Kornimate/medical-research-clean huggingface dataset:
clinical investigation of acrysof® iq panoptix™ iol model tfnt00

Conditions: Cataract

Summary: the purpose of this clinical study is to compare the visual outcomes of the acrysof iq panoptix multifocal intraocular lens (iol) model tfnt00 against that of a monofocal lens, the acrysof monofocal iol model sn60at, in order to demonstrate comparable distance vision and superior near and intermediate vision.

both eyes of a subject must require cataract surgery to qualify for enrollment into this study. subjects participating in the trial will attend a total of 10 study visits over a 7-month period. of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. primary endpoint data will be collected at the month 6 (day 120-180) post second eye implantation visit.

Eligibility criteria:
inclusion criteria: * diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision * able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures * clear intraocular media other than cataract in both eyes. * preoperative keratometric astigmatism of less than 1.0 diopter (d) in both operative eyes. exclusion criteria: * clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema * previous refractive surgery or refractive surgery procedures (including, but not limited to lasik, astigmatic keratotomy, and limbal relaxing incisions) * glaucoma (uncontrolled or controlled with medication) * degenerative eye disorders (e.g. macular degeneration or other retinal disorders) * pregnant or lactating * expected to require a second surgical intervention or retinal laser treatment.

Keywords: intraocular lens iol
efficacy of carbohydrate loading in diabetic type 2 patients undergoing cabg surgery on cpb

Conditions: Heart Surgery; Ischemic Heart Disease

Summary: enhanced recovery after surgery protocols aim to optimize perioperative care and improve surgical outcomes. preoperative carbohydrate loading has demonstrated benefits in reducing insulin resistance and improving patient outcomes. while non-diabetic patients benefit from this approach, its efficacy in diabetic type 2 patients undergoing cabg remains less understood. this study aims to address this gab by evaluating the physiological and clinical outcomes for carbohydrate loading in this specific population.

a randomized controlled trial comparing diabetic type 2 patients receiving carbohydrate loading with those undergoing traditional fasting protocols. patients will be randomized to two groups; group (a) patients will have carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade), while group (b) patients (control group) will have standard fasting protocol 8 hours before surgery. aims of the study: 1. to assess the efficacy of carbohydrate loading in reducing insulin resistance in diabetic type 2 patients undergoing cabg surgeries. 2. to monitor clinical outcomes such as infection rates, icu stay duration, and need for inotropic and vasoactive drugs. 3. to evaluate changes in inflammatory markers including crp levels. clinical outcome

Eligibility criteria:
inclusion criteria: all diabetic type 2 patients undergoing isolated on-pump coronary artery bypass surgery. exclusion criteria: * missing data. * patients outside the study period. * patients undergoing other cardiac surgeries. * patients diagnosed with type 1 diabetes mellitus.

Keywords: enhanced recovery program carbohydrate loading coronary artery bypass grafting heart surgery postoperative recovery
novel auto-continuous positive airway pressure (cpap) validation

Conditions: Sleep Apnea, Obstructive

Summary: this single-blind randomised crossover trial aims to compare the efficacy of a novel auto-cpap algorithm (spap) to conventional cpap. up to 50 patients will be recruited from an osa population, aged over 18.

auto-cpap devices change therapeutic pressure based on the needs of the patient. algorithms differ from machine to machine. this single-blind randomised crossover trial aims to compare the efficacy of spap (a novel auto-cpap algorithm) to conventional cpap. up to 50 patients will be recruited from an osa population, aged over 18. participants will consist of male and female patients diagnosed with moderate-severe osa (apnea hypopnea index (ahi) greater than or equal to 15 per hour. eligible participants, according to the protocol approved by the northern x region ethics committee, providing written informed consent will be enrolled into the study. patients will be enrolled sequentially according to the randomisation list. patients will be randomised to cpap or spap. the therapeutic pressure will be based on the most recent titration night of each patient. comparisons between data will be made using a one-tailed t-test for non-inferiority of the spap algorithm compared with conventional cpap therapy.

