Kornimate/medical-research-clean huggingface dataset:
study on feasibility of stimulation on the lumbar part of the spinal cord to improve mobility recovery in patients with sub-acute spinal cord injury

Conditions: Spinal Cord Injury

Summary: the stimo-2 study aims to investigate tess-supported rehabilitation training in sub-acute spinal cord injury (\< 6 months post-injury). the primary endpoint of this study is to assess the safety and feasibility of tess. the preliminary effectiveness of the therapy is the secondary study endpoint. the mobility recovery status of patients, who undergo tess-supported rehabilitation, will be assessed at 12 months post sci, compared to their predicted recovery expectations based on standard rehabilitation program


Eligibility criteria:
inclusion criteria (non-exhaustive list) * patient enrolled in the emsci study * age 18 to 70 years old included * focal spinal cord injury due to trauma * patient with history of sci within the past 6 months (sub-acute sci) * vertebral lesion t11 or above * psychological condition compatible with study participation * able and willing to fulfil all study procedures exclusion criteria (non-exhaustive list) * severe or chronic medical disorder pre-existing sci affecting rehabilitation * active implanted device such as a pacemaker, implantable cardiac defibrillator * inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia * pregnant or breast feeding * participation in other interventional study

Keywords: spinal cord injury
prevention of cigarette smoking in attention deficit hyperactivity disorder (adhd) youth with concerta

Conditions: ADHD

Summary: this study will consist of a six-week open-label treatment period with an extended duration methylphenidate (oros mph) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for adhd. the researchers hypothesize that oros mph treatment will be associated with low rates of cigarette smoking in adhd youth.


Eligibility criteria:
inclusion criteria: 1. adolescent outpatients between 12 to 17 years of age (inclusive). 2. subjects with the dsm-iv diagnosis of adhd, as manifested in the clinical evaluation and confirmed by structured interview. 3. subjects with sufficient current adhd symptoms to warrant treatment, as measured by a clinical global impression severity scale (cgi-s) score of greater than or equal to 4 (moderately ill); or subjects already on concerta who are judged to be responders (cgi of 1 or 2) and who tolerate treatment well. exclusion criteria: 1. any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease. 2. clinically significant abnormal baseline laboratory values 3. history of seizures 4. active tic disorder 5. pregnant or nursing females 6. mental retardation (intelligence quotient \[iq\] \< 75) 7. organic brain disorder 8. eating disorders 9. psychosis 10. current bipolar disorder (current episode) 11. current depression \> mild (cgi-s \> 3) 12. current anxiety \> mild (cgi-s \> 3) 13. substance abuse or dependence within the past 2 months 14. recent change in non-monoamine oxidase inhibitor (maoi) antidepressants (\< 3 months) 15. recent change in benzodiazepines (\< 3 months) 16. concerta non-responder

Keywords: cigarette smoking adhd adolescents concerta
vas correlation with bmi

Conditions: Morbid Obesity

Summary: the aim of the study is to observe if any correlation between body mass index and vas values exists in patients who has gone under abdominal surgery. group i : patients with bmi\ 50 after the end of surgery patients will be extubated and in the recovery room morphine pca (patient-controlled analgesia) treatment will be started according to their adjusted body weight. when vas values over 4,10 mg/kg paracetamol iv will be used as an escape treatment. vas values and delivery and demand of the pca and additional need for analgesics will be recorded in the first 48 hours.


Eligibility criteria:
inclusion criteria: * patients undergoing abdominal surgery and who will be given pca treatment for postoperative pain. exclusion criteria: * patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression

Keywords: morbid obesity postoperative pain
a capsular incision and biochemical recurrence after radical perineal prostatectomy

Conditions: Radical Perineal Prostatectomy

Summary: to evaluate the impact of capsular incisions on biochemical recurrence (bcr) and the potential risk factors of capsular incisions.

the pathological classification of the prostate following radical prostatectomy provides important prognostic information; an accurate pathology report is the cornerstone to cancer treatment and follow-up. in addition to the preoperative serum psa, gleason score on pathology specimens, seminal vesicle invasion and lymph node status, and a positive surgical margin with extraprostatic extension (epe) are significant predictors of clinical and biochemical recurrence. however, the prognostic implication of a capsular incision, a tumor extending to the inked margins without a histologically documented epe, remains to be defined.

Eligibility criteria:
inclusion criteria: * pathologically proven prostate cancer * follow-up for at least 6 months exclusion criteria: * insufficient biopsy data * seminal vesicle invasion or lymph node involvement on pathology * neoadjuvant or adjuvant therapy

Keywords: capsular incision biochemical recurrence radical perineal prostatectomy
a study to examine the long term effect of pramlintide on body weight and its safety and tolerability in obese subjects

Conditions: Obesity

Summary: this is a long term extension to study 137ob-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.


