Kornimate/medical-research-clean huggingface dataset:
pilot study of accommodative/vergence therapy to modify accommodative function in children with myopia

Conditions: Myopia

Summary: this study aims to determine the treatment effect of accommodative/vergence therapy on myopic children by assessment of accommodative function before and after therapy.

1. specific aims of the proposed clinical trial: 1.1 to prove accommodative/vergence therapy (at) can normalize the accommodative function of myopic children.。 1.2 if the accommodation function of myopic children can be improved with at therapy, the outcome will supply a basic for a randomized, multi-center clinic trail to determine the effectiveness of at to slow the progression of myopia. 2. hypothesis: accommodative/vergence therapy can normalize the accommodative functions of 8-12 years old chinese myopic children.

Eligibility criteria:
inclusion criteria: subjects enrolled in the trial must: 1. be within the age range of 8 to 12 years old inclusive; 2. -0.75d to -4.50dspherical equivalent by cycloplegic autorefraction in both eyes 3. astigmatism≤1.5d in both eyes； 4. anisometropia≤1.0d； 5. accommodation lag at near(33cm）in right eye by non-cycloplegic auto- refraction ≧1d; 6. have vision correctable to at least 0.8 or better in each eye. exclusion criteria: subjects enrolled in the trial must not have: 1. current or prior use of progressive addition lens, bifocals, or contact lenses in either eye( prior or current use of single vision lens allowed)； 2. history of any of the following functional defects: strabismus, amblyopia, nystagmus； 3. history of diabetes or seizures； 4. history of any ocular systemic, or neuro-developmental condition that might influence refractive development； 5. use of ocular or systemic medications known to affect accommodation, such as atropine, pirenzepine, and anti-epileptic medications in recent 3 months； 6. history of any ocular surgery that might influence refractive development； 7. developmental disability, attention deficit hyperactivity disorder(adhd), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment； 8. relocation anticipated for 3 years； 9. birth weight lower than 1250 grams（2lbs,12oz）； 10. siblings in the study.
effect of an enzyme-containing lozenge on dental biofilm in healthy individuals.

Conditions: Dental Plaque; Gingivitis; Microbial Colonization

Summary: the purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.

the purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. the null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.

Eligibility criteria:
inclusion criteria: * generally healthy males and females ≥18 years of age. * able to read, sign and receive a copy of the signed informed consent form. * have at least 20 natural teeth. exclusion criteria: * clinically visible active caries lesions and/or periodontitis. * significant oral soft tissue pathology based on a visual examination. * history of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients. * history of allergies to ingredients in the test product. * history of allergies towards enzymes. * self-reported as pregnant or nursing. * self-reported serious medical conditions. * antibiotic or anti-inflammatory medication within 30 days of screening visit. * orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures. * acute sinusitis or severe oral-pharyngeal infections.
a study of the safety and pharmacokinetics of levodopa following administration of cvt 301 (levodopa inhalation powder) in adults with asthma

Conditions: Asthma

Summary: this study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and pk of 3 doses of cvt 301 levodopa (l-dopa) in adults with asthma.


Eligibility criteria:
inclusion criteria: * eligible subjects will be men or women in good general health with a diagnosis of mild or moderate asthma; * on a stable regimen of asthma medications for at least 30 days prior to screening; * body mass index (bmi) 18 to 32 kg/m2; * forced expiratory volume in one second (fev1) ≥60% of predicted for race, age, sex, and height; * fev1/fvc (forced vital capacity) ratio ≥70%. exclusion criteria: * more than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness; * asthma exacerbation within 8 weeks before screening; * unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening; * history of intubation or intensive care unit admission for asthma in the past 5 years; * history of chronic obstructive pulmonary disorder (copd) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years; * renal impairment as defined by a calculated creatinine clearance of ≤ 80 ml/minute.
ovarian cancer patient questionnaire on genetic testing

Conditions: Ovarian Cancer

Summary: the objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy.

