Kornimate/medical-research-clean huggingface dataset:
linear stapler versus circular stapler in esophagojejunostomy

Conditions: Postoperative Complications; Operative Time; Hospital Costs

Summary: with the development of stapler devices, various methods of esophagojejunostomy after laparoscopic total gastrectomy were evoluated. which stapler is more advantageous has not been determined. at present, the most commonly used is linear stapler or circular stapler in esophagojejunostomy. however, there is still a lack of reliable evidence for the selection of the two staplers. the purpose of this study is to explore the advantages of linear staper versus circular stapler in esophagojejunostomy for patients with gastric cancer who underwent total gastrectomy.

with the development of stapler devices, various methods of esophagojejunostomy after laparoscopic total gastrectomy were evoluated. which stapler is more advantageous has not been determined. at present, the most commonly used is linear stapler or circular stapler in esophagojejunostomy. however, there is still a lack of reliable evidence for the selection of the two staplers. the purpose of this study is to explore the advantages of linear staper versus circular stapler in esophagojejunostomy for patients with siewert classification type ii and iii gastric cancer who underwent total gastrectomy.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the stomach, t1-t4 stages. 2. eastern cooperative oncology group performance status of 0 or 1. 3. adequate organ function. exclusion criteria: 1. patients had distant metastasis. 2. oesophageal invasion of more than 3 cm. 3. borrmann type 4 or large (more than 8 cm) type 3 carcinoma. 4. previous chemotherapy or radiation therapy for any other malignancies.

Keywords: laparoscopy total gastrectomy esophagojejunostomy linear stapler circular stapler
human intervention study of egg protein derivative on cardiovascular risk

Conditions: Hypertension

Summary: heart disease and stroke are the most common cause of death in ireland today.one of the main risk factors for heart disease and stroke is high blood pressure or hypertension. research has found that certain specific proteins or peptides found in foods such as dairy, meat, fish and eggs may promote heart health reducing blood pressure in adults with hypertension. the aim of this study is to investigate the potential beneficial effects egg peptides may have on heart health, in particular, effects on blood pressure.

poor dietary habits of irish adults has been accompanied by epidemics of obesity and metabolic disorders such as type ii diabetes leading to a substantial predicted increase in the prevalence of chronic diseases such as cardiovascular disease.hypertension is a major contributing factor to the development of cardiovascular and metabolic diseases. dietary factors play a significant role in the prevention and/or treatment of hypertension and therefore the development of foods with antihypertensive properties could prove beneficial.

Eligibility criteria:
inclusion criteria: * male and female * non-diabetic * aged 50-65 * bmi 25-35kg/m² * mild hypertensive: blood pressure 130-149 mmhg exclusion criteria: * current smoker * diagnosed hypertensive * history of cardiovascular disease * diabetic * chronic kidney disease * gastrointestinal disease * currently on anti-hypertensive medications * allergic to eggs

Keywords: blood pressure hypertension cardiovascular disease
cetuximab (erbitux®) added to two concurrent chemoradiotherapy platforms in locally advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: the main purpose of this study is to explore and compare the efficacy of cetuximab (erbitux®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.


Eligibility criteria:
inclusion criteria: * age 18 or older * stage iii and iv head and neck cancer * patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area * no prior chemotherapy or radiotherapy * prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * normal organ and marrow function exclusion criteria: * unequivocal demonstration of metastatic disease * known severe hypersensitivity to drugs used in the study * treatment with a non-approved or investigational drug within 30 days before day 1 * incomplete healing from previous surgery * pregnancy or breast feeding * uncontrolled intercurrent illness including * patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant chf * acute hepatitis or known hiv * severe baseline neurologic deficits * prior therapy which specifically and directly targets the egfr pathway * prior severe infusion reaction to a monoclonal antibody

Keywords: cetuximab erbitux locally advanced head neck cancer neoplasms squamous carcinoma lymphoepithelioma
short-term effects of exercise program versus electropuncture in patients with chronic non-specific low back pain: a randomized clinical trial.

