Kornimate/medical-research-clean huggingface dataset:
evaluation of vision after vivity iol implantation with a target of slight myopia in the non-dominant eye

Conditions: Cataract

Summary: the objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the acrysof® vivity intraocular lens (iol) when the non-dominant eye is targeted for slight myopia.

this study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. clinical evaluations will include administration of a visual disturbance questionnaire (quvid), patient-reported spectacle independence questionnaire (prsiq), and a satisfaction questionnaire (iolsat), as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility criteria:
inclusion criteria: * • presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an edf iol * meet the requirements for on-label implantation of the edf iol * gender: males and females. * age: 40 or older. * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * have regular corneal astigmatism with a magnitude that can be treated with a non-toric iol or toric iol. * have 20/32 (0.2 logmar) or better potential acuity in both eyes exclusion criteria: * • irregular astigmatism (e.g. keratoconus) * corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye) * monocular status (e.g. amblyopia) * previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, dsaek, lamellar keratoplasty) * previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) * diabetic retinopathy * macular pathology (e.g. armd, erm) * history of retinal detachment * subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. * participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).
safety and tolerability of zipsor® in pediatric subjects (ages 12-17 years) with mild to moderate acute

Conditions: Pain

Summary: as part of the prea(pediatric research equity act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of zipsor® in clinical pediatric subjects.

open-label study, subjects will be dosed with zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Eligibility criteria:
inclusion criteria: * male and female subjects between 12-17 years of age. * subjects must be post-op, having mild or moderate acute pain. other inclusions apply. exclusion criteria: * subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication. * subject has been taking analgesic for 48-72 hours prior to screening. * subject has a history of any gi event greater than 6 months before screening. * subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen. * subject has previously participated in another clinical study of zipsor or taking zipsor for any other indication. * subject is requiring treatment for pre-existing hypertension. other exclusions apply.

Keywords: pain nsaid moderate pain mild pain acute pain mild acute pain moderate acute pain mild or moderate acute pain
clinical efficacy and safety evaluation of teneligliptin in type 2 diabetes who have inadequate glycemic control with empaglyflozin and metformin

Conditions: Type 2 Diabetes

Summary: the objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin and metformin


Eligibility criteria:
inclusion criteria: * patients with type ii diabetes mellitus aged 19 years or older * subjects with 7.0%≤hba1c≤10.5% at screening visit * subjects with fasting plasma glucose ≤ 270mg/dl at screening visit exclusion criteria: * subjects with type 1 diabetes mellitus or secondary diabetes * subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit * subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin) * body mass index greater than 40 kg/m2 at the screening visit * subjects with heart failure (class iii-iv of nyha classification) or arrhythmia that requires treatment
who checklist- based infection prevention guidelines in mulago hospital

Conditions: Surgical Site Infection

Summary: this prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at mulago national referral hospital based temporarily at kawempe hospital. mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days .

to determine the level of compliance with who checklist-based infection prevention guidelines following caesarean delivery in mulago national referral hospital, kawempe. to determine the association between compliance with who checklist-based infection prevention guidelines and surgical site infection following caesarean delivery in mulago hospital, kawempe. this prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at mulago national referral hospital based temporarily at kawempe hospital. mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days of in-hospital stay for the purpose of documentation of surgical site infection. data will be collected using the checklist expansion for antisepsis and infection control questionnaire.

Eligibility criteria:
inclusion criteria: * mothers undergoing elective and emergency caesarean deliveries in mulago national referral hospital, kawempe in labour suite and gynaecology theatre. exclusion criteria: * patient who is unconscious and unknown patient
plaque removal efficacy of four dentifrices following a single brushing

Conditions: Plaque, Dental

Summary: the purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. at each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

this study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. this 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. qualified subjects will have sufficient plaque (lobene-soparkar modification of turesky plaque index). subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Eligibility criteria:
inclusion criteria: 1) 18 to 69 years exclusion criteria: 1. have any known allergies or sensitivities to marketed dentifrice or oral hygiene products. 2. have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures. 3. evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
breath analysis in chronic obstructive lung disease (copd)

Conditions: COPD

Summary: to answer the question whether a disease specific profile of breath in patients with copd can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

this is an observational study comparing the volatile organic compounds (vocs) in exhaled breath between copd patients and matched control subjects (age, gender, smoking-state). 40 copd patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by sesi-ms on the composition of exhaled breath for identification of copd specific markers.

