Kornimate/medical-research-clean huggingface dataset:
comparison of clinical performance of two monthly replacement toric soft contact lenses

Conditions: Ametropia; Astigmatism

Summary: the purpose of this study is to assess the clinical performance of total30 for astigmatism (t30fa) soft contact lenses with biofinity toric soft contact lenses.

subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). the total duration of the subject's participation in the study will be approximately 74 days.

Eligibility criteria:
key inclusion criteria: * successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months; * best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logmar in each eye; * willing and able to wear the study lenses as specified in the protocol; * other protocol-specified inclusion criteria may apply. key exclusion criteria: * biomicroscopy findings at screening that are moderate (grade 3) or higher and/or corneal vascularization that is mild (grade 2) or higher; presence of corneal infiltrates; * monovision and multifocal contact lens wearers; * habitual biofinity toric soft contact lens wearers, daily disposable contact lens wearers, and alcon toric contact lens wearers in the past 3 months prior to consent; * wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * other protocol-specified exclusion criteria may apply.

Keywords: contact lenses myopia
outcomes of using lnmes on tracheostomized children

Conditions: Trachea

Summary: tracheostomy tubes are known to have a negative impact on swallowing. dysphagia treatment includes using laryngoneuromuscular electrical muscular stimulation (lnmes). evidence exist on the efficacy of lnmes in the treatment of dysphagia in adults, and scarce in pediatrics. there is no literature available for the efficacy of lnmes in the treatment of dysphagia on patients with tracheostomy tubes. the purpose of this study to determine the outcomes on dysphagia on children with tracheostomy tubes when treated using lnmes. furthermore, the investigators aim to determine the relationship between parental stress and a child's modified diet.


Eligibility criteria:
inclusion criteria: patient cohort * children between 0-4 years 11 months * currently have tracheostomy tubes * mbss must indicate penetrations of more than 50% of swallows or aspiration of thin, ½ nectar-thick, nectar-thick or honey-thick liquids. * the child must be on a modified diet of honey-thick liquids, nectar-thick liquids, ½ nectar-thick liquids, or no liquids by mouth. * able to tolerate a voice valve parent cohort * at least one primary caregiver of a qualifying child (see child cohort). * parent/caregiver must be at least 18 years of age or older, provide primary care, and have medical decision making rights for the child. exclusion criteria: patient cohort * children who are not on modified diets or using a g-tube as an alternate means of nutrition * children with suspected or diagnosed heart problems * children with suspected or diagnosed epilepsy * children with a tendency to hemorrhage following acute trauma or fracture * children who have undergone recent surgical procedures when muscle contraction may disrupt the healing process * children for whom the lnmes would be: 1) over carotid sinus, 2) over neoplasm, 3) over active infection and 4) over areas of skin which lack normal sensation * children with difficulty tolerating tactile stimulation and tolerate the whole duration of the lnmes sessions. * children with difficulty tolerating tactile sensory stimulation such as tape and electrodes on the anterior aspect of the neck. parent cohort * the caregiver that does not provide the primary care of the child and does not have medical decision making right * parents under 18
ctdna for early detection of recurrence in melanoma

Conditions: Melanoma

Summary: this study examines circulating tumor dna (ctdna) as a biomarker for early detection of recurrence in high-risk patients, following treatment of primary melanoma. the hypothesis is that ctdna can provide accurate detection of recurrence or metastasis, at the time of or earlier than current methods, leading to improved management and hopefully prognosis, based on earlier detection.

this prospective, single-institution study will recruit patients attending follow-up for primary melanoma with high risk of recurrence, at the department of plastic and reconstructive surgery, herlev and gentofte university hospital, copenhagen university. enrolled patients will undergo regular blood sampling. samples will be centrifuged and plasma will be harvested and stored. in cases of metastasis or recurrence, tumor tissue samples will be analyzed using ngs to determine their mutational profile. plasma samples will be analyzed for ctdna corresponding to identified mutations. if ctdna is detected, previous samples will be analyzed in reverse sequential order, until no ctdna is detected. follow-up time after inclusion is five years or end of clinical-follow up, with an interim sample and data analysis scheduled for 2024 and final analysis scheduled for 2027-2028.

Eligibility criteria:
inclusion criteria: * follow-up for primary melanoma, stages iib to iii and resected stage iv exclusion criteria: * pregnancy * previous history of melanoma

Keywords: ctdna melanoma recurrence detection ddpcr ngs
clbs201 in patients with chronic kidney disease (ckd) and type 2 diabetes mellitus (t2dm)

Conditions: Chronic Kidney Diseases

Summary: clbs201 will evaluate the safety, tolerability, and therapeutic effect in subjects with ckd and t2dm.