all eligible patients being seen in the gynecology center at the m.d. anderson cancer center and at gynecologic oncology of houston for follow-up or a new diagnosis of ovarian cancer will be asked to participate in this study by completing a questionnaire. this study will end when 400 completed questionnaires have been collected. we estimate that 40-60 ovarian cancer patients are seen in the gynecology center at the m.d. anderson cancer center each week and that 20- 40 ovarian cancer patients are seen at gynecologic oncology of houston each week. the completion of 400 questionnaires will provide adequate data to address our question in an expeditious time frame. the initial phase of this study is exploratory and does not involve a comparison group.

Eligibility criteria:
inclusion criteria: * patients must have the diagnosis of ovarian cancer. * patients must be at least 18 years of age at the time of enrollment. * patients must be able to read and write in the english language. exclusion criteria: * patients that are unable to speak or write in the english language. currently, the investigators' resources in genetic counseling are limited. in the future, they plan to expand the questionnaire and study to include additional languages. * patients having previously undergone brca genetic testing.

Keywords: ovarian cancer questionnaire genetic testing survey
endo-cuff assisted vs. standard colonoscopy for polyp detection in bowel cancer screening

Conditions: Colonic Polyps; Colonic Neoplasms

Summary: the study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

problem statement: in england, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. those who test positive in the initial screening stool test are invited to have a colonoscopy. the purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. however, colonoscopy still misses up to 25% of polyps. cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. there is a need for an improved cap design which will help improve polyp detection. research question/hypothesis: does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients? study design: parallel group, single blinded randomised controlled trial study participants: patients attending for colonoscopy under the bowel cancer screening programme planned sample size: 534 planned study period: 12 months primary objective: to assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient

Eligibility criteria:
inclusion criteria: * patients referred for colonoscopy under the national bowel cancer screening programme * able to provide written informed consent exclusion criteria: * history of inflammatory bowel disease * history of hereditary non polyposis colorectal cancer

Keywords: colonoscopy early cancer detection cancer screening
a health economic trial in adult patients undergoing ileostomy reversal ma402s23b504

Conditions: Retraction of Colostomy

Summary: this study is designed to compare the standard of care against exparel (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using exparel, therefore possibly reducing total hospitalization costs.

this is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with exparel (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (iv) morphine sulfate for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age and older * patients scheduled to undergo ileostomy reversal * ability to provide informed consent, adhere to study visit schedule, and complete all assessments. exclusion criteria: * patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol. * patients who abuse alcohol or other drug substance. * patients with severe hepatic impairment. * patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at lest one month before and one month after dosing. * patients with any psychiatric, psychological, or other condition that the investigator feels may make the patient an inappropriate candidate for this clinical study. * patients who have participated in an exparel study within the last 30 days. * patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study. in addition, the patient will be ineligible if he/she meets the following criteria during surgery: * patients who have any concurrent surgical procedure. * patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents. * patients who receive entereg(r).

Keywords: ileostomy reversal
testing the efficacy of safe south africa

Conditions: Intervention; Control

Summary: in this study, investigators will examine the efficacy of safe south africa, a behavioral intervention that is developmentally- and gender-tailored to prevent human immunodeficiency virus (hiv) and intimate partner violence (ipv) among adolescent boys. south africa faces some of the highest global rates of hiv and ipv with sustained high incidence of hiv and alarming rates of ipv among adolescents and thus, is an ideal site to advance prevention science to tackle these urgent public health priorities. testing the efficacy of an integrated intervention to prevent hiv risk behavior and ipv for adolescent boys can support optimal health for young people, their future partners, and society.

