Kornimate/medical-research-clean huggingface dataset:
corneal epithelial autograft for limbal dermoid

Conditions: Corneal Dermoid

Summary: the purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial autograft is more effective than femtosecond laser-assisted limbal autograft for ocular surface reconstruction after excision of limbal dermoid.


Eligibility criteria:
inclusion criteria: 1. age between 1 to 30 years old; 2. patients with limbal dermoid, scheduled for elective surgical excision; 3. superficial lesion ranging from 5 to 9mm, without encroaching the deep stroma layer, as indicated by anterior segment optical coherence tomography images; 4. informed consent signed by a parent or legal guardian, or having the capability of understanding and signing the informed consent; 5. being able to comply with study assessments for the full duration of the study. exclusion criteria: 1. keratoconus; 2. ocular and facial active inflammation such as keratitis, trachoma, dacryocystitis, blepharitis, meibomian gland dysfunction, sjogren's syndrome, cicatricial pemphigoid etc; 3. high myopia with a spherical equivalent of -15.0 d or less; 4. corneal or ocular surface infection within 30 days prior to study entry; 5. ocular surface malignancy; 6. uncontrolled diabetes with most recent hemoglobin a1c greater than 8.5%; 7. renal failure with creatinine clearance\< 25ml/min; 8. alanine aminotransferase \> 40iu/l, or aspartate aminotransferase \> 40iu/l; 9. platelet levels \ 450,000 per microliter; 10. hemoglobin \< 12.0 g/dl (male) or \< 11.0 g/dl (female); 11. prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; an international normalized ratio greater than 3 in patients accepting anticoagulant therapy; 12. pregnancy (positive test) or lactation; 13. participation in another simultaneous medical investigation or clinical trial; 14. severe cicatricial eye disease; 15. ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases; 16. severe dry eye disease as determined by schirmer's test \< 2mm at least in one eye; 17. any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent; 18. signs of current infection, including fever and treatment with antibiotics; 19. active immunological diseases; 20. history of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
neural and antidepressant effects of propofol (phase 2)

Conditions: Treatment Resistant Depression

Summary: moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of phase 1.


Eligibility criteria:
inclusion criteria: * age 18-55 * diagnosis of major depressive disorder or bipolar disorder * current moderate-to-severe depressive episode * episode duration more than 2 months and less than 5 years * failure of at least 2 adequate antidepressant medication trials within the past 2 years * body mass index \< 40 * 16-item quick inventory of depressive symptomatology, self-rated \> 10 exclusion criteria: * contraindication to propofol or midazolam * daily use of benzodiazepine, opioid, ace inhibitor, or arb medication * symptomatic coronary artery disease or heart failure * poorly controlled hypertension or diabetes * abnormal kidney or liver function * pregnant or breast feeding * traumatic brain injury or significant neurologic signs (past year) * substance use disorder (past year) * obsessive compulsive disorder (current) * post-traumatic stress disorder (current) * schizophrenia-spectrum disorder (lifetime) * neurocognitive disorder (current) * personality disorder as a current focus of treatment * ect within the past 3 months * inappropriate for ect, or poor response to ect within the past 5 years * incompetent to provide consent
the study of ono-7913, ono-4538 and the standard of care as first-line treatment in patients colorectal cancer

Conditions: Unresectable Colorectal Cancer

Summary: to confirm the tolerability and safety of combined administration of ono-7913, ono-4538 and the standard of care folfox in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer


Eligibility criteria:
inclusion criteria: 1. unresectable advanced or recurrent colorectal cancer 2. life expectancy of at least 3 months 3. patients with ecog performance status 0 or 1 exclusion criteria: 1. patients with severe complication 2. patients with multiple primary cancers
obstructive sleep apnoea in patients with type 1 diabetes

Conditions: Type 1 Diabetes; Obstructive Sleep Apnoea

Summary: the primary aim of this study is to assess the relationship between obstructive sleep apnoea (osa) and cardiac autonomic neuropathy (can) in patients with t1d. the secondary aims of this study are to assess: (1) the prevalence of osa in patients with t1d; (2) the relationship between osa and metabolic parameters (such as glycaemic control, blood pressure, lipids and weight) in patients with t1d; (3) the relationship between osa and diabetes-related microvascular complications (retinopathy, nephropathy, peripheral neuropathy) in patients with t1d; and (4) the potential mechanisms for the relationship between osa and diabetic-related complications if such a relationship is found.

