Kornimate/medical-research-clean huggingface dataset:
pilot study to evaluate the safety and efficacy of treatment with ora102 combined with avastin (bevacizumab) versus avastin alone, in patients with neovascular age related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: this is s randomized, multi-center, double blind, 3 arm, phase i/ii pilot study to evaluate the safety and efficacy of treatment with ora102 combined with avastin (bevacizumab) versus avastin alone, in patients with neo-vascular age related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * subjects who have provided informed consent, including signing of the informed consent form * subject who are able and willing to comply with the study protocol * subject must have best corrected visual acuity etdrs between 20/40 to 20/320 in the study eye * subjects whose cnv lesion in the study eye contains more than 25% scarring and/or atrophy * women must be post-menopausal 1 year or surgically sterilized. if not, negative serum pregnancy test required within 14 days of randomization exclusion criteria: * pregnant or lactating women * patients with severe myocardial disease or coronary occlusion * patients with severe personality disorder, suicidal risk or psychosis * patients with previous history of cva * evidence for liver dysfunction - bilirubin level more than twice than upper limit of the normal value or alt/ast\>1.5x upper limit of normal value * evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of the investigational drugs or puts the patients in high risk for treatment related complications

Keywords: amd avastin ora102 macular degeneration neo-vascular age related macular degeneration (amd)
screening for kyphosis in the mean term in patients treated with kyphoplasty alone in the management of stable traumatic compression fractures of the thoracolumbar spine

Conditions: Thoracolumbar Spine

Summary: the aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures. patients will be selected from medical records archived at the neuroradiology department of dijon chu. an information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination. the radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.


Eligibility criteria:
inclusion criteria: * men or women aged at least 18; * who underwent kyphoplasty between t11 and l5, * patients who had kyphoplasty at a single level without associated surgery, * magerl type-a fracture. * non-tumoral and non-osteoporotic cause. exclusion criteria: * compression fracture outside the t11-l5 segment, or fracture other than magerl type a. * osteoporotic vertebral fracture * association with other post-traumatic fractures. * history of balloon kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy. * pregnant or breast-feeding women * patients not covered by national health insurance

Keywords: kyphoplasty at a single level (between t11 and l5) associated surgery
effects of combined robot-assisted therapy with mirror priming in stroke patients

Conditions: Chronic Stroke

Summary: the purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.

based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training. this study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.

Eligibility criteria:
inclusion criteria: 1. brain injury more than 3 months. 2. modified ashworth scale proximal part ≤ 3, modified ashworth scale distal part ≤ 2, and no serious muscle spasms. 3. the myoelectric signal can be detected to activate the instrument 4. unilateral paresis (fma score\<60) 5. no serious cognitive impairment (i.e., mini mental state exam score \> 24) 6. can provide informed consent exclusion criteria: 1. other neurological disease 2. complete sense of body defect 3. inability to understand instructions 4. current participation in any other research 5. botulinum toxin injection within 3 months

Keywords: stroke mirror therapy robotic training neurorehabilitation
image-enhanced endoscopy in the gastrointestinal tract

Conditions: Gastro-Intestinal Disorder; Inflammatory Bowel Diseases; Gastro Esophageal Reflux; Atrophic Gastritis; Neuroendocrine Tumors

Summary: this study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract. this study aims to determine: (i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions (ii) if image-enhancement techniques could potentially replace investigations currently used in daily practice (e.g. biopsy) with a view to reduce costs and shorten the interval to initiate treatment

endoscopic procedures are performed on a daily basis to visualise the gastrointestinal tract for diagnosis and intervention. the demand for procedures is growing, consequently increasing the number of additional investigations; for example, biopsies. image enhancement techniques can be performed during procedures either digitally or through the use of dye. these techniques alter the qualities of the image e.g. colour, contrast and magnification. we believe these techniques have several potential benefits: (i) improve diagnostic accuracy (ii) filter appropriate selection of additional investigations to maximise diagnostic yield (iii) the potential to replace existing investigations which are costly and intricate. participants included in the study will have an endoscopic procedure as indicated for routine clinical care. on the day of the procedure (or before), a baseline assessment will be performed - symptom questionnaires, medical history and recording any relevant investigation results performed as part of routine care. participants will have the endoscopic procedure as normal, with additional images and video obtained using different image enhancement techniques. select patients will have follow-up for up to one year to determine relapse. the image enhancement technique findings will be compared to the gold standard investigation currently available as part of routine care for the condition of interest. the study will look at a range of different image enhancement techniques: dye chromoendoscopy, blue laser imaging (bli), linked colour imaging (lci), narrow band imaging (nbi), image magnification and endocytoscopy. this will involve a range of gastrointestinal conditions. ethics approval: favourable opinion was provided by the east midlands - derby research and ethics committee, reference: 19/em/0167.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * patient has mental capacity to consent * requires endoscopic procedure as part of routine care exclusion criteria: * not meeting inclusion criteria