Eligibility criteria:
inclusion criteria: * aged ≥18 years with mild-to-severe osa (apnea hypopnea index equal to or greater than 5 per hour). exclusion criteria: * any medical condition which contraindicates (see appendix a) the use of cpap or autocpap. * unstable cardiovascular disease (untreated or resistant hypertension acceptable). * unstable psychiatric disease. * other significant sleep disorder. * inability to tolerate cpap due to nasal obstruction or claustrophobia, as determined by the investigation investigator. * any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements. * participation in another clinical trial in the previous month. * less than 2 hours recorded sleep in either arm
verification of saliva mmp-1 as a diagnostic marker of oral cavity cancer

Conditions: Oral Squamous Cell Carcinoma

Summary: the study is designed to measure salivary matrix metalloproteinase-1 (mmp-1) using the enzyme-linked immunosorbent assay (elisa) we developed previously in patients with oral potentially malignant disorders (opmd), oral squamous cell carcinoma (oscc), and healthy participants. the purpose of this study is to evaluate the potential of the newly developed salivary mmp-1 elisa as an adjunctive tool to aid in diagnosis of oscc.


Eligibility criteria:
inclusion criteria: * group oscc: patients with lesions of oscc * group opmd: patients with lesions of opmd * group hc: healthy subjects who are not suffering from any oral lesions and having behaviors of smoking, and/or betel nut chewing exclusion criteria: * subjects having personal history of other cancers or severe diseases

Keywords: mouth neoplasms head and neck neoplasms
an evaluation of the effectiveness of dual focus soft contact lenses in slowing mypoia progression

Conditions: Myopia

Summary: the purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Eligibility criteria:
inclusion criteria: * be between 8 and 12 years of age inclusive. * best-corrected visual acuity by manifest refraction of +0.10 logmar. * spherical equivalent refractive error between -0.75 and -4.00 d * inclusive astigmatism: \< -0.75 d and anisometropia: \< 1.00 d * possess wearable and visually functional eyeglasses. * agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study. exclusion criteria: * subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses. * subject is currently or within 30 days prior to this study has been an active participant in another clinical study. * current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or any other myopia control treatment. * regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents. * current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state. * a known allergy to fluorescein, benoxinate, proparacaine or tropicamide. * strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction. * any ocular, systemic or neuro-developmental conditions that could influence refractive development.

Keywords: myopia progression myopia control
clinical outcome and fusion rate of 3d printed interbody fusion cages and titanium coated peek cages

Conditions: Disk Herniated Lumbar; Disc Disease Degenerative; Spondylolisthesis

Summary: prospective, randomized, single-blind study for the evaluation of the clinical outcome and the fusion rate of 3d printed interbody fusion cages and titanium coated peek cages in transforaminal lumbar interbody fusion

this clinical study is a regulatory post market clinical follow-up (pmcf) measure and is aiming to collect clinical data on the performance and safety of the tspace® 3d implants. it is designed as a prospective, randomized, single-blind, non-interventional study in order to gain clinical data within the routine clinical application of the investigational device. the study shall answer the question if there are detectable differences between the established titanium coated polyether ether ketone (peek) cages of the manufacturer and the new 3d printed cages. differences shall be observed in terms of clinical outcome, quality of life, patient satisfaction, radiological outcome and occurrence of adverse events / serious adverse events.

Eligibility criteria:
inclusion criteria: * indication for one, two or three-segment lumbar interbody fusion according to instructions for use * written informed consent for the documentation of clinical and radiological results * willingness and mental ability to participate at the follow-up examinations exclusion criteria: * patient is not willing or able to participate at the follow-up examination * patient age \ 80 years * patient is pregnant * previous instrumented lumbar spine surgery

Keywords: transforaminal lumbar interbody fusion
development of non-invasive prenatal screening test for microdeletions based on fetal dna isolated from maternal blood

Conditions: Trisomy 21; Trisomy 18; Trisomy 13; Sex Chromosome Abnormalities; Microdeletion Syndromes

Summary: the purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal dna isolated from maternal blood.

the goal of this study is to further develop a non-invasive prenatal blood test that can diagnose genetic disorders in the fetus by looking at fetal dna (genetic material) found in the mother's bloodstream during pregnancy. women carrying a fetus diagnosed with microdeletions/microduplications (small missing or extra pieces of dna that can cause problems), aneuploidy (trisomy 21, 18, or 13) or other genetic disorders will be asked to participate. if this study is successful, it will reduce the need for invasive procedures during pregnancy such as amniocentesis and chorionic villus sampling (cvs) but still enable women to find out accurate information regarding their baby's health early in the pregnancy.

