Kornimate/medical-research-clean huggingface dataset:
the outcome of cpap titration under sleep endoscopy

Conditions: Obstructive Sleep Apnea; CPAP; DISE

Summary: the outcome of cpap titration under sleep endoscopy: a randomized controlled crossover trial

this is the study entitled "the outcome of cpap titration under sleep endoscopy: a randomized controlled crossover trial". cpap is first line golden standard treatment for obstructive sleep apnea (osa). however, the overall cpap compliance is about 50%. one of the reasons responsible for the poor compliance is the inadequate pressure setting initially. therefore, it is crucial for us to find out the adequate pressure as soon as possible. sleep endoscopy is the way to evaluate upper airway obstruction of osa patients. meanwhile, the investigators used cpap to titrate the adequate pressure to keep upper airway open under sleep endoscopy guidance. while the investigators find out this adequate pressure, the investigators set this pressure into cpap program, which osa patient will use for 1 month. to compare the different effect of cpap under either auto-cpap titration pressure or sleep endoscopy guidance pressure, those osa patients will use auto-titration cpap for 1 month as well. another highlight of this study is the sedative agent-dexmedetomidine. dexmedetomidine is a α2 antogonist, which cause patients sedative but less respiratory drive suppression. the mechanism of dexmedetomidine is more physiological for nature sleep.

Eligibility criteria:
inclusion criteria: * moderate to severe osa * ess \>10 exclusion criteria: * asa \> 3 * allergy to dexmedetomidine * second or third degree avb * severe heart failure fc class iv * asthma acute attack
trial of early initiation of cgm-guided insulin therapy in stage 2 t1d

Conditions: Type 1 Diabetes; Prediabetic State; Dysglycemia; Autoimmune Diabetes

Summary: this protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (t1d) because there currently exists no clinical guidelines for management of these children in early-stage t1d. this study hypothesizes that the trajectory of t1d can be changed, substantially reducing hba1c and risk of dka at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 t1d using continuous glucose monitor (cgm) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.

specific aims: perform randomized controlled trial of intensive follow-up of stage 2 t1d participants utilizing continuous glucose monitoring (cgm) technology and early education of families to guide early insulin therapy with the goals of: maintaining hba1c less than 7.0%. avoiding adverse outcomes: er visits, hospitalizations, dka and severe hypoglycemia improving diabetes knowledge through optimal planned education as opposed to 'a crash course' at unexpected diagnosis event. evaluating patient/caregiver satisfaction with diabetes care received evaluating impact of activity on glycemic profile collect longitudinal biomarkers of beta-cell stress and dysfunction in stage 2 t1d. use longitudinal cgm data combined with "gold-standard" ogtt and hba1c measures to provide evidence for cgm-based diagnostic criteria for stage 2 and stage 3 t1d. perform cost-analysis of intensive follow up protocol.

Eligibility criteria:
1. individuals identified in stage 2 t1d through ongoing screening studies at the barbara davis center (ask, daisy, trialnet, and teddy) who have given permission to be contacted about study opportunities. 2. presence of islet autoimmunity with high risk of progression: i. positive for multiple islet autoantibodies at 2 or more visits -or- ii. positive for a single high-affinity islet autoantibody at 2 or more visits 3. evidence of dysglycemia (stage 2 t1d) using any one of the following criteria: i. americal diabetes association (ada) criteria: 1. fasting plasma glucose 100-125 mg/dl 2. or 2-hour ogtt plasma glucose of 140-199 mg/dl 3. or a1c 5.7-6.4% 4. or ≥10% increase in a1c from previous visit ii. dysglycemia on ogtt (trialnet criteria): a. glucose above 200 mg/dl on 30, 60 or 90 minute values iii. dysglycemia on cgm worn for at least 5 days: 1. ≥15% of values above 140 mg/dl 2. or peaks ≥ 200 mg/dl on ≥2 days 3. or average sensor glucose ≥120 mg/dl iv. dysglycemia on finger stick blood glucose: 1. fasting bg above 110 mg/dl on 2 or more days 2. or 2 hour post-meal bg above 150 mg/dl on ≥ 2 days 3. or single random bg \> 200 mg/dl

Keywords: islet autoimmunity
gene therapy for blindness caused by choroideremia

Conditions: Choroideremia

Summary: - primary objective: to assess the safety and tolerability of the aav.rep1 vector, administered at two different doses to the retina in 12 patients with a diagnosis of choroideremia. - secondary objective: to identify any therapeutic benefit as evidenced by a slowing down of the retinal degeneration assessed by functional and anatomical methods in the treated eye compared to the control eye 24 months after gene delivery.

