criteria: * adults * low back pain minimum scored 4 on numeric rating scale * able to conduct exercise training exclusion criteria: * unable to understand danish * psychiatric disorder * dementia * approaching operation * current or approaching settlement regarding working ability or compensation as a result of low back pain

Keywords: patient education empowerment
treatment of copper intra uterine device associated heavy menstrual blood loss

Conditions: Menorrhagia

Summary: intrauterine contraceptive device is the most commonly reversible method used among women of reproductive age worldwide. almost one in five married contraceptive users is currently using intrauterine contraceptive device. the egyptian demographic and health survey results indicate that 30% of currently married women interviewed in the egyptian demographic and health survey were using intrauterine contraceptive device. main reasons for discontinuation of intrauterine contraceptive device as cited by women were excessive bleeding per vagina 39.68%, abdominal pain 38.62%, low backache35.97%.


Eligibility criteria:
inclusion criteria: 1. women usingsoppert380a and reporting heavy menstrual blood loss during use. 2. menorrhagia , will be defined as a pictorial blood loss assessment chart-score greater than 100. 3. no contraindication to drugs used in treatment. 4. no other cause for heavy menstrual blood loss exclusion criteria: 1. refusing to participate. 2. irregular menstrual cycle. 3. misplaced intrauterine device.
adjunctive mindfulness during opioid tapering for patients with chronic pain (the amos study)

Conditions: Low Back Pain

Summary: this study is a randomized controlled trial exploring the effects of a mindfulness interventions in reducing pain interference and opioid dose in patients with chronic low back pain. a total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. patient will be randomly assigned into the mindfulness-oriented recovery enhancement or the psychoeducation comparison control group.


Eligibility criteria:
inclusion criteria: * age\>18yo * chronic low back pain as seen on medical history as well as score of \>3 on pain visual analog scale (vas) at the start of experimental sessions. * receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider. * willing to be randomized to one of the two behavioral treatment. patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider) * able and willing to perform/tolerate pain procedures (e.g., qst) * able to communicate fluently in english * able to use a smartphone or laptop for the virtual therapy program exclusion criteria: * current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants; * medical condition known to influence qst or participation in the more intervention; serious psychiatric condition; * regular meditation practice * cognitive impairment * pregnancy * lack of english fluency * severe oud * inability to provide informed consent.
a clinical trial of elsunersen in pediatric scn2a-dee to assess efficacy and safety

Conditions: Epileptic Encephalopathy; SCN2A Encephalopathy

Summary: a randomized, multi-center, double-blind, sham-procedure-controlled clinical trial to investigate the efficacy and safety of elsunersen in pediatric participants with early onset scn2a developmental and epileptic encephalopathy


Eligibility criteria:
inclusion criteria: * has a documented gain of function scn2a variant confirmed through genetic testing. * has onset of seizures prior to 3 months of age. * seizure frequency of 4 or more countable motor seizures per 28-day during the baseline observation period. exclusion criteria: * has any clinically significant or known pathogenic genetic variant other than in the scn2a gene, or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder. * has bone, spine (eg, kyphosis, scoliosis), bleeding, or other disorder. * has received any experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to screening, including any prior use of gene therapy. * is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial.

Keywords: epilepsis early onset scn2a epileptic encephalopathy scn2a gain of function seizure
perioperative immunotherapy for nsclc (ectop-1030)

Conditions: Lung Cancer

Summary: this trial is a randomized, multicenter, open label phase ii clinical study. the main objective is to evaluate the efficacy of three perioperative immunotherapy modalities (atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab neoadjuvant+adjuvant therapy) in early-stage resectable nsclc patients. the enrolled patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the three perioperative immunotherapy groups mentioned above, and undergoing short-term pathological efficacy evaluation and long-term prognosis follow-up after surgery.


Eligibility criteria:
inclusion criteria: 1. patients who sign the informed consent form and are willing to complete the study according to the plan; 2. aged from 18 to 80 years old; 3. ecog equals 0 or 1; 4. not receiving lung cancer surgery before; 5. resectable cib-iiia tumors; 6. not receiving chemotherapy or radiotherapy before. exclusion criteria: 1. not cib-iiia tumors; 2. nodules not suitable for resection; 3. not lung adenocarcinoma diagnosed cytologically or pathologically; 4. receiving lung cancer surgery before; 5. receiving radiotherapy or chemotherapy.
functional outcomes in conduction system pacing and right ventricular synchrony (focus-right)

