Kornimate/medical-research-clean huggingface dataset:
cognitive remediation on patients with bipolar disorder and memory complaints

Conditions: Patient With Bipolar Disorder; Euthymic Status; Wirh Memory Complaints

Summary: bipolar disorder is a major health concern. intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. the implementation of cognitive remediation programs could be interesting. the aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "cogmed", targeting the working memory. the impact of this program on compliance, quality of life, and memory complaints will be evaluated. the investigator will measure whether there is a correlation between working memory and overall performances. finally, the investigator will try to achieve a profile of bipolar patients in whom the cogmed program is particularly effective on a plan of overall performance.

patients with bipolar disorder and memory complaints will be recruited. two visits : 1. at baseline (v0) : the investigator evaluate bipolar disorder, treatment, mood, quality of life, global functioning, and memory complaints. patients also have a neuropsychological assessment. the cogmed program is proposed to patients with memory complaints and explain by the investigator 2. 4-6 weeks after the end of the program (11-13 weeks after v1) : the same evaluation is realized to compare score before and after the program of cognitive remediation. between the two visits the patient will benefit of cogmed program, at home, during 5 weeks. cogmed is a remediation cognitive program, based on working memory, consisting on daily exercises at home on a computer.

Eligibility criteria:
inclusion criteria: * being diagnosed bipolar according to the diagnostic and statistical manual of mental disorders - iv (dsm-iv) criteria * memory complaints or overall performance alterations according to the memory scale (mem iii wechsler memory scale - third edition) * being euthymic at the inclusion according to montgomery-asberg depression rating scale (madrs \< 12) and young mania rating scale (ymrs \< 6) * not being treated with electroconvulsive therapy for the last year * not having drug-dependance or drug-abuse for the last six months * having a computer with internet and a cellphone at home * having signed informed consent * able to understand nature, aims and methodology of the study exclusion criteria: * patient on protective measures (guardianship or trusteeship) * deprived of liberty subject (judicial or administrative decision)

Keywords: psychiatry bipolar disorder memory complaints global functioning cognitive remediation working memory
to better understand the most important factors for patients when they decide on the type of treatment they receive for muscle invasive bladder cancer (mibc).

Conditions: Muscle Invasive Bladder Cancer; Surgery; Sexual Wellbeing; Patient Satisfaction; Patient Preference

Summary: through our study, we aim to understand the most important factors for patients when they decide on the type of treatment they receive for mibc. our study consists of a discrete choice experiment (dce): a type of questionnaire used to elicit preferences in the absence of data. dces are frequently used in oncological research to elicit preferences from participants without directly asking them to state their preferred options. participants undertaking our dce questionnaire will presented with a series of alternative hypothetical scenarios containing several variables or "attributes" (5), each of which may have a number of variations or "levels".

the study will be conducted using validated and established protocols for undertaking dces. a literature review was undertaken to assess what the most important considerations where for patients when making decisions about the treatment they receive for mibc. using this literature search as a starting point, discussion groups with relevant healthcare professionals and service users were undertaken to decide on the final attribute and levels for the questions. five attributes were selected through an iterative process - body image, life expectancy, side-effects from treatment, living as bladder cancer survivor, and sexual wellbeing the study is divided into three stages: 1. interviews with experienced healthcare professionals and service users to finalise attributes and levels to be used for the questionnaire 2. a representative sample of patients (\~10) will be asked to complete the questionnaire in addition to a brief unstructured interview to assess understanding (e.g. readability and ease of completing the questionnaire) 3. necessary changes based on feedback from the pilot study will be applied before the main study is carried out

Eligibility criteria:
inclusion criteria: * diagnosed with mibc cancer and currently undergoing treatment or have previously completed treatment for mibc exclusion criteria: * any of other type of bladder cancer (unknown, metastatic, or non muscle invasive bladder cancer)

Keywords: muscle invasive bladder cancer patient preference
effect of video monitor size on adenoma detection rate

Conditions: Colon Adenoma

Summary: the goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.

gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the mgh ambulatory endoscopy center at charles river plaza. the two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (nds 26") used at this facility while the other room will have a larger video monitor (nds 32"). the adr achieved by each physician in each room will be compared.