Eligibility criteria:
inclusion criteria: 1. adults aged 18 to 75 years, inclusive 2. documented diagnosis of type 2 diabetes 3. egfr of 30 to \<45 ml/min/1.73m at the screening visit. 4. uacr 300 mg/g to ≤ 5000 mg/g exclusion criteria: 1. hemoglobin \< 10 g/dl 2. hemoglobin a1c ≥8% at the time of screening 3. acute kidney injury within 6 months prior to screening

Keywords: chronic kidney disease type 2 diabetes mellitus diabetic kidney disease
the effect of needle placement on muscle stiffness, gait, balance, pain and functional outcomes in individuals with injury to the ankle and/or hindfoot

Conditions: Ankle and or Hindfoot Injury

Summary: the purpose of this randomized controlled trial is to assess the effect of dn at either the site of the identified myofascial trigger point/s (mtrp) of in the same muscle, but away from the mtrp site/s in individuals with ankle and/or hindfoot injury. assessments will be of self-reported outcomes, self-reported pain, gait, balance, muscle stiffness, and pain pressure threshold. the secondary purpose of this study is to determine the validity of dry needling specific muscles of the lower extremity based upon needle placement, location relative to anatomical structures and accuracy of needle placement in muscle using ultrasound imaging.

few studies have assessed the validity of needling muscles of the lower extremity. for muscles such as the tibialis posterior that are not easily accessible or directly palpable secondary to the deep anatomical position and due to the proximity of the tibial nerve and the posterior tibial artery within the deep compartment, examining accurate needle placement is clinically relevant. in addition, dn has been shown to be a beneficial management strategy for individuals with lower extremity condition; however, the investigators may be able to optimize these beneficial effects by performing dn on the mtrp versus other sites within the same muscle. if needling directly into the mtrp is more effective than needling away from the mtrp but into the same muscle, it is possible that the improved efficiency could help to optimize management of patients with injury to the ankle/hindfoot with less visits and potentially decreasing health care costs.

Eligibility criteria:
inclusion criteria: * participants with a previous lower extremity injury occurring to the ankle and/or hindfoot within the previous 12 months and * pain greater than 3 out of 10 on the numeric pain rating scale (nprs) or * limited weightbearing dorsiflexion range of motion of greater than 2.0 cm side-to-side difference as measured by the ankle lunge test (alt) or * greater than 3.5% side-to-side difference as assessed by the y-balance test. exclusion criteria: * operative fixation within the past 3 months to the lower extremity * have received dn of the lower extremity within the past 30 days * current pregnancy * have a history of systemic disorders in which dn would be contraindicated (bleeding disorders or current anticoagulant medication use) * immunocompromised * decline participation

Keywords: dry needling muscle stiffness ankle injury hindfoot injury plantar pressure
vitamin d osteoporosis long-term care study

Conditions: Osteoporosis

Summary: the research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin d therapy in the long term care (ltc) setting? secondary outcomes include the number of falls and fractures experienced by the residents in each ltc home and the number of residents receiving appropriate bisphosphonate therapy.

this is a cluster randomized controlled trial. in the long-term care (ltc) setting, more research is needed on how health care professionals can be kept up to date on the latest medical evidence for providing care to elderly residents. the ltc environment differs from other health care settings. we need to examine what types of strategies can be used to effectively educate ltc physicians, nurses, and other care professionals about the best care practices. in this study, we will deliver and evaluate a multi-component educational strategy that builds on research in ltc by our team. in order to evaluate its success, 20 homes will receive the intervention and 20 homes will receive usual care. in the intervention homes, a team of experts will give educational sessions at the ltc home, delivering key messages about "best practices", helping ltc professionals to plan changes for delivering better care, giving feedback about performance, and providing materials (e.g., dvd, treatment plans). we will also train a professional in the home to "champion" the cause after the experts are gone. the specific "best practices" topic we have chosen to test our model is osteoporosis and fractures. these conditions are very common in the elderly living in ltc and negatively impact quality of life. for example, an individual with a hip or other fracture may experience unnecessary pain and suffering and even pre-mature death. there are effective treatments that can be used to reduce fractures, including vitamin d, which is a low-cost, well-tolerated and easy treatment to deliver. unfortunately our previous studies have shown that most ltc residents are not receiving effective fracture-prevention treatments. to determine our intervention's success, we will examine whether the rate of vitamin d use and other treatments increases, and whether fewer ltc residents fall and fracture. we are also interested in studying the strategy's format and feasibility and what future changes should be made.