Keywords: endoscopy
reciprocation vs rotational single-file systems in postoperative pain

Conditions: Apical Periodontitis; Assessment, Pain; Dental Pulp Necrosis

Summary: in this study, the researchers will investigate the effect of single-file reciprocating versus single-file rotational file systems on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. the participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (reciproc blue) and rotational single-file system (oneshape). as a reference, mtwo multi-file (full-sequence) will be used.

the infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational single-file system. (reciproc blue reciprocating single-file system vs oneshape rotational single-file system). the root canals will be completed in single-visit. the patients will record their postoperative pain during the follow-up period using a vas scale.

Eligibility criteria:
inclusion criteria: * participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis. exclusion criteria: * pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.
1540nm non ablative fractional laser treatment of scars

Conditions: Scars

Summary: scars are a frequent reason of consultation in a dermatological clinic. their cosmetic aspect can play a key role in patient satisfaction and self-image. non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound healing response. there are different reports on the positive effect of these type of laser treatment in the treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars. the low morbidity of the treatment and the lack of satisfying treatment regimes for different types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with the 1540nm non ablative fractional laser in the treatment of scars. objectives: * to evaluate the efficacy of 4 laser treatments with starlux 300 lux 1540nm fractional laser handpiece ( palomar medical technologies ) 1 and 3 month after the last laser treatment for 3 different "scar" patient groups : 1. patients with hypopigmented scars 2. patients with hypertrophic scars 3. patients with scars due to grafts and reconstructions in the head and neck region. * to evaluate the treatment related pain. on a categorical scale from 0-10 * to evaluate the adverse effect of 1540nm fractional laser versus untreated control in the 3 patient groups. the study design is a prospective single blinded randomised within-patient controlled study the study involves 6 visits.


Eligibility criteria:
the patients needs to have a scar fulfilling the inclusion and exclusion criteria of one of the 3 patient groups: patient group 1: patients with hypopigmented scars : inclusion criteria: * patients with a hypopigmented scar allowing 2 side by side test areas of similar sizes and appearance within the same anatomical region. * skin type 1-4 * age at least 18 years old * willingness and ability to give written informed consent and to comply with the requirements of the protocol exclusion criteria: * pregnancy and lactation * oral retinoid drugs within the past 6 months patientgroup 2: patients with hypertrophic scars : inclusion criteria: * patients with a hypertrophic scar allowing 2 side by site test areas of similar sizes and appearance within the same anatomical region. * skin type 1-4 * male / female * age at least 18 years old * willingness and ability to give written informed consent and to comply with the requirements of the protocol exclusion criteria: * pregnancy and lactation * oral retinoid drugs within the past 6 months patient group 3: patients with scars due to grafts and reconstructions in the head and neck region. inclusion criteria: * patients with a graft or reconstruction with 2 site by site test areas of similar sizes and appearance within the same anatomical region (head and neck region). * skin type 1-4 * age at least 18 years old * willingness and ability to give written informed consent and to comply with the requirements of the protocol exclusion criteria: * pregnancy and lactation * oral retinoid drugs within the past 6 months
rituximab and ocrelizumab in serum with multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: ros-ms is a clinical pharmacological substudy to the overlord-ms study (nct04578639), designed to examine the possibilities of personalized treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.

overlord-ms is a 30 months prospective randomized double blinded multicenter non-inferiority study. the objective of overlord-ms is to demonstrate if rituximab is non-inferior to ocrelizumab with regards to efficacy and safety in treatment naïve patients with relapsing-remitting multiple sclerosis (rrms), diagnosed within the last 12 months. in the patients enrolled in the clinical pharmacological substudy ros-ms the serum concentrations of rituximab and ocrelizumab will be quantified using liquid chromatography tandem mass spectrometry (lc ms/ms) at predefined points during the dosing interval. relevant biochemical parameters will also be analyzed in these samples. based on these measurements, the investigators will examine correlations between serum concentrations, biochemical parameters and the clinical outcomes in the overlord-ms study. the objective is to evaluate whether clinical pharmacological tools, such as therapeutic drug monitoring (tdm) and pharmacokinetic pharmacodynamic models (pk-pd models), may be of value in the personalization of treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.