Conditions: Low Back Pain; Exercise Program; Electroacupuncture

Summary: this study evaluate the effectiveness that exists when performing a treatment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture in patients with chronic low back pain.

low back pain has a high prevalence in all european countries, appearing as the main cause of activity limitation in people under 45 years of age. it has got a high recurrence, which decreases the activities of daily life, facilitates the focus of attention to pain and increases the fear of movement, with the consequent muscular atrophy. a serie cases will be conducted comparing a a table of exercises versus electropuncture. objective: evaluate the effectiveness that exists when performing a tratment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture. methods: a sample of 12 subjects with chronic low back pain will be assigned to an exercise program or dry electropuncture treatment (eps), during 4 weeks (2 sessions/week). the measurement variables selected for the study were the followings: straight leg raise, vasalva, gaesslen test, algometry (pressure pain threshold), goniometry (measurement of the range of motion), scale of disability for low back pain of oswestry, beck's depression inventory (bdi), visual analogue scale (eva), mcquade's test and the roland-morrys' questionnaire, developing a pre-treatment and post-treatment assessment.

Eligibility criteria:
inclusion criteria: * chronic non-specific low back pain persisting ≥ 3 months. * age between 25 and 60 years. * not currently receiving physical therapy. exclusion criteria: * presence of lumbar stenosis. * presence of clinical signs of radiculopathy. * diagnosis of spondylolisthesis. * diagnosis of fibromyalgia. * treatment with corticosteroid or pharmachological medication within the paset 2 weeks. * a history of spinal surgery. * central or peripheral nervous system disease

Keywords: chronic low back pain physical therapy randomized clinical trial exercise program
testing e-mental health in lebanon

Conditions: Depression

Summary: the study objective is to test a guided e-mental health intervention called step-by-step for people living in lebanon. step-by-step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. first, a small study will be conducted to test the research procedure. second, a large study will be conducted to test the effectiveness of step-by-step. people residing in lebanon (i.e. lebanese, palestinians and syrian displaced people), above the age of 18 with symptoms of depression will be recruited through social media, posters, radio and television adverts, etc. minors (under the age of 18) and people who have plans to end their life will be excluded from the study. to test whether the use of step-by-step improves symptoms of depression, two groups will be compared. participants in the intervention group will receive step-by-step, while those in the control group will receive basic information about depression and a list of health centres where they can get face-to-face help that is based on evidence. in addition, participants in the intervention group will receive weekly phone or chat support (up to 15 minutes) provided through lay helpers who were trained and work under the supervision of a trained clinical psychologist. the study hypothesises that participants who receive step-by-step will have a higher symptom improvement than participants who receive basic information. in order to assess symptoms of depression and other symptoms of psychological distress, participants in this study will complete several questionnaires three times: at the beginning of the study, after 8 weeks, and then three months later (i.e. 5 months after the beginning of the study).


Eligibility criteria:
inclusion criteria: * age 18 or above * phq-9 sum score above 9 * whodas 2.0 sum score above 16 exclusion criteria: * serious thoughts or plans to end one's life
a phase 2 study evaluating the safety and efficacy of netarsudil ophthalmic solution in patients with corneal edema due to fuchs corneal dystrophy

Conditions: Corneal Edema

Summary: two different dosing regimens (qd and bid) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with fcd.


Eligibility criteria:
inclusion criteria: 1. adults aged 18 years or older 2. documented diagnosis of fcd 3. evidence of central corneal edema, in at least one eye, at the screening and baseline visit, in the eligible eye(s) 4. reduced bcva secondary to central corneal edema, at screening and baseline, in the eligible eye(s) exclusion criteria: 1. fcd so advanced that, in the opinion of the investigator, surgery would likely be required in the study eligible eye(s) within the study period 2. clinically significant ocular disease (other than fcd) or trauma in the eligible eye(s) which could interfere with study interpretation 3. history of ocular surgery within 6 months of the screening visit, or any prior corneal refractive surgery in the eligible eye(s)

Keywords: corneal edema fuchs corneal dystrophy netarsudil ophthalmic solution
vr and chronic pain pilot usability study

Conditions: Chronic Pain

Summary: this is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.