Conditions: Left Branch Bundle Block; RV - Right Ventricular Abnormality

Summary: the goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (cpet-cmr) and cardiopulmonary exercise testing in patients with pre-existing left bundle branch area pacemakers (lbbap) programmed to an atrial sensing mode. measurements of right ventricular, left ventricular function, and exercise capacity will be obtained at various lbbap programming parameters at rest and during low intensity exercise. the main aims of the study are: * demonstrate the safety and feasibility of performing cpet-cmr in patients with pre-existing lbbap programmed to p-synchronous ventricular pacing mode. * generate preliminary data evaluating differences in rv function, lv function, and exercise capacity during various pacemaker programming settings.

conduction system pacing, namely left bundle branch area pacing (lbbap) represents an important pacing modality introduced to avoid the deleterious effects of non-physiologic ventricular activation during chronic right ventricular pacing and /or left bundle branch block (lbbbp). previous studies have demonstrated that lbbap exhibits similar or superior left ventricular resynchronization compared to conventional treatment modalities, the impact of this novel pacing strategy on the right ventricle has not yet been addressed. this study aims to demonstrate the safety and feasibility of assessing lbbap performance with a focus on right ventricular function in a novel way utilizing cardiopulmonary exercise testing and exercise stress cardiac magnetic resonance. the investigators plan a 1-day prospective non-randomized controlled pilot study in which up to 20 subjects with left bundle branch area pacemakers with evidence of output dependent anodal capture will undergo low intensity exercise cpet-cmr at three different lbbap settings (underlying rhythm, non-selective left bundle pacing, non-selective left bundle pacing with anodal stimulation).

Eligibility criteria:
inclusion criteria: * presence of dual chamber lbbap implantation * presence of anodal capture with bipolar pacing configuration as determined at pacing implant. exclusion criteria: * known history of chronotropic incompetence * high degree or complete heart block * inability to tolerate nvp during initial device interrogation * pregnancy * inability to undergo mri or exercise utilizing supine bicycle at target work-load * presence of mri unsafe pacemaker components.

Keywords: pacemaker cpet-cmr
metabolomic analysis of exhaled breath condensates in patients with copd and bronchiectasis

Conditions: COPD; Bronchiectasis

Summary: metabolomics is a large-scale approach to monitoring the compounds involved in cellular processes. it may reflect changes in biological function. collection of exhaled breath is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the airway. this study is conducted for the metabolomic analysis of the exhaled gas in patients with chronic obstructive pulmonary disease (copd) and bronchiectasis.

metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. collection of exhaled breath condensate (ebc) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. the aims of this study are: (1)collecting and metabolomic profiling of the ebcs from patients with copd/bronchiectasis; (2) comparing the profiles of these patients obtained during stable and acute exacerbation periods; (3) comparing the profiles of these patients with and without pseudomonas colonization/infection; (4) correlation of ebc metabolomic profiles with clinical phenotypes, severity and outcomes of these patients.

Eligibility criteria:
inclusion criteria: * patients with copd or bronchiectasis exclusion criteria: * not willing to sign icf

Keywords: copd bronchiectasis metabolomics
expansion of the t1des pilot to a public hospital

Conditions: Type 1 Diabetes

Summary: diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens black patients ages 18-30 years with type 1 diabetes (t1d). in order to combat this issue, this study assesses the feasibility of the culturally tailored intervention t1des and evaluates the effect of the t1des intervention on diabetes outcomes in a pilot randomized clinical trial among black young adults with t1d.

this research focuses on the unique needs of black young adults aged 18-30 years to address a critical gap in the research and clinical care. the goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among black young adults with t1d, addressing the pervasive racial disparity in health outcomes for this population. the specific aims for this study are to: aim 1: assess feasibility of the culturally tailored intervention t1des by measuring intervention acceptability, demand (retention, completed \> 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team. aim 2: evaluate the effect of the t1des intervention on diabetes outcomes in a pilot randomized clinical trial among n=40 black young adults age 18-30 years with t1d and elevated hba1c (\>7.5%) by comparing changes in hba1c, diabetes distress, and self-management from baseline to 6-months postbaseline among participants randomized to t1des compared to the diabetes education-only control condition. the goal of this study is to provide diabetes education and emotion regulation support tailored for black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.

Eligibility criteria:
inclusion criteria: * grady health system patient * aged 18 - 30 years * confirmed diagnosis of type 1 diabetes * hemoglobin a1c \> 7.5 at time of enrollment * a cell phone able to send/receive text messages * self-reported race of black or african american * ability to read in english and provide informed consent exclusion criteria: * developmental delay or other cognitive impairment that would render the participant unable to provide informed consent * subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions * diabetes complications that would preclude participation in the study

Keywords: diabetes type 1
head mount display-based virtual reality rehabilitation of hemispatial neglect

Conditions: Stroke; Neglect, Hemispatial

Summary: head-mounted display based virtual reality rehabilitation for hemispatial neglect.

the investigators examine about the efficacy of field-of-regard-focused visual exploration therapy implemented using a head-mounted display virtual reality system for hemispatial neglect rehabilitation following stroke.

