Kornimate/medical-research-clean huggingface dataset:
cellular adoptive immunotherapy in treating patients with glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. aldesleukin may stimulate the white blood cells, including lymphokine-activated killer cells, to kill tumor cells. giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells. purpose: this phase ii trial is studying how well cellular adoptive immunotherapy works in treating patients with glioblastoma multiforme.

objectives: * determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in patients with glioblastoma multiforme. * determine progression-free and overall survival of these patients. * compare survival of these patients to that of contemporary and historical controls. outline: patients undergo therapeutic craniotomy. patients undergo leukapheresis to obtain lymphokine-activated killer (lak) cells 3-7 days before therapeutic craniotomy or 4-6 weeks after therapeutic craniotomy. patients receive cellular adoptive immunotherapy comprising aldesleukin-stimulated lak cells intracranially at the time of therapeutic craniotomy or via an ommaya reservoir (placed during craniotomy) no sooner than 4-6 weeks after therapeutic craniotomy. after completion of study treatment, patients are followed periodically for 5 years. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of primary malignant glioblastoma multiforme (i.e., grade iv anaplastic astrocytoma) * primary treatment (surgery, radiation, and/or chemotherapy) has been completed * candidate for surgery and willing to undergo craniotomy * no progressive or recurrent disease * no residual disease that requires reoperation, additional gamma therapy, or other modality patient characteristics: * ecog performance status (ps) 0-2 or karnofsky ps 70-100% (i.e., if symptomatic, bedridden \< half of a waking day) * life expectancy ≥ 2 months * not pregnant * negative pregnancy test * u.s. residents only * no hematopoietic, hepatic, renal, cardiovascular, or pulmonary laboratory values or other medical circumstances that would preclude surgery or aldesleukin therapy * no serious concurrent medical or psychiatric illness that would preclude informed consent or study treatment prior concurrent therapy: * see disease characteristics * at least 4 weeks since prior anticancer therapy and recovered * prior stereotactic or gamma knife radiosurgery allowed

Keywords: adult glioblastoma adult gliosarcoma adult giant cell glioblastoma
an international trial to evaluate the efficacy and safety of saber®-bupivacaine for postoperative pain control in patients undergoing hysterectomy

Conditions: Postoperative Pain

Summary: the objective is to identify the optimal dose of saber-bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. the study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. the study will provide further data on the efficacy and safety of the product.


Eligibility criteria:
inclusion criteria: * a planned elective, abdominal hysterectomy * patients suitable for general anaesthesia exclusion criteria: * known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities * known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. history of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma) * abnormal ecg * prolonged qt syndrome * current or regular use of analgesic medication for other indication(s)

Keywords: postoperative pain local anaesthesia postoperative pain after open abdominal hysterectomy surgery
effect of nano-hydroxyapatite and laser on dentin hypersensitivity

Conditions: Dentin Sensitivity

Summary: the aim of this study was to evaluate the effect of nanohydroxyapatite associated with low potency laser therapy in eliminating or reducing dentin hypersensitivity in a randomized placebo-controlled clinical trial. volunteers 18 to 50 years old with hypersensitive teeth were randomized into 4 groups: gplacebo - positioning of the laser tip without light emission + placebo dentifrice; gnhap - positioning of the laser tip without light emission + nano-hydroxyapatite; glaser - laser tip positioning with light emission + placebo substance; glasernhap - positioning by laser beam with light emission + nano-hydroxyapatite.

glaser received the laser application using the infrared light spectrum with wavelength of 808 nm with its active asgaal medium in two points of the vestibular face of the hypersensitive teeth. it was applied at each point 60 j / cm², for 16 seconds. the laser was applied in 2 sessions with a time interval of 24 hours. glasernhap first received laser application and then the application of nanohydroxyapatite according to the manufacturer's recommendations. before initiating laser therapy, the equipment was calibrated with a tester (mmoptics ltda®, são carlos, sp, brazil). the gnhap volunteers were submitted to the application of desensibilize nano p on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (microbrush, 3m espe, são paulo, brazil) for 10 minutes. then, a rubber cup (unid microdont, são paulo, sp, brazil) mounted on a low speed handpiece (dabi atlante, ribeirão preto, so, brazil) was used to scrub the desensitizing gel on teeth for 20 seconds in each tooth, according to the manufacturer's specifications. gplacebo followed the same protocol used in gn-hap. in addition to the desensitization treatment, all gnhap and gplacebo volunteers received the positioning of the laser tip to mimic the light emission produced in glaser and glasernhap. the noise emitted by the laser device during mimicry was simulated through the sound reproduction of a smartphone application (hd voice recorder - iphone 6s, apple®, cupertino, california, usa).

Eligibility criteria:
inclusion criteria: - the presence of at least one hypersensitive tooth; exclusion criteria: * patients with systemic diseases; * patients with pulpitis; * patients with carious lesions; * patients with defective restorations; * patients with cleft enamel; * patients with active periodontal disease; * patients with analgesic medication; * patients with pregnant or lactating women * patients who have received professional desensitizing treatment in the last three months.

