Kornimate/medical-research-clean huggingface dataset:
evaluation of long-term safety and performance of panoptix intraocular lens (iols)

Conditions: Aphakia; Astigmatism; Presbyopia

Summary: the purpose of this post-market clinical follow-up (pmcf) study is to describe the long-term safety and performance of the acrysof panoptix trifocal toric and non-toric iol models in subjects bilaterally implanted with these iols for 3 to 5 years. this study will be conducted in spain.

subjects will be recruited from a population that has already undergone lens implantation. retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. prospective data will be collected at visit 1, which will occur year 3-5 postoperative.

Eligibility criteria:
inclusion criteria: * subject or legally authorized representative must be able to understand and sign an institutional review board (irb)/independent ethics committee (iec) approved informed consent form. * subject must have had bilateral implantation of acrysof panoptix and/or acrysof panoptix toric iol models for 3 to 5 years prior to enrollment. a subject may have a toric lens in one eye and a non-toric in the fellow eye. * subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection. exclusion criteria: * subject currently participating in another investigational drug or device study. * subject has had corneal refractive surgery after acrysof panoptix or acrysof panoptix toric iol implantation. * subject exposed to a study iol for a minimum of 3 years prior to visit 1 that have subsequently undergone an iol exchange and are no longer implanted with a study iol at the time of enrollment. * subject is pregnant or nursing at the time of enrollment.

Keywords: cataract surgery
risk factors for post operative nausea and vomiting(ponv) in patients underwent gynecological operation under general anesthesia

Conditions: Anesthesia, General; Elective Gynecological Operation; Chinese Female Patient; Adult

Summary: risk factors for postoperative nausea and vomiting(ponv) such as past history of ponv and/or motion sickness, non-smoking status, female gender, planned opiate use for post-operative analgesia were identified in white people. whereas, risk factors for ponv in female patient with mongolian race were not clear. as a different life style and genetic background, new risk factors may associate with ponv in this population. the present study is a prospective cohort study to identify risk factors for ponv within 24 postoperative hours in chinese female patients underwent gynecology operative under general anesthesia.


Eligibility criteria:
inclusion criteria: * \>18 years old * chinese female patient exclusion criteria: * unstable vital sign * patients under mechanical ventilation * patients under sedition (rass=\<-2)

Keywords: anesthesia, general elective gynecological operation chinese female patient adult
endoscopic submucosal dissection using gel versus glycerol for submucosal injection

Conditions: Early Gastric Cancer; Rectal Polyp

Summary: the epsilon study aims to comparatively evaluate the submucosal injection using orisetm gel and glycerol during an esd procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

traditionally, esd requires the injection of some colloidal solution (glycerol, geloplasma, hydroxyethylstrach, etc.) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion. alternatives to colloid-solution assisted esd have also been developped: pocket creation method and saline-immersion esd. recently, other colloidal solutions have arrived on the market, such as gel (orisetm gel) in order to improve the lifting during esd.our preliminary experience using orisetm gel as a lifting solution for esd was unexpectedly favourable with few per-procedural bleeding, quick time and facility. as the spread of esd is closely associated to its easiness, procedure duration (itself associated to number of procedural bleedings and instruments change through the operating channel) and safety, we sought to study comparatively two submucosal solutions when conducting esd in a specific population presenting gastric or rectal superficial lesions.

Eligibility criteria:
inclusion criteria: * o patients must have given written informed consent * o subjects with documented gastric or rectal lesions with indication of endoscopic removal by esd, namely: * gastric focal lesion with suspicion of early gastric cancer (low or high grade dysplasia with features of early gastric cancer; adenocarcinoma with morphology of superficial lesion and work-up of superficial lesion) * rectal polyps (adenoma or superficial carcinoma) from 0 to 15 cm from the anal margin; with features being recognized indications of esd: more than 20mm granular lst, more than 20mm non granular lst, more than 20mm villous or bulging polyps, paris 0-iia+iic lesions, lesions with suspicious pattern (kudo vi / jnet 2b), lesions with anal canal involvement. exclusion criteria: * subjects who meet any of the following exclusion criteria cannot be enrolled in the study: * gastric and rectal neuroendocrine tumour (net) with indication of esd will be excluded * gastric and rectal lesions with indication of esd but strong fibrosis due to previous partial resection will be excluded * subject is currently enrolled in another confounding research * subjects with any other location of esd (esophagus, duodenum and colon) will not be included.

