Kornimate/medical-research-clean huggingface dataset:
"predicting glaucoma progression with optical coherence tomography structural and angiographic parameters".

Conditions: Optical Coherence Tomography Glaucoma

Summary: to predict of glaucoma progression. by imaging of the retinal nerve fiber layer rnfl, optic nerve head (onh) and macular measurements using spectral-domain oct (sd-oct) instruments ,and detection of optic disc perfusion changes using octa.

subjects will go a comprehensive ophthalmologic examination including review of medical history, best-corrected visual acuity (bcva), slit-lamp biomicroscopy, intraocular pressure (iop) measurement, gonioscopy, dilated fundoscopic examination, stereoscopic optic disc photography, and automated perimetry using swedish interactive threshold algorithm (sita standard 24-2). only subjects with open angles on gonioscopy were included. one eye of each subject will be scanned by a high-speed 1050-nm-wavelength swept-source oct instrument. oct is providing measurements of the rnfl thickness, onh, as well as the inner macula for the assessment of glaucoma progression. the split-spectrum amplitude-decorrelation angiography (ssada) algorithm will be used to compute 3-dimensional optic disc angiography. a disc flow index was computed from 4 registered scans. evaluation of progressive changes of the optic disc and rnfl will be based on event-analysis and/or trend-analysis. in event analysis, progression is defined when the difference between the baseline and follow-up measurements of the parameter of interest is greater than its test-retest variability (or the reproducibility coefficient). in trend analysis, regression analysis is performed between the parameter of interest and time.

Eligibility criteria:
1. inclusion criteria: * patients older than 18 years of age with primary open-angle glaucoma (oag) . * primary oag (poag) diagnosed on the basis of iop measurements more than 21 mmhg, open angle on gonioscopy (grade 3 or 4 on schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes. * eyes with baseline macular and onh oct images and onh photographs of adequate quality and r performed within 6 months of each other were selected 2. exclusion criteria: * participants with significant retinal disease. * non-glaucomatous optic neuropathy. * anomalous discs * any retinal pathology. a history of cataract or glaucoma surgery will not be exclusion criteria.
lume bionis: a biomarker study in patients with nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: at present there are no approved predictive tumour- or serum-derived biomarkers guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of nsclc.the objective of this nis is to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict os in nsclc patients eligible for treatment with vargatef®. the investigations in this study are exploratory in nature and considered to be hypothesis generating. the results from these investigations may help to expand our understanding of the disease and the response to vargatef®.

purpose:

Eligibility criteria:
inclusion criteria: * age = 18 years. * women and men with locally advanced, metastatic or locally recurrent nsclc with histology of adenocarcinoma. * signed and dated written informed consent. * vargatef ® is initiated and administered in accordance with the spc. * available fixed and paraffin embedded (fpe) tumour tissue routinely obtained at diagnosis and/or at re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5µm thickness). exclusion criteria: * any contraindication to vargatef® or docetaxel as specified in their respective labels. * vargatef® initiated more than 7 days prior to inclusion in this nis. * patients participating simultaneously in a clinical trial.
a 3 years naturalistic cohort survey of virtue® male sling system for male stress urinary incontinence

Conditions: Urinary Incontinence, Stress

Summary: the purpose of this study is to monitor the use of virtue® male sling in a real world population and collect medical data on effectiveness and to monitor safety of virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.

this project will be launched after the first introduction of virtue® male sling in europe. this study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with virtue® male sling system by urologists who are experienced in the device. the patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. then questionnaires will be mailed annually during 2 additional years.

Eligibility criteria:
inclusion criteria: * implanted with the virtue® male sling system exclusion criteria: * refuses to be included in the survey or that their medical data will be used for research purposes. * indication for the virtue® male sling system implantation is not for the treatment of male urinary incontinence

Keywords: urinary incontinence, stress suburethral slings prostatectomy
a comparison of the effect of dorzolamide and timolol on optic disk blood flow in patients with open angle glaucoma

Conditions: Glaucoma, Open-Angle

Summary: glaucoma is one of the most common causes of blindness in the industrialized nations. for a long time glaucoma has been defined as a disease in which high intraocular pressure (iop) leads to irreversible optic disk damage and concommitant visual field loss. however, recent investigations show that iop is not necessarily an adequate measure of clinical severity or a predictor of clinical progression: about 20% of all eyes with high iop do not develop visual field loss and some patients suffering from visual field loss due to optic disk damage have normal iop. hence, factors other than iop are likely involved in the pathogenesis of glaucoma. the role of vascular factors in the pathogenesis of glaucoma has recently received much attention and optic nerve head hypoperfusion may play a critical role in the development of glaucoma. it may therefore be important for an optimal prevention of visual field defects in glaucoma that the topical antiglaucoma drugs used do not only reduce iop but also stabilize or enhance the perfusion of the optic nerve head. therefore, the aim of the present study is to compare the effect of a 3 months treatment with timolol or dorzolamide in patients with open angle glaucoma on optic disk blood flow.