Eligibility criteria:
inclusion criteria: * included in overlord-ms (nct04578639) * willing to attend laboratory for blood sample collection at scheduled time points exclusion criteria: \* not willing to attend laboratory for blood sample collection at scheduled time points
inpatient attending physician rotation duration study

Conditions: Inpatient Attending Physician Staffing Model

Summary: the investigators are testing the effects of a change in teaching attending physicians' rotations (from 4- to 2-week blocks) on patient outcomes (unplanned urgent visits to the health care system, inpatient mortality, and length-of-stay), the educational experiences of residents and medical students and on the quality of the professional lives of the attending physicians.

design, setting, and participants cluster randomized crossover noninferiority trial, with attending physicians as the unit of crossover randomization and 4-week rotations as the active control, conducted in a us university-affiliated teaching hospital in academic year 2009. participants were 62 attending physicians who staffed at least 6 weeks of inpatient service, the 8892 unique patients whom they discharged, and the 147 house staff and 229 medical students who evaluated their performance. intervention assignment to random sequences of 2- and 4-week rotations. main outcome measures primary outcome was 30-day unplanned revisits (visits to the hospital's emergency department or urgent ambulatory clinic, unplanned readmissions, and direct transfers from neighboring hospitals) for patients discharged from 2- vs 4-week within-attending-physician rotations. noninferiority margin was a 2% increase (odds ratio \[or\] of 1.13) in 30-day unplanned patient revisits. secondary outcomes were length of stay; trainee evaluations of attending physicians; and attending physician reports of burnout, stress, and workplace control.

Eligibility criteria:
inclusion criteria: * attending physician on inpatient general medicine wards of stroger hospital, chicago, il exclusion criteria: * scheduled for less than 6 weeks during the 2009 academic year

Keywords: inpatient hospitalists residency job satisfaction burnout, professional professional practice medical education
dna methylation biomarkers to predict survival after surgery for lung adenocarcinoma

Conditions: Lung Adenocarcinoma; Surgery; Prognostic Cancer Model

Summary: this study is designed to assess dna 5-methylcytosine (5mc) methylation modifications in lung adenocarcinoma (luad) samples and develop a prognosis-predictive model for luad based on cancer tissue dna 5mc levels. the research will link post-surgical recurrence and survival outcomes to the dna 5mc profiles of patients. by collaborating with two hospitals in china, this multicentral study will utilize over three years of prognostic data from luad patients to validate the model's accuracy. additionally, the research aims to explore the potential of the model in guiding adjuvant treatment strategies by comparing the differences in outcomes between high-risk patients who receive further treatment and those who do not. this study aspires to enhance future treatment planning for luad patients, providing personalized and effective therapeutic options based on precise prognostic predictions.

* model development * the methylation data will be analyzed to identify specific 5mc methylation patterns associated with post-surgical recurrence and survival outcomes. * a prognostic model will be developed based on these methylation profiles to predict luad prognosis. * model validation * clinical data from luad patients at two hospitals in china, including over three years of follow-up information, will be used to validate the accuracy and reliability of the prognostic model. * statistical methods will be applied to assess the model's predictive power and its ability to accurately stratify patients into different risk categories. * exploration of follow-up and adjuvant therapy guidance * the study will compare outcomes between high-risk patients who receive additional adjuvant treatment and those who do not, based on the risk categories identified by the prognostic model. * this comparison aims to explore the model's potential in guiding adjuvant therapy decisions, ultimately enhancing personalized treatment strategies and improving survival rates for luad patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed early-stage lung adenocarcinoma, or clinically diagnosed early-stage lung adenocarcinoma. * underwent surgical treatment * cancer tissues well paraffin-embedded or cryopreserved exclusion criteria: * diagnosed with other serious illnesses * received other treatments before surgery * surgery to remove multiple cancerous tissues

Keywords: dna methylation prognosis luad
efficacy of tak-438 compared to ag-1749 (lansoprazole) in the treatment of gastric ulcer

Conditions: Gastric Ulcer

Summary: the purpose of this study is to investigate the efficacy of tak-438, once daily (qd), compared to lansoprazole in patients with gastric ulcer.