Eligibility criteria:
inclusion criteria: * confirmed copd gold stage i-iv, based on a post-bronchodilator spirometry (fev1/fvc \< 0.7) performed within the last 6 months * age between 18 and 80 years at study entry * healthy controls: normal spirometry exclusion criteria: * copd exacerbation within the last 6 weeks * any lung disease other than copd * acute inflammatory disease (e.g. common cold) within the last 6 weeks * acute or chronic hepatic disease * renal failure or renal replacement therapy

Keywords: exhaled breath volatile organic compounds (vocs) sesi-ms
genetic evaluation of natalizumab-treated patients with progressive multifocal leukoencephalopathy

Conditions: Progressive Multifocal Leukoencephalopathy

Summary: the purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing progressive multifocal leukoencephalopathy (pml). samples will also be collected to determine deoxyribonucleic acid (dna) sequence of jc virus (jcv). analysis of the jc virus (jcv) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing progressive multifocal leukoencephalopathy (pml) due to chronic infection with a more pathogenic variant of jc virus (jcv).

deoxyribonucleic acid (dna) will be analyzed from natalizumab-treated subjects who develop progressive multifocal leukoencephalopathy (pml). the genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.

Eligibility criteria:
key inclusion criteria: * subjects who have confirmed pml while on treatment with natalizumab note: other protocol defined inclusion/ exclusion criteria may apply.
novel augmentation of daoib and antioxidant for early dementia

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Summary: previous studies found that some nmda-enhancing agents were able to improve cognitive function of patients with early-phase dementia. in addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. whether combined treatment of an nmda-enhancing agent and a drug with antioxidant property can be better than an nmda-enhancing agent alone deserves study.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of alzheimer's disease or mild cognitive impairment * mmse between 10-26 * cdr 1 or 0.5 exclusion criteria: * hachinski ischemic score \> 4 * substance abuse/dependence * parkinson disease, epilepsy, dementia with psychotic features * major depressive disorder * major physical illnesses * severe visual or hearing impairment
the clearcoast™ magnetic resonance outcome pms study

Conditions: Breast Cancer

Summary: post marketing surveillance (pms) study. up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent bcs will serve as the historical control group, accounting for a 1:1 ratio. all study patients and the patients in the historical control group will be required to meet the study eligibility criteria. bcs will be performed with the routine standard of care (soc), including intra-operative methods used to improve margin assessment. in addition to soc process, the main specimen from patients found eligible will be scanned in the clearcoast™ system. the surgeon will utilize the information from the clearcoast images in his margin assessments evaluation which includes the diffusion at the surface of a particular aspect (suggesting irregular tissue at the specimen's surface), and decide whether to excise additional tissue. the decision-making process including mr images interpretation and the surgical decisions will be evaluated and documented. following procedure, routine histopathology examination will be performed accompanied by the clearcoast optical and parametric maps. this study is a controlled design, in which subjects previously having undergone bcs by the same surgeons, will serve as the historical control group, comparing the following endpoints: * complete surgical re-excision rate * total excised breast tissue volume the study control group is composed of historical data from patients previously undergone bcs, under the same site soc surgical practice, practicing surgeons, and study eligible criteria. this allows reducing inter-group variability and bias. a device operator trained by clearcut medical will operate the device throughout the study.


Eligibility criteria:
inclusion criteria: 1. women histologically diagnosed with invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure 2. age ≥18 3. patient is willing and capable to provide written informed consent form (icf) exclusion criteria: 4. prior surgical procedure in the same breast within 12 months prior to the surgery date 5. recurrent breast cancer surgery 6. neoadjuvant chemotherapy and/or neoadjuvant hormone therapy 7. previous radiation therapy in the operated breast 8. pregnancy 9. lactation 10. patient has subglandular breast implants in the operated breast 11. moribund patient and/or patient with comorbidities, per principal investigator discretion 12. participating in any other investigational study for either drug or device which might influence collection of valid data under this study. intraoperative: 13. specimen undergoing pathological specimen assessment (e.g. by frozen section, imprint cytology or gross assessment by sectioning), resulting in deformation of specimen shape/tissue properties (e.g. formalin conservation) 14. specimen dimension is larger than the tissue container volume (200cc) 15. inability to define aspect color/orientation and/or margin border
sars-cov-2 infection in covid-19 vaccinated patients

Conditions: COVID-19

Summary: vaccination of the population is crucial in the fight against the covid-19 pandemic. although most available vaccines have an estimated efficacy against symptomatic infection of 65-95%, this can be significantly reduced if the patient has co-morbidities such as immunosuppression or if the full vaccination schedule is not followed. infection with sars-cov-2 variants, carrying mutations, notably on the spike protein, may also be associated with escape from immunity acquired by vaccination. indeed, in vitro studies have shown a decrease in sensitivity to neutralizing antibodies acquired after vaccination or even after infection for certain variants such as variant b.1.351 (beta variant according to the who, first detection in south africa) or variant b.1.617.2. (delta variant according to the who, first detection in india). on the other hand, cases of covid-19 following a full vaccination regimen have recently been reported. with the increasing detection of new variants and in the context of increasing vaccination coverage of the population, one of the priority missions of the national reference centre (nrc) for respiratory infection viruses is to clinically and virologically investigate all cases of infection in vaccinated patients. the main objective is to determine whether a particular variant is over-represented in vaccinated patients with an infection. the secondary objective is to study the humoral immune response in covid-19 vaccinated patients with and without sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 years old * persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months. * persons affiliated to a social security scheme or beneficiary of such a scheme exclusion criteria: - pregnant or lactating woman