the investigators will conduct a study of patients with chronic pain to identify interest in participating in a large vr trial and, for those willing to join the team to test the device in person, to pilot 2 sessions of vr to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. researchers expect the entire session to last 45 minutes to 1 hour. all patients recruited will be in the active arm; this is not a randomized pilot study. the intervention being piloted is the easevrx - appliedvr, los angeles, ca - vr hardware and software. easevrx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. easevrx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. easevrx was designed for at-home use and comes with a sequence of daily immersive experiences, with each vr experience being 2-16 minutes in length (average of 6 minutes). for this pilot, researchers will be doing one in-person session, using two interoceptive vr experiences (out of 56 total).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. chronic pain (using self-report) with pain intensity \>=4 and confirmed by icd-10 codes in medical record 3. fluency in english exclusion criteria: 1. inability to give informed consent 2. current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines 3. medical condition predisposing to nausea or dizziness 4. hypersensitivity to flashing light or motion 5. no stereoscopic vision or severe hearing impairment 6. injury to eyes, face, or neck that prevents use of vr headset 7. currently pregnant, by self-report
efficacy and safety of thdb0206 compared to insulin lispro injection in participants with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial. the purpose of this study is to compare efficacy and safety of thdb0206 injection with insulin lispro injection combined with insulin glargine injection u-100 in chinese participants with t2dm.


Eligibility criteria:
inclusion criteria: * body mass index: 18.0 kg/m\^2\~35.0 kg/m\^2 (both inclusive) at the time of screening. * hba1c: 7.0%\~10.0% (both inclusive) at the time of screening. * diagnosed with t2dm for 6 months or longer at the time of screening based on the world health organization (who) classification. * treated with stable insulin regimen as follow for at least 3 months with or without oral antidiabetic drug: 1. basal insulin (neutral protamine hagedorn \[nph\] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin. 2. premixed insulin at least twice daily. exclusion criteria: * have other types of diabetes other than t2dm. * have used glucagon-like peptide 1 (glp-1) receptor agonist within 3 months prior to screening. * have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening. * have had 1 or more episodes of acute diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, diabetic lactic acidosis, etc.) within the 6 months prior to screening. * with concomitant conditions at screening that may affect the evaluation of the study, including cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, liver diseases, kidney diseases, nervous system diseases, psychiatric diseases, hematological diseases, immune system diseases, endocrine system diseases, pancreatic diseases, and/or malignant tumors.
a phase 1/2 study of gen1286 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (pk), anti-tumor activity and immunogenic potential of gen1286 in participants with advanced solid tumors. this trial consists of 2 parts: * part a: dose escalation and dose level expansion * part b: tumor-specific expansion with dose optimization


Eligibility criteria:
key inclusion criteria: * participants must be ≥ 18 years of age at the time of informed consent; have measurable disease according to recist 1.1; eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1; adequate organ, bone marrow, liver, coagulation, and renal function; and be willing to provide a pretreatment tumor specimen. * all participants must have pathologically confirmed diagnosis of advanced solid tumor. * participants must have metastatic or unresectable locally advanced, recurrent disease not amenable to further local therapy and must have previously received therapies known to confer clinical benefit (unless ineligible to receive, refused to receive, or therapy is unavailable in the region). key exclusion criteria: * prior treatment with topoisomerase 1-based antibody-drug conjugate (adc) therapy. note: other protocol-defined inclusion and exclusion criteria may apply.
pseudophakic anterior chamber depth measurement in second eye refinement cataract surgery

Conditions: Cataract

Summary: to study the effective lens position concept in second eye refinement (ser) cataract surgery, by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pacd) measured in pentacam and ser refractive outcomes.

a retrospective chart review was conducted, including demographics (age and gender) and several parameters for both the first and second eyes, including the intra-ocular lens power calculation using the hofferq, srk/t and holladay 1 formulas. pentacam hr was used for pseudophakic anterior chamber depth measurement, and manual measurement was performed by a single investigator tracing a line between the anterior surface of the intra-ocular lens and the central corneal epithelium apex. second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 50% partial adjustment of the prediction error of the first eye. to relate refractive outcomes to pacd values, the investigators performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pacd (50-600).