Keywords: esd (endoscopic submucosal dissection) rectum polyp early gastric cancer endoscopic resection submucosal injection solution
alcohol research in hiv: relapse prevention

Conditions: HIV; Alcohol Use Disorder

Summary: 3-arm type 1 pilot implementation-efficacy trial for people with alcohol use disorders to examine the preliminary effectiveness and feasibility of an adapted 2-session, computerized and person delivered relapse prevention intervention.

this study will develop a brief counseling intervention for people with hiv who have resumed alcohol use or resumed hazardous alcohol use after a minimum of 3 years of alcohol abstinence or 'lower risk' alcohol use. the investigators will develop a 2session person delivered and a 2-session computer delivered intervention which the investigators will then compare with the usual treatment for alcohol counseling offered at the hiv clinic. the investigators will also study the acceptability and feasibility of implementing both types of counseling in the clinic.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hiv * aged 18 years or older * must be enrolled in clinical care at johns hopkins hiv clinic. in addition, meet the following alcohol use criteria: 1. lifetime alcohol use disorder 2. patient reported outcomes (pro) assessment collected by the center for aids research (cfar) network of clinical systems as part of usual clinical care that show in the last 3 years: periods of no or lower risk drinking (e.g. women/men who are drinking \ 11/22 drinks per week for women/men) 3. current pro showing alcohol abstinence or alcohol use at \<11/22 drinks per week for women/men. exclusion criteria: * acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent * non-english speaking because interventions are currently available in english only
evaluate the efficacy and safety of hl151 versus talion tab. in pruritus cutaneus

Conditions: Pruritus

Summary: a multicenter, randomized, double-blinded, active-controlled, parallel, phase ⅲ study to evaluate the efficacy and safety of hl151 versus talion tab. in pruritus cutaneus. - endpoint: vas score change, investigator's assessment of overall treatment


Eligibility criteria:
inclusion criteria: 1. both gender, 19 years ≤ age 2. patients with pruritus due to the following diseases ① acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema ② contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis ③ acute prurigo (strofus, urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo) ④ systemic skin pruritus, focal skin pruritus 3. in visit 2, during the run-in period previous week the vas score of day and night time were 2 or more average points per day (maximum 4 points) 4. those who can ability to record subject diary 5. written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial exclusion criteria: 1. patients with pruritus due other medical causes (liver disease, heart failure, etc.) 2. among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease 3. patients with systemic infection symptoms at the time of clinical trials 4. asthmatic patients requiring steroid treatment 5. patients with spastic diseases such as epilepsy

Keywords: pruritus cutaneus
tolerability of grazax-r in children

Conditions: Allergy

Summary: this trial is performed to assess whether the grazax-r treatment is safe to use in children aged 5-12 years.


Eligibility criteria:
inclusion criteria: * grass pollen induced rhinoconjunctivitis * boys and girls, 5-12 years of age * positive skin prick test to grass pollen exclusion criteria: * previous treatment with immunotherapy

Keywords: allergy
vitamin d3 substitution in vitamin d deficient kidney transplant recipients

Conditions: Kidney Transplantation; Vitamin D Deficiency; Renal Osteodystrophy

Summary: the purpose of the study is to evaluate the effects of cholecalciferol (vitamin d3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and c-reactive protein levels within the first year after transplantation) in vitamin d deficient kidney transplant recipients.

apart from its classical actions in calcium homeostasis, vitamin d acts as a potent immunomodulatory agent. as such, vitamin d is thought to have beneficial effects in the transplant setting, especially in kidney transplant recipients considering the fact that approximately 40% of all kidney transplant recipients are vitamin d deficient. therefore, the objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of cholecalciferol substitution in vitamin d deficient kidney transplant recipients on graft function (glomerular filtration rate as well as serum creatinine levels), incidence of acute rejection episodes, frequency and severity (crp levels) of posttransplant infections within the first year after kidney transplantation. moreover, the impact of vitamin d3 on renal osteodystrophy will be analyzed by means of bone mineral density. dxa measurements will be performed during the first four weeks after kidney transplantation, after 5, and after 12 months posttransplant. kidney transplant recipients found to have vitamin d deficiency (defined as 25-hydroxyvitamin d \< 50 nmol/l) will be included and will be randomized to receive either oral vitamin d3 therapy or placebo. vitamin d3 will be administered at a daily dose of 6800iu over a time period of one year. all in all, 200 subjects will be included in the vita-d study.