Keywords: nano-hydroxyapatite laser desensitizing
pharmacokinetic study of skeletal muscle area-based paclitaxel infusion in patients with cancer

Conditions: Breast Cancer; Metastatic Gastric Cancer; Esophageal Cancer

Summary: the primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (sma), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal sma at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic sma normalizes the levels to those of patients with normal sma.

paclitaxel is an fda-approved and commonly used standard of care agent for patients with early-stage breast cancer. this study will use the standard dose of 80 mg/m\^2, including the typical pre-medications as per university of michigan rogel cancer center institutional standard. the only investigational component of this study is lengthening the infusion duration from 1-hour to 2 or 3 hours for a single dose in patients with low sma. jan2025 update, paclitaxel is an fda-approved and commonly used standard of care agent for patients with early-stage breast cancer or metastatic gastric or esophageal cancers.

Eligibility criteria:
inclusion criteria: * planned paclitaxel 80 mg/m\^2, 1-hour infusion * evaluable computed tomography (ct) scan, positron emission tomography computed tomography (pet-ct) scan, or mri scan (e.g. scan of the chest, abdomen, or pelvis for any indication w/in 1 year) * female * ≥ 18 years old * adequate organ function to receive paclitaxel treatment as defined in the protocol * ability to understand and the willingness to sign a written informed consent exclusion criteria: * concomitant administration of any moderate or strong inducer or inhibitor of cyp2c8, including rifampin or clopidogrel. * history of hypersensitivity reaction to paclitaxel or any components of paclitaxel (e.g., cremophor el) that precludes continued treatment with standard dose and infusion length * pregnant or nursing * receiving any other dose (i.e., not 80 mg/m2) or infusion rate (i.e., not 60 minute infusion) either due to toxicity during a previous cycle or any other reason

Keywords: pharmacokinetics
handling comparison between two contact lens types

Conditions: Presbyopia

Summary: subjects will evaluate each study lens in a random order. the lenses will be worn in both eyes for a short period.


Eligibility criteria:
inclusion criteria: 1. the subject must read, understand and sign the statement of informed consent and receive a fully executed copy of the form. 2. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. the subject must be between 40 and 70 years of age. 4. the subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye. 5. the subject's refractive cylinder must be less than or equal to -0.75 d in each eye. 6. the subject's add power must be in the range of +0.75 d to +2.50 d in each eye. 7. the subject best corrected visual acuity of 20/20 -3 or better in each eye. 8. subject must own a wearable pair of spectacles. 9. the subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration) 10. the subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "presbyopic symptoms questionnaire". exclusion criteria: 1. currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. any ocular abnormality that may interfere with contact lens wear. 5. use of any ocular medication, with the exception of rewetting drops. 6. any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (prk), laser-assisted in situ keratomileusis (lasik), etc.) 7. any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. 8. any ocular infection or inflammation. 9. history of herpetic keratitis. 10. any corneal distortion or irregular cornea. 11. history of binocular vision abnormality or strabismus. 12. any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. hiv). 13. current history of diabetes. 14. participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
the physical dosimetry study and preliminary clinical results of 3d-printing non co-planar template assisted with ct-guidance for iodine-125 seed brachytherapy in pelvic recurrent rectum carcinoma after surgery and external beam radiotherapy

Conditions: Rectum Cancer, Recurrent; Brachytherapy, Radioisotope

Summary: this study observes the efficacy and side effects of 3d-printing non co-planar template(3d-pnct) assisted with ct-guidance for radioactive iodine-125 seed(ris) brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.

3d-pnct assisted with ct-guidance for radioactive iodine-125 seed brachytherapy is a conventional treatment in peking university third hospital. radioactive iodine-125 seed brachytherapy is the implantation of iodine-125 seed into tumors.the radioactive iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. 3d-printing non co-planar template is made individually which guides the implantation of iodine-125 seed into the tumor and ensures the accuracy of the position.this study collects the data of patients with pelvic recurrent rectal carcinoma who underwent 3d-pnct assisted with ct-guidance for radioactive iodine-125 seed implantation from 2015 to 2018. we evaluate the dose that covers 90% target volume(d90),the volume that 100% prescription dose covers(v100) and other dosimetric parameters after the implantation. the efficacy and adverse effects were observed. local control(lc) time and overall survival(os) time are evaluated.

Eligibility criteria:
inclusion criteria: * treated with 3d-printing non co-planar template assisted with ct-guidance for iodine-125 seed brachytherapy in peking university third hospital * histological proven recurrent rectal cancer * inoperable local recurrent cases * previous external beam radiotherapy, incapable of re-irradiation * expected life span\>3 months exclusion criteria: * serious medical illness * unable to tolerate anesthesia * blood coagulation dysfunction

Keywords: three-dimensional printing rectum cancer, recurrent radioactive iodine-125 seed implantation
drug interaction study with atazanavir administered with and without ritonavir and a cytochrome p450 substrate rosiglitazone

Conditions: HIV Infections

Summary: the purpose of this clinical research study is to assess the effect of atazanavir 400 mg qd and atazanavir/ritonavir 300/100 mg qd at steady state on the single dose pharmacokinetics of rgz in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects between the ages 18 to 50 years old with a bmi 18 to 32 kg/m2