adolescence presents an ideal developmental transition period for an integrated intervention targeting prevention of hiv risk behaviors and intimate partner violence (ipv), including sexual violence. adolescent boys in particular are at high risk for hiv and perpetration of ipv. yet, few behavioral interventions integrate hiv-ipv prevention and are tailored for the unique developmental needs of adolescent boys. in this study, investigators build on previous scientific work that demonstrated the acceptability and feasibility of safe south africa, an integrated hiv-ipv intervention that uses a developmentally- and gender-tailored approach grounded in social norms theory to prevent adolescent hiv risk behavior and ipv. investigators will conduct the work in south africa, a country with the largest hiv epidemic and some of the highest rates of ipv in the world. the investigative team propose the following specific aims: (1) tailoring safe south africa intervention content to address the unique behavioral and social norms data that drives hiv and ipv behaviors among boys in their socioecological environments. (2) testing the efficacy of the safe south africa intervention in preventing hiv/stis and reducing ipv frequency among n=836 adolescent boys (ages 15- 17), with the scientific team's working hypothesis that the intervention, relative to the usual care condition, will show (a) lower incidence of any sti (including hiv); and (b) reductions in ipv perpetration frequency and decreased endorsement of ipv supportive attitudes. (3) identifying barriers and facilitators to implementing safe south africa within a school setting to provide data for future dissemination (presuming safe south africa is efficacious). investigators will examine processes critical to future dissemination through (a) fidelity data examining adherence to core active components of the standardized intervention manual guiding consistent delivery of the intervention; and (b) qualitative data on the experience during and post-implementation from adolescents and stakeholders using n=20 in-depth interviews with each group.

Eligibility criteria:
inclusion criteria: * identification as boys * ages 15-17 years * enrolled at public high schools in south africa situated in communities with high rates of hiv and violence exclusion criteria: * does not have written parental consent * does not have written assent
effect of acupuncture on the clinical outcome of ivf-et in patients with recurrent implantation failure

Conditions: Acupuncture; Recurrent Implantation Failure

Summary: in order to explore the effect of acupuncture on the clinical outcome of ivf-et in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. in the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. in the control group, those patients do not receive any treatments during embryo transfer cycle. statistical analysis of the two groups of primary endpoint and secondary endpoint are done.

in the field of assisted reproduction techonology, there are still 10% of patients with recurrent implantation failure. in order to explore the effect of acupuncture on the clinical outcome of ivf-et in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. in the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. in the control group, those patients do not receive any treatments during embryo transfer cycle. both of two group patients are checked including endometrial receptivity index and fill in sas anxiety scale form. statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (embryo implantation rate, biochemical pregnancy rate, early pregnancy loss rate, ongoing pregnancy rate, live birth rate)are done.

Eligibility criteria:
inclusion criteria: 1. a: ≥ 3 times embryo transfer failures，and at least accumulated 4 high-quality embryos were transferred b: two times consecutive embryo transfers failures, at least accumulated 4 high-quality embryos were transferred 2. undergo ivf / icsi / pgt; 3. transfer 1-2 d3 cleavage embryos or blastocysts in ivf / icsi and transfer 1 blastocyst in pgt; 4. 20-38 years old female 5. sign the informed consent voluntarily. exclusion criteria: 1. contraindications for pregnancy or assisted reproductive technology; 2. chromosome abnormality of husband or wife (except polymorphism); 3. abnormal gene diseases; 4. untreated of uterine diseases that affect the uterine cavity morphology (uterine malformation, submucous myoma, adenomyosis, endometriosis and endometriosis etc.); 5. amh \< 1.1ng/ml or afc \< 7; 6. the most thickness of endometrium is less than 7 millimeter; 7. those who have more than 2 times clinical pregnancy abortion; 8. patients with serious primary diseases including cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and mental diseases 9. the treatment (such as acupuncture and traditional chinese medicine) related to help pregnancy had been carried out in the last 3 months.