Eligibility criteria:
inclusion criteria: * age \> 18 * deceased donor kidney transplant recipients * only kidney transplant recipients * vitamin d deficiency defined as 25 (oh)d \< 50nmol/l exclusion criteria: * re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program * re-transplantation for the third or further time * significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, zollinger-ellison-syndrome * history of inflammatory bowel disease: crohn's disease, ulcerative colitis * previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery * severe liver disease: cirrhosis * hiv positive

Keywords: vitamin d cholecalciferol vitamin d3 25-hydroxyvitamin d3 immunomodulation vitamin d deficiency kidney transplantation renal transplantation graft function acute rejection renal osteodystrophy posttransplant bone loss
evaluation of the efficacy of a coordinated interprofessional care pathway on disability in patients with chronic and at risk of chronic low back pain in primary care

Conditions: Low Back Pain

Summary: low back pain is a public health problem with major individual and socio-economic repercussions. in primary care, strong disparities are observed in the management of low back pain patients. while general practitioners (gps) and physiotherapists appear as two essential first-line caregivers, collaboration between these professionals remains underdeveloped, most often characterized by a lack of consultation or coordination. systematic increased interprofessional collaboration is likely to improve the results of the care pathway, by optimizing the existing care offer.


Eligibility criteria:
inclusion criteria: adult patients between the ages of 18 and 65 * patients consulting their gp for a first or new eisode of acute low back pain (more than 12 months from the previous one) with a start back screening tool score greater than 3. * or low back pain at risk of chronicity (presence of yellow flags, according to the recommendation of the high health authority (has) of 2019 * or recurrent low back pain: in the event of recurrence of low back pain within 12 months after the previous episode, then considered to be at risk of chronicity * or having chronic low back pain (low back pain for more than 3 months) * patients benefiting from the general social security system * patients who understand and speak french fluently * patients who have given their consent after having received complete information on the protocol exclusion criteria: * minor patients * pregnant women (declared pregnancy) or immediately postpartum (up to 3 months) * patients with "red flags" (serious neurological impairment, cancer, infection, fracture or inflammatory disease), according to the 2019 has recommendation * patients referred immediately for imaging or specialist advice during the first consultation with the gp (suspicion of underlying pathology) * patients with no history of acute low back pain, at low risk of chronicity (start back screening tool score less than or equal to 3) * patients with a contraindication to rehabilitation by physiotherapy * patients who have already undergone spine surgery * patients with cognitive impairment * patients whose life expectancy is less than 12 months * patients under guardianship or curatorship, under judicial protection or safeguard of justice * patients not affiliated to the general social security system * patients with difficulties in understanding the french language * patients with an inability to give express consent
hepatic arterial infusion with floxuridine and dexamethasone in combination with intravenous oxaliplatin plus irinotecan in patients with unresectable hepatic metastases from colorectal cancer

Conditions: Colon Cancer; Rectal Cancer

Summary: the purpose of this study is to see how well patients tolerate the side effects of treatment with floxuridine, oxaliplatin and irinotecan. we also want to know if these methods used together are a useful way of treating cancer. we have studied these drugs and know the best doses of each when they are used alone. we do not yet know how well the drugs work with each other. this study will tell us the best doses of each drug when they are given over the same period of time.


Eligibility criteria:
inclusion criteria: * history of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. confirmation of diagnosis must be performed at mskcc. * patient's liver metastases must be deemed unresectable and comprise \<70% of the liver parenchyma. * a patient may have had prior chemotherapy or be previously untreated. * patient may not have received prior treatment with fudr or \>2 doses of oxaliplatin. * kps \> or = to 60%. * wbc \> or = to 3,000 cells/mm3 and platelet count \> or = to 100,000 cells/mm3 within 14 days of registration. * creatinine \< or = to 1.5 mg/dl within 14 days of registration. * total serum bilirubin \< or = 2.0 mg/dl within 14 days of registration. exclusion criteria: * no active concurrent malignancies: except a patient's potentially resectable colorectal primary. * patient must not have obstruction of gi or gu tract. * patient must not have current, symptomatic peripheral sensory neuropathy. * no prior radiation to liver. * no active infection, ascites, or hepatic encephalopathy. * age ≥ 18 years. * female patients cannot be pregnant or lactating. * signed informed consent.

Keywords: dexamethasone floxuridine irinotecan (cpt-11) camptosar oxaliplatin
evaluation of dental anxiety in second-stage implant surgery with er,cr:ysgg laser

Conditions: Dental Anxiety

Summary: implants embedded under the oral mucosa were exposed with scalpel (group 1) or laser surgery (group 2). before the operation the patients were asked to fill the state-trait anxiety inventory (stai) and dental anxiety scale (das) while resting in the waiting room.