obstructive sleep apnoea (osa) has been reported to be very common in patient with type 2 diabetes (t2d), and this relation is expected as both conditions share obesity as a common risk factor. despite that several articles have stated that osa is an independent risk factor for abnormal glucose metabolism, hypertension, and cardiovascular diseases. in contrast, patients with type 1 diabetes (t1d) are leaner and younger than patients with t2d, so it was expected that osa might be less common in patients with t1d. however, few studies have reported the prevalence of osa in t1d with a range between 8 and 46%. the relationship between osa and diabetes-related vascular disease is poorly explored in patients with t1d. this suggests a mechanism other than obesity may be responsible for osa in patients with t1d. therefore, the investigators hypothesized that (1) osa is related to can rather than obesity in patients with t1d. (2) osa is common in patients with t1d. (3) osa is associated with worse metabolic profile and microvascular complications in t1d. (4) oxidative and nitrosative stress are possible mechanisms relating osa to t1d complication.

Eligibility criteria:
inclusion criteria: * t1dm patient aged 18 and above, who was diagnosed more than 4 years ago. * able to give informed consent. * has sufficient proficiency in english to verbally answer interview questions. exclusion criteria: * past medical history of severe respiratory disorders including treated osa. * patients using oxygen supplements. * patients with end-stage renal disease receiving dialysis. * pregnancy. * dementia. * end stage diseases with life expectancy below 6 months. * patients with implantable devices * patients with known atrial fibrillation

Keywords: obstructive sleep apnoea (osa) type 1 diabetes (t1d) type 2 diabetes (t2d) insulin-dependent diabetes mellitus (iddm)
effect of fiber supplementation on the need for medication with gestational diabetes

Conditions: Gestational Diabetes Mellitus (GDM)

Summary: the hypotheses to be tested are 1) fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. in this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.

the study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as gdma1). the participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. the participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.

Eligibility criteria:
inclusion criteria: * singleton gestation * known or new diagnosis of gestational diabetes without reason for medication * age \>=18 to \<=50 exclusion criteria: * - non-english as primary language. * known or suspected fetal anomaly or aneuploidy. * known lower bowel disorder * known phenylketonuria * prisoners. * management of diabetes outside of eastern virginia medical school maternal fetal medicine.

Keywords: gestational diabetes mellitus fiber gdm
security efficacy covid-19 vaccination

Conditions: Autoimmune State; SARS-CoV-2 Infection

Summary: preliminary data support a possible molecular mimicry between sars-cov-2 and autologous components. this suggests the occurrence of autoimmunity during covid-19. consistently, autoimmunity may occur after sars-cov2 vaccination. the study aims to investigate the production of autoantibodies after vaccination in healtcare workers.

healtcare workers undergoing sars-cov-2 vaccination (with rna-vaccines) will be included on a voluntary basis. blood samples will be collected before and after vaccination (1 -3 - 6 - 12 months). all the vaccination side effects will be registered.

Eligibility criteria:
inclusion criteria: * healthcare workers undergoing sars-cov-2 vaccination exclusion criteria: * pregnancy * full blown autoimmune diseases * active vaccinations within 3 months before enrolment (excluding the influenza vaccine) * previous vaccination severe side effects

Keywords: sars-cov-2 vaccine
nivolumab dose optimization in patients with a complete, partial or stable response