Keywords: sars-cov-2, covid-19 vaccine, variant host-immune response
phase ii study of neoadjuvant chemotherapy regimen choice in breast cancer

Conditions: Breast Cancer

Summary: the study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. the neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.

the investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. the patients are randomized two chemotherapy regimens. one is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.

Eligibility criteria:
inclusion criteria: * diagnosis of invasive ductal or lobular breast cancer. * previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer. * no anti-her2 therapy if her2 positive ( defined as 3+ ihc or fish positive) * performance status ecog \<2 * age \> 18 years * tumor \> 2.0 cm by mri and/or sonographic or clinical exam measurements.or karnofsky \>50% * lab test : * absolute neutrophil count \> 1,500/mm3 * total bilirubin ≤ 2×uln * ast and alt ≤ 2.5×uln * serum creatinine ≤ 1.5×uln exclusion criteria: * pregnant or breast feeding patients are excluded * stage ⅳ breast cancer * history of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin * uncontrolled cardiac disease * active infection or chronic infection requiring chronic suppressive antibiotics * history of hypersensitivity reaction to investigating drugs
reliability of polish-version overactive bladder syndrom scores (oabss)

Conditions: Overactive Bladder; Urinary Incontinence

Summary: the aim of this study was to develop and assess the effectiveness of a polish version of oabss and to correlate the oabss with urodynamic study results and udi-6, iiq-7 questionnaires

the translation into polish followed standardized procedures. women aged between 18-75 years were included into the study. all patients were recruited from women attending the outpatient clinic of the 2nd gynecology department of the medical university in lublin. sui was observed in 290 cases; oab in 283 patients and 249 had mui (confirmed by medical history, and urodynamic investigation). all patients completed the polish version of the oabss on two separate visits: week 0 and week 2 and additionally udi-6, iiq-7 during visit- week 2.

Eligibility criteria:
inclusion criteria: * confirmed urinary incontinence in urodynamic study (sui, oab, mui) * female aged 18-75 years old exclusion criteria: * malignant disorders * uncontrolled diabetes * inability to understand informed consent
presence of sars-cov-2 (covid-19) in semen: impact on fertility preservation in male oncological patients ?

Conditions: Sperm Preservation in Oncological Patients; Fertility; Cryopreservation

Summary: during the covid-19 pandemic, the french agency of biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. however, no study has examined the presence of sars-cov-2 in sperm from cancer patients. this study aims therefore to detect the presence of sars-cov-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. the investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, covid symptoms, specific serological profiles and particular oncological pathologies/treatments.

to perform this, all patient undergoing oncological fertility preservation will be evaluated for covid-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). in addition, a nasopharyngeal swab for sars-cov-2 research by rt- qpcr will be performed on the day of semen collection. on the same day, serological tests will be carried out, and 30 to 50 days after, according to has specifications with methods validated by the national reference center. seminal fluid and spermatozoa will be separated by density gradient centrifugation for a posteriori molecular analysis of sars-cov-2 presence. will thus be measured, within the same ejaculate, the concordance between the presence of sars-cov-2 in the seminal fluid and in the sperm cells fraction. the investigators will also determine if the virus presence in the sperm is related with : * (i) the presence of sars-cov-2 in the nasal swab; * (ii) patient symptomatology; * (iii) a specific serological profile; * (iv) a particular oncological pathology and / or treatment. the investigators may also find out if the presence of the sars-cov-2 in semen affects sperm quality. this study will be the first one examining the presence of sars-cov-2 in semen from cancer patients. this will guarantee the safety of fertility preservation procedures during the covid-19 pandemic.

Eligibility criteria:
inclusion criteria: * man above 18 years of age, of reproductive age, needing oncofertility preservation through spermatozoa cryopreservation prior to a putative gonadotoxic treatment during the covid-19 pandemic. * symptomatic and asymptomatic covid-19 patients. a patient is considered as symptomatic if he presents one or several of the following clinical signs: fever, cough, cephalalgia, myalgia, diarrhea, anosmia, pharyngodynia. * a sufficient number of remaining spermatozoa straws to perform at least six art attempts exclusion criteria: * azoospermia * severe oligo-astheno-teratozoospermia (oat) or cryptozoospermia * semen collection failure * non-emergency fertility preservation or treatment with low gonadotoxic risk

Keywords: fertility preservation sperm cancer covid-19 sars-cov-2