detailed description may be found in the following scientific publication: retinal gene therapy in patients with choroideremia: initial findings from a phase 1/2 clinical trial, the lancet, volume 383, issue 9923, pages 1129 - 1137 (29 march 2014). links: www.thelancet.com/journals/lancet/article/piis0140-6736(13)62117-0/abstract ; http://dx.doi.org/doi:10.1016/s0140-6736(13)62117-0

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study, * male aged 18 years or above, * diagnosed with choroideraemia and in good health, * active disease with slo changes visible within the macula region, * willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study, * vision at least 6/60 or better in the study eye. exclusion criteria: * female and child participants (under the age of 18), * men unwilling to use barrier contraception methods, if relevant, * previous history of retinal surgery or ocular inflammatory disease (uveitis), * grossly asymmetrical disease or other ocular morbidity which might confound use of the fellow eye as a long-term control, * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study, * participants who have participated in another research study involving an investigational product in the previous 12 weeks.

Keywords: tapetoretinal degeneration, choroideraemia, x-linked retinitis pigmentosa
sexual health and problems during the covid -19 infection

Conditions: Sexual Behavior

Summary: covid-19 is an emerging critical highly infectious virus

the covid-19 pandemic is a very harmful crisis that affects all human activities

Eligibility criteria:
inclusion criteria: * any partners between 18-60 years exclusion criteria: * any husband or wife that have organic sexual problems
study of cerebral glucose metabolism in neurodegenerative diseases and head trauma

Conditions: Neurodegenerative Diseases

Summary: the reason why each specific degenerative disease is characterized by a different fdg pet pattern is still unclear today. there are four main hypotheses proposed to explain this selective vulnerability: 1) nodal stress, theory according to which the main nodes of specific brain networks undergo wear and tear, 2) trans-neuronal diffusion, theory according to which some toxic agents/proteins or altered propagate along network connections through "prion-like" mechanisms, 3) trophic failure, in which the interruption of inter-modal connectivity causes the loss of collateral trophic factors, and finally 4) shared vulnerability in which regions also distant from each other are part of a common network which gives a susceptibility uniformly distributed throughout the network. fdg pet provides in-vivo information on the distribution of brain synaptic dysfunction prior to complete neural death, and represents the main in vivo biomarker of neural dysfunction associated with different clinical conditions characterized by neurodegeneration phenomena. for this reason, fdg pet is considered a fundamental approach to shed light on the causes of selective brain vulnerability in various pathological conditions.


Eligibility criteria:
inclusion criteria: * presence of diagnosis of neurodegenerative disease. exclusion criteria: * patients\< 18 years
feasibility trial of neoadjuvant chemoradiotherapy for locally advanced gastric cancer

Conditions: Gastric Cancer; Chemoradiation

Summary: because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (nac) are performed in japan. however, neoadjuvant chemoradiotherapy (nacrt) achieves superior local tumor control compared with nac. this feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (nacrt) in this type of gastric cancer.

since s-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with s-1 has been the standard treatment for stage ii/iii gastric cancer. however, for far-advanced gastric cancer, various adjuvant chemotherapies, including s-1, have not achieved satisfactory results. therefore, japan clinical oncology group (jcog) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (nac) for locally far-advanced gastric cancer. however, previous studies of nac have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control. on the other hand, other studies have reported that anticancer drugs, including s-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (nacrt) achieves superior local tumor control compared with nac. therefore, we conducted a feasibility trial of nacrt with s-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.

Eligibility criteria:
inclusion criteria: * histologically proven gastric adenocarcinoma * tumor invasion of adjacent structures (t4) and/or tumors with bulky nodal metastases * no metastases outside of group 2 lymph nodes * neither peritoneal metastasis nor liver metastasis * no other distant metastasis * an eastern cooperative oncology group performance status of between 0 and 2 * no prior radiation therapy * sufficient organ function exclusion criteria: * a synchronous or previously active malignancy * insufficient oral intake * a history of severe allergy * watery diarrhea * severe co-morbidities * requiring therapy for pericardial effusion or pleural effusion * contraindications to s-1 or radiotherapy.

Keywords: gastric cancer chemoradiotherapy adjacent tissue invasion feasibility trial
comparison of changes of onsd between groups of laparoscopic surgery with and without epidural saline injection

Conditions: Optic Nerve Sheath Diameter; Pneumoperitoneum; Epidural

Summary: this study targets patients undergoing laparoscopic gastric cancer surgery. the investigators would like to compare two factors that influence intracranial pressure through optic nerve sheath diameter measurement. first factor is intraperitoneal pressure. second factor is epidural pressure. the investigators divided the patients into three groups. group a is patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter. group b is patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter. group c is patients with open gastric surgery.


