Kornimate/medical-research-clean huggingface dataset:
selection of aspheric diffractive multifocal intraocular lens (iols) based on corneal wavefront

Conditions: Cataracts

Summary: given the availability of aspheric diffractive iols with varying negative spherical aberration it may be feasible, by selecting the best fit iol, to minimize aberrations and thereby maximize visual performance.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * scheduled to undergo bilateral cataract or refractive lens surgery * visual potential of 20/30 or better in each eye after lens removal and iol implantation * naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes * preoperative regular corneal astigmatism of 2.5 d or less * clear intraocular media other than cataract * availability, willingness, and sufficient cognitive awareness to comply with examination procedures exclusion criteria: * ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance. * astigmatism not correctable by limbal relaxing incisions (greater than 2.5 d) * use of systemic or ocular medications that may affect visual outcomes * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) * uncontrolled systemic or ocular disease * history of ocular trauma or prior ocular surgery * amblyopia or strabismus * known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) * diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30 * subjects who may be expected to require retinal laser treatment or other surgical intervention * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) * pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils) * contact lens usage within 6 months for pmma lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses * requiring an intraocular lens power \ 26.0 diopters

Keywords: tecnis multifocal patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses
effectiveness of the transversus abdominis plane block associated with opioid spinal anesthesia on analgesia after cephalic duodenopancreatectomy

Conditions: Pancreatic Cancer

Summary: duodenopancreatectomy is a major, risky surgery that causes significant post-operative pain. optimizing perioperative analgesia remains a challenge, and requires multimodal management, notably involving locoregional analgesic techniques. the thoracic epidural helps reduce perioperative pain, as well as certain postoperative complications. however, epidural analgesia is not without effects, and the data remains quite heterogeneous depending on the studies regarding its benefits and risks: more frequent hypotension, significant technical failures, length of hospitalization depending on the series, marginal benefit clinically of little relevance... and the existence of contraindications to the epidural such as the performance of vascular resections requiring curative intraoperative anticoagulation also limit its daily use. the search for alternatives to the epidural in this context has seen the emergence of the use of intrathecal injection of morphine and the performance of tap block perioperatively for duodenopancreatectomies. morphine spinal anesthesia is an analgesic technique that is simpler and just as effective as the thoracic epidural. the tap block has also proven its effectiveness in major colorectal surgeries. the literature on the subject remains poor and very few studies have focused on alternatives to thoracic epidurals. if the superiority of tap block and spinal anesthesia have been evaluated in isolation, no study has yet compared the effectiveness of the combination of tap block-spinal anesthesia compared to that of tap block alone in the management of post pain. duodenopancreatectomy. at the strasbourg university hospital, the anesthesia team in hepatic and pancreatic surgery made a change in practice in june 2023: from a tap block, the team performs a tap-block combined with a unique morphinic spinal anesthesia preoperatively for cephalic duodenopancreatectomy (cdp). the objective of the study is to evaluate the effectiveness and safety of this change in practice.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * planned cephalic or total duodeno-pancreatectomy surgery, associated or not with additional vascular procedures or liver resections by laparotomy, at the strasbourg university hospital for the period from june 1, 2022 to may 31, 2024. * subject who has not expressed opposition to the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed opposition to participating in the study * admission to intensive care following the operation * drug addiction withdrawn or not * surgery shortened by surgical decision

Keywords: pancreatic cancer cephalic duodenopancreatectomy transversus abdominis plane block tap bloc
selecting the ssv-1 as liv in scheuermann's kyphosis

Conditions: Scheuermann's Kyphosis

Summary: the proper selection of the lowest instrumented vertebra (liv) remains controversial in the surgical treatment of scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (ssv-1) as liv. the purpose of this study is to investigate whether ssv-1 could be a valid liv for scheuermann kyphosis (sk) patients with different curve patterns.