Eligibility criteria:
inclusion criteria: * men and women older than 19 years * primary open angle glaucoma or ocular hypertension with iop higher than 22 mmhg in at least one eye * washout period for previous antiglaucoma treatment: two weeks for adrenergic agonists, one week for parasympathomimetic agents exclusion criteria: * exfoliation glaucoma, pigmentary glaucoma * history of acute angle closure * intraocular surgery or argon laser trabeculoplasty within the last 6 months * ocular inflammation or infection within the last 3 months * contact lenses * patients with bradycardia (heart rate less than 50 beats/min) * second or third degree heart block * asthma * copd * congestive heart failure * severe renal impairment (creatinine clearance less than 1.8 l/h * history or hypersensitivity to one of the study drugs or drugs with similar chemical structure * history of non-iop responder to beta-blockers or carbonic anhydrase inhibitors * pregnancy

Keywords: open angle glaucoma timolol dorzolamide
the trans-cutaneous effects on physiological tremor entertainment during tacs

Conditions: Tremor, Limb

Summary: transcranial alternating current stimulation (tacs) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. this has been shown to have effects on the motor system, cognition and behavior. the exact mechanism by which tacs causes such effects is not fully understood. some studies suggests a contribution from the stimulated peripheral nerves present in the scalp rather than direct brain effects. to test this hypothesis two arms will be done. first, 12 subjects (arm 1) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes over the motor cortex and the effects will be compared between anesthetized and non-anesthetized scalp. the effects of anesthetizing the scalp will be tested on three different stimulation amplitudes off (0 ma), low (0.5 ma) and high (2.5 ma). then, 10 subjects (arm 2) will be stimulated over the contralateral arm to exclude any direct brain stimulation effects and to test if peripheral nerve stimulation can entrain the tremor. three outcome measurements will be measured during the experiments which are: tremor entrainment, sensation intensity and sensation threshold.


Eligibility criteria:
inclusion criteria: * above 18 * signed informed consents exclusion criteria: * pregnancy * history of epilepsy * family history of epilepsy
naturalistic study to evaluate the utilization of care services associated to the diagnostic process of any kind of epilepsy

Conditions: Epilepsy

Summary: naturalistic, multicentre, epidemiological study to evaluate the care services used during the process of diagnosis of any kind of epilepsy. data about services since first seizure until confirmed diagnosis will be examined.


Eligibility criteria:
inclusion criteria: * patients of both sexes 16 years old or older, being diagnosed of any kind of epilepsy (criteria ilae) and with diagnosis being confirmed by a neurologist over the last 6 months and with write informed consent. exclusion criteria: * patients with epilepsy diagnosis confirmed by a neurologist over the last 6 months before the study or with incapacity to fulfill the requirements of the study.

Keywords: naturalistic, retrospective, utilization of care services, diagnosis, epilepsy
bostongene-integrated genomic registry (bigr)

Conditions: Malignancy

Summary: the purpose of this project is to develop a comprehensive database of genomic, transcriptomic, molecular, and clinical characteristics of oncology patients to discover, define, and develop genomic and transcriptomic markers to improve future clinical outcomes across cancer types

immuno- and targeted therapies have shown promising results for many types of cancer (1). however, the effectiveness of these treatments is not optimal for many patients (2). therefore, further research is needed to discover, define, and develop genomic, transcriptomic, and integrated molecular markers that can improve clinical outcomes across cancer types (3). unfortunately, current research is restricted by the limited availability of genomic and transcriptomic results linked to clinical outcomes (3). this study will allow for the collection of key clinical data, including longitudinal follow-up, linked with individual genetic and molecular findings in a single comprehensive registry-based databank. analysis of these data may lead to advances across cancer subtypes through the identification of transcriptomic and genomic associations with therapies. clinical and pathological information, including detailed genetic information from a participant's tumor biopsy, will be obtained by the research staff for each participant enrolled in the bigr study. clinical information will include relevant details about the patient's diagnosis and treatment and will be stored in a secure electronic registry database. no extra scans or procedures for this study will be collected as part of this study. information will be collected regarding a participant's initial diagnosis, treatment, and outcome. to obtain this information, study staff will contact participants or a participant's doctor at regular time intervals for up to 15 years.