Eligibility criteria:
inclusion criteria: * physician endoscopist performing colonoscopy at massachusetts general hospital gi endoscopy unit * patients receiving these procedures at massachusetts general hospital gi endoscopy unit exclusion criteria: * refusal to participate
hypoxic preconditioning on patients

Conditions: Hypoxic Preconditioning; Carotid Artery Stenosis; Ischemic Cerebrovascular Disease

Summary: the purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.


Eligibility criteria:
inclusion criteria: 1. informed written consent from the patient. 2. han nationality, age \>18 years. 3. carotid artery stenosis on at least one side, measuring more than 70% by ultrasonic detection and requiring carotid artery stenting or a carotid endarterectomy. 4. long-term residence at an altitude of \<100 m (the altitude of tianjin is 2-5 m). 5. not having been to an altitude ≥1500 m in two years. exclusion criteria: 1. planned vessel sacrifice as the primary modality for ischemic cerebrovascular treatment. 2. systemic blood disease before intervention. 3. regular physical activity exercise: frequency \>1 time/week, duration \>20 min. 4. history of brain disease or history of stroke or transient ischemic attack within the previous six months. 5. history of heart, liver, kidney or lung disease. 6. history of hypertension and poor blood pressure control, with blood pressure \>160/90 mmhg. 7. pregnancy.

Keywords: hypoxic preconditioning carotid artery stenosis ischemic cerebrovascular disease
improvement of rarp outcomes via 3d printed/virtual prostate models

Conditions: Prostate Cancer

Summary: study the effect 3d printed or 3d virtual prostate models of a patient, when manipulated by surgeons during rarp, has on positive surgical margins and functional outcomes of patients. our main hypothesis is that there is a reduction of positive resection margins and functional outcomes of patients undergoing rarp when surgeons are presented with 3d printed or 3d virtual patient-specific prostate models during surgery. specifically, we hypothesize that the anatomical knowledge of surgeons that results from the manipulation of 3d printed/virtual models constructed from automated segmentations reduces positive resection margins and functional outcomes.

this is a parallel group research feasibility study consisting of two intervention arms (3d printed and 3d virtual models) and a control group (standard practice). intervention groups are prospective; control group is retrospective. prospective patients, complying with the inclusion criteria, will randomly be allocated to only one intervention group. primary outcomes study the effect of two-intervention arms (3d printed and virtual prostate models) have on the improvement of positive resection margins after rarp, validate the accuracy of automated methods when identifying masks of the prostate gland and, cancer lesions urethra, neurovascular bundles, and external sphincter, and validate the effectiveness of an automated deployment pipeline with the goal of setting groundwork in preparation for a randomise control trial in a subsequent study. secondary outcomes study the effect of two-intervention arms have on functional outcomes, surgeons' and patients' perspectives on using 3d prostate models. a total of 162 cases will be considered in this feasibility study stratified into 3 cohorts: * control group. the control group will consist of 54 retrospective case-matched dataset whereby mp-mri, positive resection margins, and functional outcomes will be collected and used as a baseline. automated segmentation of prostate gland and lesions will be done on mp-mri. * intervention arm 1 - 3d printed models. this cohort will consist of 54 prospective cases whereby patient-specific 3d printed models will be available to the surgeon during rarp for manipulation. * intervention arm 2 - 3d virtual models. this cohort will consist of 54 prospective cases whereby 3d virtual models will be available to the surgeon during rarp for manipulation using innersight labs platform.

Eligibility criteria:
inclusion criteria: * eligible for rarp after assessment of mp-mri during multi-disciplinary team meetings at guy's hospital * t2b-t3 prostate cancer patients * gleason's score\>=3+4 . exclusion criteria: * prior treatment for prostate cancer * patients with pre-existing urinary incontinence problems * patients where mp-mri scans are not possible * patients participating in other studies investigating functional outcomes after surgery will be excluded. this is to avoid other studies influencing our secondary endpoints.
special investigation of humira® (adalimumab) on long-term treatment in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of humira® (adalimumab; 40mg/0.8 ml) in japanese participants who received the drug for the treatment of rheumatoid arthritis.

rheumatoid arthritis is a chronic autoimmune disease which requires long-term treatment. due to the need of long-term safety data in japanese participants and to fulfil the conditions of approval of adalimumab by the japanese regulatory authority, this post-marketing observational study (pmos) was conducted. the study investigated the long-term safety of adalimumab, particularly associated with the development of infections and malignant tumors. data was collected once every 6 months up to 3 years.