the proper selection of the lowest instrumented vertebra (liv) remains controversial in the surgical treatment of scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (ssv-1) as liv. the purpose of this study is to investigate whether ssv-1 could be a valid liv for scheuermann kyphosis (sk) patients with different curve patterns. this was a prospective study on consecutive sk patients treated with posterior surgery between january 2018 and september 2020, in which the distal fusion level ended at ssv-1. the liv was selected at ssv-1 only in patients with risser \> 2 and with liv translation less than 40mm. all of the patients had a minimum of 2-year follow-up. patients were further grouped based on the sagittal curve pattern as thoracic kyphosis (tk) and thoracolumbar kyphosis (tlk). radiographic parameters including global kyphosis (gk), lumbar lordosis (ll), sagittal vertical axis (sva), liv translation, pelvic incidence (pi), pelvic tilt (pt), sacral slope (ss) were measured preoperatively, postoperatively and at the latest follow-up. the intraoperative and postoperative complications were recorded. the scoliosis research society (srs)-22 scores were performed to evaluate clinical outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of sk patients; * underwent one-stage posterior spinal fusion (psf) with multi-level ponte osteotomies; * selecting ssv-1 as liv; * with a minimum follow-up of 2 years. exclusion criteria: * with previous spinal surgical history; * with any other spinal deformities; * without complete follow-up data.
safety and efficacy study of anti-b7-h3 car-t cell therapy for recurrent glioblastoma

Conditions: Glioblastoma

Summary: this is an open, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability and preliminary effectiveness of b7-h3-targeting chimeric antigen receptor-t (car-t) cell therapy on patients with recurrent glioblastomas. the study also plan to explore the maximum tolerated dose (mtd) and determine the recommended phase ii dose (rp2d) of the car-t cell therapy.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 18-75 years (including 18 and 75 years old)； 2. patients with relapsed glioblastoma, as confirmed by positron emission tomography (pet) or histologic pathology； 3. a \>= 30% staining extent of b7-h3 in his/her primary/recurrent tumor tissue by the immunochemical method; 4. karnofsky scale score\>=50 5. availability in collecting peripheral blood mononuclear cells (pbmcs) ； 6. adequate laboratory values and adequate organ function; 7. patients with childbearing/fathering potential must agree to use highly effective contraception； exclusion criteria: 1. pregnant or breastfeeding females； 2. contraindication to bevacizumab； 3. within 5 days before the car-t cell infusion, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid)； 4. comorbid with other uncontrolled malignancy； 5. active immunodeficiency virus (hiv) or hepatitis b virus or hepatitis c virus or tuberculosis infection; 6. subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment; 7. autoimmune diseases; 8. receiving long-term immunosuppressive treatment after organ transplantation; 9. severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes; 10. not recovered from the toxicities or side effects by previous treatment; 11. subjects who have participated the other interventional trial within one month before the enrollment, or have received other car-t cell therapies or gene-modified cell therapy before enrollment. 12. subjects with medical conditions that affect signing the written informed consent or complying with the research procedures, the medical conditions including, but not limited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonary embolism, coagulation disorders, active systemic infection, uncontrolled infection et. al; or patients who are unwilling or unable to comply with the research procedures; these 13. subjects with other conditions that would interfere trial participation at the investigator's discretion.
laparoscopic versus vaginal approach closure complications

Conditions: Vaginal Vault Prolapse

Summary: hysterectomy is considered as a common operation in gynecology. hysterectomy could be made by vaginally, laparoscopically or abdominally. the american congress of obstetricians and gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

laparoscopic hysterectomy (lh) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems. vaginal cuff dehiscence (vcd) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (tlh) compared with abdominal and vaginal hysterectomy. the study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.