Eligibility criteria:
inclusion criteria: * patients admitted for bilateral age-related cataract surgery exclusion criteria: * age \< 18 years old * previous or combined ocular surgery * manual extracapsular cataract extraction and not phacoemulsification * corneal sutures * implantation of any other iol type * iol implanted in the sulcus * intra or postoperative complication * post-operative best-corrected visual acuity worse than 5/10 * anterior corneal astigmatism\>3.00 d * inadequate cooperation for pentacam hr examination

Keywords: cataract surgery biometry second eye refinement effective lens position
investigation and diagnosis of the chromosome variation in donated/abandoned blastocyst

Conditions: Chromosome Translocation; Genetic Disorders in Pregnancy; Recurrent Miscarriage

Summary: blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the gardner system. as part of the embryo selection process, cells of te biopsy were collected, and blastocysts were vitrified. the clinical te biopsies were subjected to whole genome amplification (wga) with sureplex reagents (illumina) followed by ngs-based pgt-a using illumina's veriseq kit (illumina) on a miseq system (illumina) according to the manufacturer's protocol.

collected 200 donate abandonment embryos (well-developed blastocysts) for research under the national assisted reproduction act of taiwan. 1. collected 200 donate abandonment embryos: five to six days after egg retrieval, well-developed embryos (called blastocysts). 2. blastocysts derived from patients seeking infertility treatment were generated. 3. embryos biopsies for pgt-a (by use of ngs platforms from our institute) will be used for the validation of our lab qc embryo. 4. to standardize the operating procedures 5. paper writing.

Eligibility criteria:
inclusion criteria: * the surplus blastocysts * parents consent to donate the embryos exclusion criteria: * not agree to participate in this program * whose embryo morphology and quality do not meet the technical requirements for genetic testing

Keywords: pre-implantation genetic diagnosis balanced reciprocal translocation (brt) structural variation (sv) next generation sequencing abandoned blastocysts
virtual pain care trial

Conditions: Wound; Wound and Injuries; Pain

Summary: the main objective of this study is to evaluate the effect on pain of virtual reality therapy as add-on therapy during wound care procedures in adults.

after inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1 ratio. randomization will not be blinded since both the provider and patient know if the patient will be wearing the vr system during wound care or not wearing the vr system. patients are randomly assigned to one of two groups: group 1 - intervention group 1, virtual reality therapy group 2 - control group, care as usual

Eligibility criteria:
inclusion criteria: * individuals aged 18 or older with wounds receiving wound care * individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures * at least 1 prior painful wound care procedure, where they have indicated a vas ≥ 4, or patients reporting a vas ≥ 4 before initiating the wound care procedure. exclusion criteria: * individuals not being able to understand dutch language at primary school level * individuals not being able to read or write dutch * individuals diagnosed with dementia and/or cognitive impairment * individuals diagnosed with epilepsy * individuals diagnosed with migraine * individuals with severe dizziness and/or nausea * individuals with a known history of claustrophobia * individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide * individuals who have no feeling in the wound care area * individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the vr headgear and/or headphones

Keywords: wound care virtual reality pain management
safety study of xp12b in women with menorrhagia

Conditions: Menorrhagia; Heavy Menstrual Bleeding

Summary: the purpose of this study is to evaluate the safety of xp12b in women with heavy menstrual bleeding associated with menorrhagia.


Eligibility criteria:
inclusion criteria: * women with menorrhagia * 18-49 years of age * regularly occuring menstrual periods exclusion criteria: * history or presence of clinically significant disease or abnormalities that might confound the study * history of bilateral oophorectomy or hysterectomy

Keywords: menorrhagia heavy menstrual bleeding
cap48 - autism in children and adolescents

Conditions: Autism Spectrum Disorder

Summary: evaluation and follow-up of children diagnosed with an autism spectrum disorder in french-speaking belgium in order to optimize diagnostic protocols, the quality of care required and its accessibility, and to determine the impact of an autism spectrum disorder on schooling, family and society.

the aims of the research project: * to collect a wide range of data in order to improve knowledge of children with autism spectrum disorder (asd) in french-speaking belgium by prospectively including all children and adolescents making a request to the centres of reference. the creation of a common database will make it possible to collect general socio-demographic, geographical and epidemiological data, to characterise the different profiles and to accurately monitor developmental trajectories. * evaluate the feasibility and practical implementation of the treatment proposed following a diagnosis of asd in a child. * implement protocols to improve the quality of care for beneficiaries. * to enable the development of fundamental research protocols. many questions remain unanswered about the genetic, neuro-cognitive and linguistic characteristics of autism. only rigorous studies carried out on large, carefully defined samples can advance research. * increase public knowledge and understanding of the asd.

Eligibility criteria:
inclusion criteria: * children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center from french-speaking region of belgium. exclusion criteria: * refusal by the family to allow their child's data to be included in the database.