Eligibility criteria:
inclusion criteria: 1. participants who received adalimumab in accordance with its indications for treatment and dosage regimens. 2. participants who used adalimumab continuously. 3. participants without current or past history of malignant tumors. 4. participants evaluated for disease activity score 28 - 4 erythrocyte sedimentation rate (das28-4esr). 5. participants evaluated by health assessment questionnaire (haq) or modified health assessment questionnaire (mhaq) prior to the initiation of adalimumab treatment in the all-case pmos. exclusion criteria: 1. contraindications according to the package insert. 2. participants with serious infections. 3. participants with tuberculosis. 4. participants with a history of hypersensitivity to any ingredient of adalimumab. 5. participants with demyelinating disease or a history of demyelinating disease. 6. participants with congestive cardiac failure.

Keywords: rheumatoid arthritis
a study of the effect of roactemra/actemra (tocilizumab) in combination with methotrexate on articular damage in the hand in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological dmards

Conditions: Rheumatoid Arthritis

Summary: this open-label, single arm study will evaluate the effect of roactemra/actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (dmards). patients will receive roactemra/actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * diagnosis of rheumatoid arthritis according to acr/eular classification (2010) of \>/= 6 months duration * active moderate to severe rheumatoid arthritis (das \>/= 3.2) * swollen joint count (sjc) \>/= 6, tender joint count \>/= 8 * synovitis in the dominant hand * inadequate response to stable dose of a non-biological dmard for at least 3 months * oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug * patient on outpatient treatment exclusion criteria: * major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization * rheumatic autoimmune disease other than rheumatoid arthritis * american college of rheumatology (acr) functional class iv * history of or current inflammatory joint disease other than rheumatoid arthritis * previous inadequate response to a biologic dmard; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment * intra-articular or parenteral corticosteroids within 6 weeks prior to study start * inadequate hematologic, renal or liver function * positive for hepatitis b, hepatitis c or hiv infection * pregnant or lactating women * history of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies * current infections or history of recurrent infections * history of or currently active primary or acquired immunodeficiency * active tuberculosis requiring treatment in the previous 3 years * body weight \> 150 kg
evaluation of blood flow regulation with laser speckle flowgraphy

Conditions: Low Tension Glaucoma

Summary: the study includes caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (lsfg). also, the intraocular pressure (iop), systolic and diastolic blood pressure, heart rate (hr), mean arterial pressure (map) as well as ocular perfusion pressure (opp) will be evaluated. after baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. measurements will be repeated after 15, 30 and 45 minutes.


Eligibility criteria:
inclusion criteria: * presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (rnfl) thinning (evaluated by oct as defined by the on-board software) * iop ≤ 21mmhg without therapy * normal open angle in a gonioscopic examination * age \> 40 years exclusion criteria: * iop \> 21 mmhg in patients' history * ametropia \> 6 diopters * cataract with severity greater than grade 2 of the lens opacities classification system (locs) classification * presence of corneal opacities * uncontrolled hypertension with systolic blood pressure (sbp) \> 165mmhg and/or diastolic blood pressure (dbp) \> 100mmhg
new tool of subjective and objective functional evaluation and the quality of life after arthroplastic surgery of the hip and the knee assisted or not by computer and mini-invasive arthroplasty

Conditions: Hip Arthritis; Knee Arthritis

Summary: hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. the main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.


Eligibility criteria:
inclusion criteria: * weight \< 100 kg * score ucla \> 4 * prosthesis of first intention exclusion criteria: * pregnant * score ucla \< 4 * osteotomy near to prosthesis * prosthesis requiring an osseous transplant * prosthesis already set up * infections, contagious diseases (hiv, tuberculosis, hepatitis, venereal diseases) or metastasis * neuromuscular diseases able to perturb walking or staying * congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon
effect of oral zinc sulfate supplementation on enzymes of urate pathway

Conditions: Infertility Unexplained

Summary: although many reports have investigated the relationship between subfertility and uric acid levels in semen, to the best of author knowledge, there is no study have been published to yet focus on the effects of asthenospermia treatments, such as given an oral zinc supplementation, on the activity of urate-related enzymes, which are important in fertility of human.

the present study was designed to investigate the effect of zinc supplementation on the qualitative and quantitative characteristics of semen, along with uric acid levels and urate-related enzymes in the seminal plasma and spermatozoa of asthenospermic males.