Eligibility criteria:
inclusion criteria: * ltc homes in ontario that are serviced by mpgi

Keywords: long-term care vitamin d
tooth wear and associated risk factors

Conditions: Tooth Wear

Summary: this study compares the associated risk factors between adults with tooth wear and age- and sex-matched controls without tooth wear.

some people are at greater risk due to their eating and brushing habits. poor oral health behaviors and malnutrition are the leading causes of tooth surface loss in adults. fluid consumption trends have changed, and the increased consumption of carbonated drinks coincides with a decline in the consumption of dairy products and increases in the use of packaged products. frequent and faulty brushing with abrasive oral hygiene products can also increase tw. individuals unhappy with the color of their teeth may also frequently use whitening toothpaste. saliva is considered the biological factor with the greatest potential to modify the progression of tw. there are several potential mechanisms by which saliva may protect enamel from dietary acid erosion. saliva protection mechanisms include the dilution of erosive agents in the mouth, neutralization, effects of calcium and phosphate ions, and slowing of the rate of enamel dissolution. the loss of dental tissue can lead to the character's loss of precision and form, and in advanced stages the dentin surface can be exposed. tw is initially painless and unrecognizable. in the next stage, complaints often include tenderness and non-aesthetic factors. it is difficult to recognize the signs of tw and very important to avoid premature diagnosis, as tw can often be diagnosed by a dentist. correct diagnosis is an important part of the treatment and will help the dentist determine recommendations for the patient.

Eligibility criteria:
inclusion criteria: subject is in good health. subject is able to understand and read the questionnaire. exclusion criteria: wearing orthodontic appliances, having crowns or partial dentures using any medications.

Keywords: tooth wear, risk factors, saliva, diet, oral hygiene
pain types and pain severity in chronic low back pain

Conditions: Chronic Low-back Pain

Summary: the aim of this study is to characterize the distribution of pain phenotypes in people with chronic low back pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life. participants will be examined to determine the type of pain and questions will be asked to identify the effects.


Eligibility criteria:
inclusion criteria: * having chronic low back pain * be over 18 years old exclusion criteria: * those under the age of 18 * those with major psychiatric illness, * those with communication problems
study of abt-267 in both healthy volunteers and hepatitis c virus (hcv) genotype 1 infected subjects

Conditions: HCV Infection

Summary: study of abt-267 in both healthy volunteers and hepatitis c virus (hcv) genotype 1 infected subjects.


Eligibility criteria:
inclusion criteria main selection criteria for healthy volunteers: * subject has provided written consent. * subject is in general good health. * females must be post-menopausal for at least 2 years or surgically sterile. * females must not be pregnant or breast-feeding. if male, subject is surgically sterile or practicing specific forms of birth control. main selection criteria for hcv genotype 1-infected volunteers: * subject has provided written consent. * subject has chronic hcv genotype 1 infection at screening. * liver biopsy within 3 years with histology. * females must be post-menopausal for at least 2 years or surgically sterile. * females must not be pregnant or breast-feeding. if male, subject is surgically sterile or practicing specific forms of birth control. * subject is in general good health, as perceived by the investigator, other than hcv infection. main selection criteria for volunteers in the resistance monitoring portion of the study: * subject has provided written consent, has received at least one dose of abt-267 or placebo in the study, and is considered suitable by the investigator to participate. exclusion criteria main exclusion criteria for healthy volunteers: * positive test for hav igm, hbsag, hcv ab or hiv ab. * clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder. * use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration. * abnormal screening laboratory results. * significant sensitivity to any drug. * requirement for any over the counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis. main exclusion criteria for hcv genotype 1-infected volunteers: * significant sensitivity to any drug. * positive hbsag, hav-igm, and hiv ab. use of cyp enzyme inducers or inhibitors within 1 month of dosing. * clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid disease (except hypothyroidism on stable thyroid replacement therapy), or any uncontrolled medical illness or psychiatric disorder. * use of any medications (prescription and over-the counter) within 2 weeks prior to study drug dosing without prior approval by the abbott medical monitor. * use of any vitamins or herbal supplements within 2 weeks prior to study drug dosing. * prior treatment with any investigational or commercially available anti-hcv agents. * abnormal screening laboratory results.
comparison of a novel transperineal targeted fusion biopsy system to conventional transrectal targeted fusion biopsy