Eligibility criteria:
inclusion criteria: * subject has completed protocol 137ob-201.

Keywords: obesity weight loss amylin pramlintide
audio and video brochures for increasing colorectal cancer screening among adults living in appalachia

Conditions: Colorectal Carcinoma

Summary: this clinical trial compares audio brochures and video brochures to usual care for increasing colorectal cancer (crc) screening among adults living in appalachia. adults living in rural appalachia experience increased rates of crc, possibly due to the unique barriers to screening this population faces, such as lower socioeconomic status, limited health literacy, and less access to healthcare. the fecal immunochemical test (fit) is a common crc screening technique which allows individuals to complete the test at home and mail the kit back. a limitation of the current process for fit screening outreach is that the instruction materials are heavy in text and not appropriate for individuals with limited health literacy. the audio and video brochures used in this clinical trial are instruction materials that have been specially designed to be appropriate for individuals of all health literacy levels. providing these audio and video brochures with the fit kits may increase crc screening among adults living in appalachia, compared to usual care.

primary objective: i. conduct a pilot study of the two developed mail-based fit outreach interventions versus (vs.) mailed usual care materials to establish acceptability and obtain preliminary efficacy data on increasing crc screening. outline: participants are randomized to 1 of 3 arms. arm i: participants receive the fit kit and usual care on study. arm ii: participants receive the fit kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. arm iii: participants receive the fit kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.

Eligibility criteria:
inclusion criteria: * mid-life men and women (50-64 years old) * live in appalachia * had a medical visit in the past two years * are at average-risk for crc (no history of crc, polyps, inflammatory bowel disease, family history of crc or hereditary crc syndromes) * are not within crc screening guidelines (no fecal occult blood test/fit in the past year; flexible sigmoidoscopy in past five years; colonoscopy in past ten years)
birth weight-discordance in twins pregnancy: a multicenter retrospective study

Conditions: Twin; Pregnancy, Affecting Fetus or Newborn

Summary: the rate of twin pregnancies in china has increased by 50 percent over the past decade and now stands at about 3 percent. this is significantly higher than the european and american countries. there are significant differences in birth weight of some newborns, that is, birth weight-discordance in twin pregnancies (bwdt). bwdt was significantly associated with fetal death, preterm birth, neonatal death, and neonatal complications. existing studies mainly focus on the perinatal outcomes of mothers and infants with bwdt, or are reported from small samples in developed countries. the investigators are aware of the need to further explore the occurrence of birth weight inconsistency and adverse neonatal outcomes in china with a large sample. through retrospective study design, the investigators will collect clinical data of live twin births at multiple study sites, investigate the incidence of bwdt, and analyze its adverse outcomes.

the investigators adopted a multicenter retrospective case-control study design and enrolled live twin births delivered from 2018 to 2020 in 22 hospitals in 12 provinces in china. children with congenital and hereditary diseases, such as inherited metabolic diseases, complex congenital heart disease, and digestive tract malformations, were excluded from the study. the investigators collected the following information: (1) general information: maternal age, year of delivery, number of delivery, mode of conception, mode of delivery, chorionic nature, education level, newborn sex; (2) maternal risk factors associated with intrauterine development: induced abortion ≥2 times, placental disease, uterine tumor, gestational diabetes mellitus, gestational hypertension disease, intrahepatic cholestasis, connective tissue disease, hypothyroidism, and chorionic amnitis; (3) infant birth outcome: gestational age, birth weight, birth length, birth head circumference, very low birth weight infants, ultra-low birth weight infants, the apgar score, whether transferred to neonatology department. (4) information of hospitalization during the neonatal period: pulmonary surfactant use, duration of oxygen therapy, neonatal complications (i.e., pulmonary hemorrhage, bpd, nec, pda, rop, pvl, ivh, anemia, infection, etc.), feeding status (i.e., duration of milk opening, duration of full feeding, feeding style and feeding materials at full feeding, time to recovery of birth weight), and discharge outcome (i.e., total hospitalization cost, length of stay, gestational age corrected for discharge, discharge status, discharge physique).

Eligibility criteria:
inclusion criteria: live twin births 1. delivered from 2018 to 2020 exclusion criteria: 1. congenital and hereditary diseases 2. inherited metabolic diseases 3. complex congenital heart disease 4. digestive tract malformations

Keywords: twins birth weigh-discordant occurrence birth outcomes multi-center study
safety and efficacy study of vilazodone and discovering genetic markers associated with response in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone in depression.