Eligibility criteria:
inclusion criteria: * gastric surgery due to cancer exclusion criteria: * coagulopathy * infection * previous history of thoracic spine surgery * ophthalmic diseases * history of increased intracranial pressure

Keywords: onsd pneumoperitoneum epidural
to investigate the effect of esketamine hydrochloride on pulmonary complications

Conditions: Heart Diseases; Heart Valve Diseases

Summary: the objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications

after being informed of the study and potential risks, all patients who gave written informed consent will undergo pre-operative screening to determine eligibility for study enrollment. before operation, eligible patients were randomly divided into esketamine group (0.2mg/kg, intraoperative pump), esketamine group (0.4mg/kg, intraoperative pump) and blank control group (physiological salt pump) in a double-blind way at a ratio of 1:1:1.

Eligibility criteria:
inclusion criteria: * age 18-75 years old, gender unlimited. * elective heart surgery. * patients who plan to undergo mitral and (or) aortic valve replacement (or repair) surgery, requiring extracorporeal circulation and aortic occlusion. * the new york heart association class is less than 4. * voluntarily sign informed consent. exclusion criteria: * non-cardiac surgery. * second heart surgery. * interventional surgery in heart valve surgery (tavi, mitral clamp). * the patient refuses. * pregnant women. * patients with a history of lung surgery. * patients with acute kidney injury requiring dialysis. * patients with chronic renal insufficiency (stage iii and above). * the patient was intubated before arriving at the operating room. * patients with existing pulmonary complications (respiratory tract infection, pneumonia, pleural effusion, respiratory failure, atelectasis, pneumothorax, bronchospasm, ards). * the patient had neuropsychiatric disease and cognitive impairment before surgery. * drug users and other long-term use of antipsychotic drugs. * patients with any of the following contraindications for the use of esketamine injection: patients with serious risk of elevated blood pressure or intracranial pressure; patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic pressure exceeding 180 mmhg, or resting diastolic pressure exceeding 100mmhg); patients with untreated or undertreated hyperthyroidism (hyperthyroidism). * liver function alt, ast \> 2 times normal.
persistence of antibodies and kinetics of b cell response in healthy children after vaccination with mcc vaccine

Conditions: Prevention of Meningococcal Infection

Summary: persistence of antibodies and kinetics of b cell response in healthy children after vaccination with mcc vaccine


Eligibility criteria:
inclusion criteria: * healthy children exclusion criteria: * known hypersensitivity to any vaccine products * any immunodeficiency, genetic anomaly or severe acute or chronic illness

Keywords: prevention of meningococcal meningitis vaccines conjugate immunology children antibody persistence
tooth wear monitoring using intraoral scanner

Conditions: Dental Wear

Summary: the overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. forty-six participants were selected according to the established inclusion and exclusion criteria. monitoring of tooth wear, evaluation of possible aetiological factors, as well as patient satisfaction with the use of the intraoral scanner were carried out.

the overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. the specific objectives were (1) to determine whether the intraoral scanner is capable of detecting tooth wear superior to traditional visual indices, (2) to identify whether any aetiological factors may be associated with tooth tissue loss, (3) to establish a degree of patient satisfaction with the intraoral scanner as a diagnostic tool. forty-six participants were selected according to the established inclusion and exclusion criteria. the protocol was accepted by the regional ethics committee of the community of madrid. digitisation of the dental arches was recorded at 3 types of evaluation: 0, 6 months and 12 months. the recording of possible etiologic factors was carried out at the three established evaluation times. the evaluation of satisfaction was recorded at the third evaluation time.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * patients who were to stay at the university for more than one and a half years * patients who agreed to sign the informed consent form. exclusion criteria: * pregnant women * patients who planned to modify the oral situation with orthodontic, surgical and/or rehabilitative treatments * patients who had some kind of personal or academic relationship with the investigators of this study.

Keywords: dental wear intraoral scanner etiological factors monitoring
preterm premature rupture of membranes, outpatient management vs inpatient management

Conditions: Preterm Premature Rupture of Membranes

Summary: this study is to compare the maternal and neonatal outcomes in the patients with pprom who are managed at home versus those managed at hospital, half the patients will be managed at home and the other half will be managed inpatient.

now the current practice is to manage patients with pprom at hospital, however it is not known yet whether this practice is better than outpatient management as regard maternal and neonatal outcome. there is some recent evidence that home management of pprom is safe for both mother and neonate, home management is also more convenient with less expenses.