Conditions: Prostate Cancer

Summary: this study is designed as a randomized control trial which intends to determine if transperineal (tp) targeted biopsy is not inferior to transrectal (tr) targeted biopsy for diagnosis of clinically significant prostate cancer while comparing post-procedural infection rates between the two techniques. the study will also look to compare patient reported pain scores related to the procedure, rates of other minor complications (e.g. bleeding, urinary retention) and procedure time. the expected sample size at the ottawa hospital is 360 men.

patients undergo mp-mri, at the discretion of the treating urologist, when they are referred to the cancer assessment clinic for their initial visit with a risk factor for prostate cancer (e.g. abnormal digital rectal exam \[dre\] or elevated prostate serum antigen \[psa\] level). performing an mp-mri in a man with risk factors for prostate cancer prior to an initial biopsy has become the standard of care for diagnosis of prostate cancer based on two large multi-center randomized control trials. at the second visit, which is standard of care, the urologist (or delegate \[resident, fellow\]) will discuss targeted biopsy and will introduce the trial design obtaining informed consent to participate. if consent is obtained, the patient will be randomly assigned to receive either the standard transrectal (tr) ultrasound guided targeted fusion biopsy or the novel transperineal (tp) targeted fusion biopsy system which has also been preliminarily validated as being accurate for detection of significant prostate cancers at targeted biopsy. patients will be notified regarding which method of targeted biopsy will be employed at time of scheduling. both the tr and tp biopsies will be conducted in existing biopsy rooms in the ottawa hospital (toh) and will employ a brief 30-minute post-procedural observation period at which point the patient is required to urinate prior to discharge. level of pain will be recorded by the ultrasound technologists during the 30 minutes observation period as well. this study aims to compare ultrasound guided transrectal and transperineal targeted fusion biopsy for diagnosis of prostate cancer in abnormalities detected on mri for the purpose of reducing or completely eliminating the risk of serious infection associated with the transrectal approach.

Eligibility criteria:
inclusion criteria: * mri positive - abnormal area detected * patient re-evaluated in the toh prostate cac (cancer assessment centre) for planning of targeted biopsy * signed consent exclusion criteria: * mri negative - no abnormal area detected * patient with a prior diagnosis of prostate cancer enrolled in active surveillance

Keywords: transperineal transrectal fusion biopsy
distress, anxiety and psychosexual health in bot

Conditions: Ovarian Neoplasm Epithelial Borderline

Summary: the aim of this study is to assess the prevalence of distress, anxiety and psychosexual anguish in patients diagnosed with borderline ovarian tumor (bot) compared to controls confronted with surgical treatment for benign ovarian tumors.

appropriate surgical care is primordial for the patient after diagnosis of a bot. taking into account the good prognosis and long live expectancy caregivers should also be concerned about non-oncological complains during the follow-up to guarantee the overall well-being of the patient. women diagnosed with gynaecological cancer are likely to face additional consequences beyond those common to all cancer patients. not surprisingly, previous research shows that women affected by gynaecological cancer are likely to suffer significant physical and psychological morbidity. studies including women of all ages with gynaecological cancers indicate higher levels of psychological distress, including clinical levels of anxiety, depression and posttraumatic distress disorder as well as greater decrements in body image and more sexual problems than in other types of cancer. high levels of distress were reported up to four years following the diagnosis. longitudinal studies addressing the prevalence of psychological distress, anxiety or psychosexual health during follow up in bot patients are lacking. due to the connotation between sexuality and internal genitals, diagnosis of the bot and following surgery are possibly negatively influencing each other. large prospective or randomized control studies are unachievable due to the low prevalence of bot and limited recurrences or death. identification of the presence of psychological morbidity, including anxiety and depression is clinically useful because, unlike most demographic and clinical factors, psychological illness and psychosexual complaints are modifiable. the study material consists out of two main parts of questionnaires. a first questionnaire addressing the distress and anxiety consists of validated questionnaires: * hospital anxiety and depression scale (hads), * body image scale (bis), * perceived stress scale (pss). and a second questionnaire concerning psychosexual health, built up out of validated questionnaires; * female sexual function index (fsfi), * female sexual distress scale - revised (fsds-r), * european organisation for research and treatment of cancer (eortc) quality of life (qol) questionnaire designed to measure the qol of patients with ovarian cancer (eortc qlq-ov28) (only questions 50-58) * eortc sexual health questionnaire (eortc shq-c22) for assessing sexual health in cancer patients (only the part concerning women).

Eligibility criteria:
inclusion criteria: * diagnosis and surgery for benign or borderline ovarian tumors. * \>18 y. exclusion criteria: * known former psychological morbidity evaluated by the investigators. * history of another cancer type.

Keywords: low malignant potential sexual health anxiety distress surgery