Eligibility criteria:
inclusion criteria: * male or female patients 18-65 years of age, inclusive.
a study of exg102-031 in participants with wamd

Conditions: Neovascular Age-related Macular Degeneration

Summary: in neovascular (wet) age-related macular degeneration (wamd), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. this leakage affects the vision over time and can lead to severe blurriness or blinding. exg102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. before exg102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with wamd.

age-related macular degeneration (amd) is a major cause of blindness and visual impairment in older adults. the wet form of amd, also called neovascular amd (namd) usually causes faster vision loss than the dry form. the most common current treatments of namd are products that inhibit vascular endothelial growth factor (vegf) (including ranibizumab (lucentis®, genentech) and aflibercept (eylea®, regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. this open-label, dose-escalation phase i/iia study is designed to evaluate the safety and efficacy of exg102-031 intraocular injection in participants with wet(neovascular) age-related macular degeneration（wamd）.

Eligibility criteria:
inclusion criteria: 1. male or female, age ≥ 50 years of age; 2. diagnosis of wamd and current active lesion in the study eye at screening; 3. an etdrs bcva letter scores between 73 and 9 letters in the study eye; 4. response to anti-vegf treatment within 6 months prior to screening or at the time of screening introduction; 5. the study eye must be a intraocular lens eye(post-cataract surgery status) and be at least 1 month post iol implantation at enrollment; 6. voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening. exclusion criteria: 1. presence of any ocular disease or history of disease in the study eye other than wamd that may affect central visual acuity and/or macular detection; 2. presence in the study eye of cnv or macular pathology pathography due to causes other than wamd; 3. the study eye has severe and irreversible retinal structural damage involving the fovea (such as retinal pigment epithelial (rpe) atrophy, retinal fibrosis, laser scars, dense hard exudation); or other retinal damage in the target eye that, in the opinion of the investigator, may impede visual improvement after resolution of macular edema ; 4. subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters; 5. presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye; 6. prior receipt of any ocular or systemic gene therapy agent.

Keywords: wet age-related macular degeneration
analysis of risk factors for recurrence of periprosthetic infection in megaprostheses implanted for sarcoma of bone

Conditions: PJI

Summary: the goal of this observational study is to collect a large and homogeneous case report of periprosthetic infections in megaprostheses in patients with a history of bone sarcoma.

the incidence of periprosthetic infections (pji) is high in megaprostheses (mp), 3-30% after primary surgery, up to 60% after prosthetic revision. patients with megaprosthesis implanted in a primary sarcoma of bone have an increased risk of infection, compared with joint prostheses implanted on arthrosis, due to several factors, including treatment with chemotherapy, extensive periarticular soft tissue sacrifice, and duration of surgery. pji of an mp can result in important consequences: prolonged hospitalizations, expensive treatments, multiple surgeries, risk of amputation and reduced quality of life. diagnosis and treatment of mp infections are challenging. surgery is the focus of treatment, and identification of the microorganism responsible for infection is necessary for diagnostic confirmation and to set up targeted antibiotic treatment. treatment, similar to standard joint replacement, includes surgical cleaning without implant replacement and complete revision of the prosthesis in one or two stages. data currently available in the literature about patients with infection of a megaprosthesis implanted after excision of a bone sarcoma is scarce; in particular, most case series are small and heterogeneous. the aim of this study is to obtain more information about this condition by collecting a large and homogeneous data of pji in mp, in order to identify predictive factors in the treatment of pji. the treatments to which the patients underwent and thus analyzed for the study are those expected by normal clinical practice.

Eligibility criteria:
inclusion criteria: * patients with pji caused by a megaprosthesis, implanted for a primary sarcoma of bone; * age \>= 18 years at the time of diagnosis; * megaprosthesis site: proximal humerus, proximal femur, total femur, distal femur, tibia proximal; * prosthetic revision in two stages; * obtaining informed consent for the study exclusion criteria: * early infection (within 6 weeks after implantation of the prosthesis); * recurrence of infection; * follow-up \< 12 months after prosthetic re-implantation; * reconstruction other than a megaprosthesis (e.g., bone graft, composite prosthesis)

Keywords: megaprosthesis
effect of oxygen supplementation on cerebral oxygenation, symptoms and performance during stst in copd patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: it is a randomised, single-blind trial of the effect of acute oxygen supplementation on cerebral oxygenation during the 30 sec sit-to-stand test (stst) in chronic obstructive pulmonary disease patients, without resting hypoxemia. after an initial clinical assessment, patients preform the 30sec stst under near-infrared spectroscopy, a non invasive technique which assesses cerebral oxygenation at the prefrontal lobe. measurements are performed twice, under oxygen supplementation or medical air, in a random order, and the patients are be blinded to the treatment (oxygen or medical air) given.