Eligibility criteria:
inclusion criteria: 1. patients who undergo laparoscopic hysterectomy 2. age ranged from 40 to 80 years. 3. patients suffering from chronic pelvic inflammatory disease (pid) 4. dysfunctional uterine bleeding 5. adenomyosis 6. endometriosis 7. fibroid 8. endometrial hyperplasia 9. benign ovarian cyst exclusion criteria: * patients with known malignancy

Keywords: laparoscopic hysterectomy vaginal hysterectomy
automated oxygen administration in patients with hypoxemic pneumonia and pleuropneumonia

Conditions: Pneumonia; Pneumonia, Ventilator-Associated; Length of Stay

Summary: hypoxemic pneumonia is a major cause of hospitalization in pulmonology. the patient's dependency on oxygen prevents early discharge from the hospital. an automated oxygen therapy is a system that allows administration of oxygen with a flow that is automatically adjusted to the patient's saturation, which is continuously monitored. this system has proven to be particularly effective with chronic obstructive pulmonary disease (copd) patients, by decreasing the time spent in hypoxia and hyperoxia, and by accelerating the weaning of oxygen. our hypothesis is that automated oxygen therapy leads to a diminution on the length of hospital stay.

prolonged hospitalization has many consequences, including loss of autonomy and nosocomial infection. moreover, these complications themselves lead to an extension of the length of stay. this has an impact on the cost of care: several studies have shown that hospitalization is the most costly factor in the management of pneumonia, and that even a small amount of hospital stay, led to significant financial savings. automated oxygen therapy is a device that automatically adjusts with the saturation the amount of oxygen administered. investigator hypothesis is that automated oxygen therapy could shorten the length of stay of patients hospitalized for hypoxemic pneumonia. one group of patients will receive the automated oxygen therapy and the other group will receive the standard oxygen therapy. the investigator will compare in each group the average length of stay, the duration of oxygen therapy, the time spent outside of the target saturation, the cost on the medical-economic level and the patient's experience.

Eligibility criteria:
inclusion criteria: * adult * patient living at home or in an institution * patient hospitalized for less than 48 hours * pneumonia defined (according to the 2006 french-speaking infectious pneumology society (spilf) criteria) by: * respiratory functional symptoms (cough, sputum, dyspnea, chest pain) and * hyperthermia \>38,5°c or hypothermia \<36°c and * radiological signs of pneumonia * hypoxia : spo2 \< 94% in ambient air and/or pao2\< 60 mmhg in ambient air exclusion criteria: * pneumonia acquired at the hospital. * patient hospitalized in another department more than 48 hours before admission * chronic respiratory failure * active neoplasia * patients undergoing oxygen therapy and / or long-term niv * associated cardiac decompensation (clinical signs and / or ntprobnp\> 1800ng / ml) (3 * initial need for high flow oxygen therapy or ventilatory support (niv, vi) * difficulties expected from home support.

Keywords: randomized therapeutic trial hypoxemic pneumonia automated oxygen therapy length of stay medico-economic cost
impedance spectroscopy in detection of obstetric anal sphincter injuries

Conditions: Obstetric Anal Sphincter Injury; Delivery, Obstetric

Summary: the main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. the study is prospective. the study group comprises 24 patients; included in it 6-8 weeks after natural delivery. the planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time. after obtaining written consent, at the screening visit (v0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. on the second visit (v1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out. on the third visit (v2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. the collected data will be used to select the optimal therapeutic method for each participant individually.


Eligibility criteria:
inclusion criteria: * after natural delivery and post-partum period (6-8 weeks after delivery) * physiological pregnancy * observed a perianal tear of grade 1-4 in the oasis classification * signed informed consent exclusion criteria: * presence of acute diseases during treatment * presence of chronic diseases untreated or insufficiently treated (e.g. poorly controlled hypertension), * presence of diseases, with symptoms of fecal incontinence, * previous proctological operations, * the presence of inflammatory bowel diseases in the stage of exacerbation, * treatment in the last year due to severe, progressive, uncontrolled cardiac, pulmonary, nephrological, infectious or psychiatric disease, which course could affect the patient's risk due to participation in study, * significant deviations from the norm in a physical examination during v0 visit or laboratory tests taken during the same visit, * significant disease symptoms so far undiagnosed and reported during the v0 visit * presence or suspected malignant disease or previous oncological treatment during the last 5 years, * presence of a cardiac stimulator or cardioverter-defibrillator, * severe surgery or severe trauma in the last year.