Keywords: hiv
mapping the longitudinal, multidimensional impact of ms in relation to variables indicative of neurological reserve

Conditions: Multiple Sclerosis

Summary: some ms patients quickly accumulate neurological deficits, while others remain well for decades. even though associations with age, sex, health behaviors, comorbidities and social determinants of health are widely acknowledged, the clinical heterogeneity in ms is poorly understood and variables with a robust prognostic value are lacking. recent data suggest a key role for resilience in the central nervous system, potentially supporting the concept of neurological reserve in ms.

the first phase of the study will take place at the national ms center melsbroek (nmsc). all data from the edmus database, a single center database at the nmsc, will be exported and checked (quantity, quality) aiming to come to a well-organized ms data structure. this ms register will be completed with volume data (intracranial, spinal canal) in a subset of patients. as a substantial number of ms patients are followed over the long-term in the ms center, the investigators expect to have longitudinal data well beyond a disease duration of 10 years at least for part of the patients. following the export and cleaning phase of the data, the investigators will come to the basic descriptive statistics. this allows us to have an overview of all data and determine the most appropriate baseline variables or covariates as well as to define the most appropriate outcome variables. multivariable regression analysis will be used to predict the value of outcome variables based on the independent variables whose values are known. in view of the relevance of age and disease duration in the context of ms disability and progression, time-to-event analysis will be performed, with the time to reach irreversible milestones of ambulatory disability as outcome. in case of associations, the second phase of the study will be initiated for further analysis at the aims research group, vub. at the aims group, vub, the potential of false positive findings will be addressed using more sophisticated approaches (splitting cohorts in exploratory and discovery cohort, or cross-fold validation).

Eligibility criteria:
inclusion criteria: diagnosis of ms needs to be based on diagnostic criteria valid at the time of data entry and confirmed during follow up exclusion criteria: * neuromyelitis optica diagnosis, aq4 positive or mog positive
effect of perioperative tranexamic acid on blood loss during management of maxillofacial trauma

Conditions: Blood Loss

Summary: this is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.

this is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. any surgical or postoperative complications are noted. scores are aggregated for statistical analysis.

Eligibility criteria:
inclusion criteria: * patients undergoing orif under ga for maxillofacial fractures * patients between with ages of 16-65 * no cardiac comorbidities (hypertension, congenital heart malformation) * no known coagulopathy * no regular prescription medication altering normal blood coagulation (nsaids, other anticoagulants) * asa i and ii patients exclusion criteria: * patients younger than 16 and older than 65 * patients with known coagulopathy * patients with cardiac comorbidities * patients with a family history of bleeding disorders * asa iii or higher

Keywords: maxillofacial trauma; blood loss
oral anti-infective agent for esophageal anastomotic leakage

Conditions: Anastomotic Leakage

Summary: anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. this study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.

goal: the effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not yet been studied for along time. we will use a random cohort study model and investigate the effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic wound healing. method: 1. design: one hundred and twenty patients are divided into 3 groups and each group has 40 esophageal patients. minimization stratified randomization will be applied. oral anti-infective gargling agent, mycostatin oral suspension, will be employed for one week before operation. the first groups will be treated without oral gargle agent; the second groups will be treated with gargling water; and the third groups will be treated with anti-infective gargling agent. an end-to-side two-layer esophagogastric anastomosis will be constructed using interrupted sutures with metallic staple through cervical wound. on the other hand, the anastomotic leakage rates in different groups will be investigated. 2. data collection and statistic analysis: the records of all patients, various biologic parameters, and the management of leakage are analyzed. thirty-day morbidity and mortality are determined, and stepwise multivariable logistic regression analysis assesses the effect of preoperative and postoperative variables on anastomotic leakage. time variation of starting oral feeding and hospital stay are compared using the kaplan-meier method.

Eligibility criteria:
inclusion criteria: * carcinoma of the esophagus, operable stage i to iii exclusion criteria: * patients who were inoperable, * patients who had obvious impaired blood supply of gastric substitutes, and * patients who had non-cervical esophagogastrostomy.

Keywords: esophageal cancer anastomotic leakage prevention of anastomotic leakage after esophageal surgery
myopia intervention in children and adolescents and establishment of a precise intervention model

Conditions: Myopia

Summary: investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.

investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.

Eligibility criteria:
inclusion criteria: * children aged from 8-15 years old; * children with spherical degree ranged from -1.0d to -4.0d, cylindrical degree less than -1.50d, astigmatism with the rule less than -1.25d, astigmatism with other axial distribution less than -0.50, anisometropia less than -1.50d; * children with bcva less than 0.1 logmar for both eyes; * children without other eye diseases except for ametropia exclusion criteria: * children with other eye diseases: amblyopia, strabismus, eye trauma, etc; * children with cycloplegia contradictions; * children who have used atropine or orthokeratology; * children who are severly allergic with atropine; * children who are using other eye drops for treatment; * children who have contraindications to orthokeratology or cannot cooperate with it; * children with severe heart, lung, liver and kidney diseases

Keywords: myopia progression atropine orthokeratology