Eligibility criteria:
inclusion criteria: 1. pprom with gestational age between 27 to 34 weeks 2. cephalic presentation 3. clear amniotic fluid 4. oral temperature \> 38 c 5. near distance from the hospital (the patient can reach hospital within one hour ) 6. home environment safe and amenable to rest , availability of family support such as a sister or mother who will help the patient at home . 7. maternal and fetal condition remain stable after hospitalization for 72 hours exclusion criteria: 1. patient with equivocal diagnosis of rupture of membranes 2. advanced labor 3. intrauterine infection 4. vaginal bleeding or 5. non reassuring fetal heart rate.
long-term ophthalmic outcomes in ex-premature infants

Conditions: Retinopathy of Prematurity (ROP); Premature Birth

Summary: there is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. this study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.

every year, around 18.000 children in the netherlands are born prematurely, which means that they were born before 37 weeks gestational age. the who defines three different categories of prematurity: moderate to late preterm (32-37 weeks), very preterm (\<32-28 weeks), and extremely preterm (\<28 weeks). preterm birth is associated with numerous health problems, which can have both short-term and long-term consequences on the development of the child. a relatively rare complication of (very or extreme) preterm birth is lifelong visual impairment or blindness due to retinal detachment as a result of prematurity retinopathy (rop). rop is a vasoproliferative condition that affects the vessels in the retina. an inventory study shows that 305 children were diagnosed with rop in the netherlands in 2017. the majority of these children experienced spontaneous regression of the condition, but 13% of cases required treatment to prevent retinal detachment. in the long-term, rop predisposes for ocular conditions such as visual field abnormalities, refractive error, strabismus, amblyopia, glaucoma and retinal detachment. however, research also indicates that prematurity, regardless of rop diagnosis, can also be associated with adverse ophthalmological outcomes such as refractive error, strabismus, amblyopia and cerebral visual impairment (cvi). although there are various publications on the ophthalmological outcomes of rop and prematurity at school-age, less is known about these outcomes in the adult population. this study aims to investigate the anatomy and functionality of the eye in ex-premature infants who were born between 1991 and 2006. in addition, the differences in outcomes between ex-premature infants with and without rop, and the differences in outcomes between treated and spontaneously regressed rop, will be studied.

Eligibility criteria:
inclusion criteria: * subjects eligible for rop screening, and admitted to erasmus mc between 1991 and 2007. exclusion criteria: * subjects born after 2008, * subject has passed away before the start of the study * subject resides outside of the netherlands * subject has a physical or mental disability that makes it impossible to participate in a routine eye exam, or has a disability that classifies the subject as an incapacitated adult.

Keywords: retinopathy of prematurity preterm birth visual acuity visual outcomes long term outcomes
a 6 microrna tool for stratifying stage ii colon cancer of receiving adjuvant chemotherapy

Conditions: Colonic Neoplasms; Effects of Chemotherapy

Summary: whether patients with stage ii colon cancer should receive adjuvant chemotherapy or not is still on debate.microrna(mirna) is a promising tool. investigators invented a tool consisting of 6 mirna(mir-21、mir-20a-5p、mir-103a-3p、mir-106b-5p、mir-143-5p and mir-215) that was effective to identify one should accept adjuvant chemotherapy or not. here investigators randomly assign patients to be assessed by classical pathological features or the mirna tool of determining who should accept chemotherapy. disease free survival and overall survival are the end points of observation.

investigators randomly assign patients to be assessed by classical pathological features(control group) or the mirna tool(experimental group). pathological features include poorly differentiated histology(exclusive of those cancers that are msi-h),lymphatic/vascular invasion,bowel obstruction and \<12 lymph nodes examined.microrna tool contains mirna of mir-21、mir-20a-5p、mir-103a-3p、mir-106b-5p、mir-143-5p and mir-215. investigators evaluate these mirna status of surgical specimens using qrt-pcr and calculate their risk score(risk score =(0.108×status of mir-21-5p)+(0.086×status of mir-20a-5p)+(0.240×status of mir-103a-3p)+(0.095×status of mir-106b-5p)-(0.238×status of mir-143-5p)-(0.237×status of mir-215),low expression status equals 0 and high expression status equals 1). investigators defined high risk patient if had any pathological features in control group or the score larger than 1 in the experimental group ,the others as low risk patient.the high risk group should receive adjuvant chemotherapy while the low risk group deserve observation. primary endpoint is the disease free survival and overall survival.

Eligibility criteria:
inclusion criteria: * the informed consent has been obtained from the patient. * with confirmed diagnosis of stage ii colon cancer. * with moderate/good ecog health rating (ps): 0-1 score. * the patient receive no anti-cancer treatment before primary surgery. * the patient receive radical operation for colon cancer with negative margin. exclusion criteria: * with severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * with bad compliance or contraindication to enrollment. * pregnant woman or lactating woman. * with contraindication to receive adjuvant chemotherapy.