Eligibility criteria:
inclusion criteria: 1) clinical diagnosis of copd, based on smoking history of at least 100 cigarettes and post bronchodilation forced expiratory volume (fev1) to forced vital capacity (fvc) ratio \ 60 mmhg, according to recent (within a week) arterial blood gases assessment. exclusion criteria: 1) recent copd exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), 2) history of specific balance problems (i.e., diagnosed neurological or vestibular disorder), 3) spinal surgery, and 4) lower limb musculoskeletal problems (i.e., surgery, injury or pathology at hip, knee, ankle or foot) -
the effectiveness and change mechanisms of mentalization based therapy for children (mbt-c)

Conditions: Mental Disorder, Child

Summary: the main aim of the project is to investigate the effectiveness and change mechanisms of mentalization based therapy for children (mbt-c; midgley et al., 2017). mbt-c is a transdiagnostic treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. parallel parental work takes place to increase parental mentalization. this project will test the effectiveness of mbt-c in a parallel group single blind pragmatic randomized controlled trial (prct) conducted in turkey in comparison to a parenting and social skills group. the sample will include 240 children between 5-12 years old with internalizing and externalizing and comorbid internalizing/externalizing problems and their parents. during the study, the patients will be randomized to two arms, and the treatment's effectiveness will be investigated both at short (8th and 12th weeks) and long terms (24th and 36th week) to also assess relapse prevention. thelarge sample size and the longitudinal evaluation of primary (decrease in problems), and secondary outcomes will enable the investigation of mediators and moderators. this project will also undertake a rigorous psychotherapy process study within the rct, examining for the first time, for which children and under what circumstances mbt-c may be most effective, meaningfully linking process with outcome. for this purpose, patients' baseline characteristics, especially attachment security and mentalization deficits that may interact with treatment outcome (moderators) and different dimensions of mentalization that develop over the course of the treatment (change mechanisms/mediators) will be assessed.


Eligibility criteria:
inclusion criteria 1. child age 5 to 12 years old 2. clinical levels of child internalizing, externalizing and comorbid internalizing/externalizing problems (clinical levels on cbcl) exclusion criteria children 1. a clinical diagnosis of autistic spectrum disorders (asd) (meets ksads-pl threshold criteria) 2. severe intellectual impairment (below 5th percentile on kbit-2) 3. a clinical diagnosis of psychosis (meets ksads-pl threshold criteria) 4. severe conduct disorder (clinical range on cbcl dsm-oriented conduct problems scale) 5. severe substance abuse and dependence (meets ksads-pl threshold criteria) 6. acute risk of harm to self and others (ksads-pl risk item scores = 3) 7. an emergency/crisis referral, where an immediate response to a significant risk is required parents 1. risk of psychotism (clinical on bsi psychotism scale) 2. severe intellectual impairment (below 5th percentile on kbit-2) 3. severe substance abuse and dependence (positive case on bapirit) 4. acute risk of harm to self and others (bsi item 9, 39 \& 40 = 4) 5. an emergency/crisis referral, where an immediate response to a significant risk is required

Keywords: mentalization internalizing problems externalizing problems comorbid internalizing/externalizing problems
split face study of the duration of local anesthetics - fourth arm

Conditions: Anesthesia, Local

Summary: this is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. the investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites.

the investigators seek to further investigate how the vascularity of an anatomical region influences the duration of local anesthetics during dermatologic surgery. the investigators hypothesize that regional vascularity, by increasing the rate of uptake and removal of the anesthetic from the infiltrated site, will significantly reduce the duration of action of increased doses of infiltrative anesthesia. specifically, the investigators will compare the duration of a commonly used local anesthetic (lidocaine ± epinephrine) injected at two different volumes at the nasal ala. the investigators will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthesia. the investigators aim to demonstrate that there will be no clinically significant difference in the duration of action of varying volumes of the same local anesthetic injected at bilateral areas of the face. this study record uses the same protocol document of a previous study under clinical trials record nct05767749, but documents a fourth arm for which data will be analyzed separately from data in nct05767749

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * normal skin sensation at both nasal ala assessed by pinprick * ability to provide informed consent exclusion criteria: * previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated * pregnant or breastfeeding volunteers (assessed by self-report) * patients taking monoamineoxidase inhibitors (maoi) or antidepressants of the triptyline or imipramine types