Eligibility criteria:
inclusion criteria: * patients undergoing second-stage implant surgery exclusion criteria: * patients without sufficient keratinized gingiva * bone overlap on closure screw * implants that can not be localized due to gingiva thickness,

Keywords: dental anxiety stai er,cr:ysgg oral surgery
health-related outcomes in patients who were previously treated for rhabdomyosarcoma

Conditions: Long-term Effects Secondary to Cancer Therapy in Children; Sarcoma

Summary: rationale: cancer treatment may have risks that affect health outcomes later. it is not yet known what health outcomes may be related to previous treatment for rhabdomyosarcoma. purpose: study to determine health outcomes in patients who have survived 5 years after receiving treatment for rhabdomyosarcoma on the intergroup rhabdomyosarcoma study group protocols.

objectives: i. determine the frequency of self reported health related outcomes in patients with rhabdomyosarcoma who survived 5 years from diagnosis after treatment on intergroup rhabdomyosarcoma study group (irsg) protocols i, ii, iii, and iv pilot. ii. determine the mortality of these patients and compare this mortality to the general population, especially in the third and fourth decades of life. iii. determine treatment specific risks of developing a second malignancy following treatment of rhabdomyosarcoma and the potential genetic influences (family history of cancer). iv. determine the association between decreased fertility/offspring and dose, schedule, and total dose of alkylating agents (especially cyclophosphamide) received during treatment and with selected genitourinary and paratesticular primaries. v. determine the effect of the dose and location of therapeutic radiation for primary head and neck cancer on achieved final height. vi. determine the association of therapy with doxorubicin (dose and age when received) with cardiac and vascular events. outline: patients (or parent or surviving family member) complete the baseline questionnaire plus other questionnaires (offspring, family history, other topic specific). medical data is also collected from past records. projected accrual: approximately 1600 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: prior registration on intergroup rhabdomyosarcoma study group study irs-i, irs-ii, irs-iii, irs-iv pilot, irs-v, or irs-v pilot, or one of the protocols of irs-v (d9501, d9502, d9602) and survived for 5 years after diagnosis (may be deceased now) patient characteristics: age: 5 and over performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: see disease characteristics

Keywords: long-term effects secondary to cancer therapy in children previously treated childhood rhabdomyosarcoma
a study of amdx-2011p in participants with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of amdx-2011p in participants with alzheimer's disease (ad).

this open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (pk) and biological activity of an intravenous (iv) dose of amdx-2011p in participants with ad. assessments of retinal images will be conducted by central masked assessors. participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. amdx-2011p will be administered through a single iv bolus injection followed by safety assessments, retinal imaging and pk blood collection.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of alzheimer's disease (ad) with documented positive amyloid beta signal via positron emission tomography (pet) brain scan 2. must be willing to consent to genotyping for apolipoprotein e (apoe) 3. ability to fixate and undergo retinal imaging of both eyes exclusion criteria: 1. presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol 2. diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination, visual field, and/or optical coherence tomography (oct) results 3. diagnosis of intermediate dry, wet/neovascular, or geographic atrophy forms of age-related macular degeneration (amd) in either eye, or as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination and/or optical coherence tomography (oct) results 4. clinically significant laboratory abnormalities as assessed by the investigator 5. prolonged qtcf (corrected qt interval by fridericia method) (\>450 ms for males and \>470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ecg), as judged by the investigator.

Keywords: ad
uroflowmetry in children with enuresis nocturnal

Conditions: Enuresis

Summary: background: enuresis nocturna is an important social and psychological problem in children. uroflowmetry is an important test used to investigate lower urinary tract symptoms.. objective:to evaluate the uroflowmetry (ufm) results of children with nocturnal enuresis (ne). method: the uroflowmetry findings of healthy and visualized children without any urinary symptoms and who were prospectively admitted to the urology and pediatric surgery outpatient clinic with the complaint of enuresis nocturna between january 2020 and july 2021 were compared. information (anamnesis, physical examination, radiology results and laboratory tests) and uroflowmetry results of ne and healthy children included in the study were recorded.

smale and female,

Eligibility criteria:
inclusion criteria: primer monosymptomatic enuresis nocturna exclusion criteria: urinary infectious diabetes spina bifida, epispadias, hipospadias vur extrophia vesica epilepsy cerebral palsy

Keywords: enuresis nocturna uroflowmetry child