Conditions: Melanoma

Summary: patients with advanced melanoma are, amongst others, currently treated with nivolumab monotherapy or with nivolumab and ipilimumab followed by nivolumab. even though registration studies administered nivolumab in a 3 mg/kg 2 weekly scheme, currently, nivolumab monotherapy is either administered in a 240 mg 2-weekly scheme or in a 6 mg/kg or 480 mg 4-weekly scheme. with the current dosing regimen, steady-state is achieved after approximately 5 to 6 months, whereas a tumour response is usually observed earlier in patients with metastatic melanoma. moreover, pd-1 receptor occupancy is almost saturated above doses of 0.3 mg/kg, or at nivolumab serum levels of 10 mg/l, which is a concentration that is achieved after one treatment cycle. in melanoma patients, the additional probability on response in patients treated with 3 mg/kg compared to 1 mg/kg seems limited. pfs and os for 3 mg/kg were not superior to 1 mg/kg. therefore, in this study, our aim is to investigate nivolumab trough levels and pharmacokinetic parameters after 3 reduced nivolumab doses.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * advanced or metastatic melanoma * current treatment with nivolumab for advanced or metastatic melanoma, in a 6 mg/kg or 480 mg, 4 weekly scheme * documented confirmed and ongoing cr, pr or sd according to recist v1.1 * on treatment for at least 6 months exclusion criteria: * unable to draw blood for study purposes * patients willing to participate or already included in the safe-stop trial
scot registry: small cell lung cancer treatment and outcome

Conditions: Lung Cancer, Small Cell

Summary: the registry is an international, multicenter, observational registry of newly diagnosed patients with sclc. data will be entered into an electronic crf (ecrf) via internet access. treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with sclc. approximately 60 centres in 13 countries will take part in this registry. it is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.


Eligibility criteria:
inclusion criteria: * male or female \>/= 18 years * diagnosis of small cell lung cancer * patient newly diagnosed with sclc * has given written informed consent (if applicable) exclusion criteria: * concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. * patient presenting with recurrence of sclc. * patients who has received any chemotherapy for the sclc.
laser acupuncture versus high protein/low carbohydrate diet on endothelial markers in obese females

Conditions: Obesity

Summary: the purpose of this study is to compare the effects of laser acupuncture and high protein low carbohydrate diet on the treatment of obesity and lowering of endothelial markers.

sixty females above 20 years of age with a body mass index (bmi) of over 30 kg/m2 will be divided into three groups (20 in each): two experimental groups (laser; high protein low carbohydrate diet) and control. each subject will receive the treatment relevant to their group, in addition to obtaining 3 days dietary recalls and measurements including bmi, serum insulin and endothelial markers. laser and control group will receive 24 activated or sham laser acupuncture treatments. high protein low carbohydrate group will be instructed to take a tailored high protein/low carbohydrate diet.

Eligibility criteria:
inclusion criteria: * obese females of bmi more than 30 kg/m2, and * of age range from 20 to 50 years. exclusion criteria: * medical history of chronic diseases, * pregnancy, * photosensitivity reactions to laser treatment, * a pacemaker, * medications known to affect one's weight up to 1 month in advance, or * are unwilling to comply with the study protocol.
study evaluating the safety and efficacy of tigecycline in hospitalized patients with csssi

Conditions: Skin Diseases, Infectious

Summary: tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.

to evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.

Eligibility criteria:
inclusion criteria: * hospitalized male and female patients, 18 years of age or older. * anticipated need for intravenous antibiotic therapy of 5 days or longer. * patients known or suspected to have a complicated skin and skin structure infection. exclusion criteria: * patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed. * patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely. * infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing.

Keywords: tigecycline csssi complicated skin and skin structure infections
social network overdose prevention and education intervention

Conditions: Drug Overdose

Summary: the purpose of this study is to test a social intervention focused on overdose prevention and care. in the investigators prior work, the investigators have shown that people who use opioids (pwuo) can be effective peer educators (pes).

the purpose of this study is to test a social intervention focused on overdose prevention and care. in the investigators prior work, the investigators have shown that people who use opioids (pwuo) can be effective peer educators (pes). the investigators have utilized pes for overdose prevention in interventions that have focused on training network members who use drugs to respond to an overdose. yet, many overdoses are witnessed by people who do not use drugs. additionally, many pwuo report using drugs at home and living with someone who does not use drugs, which highlights the importance of training non-using network members on overdose response. based on pilot data, the investigators propose expanding an overdose peer education intervention to focus on non-using network members. the intervention seeks to prepare network members to respond to an overdose and normalize discussions about overdose prevention planning between index pwuo and non-using network members. the intervention condition consists of 3 individual sessions focused on overdose prevention and response. this condition is designed to train index study participants to be peer educators. in addition to the three sessions, the non-drug using network member will be offered one session. the control condition is only 1 session focused on overdose prevention and response. both intervention and control participants will invite social network members to take part in data collection activities