Keywords: obstetrical anal sphincter injury impedance spectroscopy
calcium levels in major trauma

Conditions: Major Trauma

Summary: to assess and treat the calcium level abnormalities in major trauma pre and post receiving blood transfusions .

primary objective: * to evaluate the level of ionized calcium in multiple trauma patients with massive hemorrhage secondary objective: * to build a relation between the level of ionized calcium and the degree of hemorrhagic shock

Eligibility criteria:
inclusion criteria: 1. \>18 years old - \< 70 years 2. major trauma patients. 3. admission and ionized calcium measurement before blood transfusions exclusion criteria: 1. patients below 18 years or \> 70 years of age. 2. pregnant women 3. arrested patients 4. patients managed outside the hospital and had received blood transfusions
an intervention with weighted blankets for children with adhd and sleep problems

Conditions: Adhd; Sleep Disturbance

Summary: the aim of the study is to evaluate a sleep intervention with weighted blankets for children with adhd and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness. the study is an rct with cross-over design. the participants will be randomized to start with an active or placebo blanket, and then change blankets during the 16 week study period.

there is limited evidence about health outcomes or health-economic benefits of sleep interventions with weighted blankets for children with neuropsychiatric syndromes (nps). the aim of the study is to evaluate a sleep intervention with weighted blankets for children with adhd and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness. the participants, n=100 children between 6 and 13 years old, will be recruited from the adhd unit in child and adolescent mental health service (camhs) and randomly assigned into two groups: fiber weighted blankets (intervention 1) and control blankets (controls). the children will use each blanket respectively for 4 weeks, then change blankets. a long term follow-up will be conducted 16 weeks from baseline.

Eligibility criteria:
inclusion criteria: * children diagnosed with adhd with sleep problems (defined by screening instrument). - * being a patient at child and adolescent mental health service (camhs) in region halland, sweden. * parents and children should understand (written and spoken) swedish language. exclusion criteria: * already used weighted blankets as a sleep intervention, * if they have received a new prescription or change of pharmacological treatment for sleep problems

Keywords: children non-pharmacological intervention adhd sleep
routine angiography follow-up after percutaneous coronary intervention in high-risk patients

Conditions: Coronary Artery Disease

Summary: comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * successful pci with at least two of the following high-risk factors: a. left main lesion; b. bifurcation lesion (true bifurcation); c. ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); d. chronic total occlusion; e. multivessel revascularization (≥ 2 vessels); f. in-stent restenosis; g. diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); h. severe calcified lesion (significant severe calcification on angiography); i. bypass graft lesion; j. diabetes mellitus; k. chronic kidney disease (defined as an estimated glomerular filtration rate of \<30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); l. myocardial infarction; - he/she or his/her legally authorized representative provides written informed exclusion criteria: * revascularization with bare metal stents and/or balloon angioplasty with non-drug-coated balloons. * pregnant and/or lactating women. * life expectancy of less than 2 years. * repeat interventional therapy is planned. * subject was unable to provide written informed consent.
trial of talabostat and gemcitabine in patients with stage iv adenocarcinoma of the pancreas

Conditions: Pancreatic Cancer; Neoplasm Metastasis; Adenocarcinoma

Summary: the purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage iv adenocarcinoma of the pancreas.


Eligibility criteria:
inclusion criteria: * men or women age ≥18 years * histologically confirmed metastatic (stage iv) adenocarcinoma of the pancreas * measurable disease defined per recist * karnofsky performance status ≥50 * expected survival ≥12 weeks * provide written informed consent exclusion criteria: * cns metastases * prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer * radiation therapy to \>25% of the bone marrow * clinically significant laboratory abnormalities * any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix * the need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy with \>10mg/day prednisone equivalents * any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol * patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. all side effects of prior treatment must have resolved at study entry. * pregnancy or lactation

Keywords: pancreatic cancer cancer of the pancreas adenocarcinoma of the pancreas pancreatic neoplasms metastatic pancreatic cancer (stage iv) stage iv adenocarcinoma of the pancreas