Eligibility criteria:
inclusion criteria: * presence of left hemispatial neglect as demonstrated by a score above the cut-off on the line bisection test or star cancellation test of the behavioral inattention test, or mild-to-moderate neglect-related functional impairment defined by a score of 1-20 points on the catherine bergego scale * age 19 to 65 years * first-time right hemispheric ischemic or haemorrhagic stroke as evidenced by brain imaging and medical records * a score \>25 on the mini-mental state examination exclusion criteria: * presence of oculomotor palsies or visual defects as assessed via standard neurological examination * orthopaedic disorders affecting neck movement * inability to maintain a seated position.

Keywords: stroke neglect virtual reality head mount display rehabilitation
a retrospective study using caliber® tlif expandable spacer in the treatment of ddd: 2 year follow-up.

Conditions: Degenerative Disc Disease

Summary: the purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.

this is a multi center retrospective study with 200 patients. sites will screen their patient records for patients who have had a tlif utilizing the caliber® expandable interbody spacer in conjunction with the revolve® or revere® posterior stabilization systems and subsequent follow-up visits. the study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.

Eligibility criteria:
inclusion criteria: * objective evidence of degenerative disc disease at 1 or 2 level(s) between l2 and s1 resulting from degeneration of disc confirmed by history and radiographic studies. * at least 18 years of age and maximum 80 years of age exclusion criteria: * • presence of systemic or localized infection at the site of surgery * more than 2 levels to be instrumented * previous fusion attempt at the involved level(s) * spondylolisthesis unable to be reduced to grade 1 * previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated * diagnosis of a condition or on postoperative medication(s), which may interfere with bony/soft tissue healing * presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, hiv, long term use of steroids, etc.) * history of substance abuse (drugs or alcohol) * mentally incompetent or prisoner
an observational study of avastin and conventional chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal cancer (avaplus)

Conditions: Colorectal Cancer

Summary: this observational study will evaluate the use of avastin (bevacizumab) and conventional chemotherapy in patients \>/= 70 years of age with previously untreated metastatic colorectal cancer. data will be collected from each patient from initiation of treatment until disease progression occurs (minimum follow-up 12 months).


Eligibility criteria:
inclusion criteria: * adult patients, \>/ 70 years of age * previously untreated metastatic colorectal cancer * patient considered suitable to receive chemotherapy with or without avastin exclusion criteria: * participation in any other clinical trial or study with the exception of participation in registries
misoprostol for secondary prevention of postpartum hemorrhage at the community level in india

Conditions: Postpartum Hemorrhage

Summary: this study compares two community-level strategies: selective administration of 800 mcg sublingual misoprostol to women at 350 ml blood loss for secondary prevention of postpartum hemorrhage (pph) with universal use of 600 mcg oral misoprostol at the time of delivery for primary prevention of pph. the study hypothesizes that at community-level births, secondary prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis provided to women for primary prevention of pph. this cluster-design non-inferiority trial has the potential to inform service delivery programs on clinical outcomes, program feasibility, cost and acceptability of two different community models of pph care using misoprostol.

rationale for research: there is an absence of concrete data on the programmatic and cost-effectiveness of different service delivery models for prevention and treatment of postpartum hemorrhage with misoprostol, prompting a discussion of whether resources are best spent on misoprostol for primary prevention at lower levels (with treatment carried out at higher levels via referral) or whether immediate proactive treatment strategies should be considered. as the training and policy implications of universal prevention versus selective treatment approaches vary, simple and effective service delivery models are urgently needed to help governments and organizations decide how to best focus their limited resources. this study proposes to study the efficacy of a hybrid strategy (i.e., secondary prevention) that combines elements of prevention and treatment. results of this study could provide a new model of care that will medicate fewer women, save costs and address the clinical conundrum of guessing at the safety of administering a prevention dose of misoprostol followed quickly by a larger treatment dose. study design: this randomized cluster trial will recruit women with deliveries attended by auxiliary nurse midwives (anms) that occur at homes or at health sub-centers. anms will be randomized to administer the intervention as described in the primary or secondary prevention arm.

Eligibility criteria:
inclusion criteria: 1. delivering at home or sub-center with an auxilliary nurse midwife (anm) 2. able and willing to provide informed consent 3. meeting ministry of health guidelines for home or sub-center delivery exclusion criteria: 1. high-risk pregnancy

Keywords: postpartum hemorrhage prevention misoprostol developing countries nurse midwife