Eligibility criteria:
inclusion criteria: * self-reported illicit opioid use at least 2 times in the past two weeks; * age 18 and older; * living in the baltimore metropolitan region; * willing to engage in peer education; and * having and willing to recruit at least one non-using network member. exclusion criteria: participants without the cognitive ability to provide informed consent and have the physical ability to participate in in-person intervention sessions.
role of novel urinary genomic and metablomic markers in diagnosis of bladder cancer in patients with hematuria

Conditions: Hematuria; Bladder Cancer

Summary: our goal is to develop a noninvasive, fast and simple assay to detect bca on the genexpert system and metablomic genes.

the xpert bca monitor is a novel mrna-based urine test that measures five mrna targets (abl1, anxa10, upk1b, crh, and igf2) in urine sample by real time rt-pcr. previous studies had investigated the feasibility and diagnostic performance characteristics of xpert monitor for surveillance of nmibc patients (12, 13). it demonstrated a high sn and npv in relation to urine cytology. on the other hand, metabolic dysfunction has been implicated in a wide variety of human diseases including bc (14). growth and division of tumor cells are associated with an increase in the activity of a variety of metabolic pathways. significant alterations in the carnitine-acylcarnitine metabolic pathways were detected in urine speci¬mens from bc patients compared to those of healthy controls (15). the expression of six genes involved in the carnitine-acylcarni¬tine metabolic pathway (cpt1a, cpt1b, cpt1c, cpt2, slc25a20, and crat) was assessed by won and colleagues. crat and slc25a20 were found to be significantly down regulated in bc patients (16). in this context, we aimed in the current study at prospective assessment of diagnostic performance characteristics of xpert bladder cancer monitor (xpert monitor) test and urinary metabolomics (urinary metabolites of tissue mrna genes expression crat and slc 25a20) for bladder cancer detection in patients with hematuria.

Eligibility criteria:
inclusion criteria: * patients with gross or persistent microscopic hematuria with irritative bladder symptoms exclusion criteria: * patients on anticoagulants * patients with history of radiotherapy

Keywords: hematuria bladder cancer biomarkers mrna cytology metabolomics
use of hearing aids. development and implementation of a counselling program for hearing aid users

Conditions: Presbyacusis

Summary: the proportion of elderly people is expected to increase greatly within the next couple of decades, resulting in a proportional increase in the need for hearing rehabilitation. however, studies suggest that as many as 40% of hearing aids are never or seldom used. thus, a major challenge for audiological rehabilitation is facilitating the use of fitted hearing aids. this study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up appointment on hearing aid use, 2) to implement a specialized counselling program based on mi, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use with datalogging technology.

hearing impairment is one of the most common health issues among adults in western countries. socioeconomic status and level of family support are known to influence help-seeking among older hearing-impaired individuals. although hearing loss can have significant adverse effects on an individual's quality of life, these effects have been found to be reversible through the use of hearing aids. even short-time use has been found to improve the emotional and social experience of hearing impaired subjects. unfortunately, of the approximately 200 000 people who have been provided with hearing aids in norway, it is estimated that as many as 20-40% seldom or never use them. lack of follow-up support and low motivation may explain why hearing impaired people do not use their hearing aids, but few research studies have addressed these issues. the aim of this study is to evaluate two approaches for increasing hearing aid use, to obtain objective estimates of actual hearing aid use, to identify factors barriers to regular use and to study hearing aid use related to age and gender. the study will examine the extent to which follow-up appointments motivate use of hearing aids among people with hearing loss. a randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed of the follow-up appointment. for decades, the use of hearing aids has been estimated using questionnaires. in the present study, hearing aid use will be objectively measured in hours pr.day using the hearing aid's datalogging. in addition, the study will develop, implement and evaluate a specialized counseling program for hearing aid users. difficulties with and barriers to hearing aid use will be documented and analyzed.

Eligibility criteria:
inclusion criteria: * age 65 + years old * subjective and objective need for hearing aids. exclusion criteria: * not being able to communicate in norwegian.

Keywords: hearing rehabilitation elderly hearing aid use