Eligibility criteria:
inclusion criteria: 1. suspected or confirmed malignancy 2. planned comprehensive genomic (\> 100 genes) and/or molecular analysis; or genomic and/or molecular data available from prior sequencing 3. baseline demographics and treatment information available 4. willingness for future contact by birg study personnel to provide information regarding associated cancer outcomes and treatment. 5. signed informed consent to participate in the study. 6. living in the united states at the time of enrollment exclusion criteria: life expectancy \< 3 months

Keywords: cancer precision medicine wes rna-seq immuno-therapy genomic transcriptomic multiomic
clinical outcomes of premolars restored with ceramic vonlay restorations versus onlay using modified usphs criteria

Conditions: Clinical Performance of Ceramic Vonlays

Summary: evaluation the clinical performance of premolars restored with ceramic vonlays versus onlays using modified usphs criteria after follow-up period of 0,3,6,9,12 months

two groups of patients with vital premolars indicated for fixed restorations will be selected according to special inclusion criteria (n=13) in each group (total of 26). one group will receive minimally invasive cavity preparations for posterior indirect restorations either vonlay or onlay according to each group the patient will be assessed using modified usphs criteria at 0,3,6,9,12 months regarding fracture, marginal integrity and marginal discoloration

Eligibility criteria:
inclusion criteria: 1. age range of the patients from 25-44 years old, who could read understand and write to sign the consent by himself /herself 2. have no active periodontal or pulpal diseases, have teeth with good restorations.(19) 3. psychologically and physically able to withstand conventional dental procedures 4. patients with teeth problems indicated for onlay and vonlay (premolars). 1. decayed teeth. 2. teeth restored with large filling restorations. 5. able to return for follow-up examinations and evaluation. exclusion criteria: 1. patient less than 25 or more than 44 years. 2. patient with active resistant periodontal diseases. 3. patients with poor oral hygiene, high caries risk and uncooperative patients. 4. pregnant women. 5. patients in the growth stage with partially erupted teeth. 6. psychiatric problems or unrealistic expectations. 7. lack of opposing dentition in the area of interest. 8- the presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region

Keywords: ceramics, vonlay, onlay, fracture
a study to learn about the effectiveness of the medicine called elranatamab in people with relapsed refractory multiple myeloma as compared with standard of care therapies

Conditions: Multiple Myeloma

Summary: this study is to understand how well elranatamab (pf-06863135) may be used for relapsed refractory multiple myeloma (rrmm). sometimes mm might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). this study medicine will be compared with standard-of-care (soc) therapies used in real-world clinical practice. for people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (magnetismm-3). the investigators will also use data from a real-world data source, representing the soc in clinical practice. this study does not seek any participants for enrollment. the investigators will compare the experiences of people receiving elranatamab to people receiving soc therapies. this way, it will help the investigators to know how well elranatamab can be used for rrmm treatment.


Eligibility criteria:
inclusion criteria: * aged 18 years and older at index date * diagnosis of mm * measurable disease according to imwg criteria * ecog performance status ≤2 * refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-cd38 treatment (ie, triple-class refractory \[tcr\]) * at least 1 treatment following their tcr eligibility exclusion criteria: * acute plasma cell leukemia * amyloidosis * smoldering mm * stem cell transplant within 12 weeks of index or active graft versus host disease (gvhd) * active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ * administration with an investigational drug within 30 days prior to index
xw004 to evaluate the safety, tolerability, pk, and pd of oral ecnoglutide tablet in healthy adults

Conditions: Obesity; Type 2 Diabetes Mellitus

Summary: xw004 is an acylated human glucagon-like peptide 1 (glp-1) analogue and is being developed for type 2 diabetes mellitus (t2dm) and obesity management.

this is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (cohorts 1a/1b, 2, 3, 4, 5, 6) with a semi-parallel design. the study is designed to evaluate the safety, tolerability, pk, and pd of oral ecnoglutide tablet in healthy participants. participants will undergo a screening period beginning up to 28 days (cohort 1 to 4) and 42 days (cohort 5 and 6 ) prior to randomisation/dose administration and will be required to sign an informed consent form (icf) before undertaking any study specific procedures or assessments. participants who meet all of the inclusion and none of the exclusion criteria will be enrolled. eligible participants will be admitted to the cru on day -1 for review of inclusion and exclusion criteria prior to the start of study procedures on day 1. a safety review committee (src) will be established to monitor the progress of this trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.