Eligibility criteria:
inclusion criteria: * the presence of asthenozoospermia in the semen sample. * must be unable to reproduce. exclusion criteria: * the absence of endocrinopathy, varicocele, and female factor infertility. smokers and alcoholic men were excluded from the study because of their recognized high seminal ros levels and decreased antioxidant levels.

Keywords: uric acid adenosine deaminase zinc sulfate 5'-nucleotidase asthenospermia. xanthine oxidase
pharmacokinetics of fdl169 in healthy female subjects

Conditions: Cystic Fibrosis

Summary: to determine the pharmacokinetics of single and multiple doses of fdl169 in healthy female subjects.

this is a two-part study. part 1: part 1 of the study is a single-dose, dose-escalation, study to assess the safety, tolerability and pk profiles following oral administrations of fdl169 to healthy female volunteers in the fed state. up to five doses will be assessed. part 2: part 2 of the study is a multiple-dose study to assess the safety, tolerability and pk profiles following oral administrations of fdl169 to healthy female volunteers in the fed state.

Eligibility criteria:
inclusion criteria: 1. healthy female subjects aged 18 to 55 years inclusive and of any ethnic origin with a body mass index (bmi) of \> 19 and \< 30 kg/m2. body mass index = body weight (kg) / \[height (m)\] 2. subjects must be willing to use an effective method of contraception from first dose of investigational medicinal product (imp) and for 3 months after the last dose of imp (unless they are of non-child bearing potential). exclusion criteria: 1. participation in a new chemical entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. 2. subjects who have any renal or clinically significant cardiac, renal or hepatic disease at screening. 3. subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (with the exception of gilbert's syndrome or asymptomatic gallstones), endocrine or immunologic disease at screening. 4. have an abnormal twelve-lead ecg or an ecg with abnormality considered to be clinically significant in the opinion of the investigator or an ecg with a single qtcb \> 450 msec. 5. subjects with a positive urinary drugs of abuse screen or positive alcohol screen at screening or day -1. 6. history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \> 21 units. 7. subject with history of hiv or positive human immunodeficiency virus, hepatitis b or hepatitis c results. 8. donation of 500 ml or more of blood within the previous 3 months. 9. use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and fdl medical monitor the medication will not interfere with the study procedures or compromise subject safety. 10. smoking or use of tobacco products or substitutes equivalent to \> 15 cigarettes/day. 11. any subject who is pregnant or nursing.
intervention for low-performing first graders in mathematics

Conditions: Mathematics Disorder

Summary: the aim of this study is to investigate the effect of an intervention program for low-performing first graders in mathematics. .

there were sent a request to a school in the central of east-norway to participate. the principal answered yes, and then asked the teachers at first grade if they would like to participate. the teachers were positive to the study, and therefore the students and parents were asked to participate. it was total 74 students and 54 of them accepted to participate in the study. the inclusion criteria of the study is that the participants talks and understand norwegian approximate fluently. in this study that means one participant was excluded. the study will use a design of randomized control trial (rct) where the population of 53 students will be doing av screening-test. after the screening 20% of the lowest-performance will make up the sample and they will be departed in a clinical-group and a control-group. these students will then be tested with test of basic arithmetic and numeracy, the norwegian test called arithmetic fact-test, the vocabulary and calculation tasks from wechsler intelligence scale for children - fifth edition and ravens colored progressive matrices. the randomization will be conduct using randomize.org and the parents will get information about which group their child will participate in. the intervention are eight week long with 4 lessons per week. each lesson are about 45-50 minutes long. the start of the intervention will be in week 42, 2022 and end in week 49, 2022. the intervention-group will follow an intervention conducting elements from an education program called "thinkmath" and self-developed tasks. the control-group will follow ordinary classroom-lessons. after ended intervention-period the students will be tested with the same test-battery as were used in front of the start point.

Eligibility criteria:
inclusion criteria: performing under the cut off score of a screening tool for first graders, i.e. 20th percentile - exclusion criteria: * not proficient norwegian language skills