Eligibility criteria:
inclusion criteria: * age 18 or older at enrollment * gestation age of at least 9 weeks, 0 days by best obstetrical estimate * one or more fetuses with a clinically confirmed diagnosis of a genetic variant of interest via karyotype, fish, chromosomal microarray or other genetic assay and/or * one or more fetuses with any variant of fetal structure that is expected to require medical or surgical intervention in the newborn period, shorten lifespan, affect intellectual development or otherwise indicate a genetic anomaly and/or * positive high risk noninvasive prenatal screening or serum screening result * able to provide informed consent exclusion criteria: •maternal history of bone marrow or organ transplantation

Keywords: 22q 1p36 angelman cri-du-chat prader-willi digeorge turner syndrome patau syndrome edwards syndrome down syndrome
peripheral blood stem cell transplantation for hematologic malignancies with alpha beta tcell and b cell depletion using the clinimacs device

Conditions: Hematologic Malignancies

Summary: this is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/haploidentical mobilized peripheral stem cells (pscs) using the clinimacs system for alpha beta t cell depletion plus cd19+ b cell depletion to determine efficacy as determined by engraftment and gvhd, and one year leukemia free survival.

the purpose of this research study is to evaluate a new method of t cell depletion using the miltenyi clinimacs™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. this new method is called α/β (alpha/beta) t cell depletion and cd19+ b cell depletion. this pilot study will evaluate if this new method of t cell and b cell depletion is a more effective way of removing t cells thus reducing the risk of severe acute and chronic gvhd and result in a durable engraftment.

Eligibility criteria:
inclusion criteria: patient: 1. age. patient age \< 23 years. both genders and all races eligible. 2. disease eligibility leukemias/lymphomas: * acute myeloid leukemia, primary or secondary * disease status: remission or \<10% bone marrow blasts * myelodysplasia * acute lymphoblastic leukemia * disease status: in hematologic remission * chronic myelogenous leukemia: * disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase. * mixed lineage or biphenotypic acute leukemia * lymphoblastic lymphoma * disease status: remission * burkitt's lymphoma/leukemia: * disease status: in remission exclusion criteria: * patient 1. patients who do not meet disease, organ or infectious criteria. 2. no suitable donor
observational study of lumigan® 0.01% for treatment of primary open angle glaucoma (poag) or ocular hypertension (oht)

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: this is an observational study in patients with poag or oht that will collect data on the use of lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.


Eligibility criteria:
inclusion criteria: * diagnosis of poag or oht * prescribed lumigan® 0.01% exclusion criteria: * none
effect of dialysis membranes on inflammatory and immune processes in hemodialysis

Conditions: Kidney Failure; Renal Insufficiency, Chronic; Dialysis Related Complication

Summary: double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.


Eligibility criteria:
inclusion criteria: * patients who are older than 18 years and younger than 65 years * patient with end-stage renal disease, hemodialysis more than 6 months * patients under hemodialysis with high-flux dialyzer more than 3 months * patients willing to participate after given fair and clear information about study exclusion criteria: * patients living with hepatitis b or c, * patients with malignancy * patients under immunosuppressive treatment * patients with autoimmune diseases such as systemic lupus erythematosus, etc. * patients with active infections * patients planned to have a kidney transplantation in 6 months * patients having vascular access problems * patients planned to transfer to another center
study to assess the safety and tolerability of pt010, pt009 and pt003 in subjects with moderate to very severe chronic obstructive pulmonary disease

Conditions: COPD

Summary: study to assess the safety and tolerability of pt010, pt009 and pt003 in subjects with moderate to very severe chronic obstructive pulmonary disease

a randomized, double-blind, parallel-group, 52-week, chronic-dosing, multi-center study to assess the safety and tolerability of pt010, pt009 and pt003 in subjects with moderate to very severe chronic obstructive pulmonary disease

Eligibility criteria:
inclusion criteria: given their signed written informed consent to participate. must have agreed to participate in and complete the lead-in study pt010006.(nct02497001) exclusion criteria: severe osteoporosis unable to achieve an acceptable dexa scan inability to achieve pupil dilation to at least 6 mm subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery
real-world study of sunvozertinib treatment in advanced egfr-mutant nsclc after egfr-tki treatment failure

Conditions: Non Small Cell Lung Cancer

Summary: observe the efficacy and safety of sunvozertinib in the real world in the treatment of egfrm ansclc patients with previous egfr-tki treatment

locally advanced or metastatic nsclc with egfr-sensitive mutations who have been previously treated with egfr-tkis and pd for last therapy can be involved in this study. investigators will assess patients whether to be suitable for sunvozertinib treatment. and this study will evaluate the safety and efficacy.