Keywords: acupuncture recurrent implantation failure
bezlotoxumab (mk-6072) versus placebo in children with clostridium difficile infection (cdi) (mk-6072-001)

Conditions: Clostridium Difficile Infection

Summary: the primary objectives of this study are to evaluate the pharmacokinetics (pk), safety, and tolerability of bezlotoxumab (mk-6072) in children aged 1 to \<18 years of age with a confirmed diagnosis of clostridium difficile infection (cdi) who are receiving antibacterial drug treatment. the primary hypothesis is that the area under the concentration-time curve from 0 to infinity (auc0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the auc0-inf of bezlotoxumab after treatment of adults with bezlotoxumab.

historical adult pharmacokinetic data is from nct01241552 and nct01513239.

Eligibility criteria:
inclusion criteria: * at screening has suspected or confirmed clostridium difficile infection (cdi), and is receiving or is planning to receive a 10- to 21-day course of antibacterial drug treatment for cdi * at study infusion has a diagnosis of cdi confirmed by a diagnostic assay which detects the presence of c. difficile toxin in stool, and is still receiving antibacterial drug treatment for cdi * female is not pregnant, and not breastfeeding; but if of childbearing potential agrees to follow contraceptive guidance during the treatment period and for at least 12 weeks after the last dose of study treatment * participant and/or parent or caregiver must be able to read, understand, and complete the daily diary exclusion criteria: * has an uncontrolled chronic diarrheal illness * has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its excipients * at randomization, their planned course of antibacterial drug treatment for cdi is longer than 21 days * at screening has received any listed prohibited prior and concomitant treatments and procedures * has previously participated in this study, has previously received bezlotoxumab, has received an experimental monoclonal antibody against c. difficile toxin b, or has received a vaccine directed against c. difficile or its toxins. * has received an investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical study with an investigational agent during the 12-week study period
deep learning for classification of scheimpflug corneal tomography images

Conditions: Eye Diseases

Summary: keratoconus is a common disorder. an early diagnosis influences the disease prognosis in the affected patients and prevents postoperative complications in patients with keratoconus considering refractive surgery. machine learning approaches have been widely used for image classification. here, we will assess the ability of deep learning to enable high-performance image classification of the color-coded corneal maps obtained by scheimpflug camera in patients with keratoconus, subclinical keratoconus, and normal individuals.


Eligibility criteria:
inclusion criteria: keratoconus group: * presence of a central protrusion of the cornea with fleischer ring, vogt striae, or both by slitlamp examination. * irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by pińero and colleagues : * focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones * focal areas with diopteric (d) values \>47.0d * inferior- superior(i-s) asymmetry measured to be \> 1.4 d * angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis(srax) . suspicious group: • defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (forme fruste keratoconus). normal group: * refractive surgery candidates * refractive error of less than 8.0 d sphere * less than 3.0 d of astigmatism * without clinical, topographic or tomographic signs of keratoconus or suspect keratoconus. exclusion criteria: * systemic disease * other corneal disease such as pellucid marginal degeneration * history of trauma * corneal surgery such as corneal cross- linking for progressive keratoconus.

Keywords: keratoconus deep learning scheimpflug camera corneal tomography
integrative therapy in alcoholism

Conditions: Alcoholism

Summary: the main aim of this project consists in the investigation of the interaction of behavior therapy and acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication acamprosate vs. placebo) double blind design. a total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.

the objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. this investigation should contribute to the issue of effective relapse prevention. each treatment condition is lasting 6 months: a) behavior group therapy + acamprosate, b) behavior group therapy + placebo and c) support and counseling + acamprosate. follow-up examinations carried out 3 and 6 months after the end of treatment.

Eligibility criteria:
inclusion criteria: * dsmiv criteria of alcoholism * age between 25 and 60 * informed consent exclusion criteria: * residence outside of the catchment area * legal reasons * insufficient knowledge of the german language * substance abuse or addiction other than alcohol or nicotine * pregnancy * serious physical illness * organic brain disease * contraindication to acamprosate treatment

Keywords: alcoholism abstinence enhancement psychotherapy cognitive behavior therapy vs. supportive counseling acamprosate vs. placebo multi-center study