Eligibility criteria:
inclusion criteria: 1. participants must have endoscopically confirmed gastric ulcers (mucosal defect with white coating) at least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (visit 1) 2. outpatient (including short inpatient for examination and others) exclusion criteria: 1. participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (visit 1) 2. participants with an acute gastric mucosal lesion (agml) on endoscopy at baseline (visit 1) 3. participants with a linear ulcer (including scarring) on endoscopy at baseline (visit 1) 4. participants with a postoperative ulcer (e.g., ulcer after emr/esd) on endoscopy at baseline (visit 1) 5. participants with a duodenal ulcer on endoscopy at baseline (visit 1) 6. participants with an ulcer for which medical treatment is not indicated (e.g., perforation, pyloric stenosis, duodenal stenosis, large hemorrhage) 7. participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (visit 1) 8. participants with a previous or current history of zollinger-ellison syndrome, or other gastric acid hypersecretion disorders 9. participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)

Keywords: drug therapy
bladder distension for pain relief in patients with excessive anteflexion of uterus undergoing office hysteroscopy

Conditions: Hysteroscopy

Summary: this study is conducted to assess whether the passive uterine straightening of the uterus by means of bladder filling is associated with less pain experienced by patients with excessive anteflexion of the uterus during office hysteroscopy.


Eligibility criteria:
inclusion criteria: * patients with excessive anteflexion of the uterus exclusion criteria: * cervical pathology * previous cervical surgery * severe vaginal bleeding

Keywords: full bladder pain excessive anteflexion of the uterus
brain mechanisms of pharmacotherapy in opioid use disorder

Conditions: Opioid Dependence

Summary: this study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, oud), through investigation of the neural circuits underlying key cognition functions. the study will use previously validated cognitive probes, functional magnetic resonance imaging (fmri), and novel extended-release injectable preparations of opioid partial agonist buprenorphine and antagonist naltrexone, in oud patients to explain the individual heterogeneity of oud treatment response.

this proposal seeks to identify the neural circuits underlying the cognitive effects of medication assisted therapy (mat) for oud. the study will examine the neurocognitive effects of mat by comparing two preparations with different pharmacodynamic properties (extended release buprenorphine and naltrexone, xrbup, xrntx) in three key domains (incentive salience, executive functioning, and emotion processing) using task functional magnetic resonance imaging (mri). in the 1st phase of the study, forty treatment-seeking oud patients will be randomized to xrntx or xrbup groups after detoxification. participants will undergo medication induction followed by monthly injections and urine toxicology monitoring for 120 days. neuroimaging will follow completion of detoxification (pre-treatment) and 15 days after the second injection (on-treatment). the second study phase will extend the paradigm to an independent sample of 160 additional participants and test the explanatory value of mat-induced changes in the neuroimaging signal in the classification of oud treatment outcomes.

Eligibility criteria:
inclusion criteria: 1. males and females 2. 18-65 years old 3. oud by dsm5 criteria, confirmed by history and physical examination including urine toxicology, medical records and self-report 4. opioids are the drug of choice 5. interested in injectable extended release agonist or antagonist treatment 6. have a stable address, working command of english language, and telephone access. 7. women of childbearing age must use an effective contraceptive exclusion criteria: 1. psychiatric co-morbidities: 1. lifetime diagnoses of any psychotic disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder type 1. 2. psychiatric co-morbidities: psychiatric disorders requiring current medication treatment, e.g. moderate to severe depression. mild to moderate depressive and anxiety disorders and attention deficit hyperactivity disorder that do not require prescription stimulants and dsm5 cluster b and c personality disorders are also allowed. 3. polysubstance users whose drug of choice is not opioids. 2. contraindications for xrntx or xrbup e.g. active liver disease. 3. medical and surgical conditions such as malignancy that may affect patients' ability to receive xrntx or xrbup treatment because it may interfere with opioid analgesia 4. contraindications for mri, e.g. claustrophobia, indwelling foreign magnetic agents.

Keywords: naltrexone buprenorphine neuroimaging