Eligibility criteria:
inclusion criteria: 1. to provide a signed and dated, written informed consent. 2. age ≥ 18 years old 3. histologically or cytologically confirmed non-squamous nsclc with documented egfr mutations from a local laboratory 4. egfr-sensitive mutations including exon 19 deletion and exon 21 l858r mutated，at least one line chemotherapy and progress again 5. predicted life expectancy ≥ 12 weeks 6. adequate organ system function: 7. patient must have measurable disease according to recist 1.1. - exclusion criteria: 1. spinal cord compression or meningeal metastasis 2. not recover from aes caused by previous treatment yet 3. a history of stroke or intracranial hemorrhage within 6 months prior to initial dosing. 4. any severe or poorly controlled systemic disease per investigator's judgment .active infections, including but not limited to hepatitis b (hbv), hepatitis c hcv, and human immunodeficiency hiv

Keywords: non small cell lung cancer sunvozertinib egfr
observational study of double cord blood transplant

Conditions: Adult Double Unit Cord Blood Transplant

Summary: the efficacy and safety of non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation from unrelated donors in adult patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation are evaluated through prospective observation and analysis of actual clinical data collection


Eligibility criteria:
inclusion criteria: * (1) aged 19 and older (2) patients scheduled for umbilical cord blood transplantation as a primary allogeneic hematopoietic stem cell transplantation for the treatment of the following hematologic diseases: * acute leukemia (myeloid/lymphoid/mixed lineage) planned for transplantation for treatment purposes * myelodysplastic syndromes planned for transplantation for treatment purposes ③ chronic leukemia (myeloid/lymphoid/monocytic) and myeloproliferative neoplasms planned for transplantation for treatment purposes ④ malignant lymphomas, multiple myeloma planned for transplantation for treatment purposes ⑤ other malignant hematologic malignancies planned for transplantation for treatment purposes ⑥ planned for transplantation for the treatment of bone marrow failure diseases, including aplastic anemia (3) if all contents of the consent form are understood and consented to in writing. exclusion criteria: * (1) patients with a history of allogeneic hematopoietic stem cell transplantation or those undergoing transplantation for the treatment of engraftment failure (secondary allogeneic hematopoietic stem cell transplantation is an exclusion criterion; however, patients eligible for registration include those undergoing their first allogeneic stem cell transplantation following an autologous stem cell transplantation). (2) patients with severe, uncontrolled infections or severe cardiopulmonary dysfunction, as judged by the investigator. (3) patients with an ecog performance status (ps) greater than 3 or those receiving mechanical ventilation in the intensive care unit. (4) patients who do not consent to participate in the study or those deemed unsuitable for sincere participation by the attending physician.
interactive telehealth intervention to increase longitudinal adherence to repeat faecal immunochemical test screening

Conditions: CRC, Colorectal Cancer

Summary: in hong kong, colorectal cancer ranks second in both cancer incidence and mortality. the government-subsidized population-based crc screening program (the program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial fit screenings. a subsidized follow-up colonoscopy is offered to participants with positive fit results. participants are advised to repeat the fit screening 2 years after receiving a negative result. an automated noninteractive short message service (sms) text reminder, used by the program as standard care (sc), is delivered to participants who are due for repeat fit. according to unpublished data, despite sc, only 34% of participants adhere to biennial repeat fit in the crc screening program. nonadherence to repeat fit screening is caused by forgetfulness and is associated with an individual's psychological health behaviour.

eligible subject will be randomised to either the ti group or sc group. all subjects will receive an automated sms text reminder delivered by the program as the standard care. subjects randomized to the ti group will receive the sc as well as an interactive ti with interactive health education messages via a whatsapp-based chatbot on the repeat fit due date. all subjects will be followed up on whatsapp at 3 months after their repeat fit due date and asked about their repeat fit status. subjects will be invited to participate in four focus group discussions to elucidate how the study intervention influences repeat fit adherence behaviours, explore the complexity of regular fit screening, and reveal, based on the participants' accounts, the barriers to and facilitators of their adherence to the repeat fit screening. the discussion will be audiotaped.

Eligibility criteria:
inclusion criteria: * 50-75 years old * already enrolled in the program with negative fit results in 2022 * eligible for the program inclusion and due for repeat fit screening in 2024 * either the participants themselves or their family members / caregivers have access to and agree to be contacted via whatsapp * ability to understand chinese exclusion criteria: * who have incomplete conversations with the chatbot, lack of access to whatsapp, or are unable to provide informed consent will be excluded

Keywords: colorectal cancer, screening, fecal immunochemical test