Eligibility criteria:
key inclusion criteria: * healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting); * participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at screening and/or before administration of study drug; * stable body weight for at least 3 months prior to screening (i.e., \<5% change) by self-declaration; * participants must have a body mass index (bmi) ≥22.0 kg/m2 and \<32.0 kg/m2 and weigh ≥55 kg at screening (cohorts 1a/1b to 3), or participants must have a bmi ≥30.0 kg/m2 and \<40.0 kg/m2 and weigh ≥75 kg at screening (cohort 4, 5 and 6 only); key exclusion criteria: * prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product (ip) or procedures or interfere with study assessments; * confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to screening; * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;

Keywords: obesity type 2 diabetes mellitus
efficacy of microneedling with topical vitamin c in treatment of acne scarring

Conditions: Acne Vulgaris; Acne Scars

Summary: this study aimed to evaluate the efficacy of dermaroller and topical vitamin c- either separate or combined- in treatment of post acne scars. prospective randomized clinical trial that was the study was a randomized controlled trial, conducted in sohag dermatology outpatient clinic between june 2016 and of february 2018. 30 patients with acne scars were included. all patients were informed about the entire procedure, medication, possible side effects and outcomes. a written informed consent was signed from each participant.

study population: each study group included 10 patients. detailed history and full clinical examination was conducted for each patient. patients had 6 visits at one month interval to receive treatment and evaluated one month after the end of treatment visits. the first group: patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions. the second group: received a series of six treatments by dermaroller at 4 weeks interval with the same maneuver and instructions as first group and each session was followed by immediate application of topical vit.c serum plus once daily application in between sessions. the third group: received once daily topical vit.c serum capsule at night for six months. with monthly evaluation. assessment of patients during visits was as follow: a) clinical evaluation by b) photographic documentation c) patient satisfaction d) safety assessment

Eligibility criteria:
inclusion criteria: * facial acne scars exclusion criteria: * active inflammatory acne. * active infection in the treatment area (e.g., herpes simplex and verrucae). * melanoma or lesions suspected of malignancy. * isotretinoin use in the past year. * dermatoses (e.g., eczema and psoriasis). * sunburn. * anticoagulant therapy. * systemic disease (diabetes, hypertension, collagen disease or bleeding tendency).

Keywords: acne scars dermaroller vitamin c
evaluate adherence to treatment with glucophage sachets versus tablets in diabetes type 2 patients previously treated with metformin tablets

Conditions: Diabetes Mellitus Type 2

Summary: this is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with glucophage sachets versus patients treated with glucophage tablets.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 diagnosed (baseline glycemia \> 7,0 mmol/l (126 mg/dl) or overload glycemia \> 11,0 mmol/l (198 mg/dl) * on treatment with metformin tablets * patients with at least 2 treated co-morbidities * established dose of metformin \> 1.700 mg/day * age \> 18 years old * given informed consent exclusion criteria: * patients not able to take medication orally * according to summary of product characteristics (smpc) * participating in another clinical trial 30 days prior to randomization * any other illness or medical or psychiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results

Keywords: diabetes glucophage metformin sachets tablets
eras after bariatric surgery in morbidly obese

Conditions: ERAS; Obesity

Summary: recently, the number of bariatric surgery is increasing but eras (enhanced recovery after surgery) protocol for bariatric surgery needs revision with evidence. so we investigated usefulness of eras protocol for bariatric surgery in morbidly obese patients.

patients undergoing elective laparoscopic bariatric surgery are going to be recruited and divided into 2 groups: group e will receive eras protocol, and group c will receive standard perioperative care. eras protocol comprises 8 hours of fasting and ingestion of oral carbohydrate 2 hour before surgery, tiva(total intra-venous anesthesia), tap(transversus abdominis plane) block and iv-pca using nsaids after surgery, and resumption of oral intake 2 hour after surgery. conventional anesthesia is composed of 8 hours of fasting, inhalation anesthesia, iv-pca using nsaids, and resumption oral intake 6 hour after surgery. in both groups, gastric ultrasonography will be used to measure gastric volume before surgery. functional hospital stay will be recorded from the end of surgery until all discharge criteria had been met. pain scores will be recorded at 30 minutes, 4 hours, and 24 hours after surgery. also, nausea and vomiting, time to ambulation, will be documented. after the patients are discharged, their charts are going to be reviewed and their medical expenses will be documented.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists grade 1 \~ 3 * bmi(body mass index) ≥30 * scheduled for elective laparoscopic bariatric surgery exclusion criteria: * american society of anesthesiologists grade 4 or 5 * history of abdominal surgery