Kornimate/medical-research-clean huggingface dataset:
unraveling active ingredients of neurorehabilitation: investigating cortical activity during task-oriented exercises

Conditions: Multiple Sclerosis; Healthy Volunteer

Summary: the driving idea of this project is to use new imaging techniques during 0functional movements to study relearning during a typical rehabilitation session. the novelty of this project is to move from studies inquiring changes in brain activity patterns before and after rehabilitation toward a paradigm in which cortical activity is studied during the execution of the exercise. this would allow better understanding of cortical mechanisms underpinning functional improvements. the project builds on preceding studies, partially funded by fism, from the three research units involved in this project, aimed at assessing the impact of rehabilitation on mobility and balance and at assessing the effects of neurorehabilitation on brain plasticity. in this study, we will include 40 healthy subjects and a sample of 20 consecutive people with multiple sclerosis (pwms), and we will investigate brain cortical activity during a typical session of task-oriented exercises. in specific, participants will undergo a treadmill training in which they will be required to keep their trunk and head stable in space using a biofeedback device. to study the effects of the session in improving dynamic stability, head/trunk movements will be registered by inertial measurement units, while cortical activity will be concurrently assessed by functional near-infrared spectroscopy (fnirs). the first phase of the project will include healthy subjects and will be useful to understand the main cortical areas involved in the proposed motor tasks, in order to design the appropriate montage and protocol for fnirs acquisition in pwms. finally, the analysis of the possible differences in cortical activation during different experimental conditions (e.g., biofeedback rehabilitation) in healthy subjects and pwms will serve to develop a model for neurological rehabilitation.


Eligibility criteria:
inclusion criteria: * subjects between 18 and 60 years of age, * diagnosis of ms (mcdonald criteria, thompson et al, 2018), stable disease course without worsening more than 1 edss point over the last 3 months, edss between 3 and 4.5 points, * healthy right-handed volunteers, * able to release a written informed consent. exclusion criteria: * unable to comprehend the aims of the study and to follow test instructions; * diagnosis of major depression (dsm-5); * severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment); * cardiovascular diseases; * severe visual impairments interfering with the execution of the protocol; * epilepsy; * intake of neuroleptic and antiepileptic drugs.

Keywords: rehabilitation multiple sclerosis motor control cortical plasticity
the short physical performance battery in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: patients with copd often have limitations to physical performance. there are several tests for evaluating physical performance, unfortunately many of them can be time consuming and require specialized equipment an substantial space. short physical performance battery is a simple test that requires little resources and can be performed both at institutions and in the homes of patients. sppb has high predictive abilities in identifying older adults at greater risk for mortality, nursing home admission, hospitalization, and incidence of disability. the investigators would like to evaluate possible changes in the sppb score after a 4-week rehabilitation program. the investigators would also like to look at possible relationships between the sppb and other physical performance measures, dyspnea, anxiety, depression, fatigue, and health related quality of life.


Eligibility criteria:
inclusion criteria: * patients with all stages of copd * decision making capacity to provide informed written consent * ability to understand and complete the questionnaires exclusion criteria: * exacerbation within the last four weeks * co-morbidities that limits the patient's physical performance more than copd * any patient whom is deemed unsafe to exercise * patients tested on treadmill protocol 4 (i.e. glittre testing protocol)
the relationship between psychosocial factors affecting pain perception and physical activity level in pregnant women with lumbopelvic pain

Conditions: Investigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic Pain

Summary: lumbopelvic pain (lpp) is a common condition encountered during pregnancy. during pregnancy, 50% of women experience lpp. this study was planned to show the relationship between psychosocial factors affecting the perception of pain such as pregnancy-related psychosocial factors, pregnancy-related distress, catastrophization and pain self-efficacy and physical activity level in pregnant women with lumbopelvic pain. this study was conducted using the questionnaires.

in pregnant women with lumbopelvic pain, physical activity during pregnancy has many positive effects on both maternal and infant health. therefore, it is necessary to know the factors affecting physical activity during pregnancy and make arrangements regarding these factors. this study was planned to reveal the relationship between pregnancy-related psychosocial factors, pregnancy-related distress, catastrophizing, and pain self-efficacy, which affect pain perception, and physical activity level in pregnant women with lumbopelvic pain. the study was conducted with 60 pregnant women who met the inclusion criteria. this study was conducted using the questionnaires prepared in the electronic environment and sent to the participants. this study aims to investigate the relationship between the psychosocial factors affecting pain perception and physical activity levels in pregnant women with lpp.

Eligibility criteria:
inclusion criteria: * women between the ages of 18-45, who had pain in the lumbopelvic region for more than a week, who had pain between 1-10 according to the vas, who could read and understand turkish, who were in the second or third trimester of pregnancy, and who did not exercise regularly before pregnancy were included in this cross-sectional and descriptive study. exclusion criteria: * having pregnancy complications (preeclampsia, pregnancy-related hypertension, diabetes, etc.), having gynecological or urological problems leading to pain during pregnancy, and having a history of acute or chronic disease, surgical intervention and trauma in the musculoskeletal or nervous system.

Keywords: lumbopelvic pain, psychosocial features, physical activity, pelvic pain, pregnancy
robotic surgical management of endometriosis: excision versus ablation

Conditions: Endometriosis

Summary: patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned to either ablation or excision of endometriosis. the investigators think that patients who have excision of endometriosis will have greater relief of pain.

patients with known endometriosis based on prior surgical pathology or suspected endometriosis based on symptomatology who plan on undergoing diagnostic laparoscopy will be offered enrollment in the study. they will complete preoperative pain assessments with the tools outlined above. at the time of diagnostic laparoscopy, patients found to have endometriosis will be staged according to the american society of reproductive medicine guidelines. patients with stage 4 or deeply infiltrating endometriosis will be excluded from the study. at that point, the patients will be randomized in the operating room to either laparoscopic excision of endometriosis or laparoscopic ablation with the argon beam coagulator. patients will be stratified according to the presence or absence of the levonorgestrel-intrauterine device. pain assessments will be performed immediately postoperatively in the recovery area. pain assessments will again be performed at 4 weeks, 6 months and 12 months. we will use the vas pain scale and validated questionnaires.

Eligibility criteria:
inclusion criteria: * endometriosis * chronic pelvic pain * stage 1-3 endometriosis * reproductive aged women exclusion criteria: * stage 4 endometriosis * deeply infiltrating endometriosis * patients who decline surgical management of endometriosis

Keywords: robotics laparoscopy endometriosis argon gynecology
global calm implementation study

Conditions: Depression

Summary: this study seeks to evaluate the implementation of the managing cancer and living meaningfully (calm) program in diverse cultural settings, including its feasibility, fidelity, and acceptability. it will also assess the cross-cultural generalizability of the calm intervention with a particular focus on patient-reported outcomes with regard to psychological well-being and quality of life.

calm is a semi-structured, manualized, individual psychotherapy designed for patients with advanced cancer and their loved ones. research conducted over the past decade has shown that calm is a feasible, acceptable, and effective therapy for patients with advanced or metastatic cancer. the calm training program was developed to train oncology clinicians in the delivery of calm. the training program consists of: 1) introductory workshops, which provide foundational training in the intervention; 2) advanced workshops, which support the development of advanced therapeutic skills; and 3) ongoing case supervision, delivered in small-group format, either in-person or online, which provides an opportunity for continuing improvement and refinement in the delivery of calm. to evaluate the implementation of the calm program at the clinician and organization levels, we will approach clinicians engaging in the calm training program and invite them to participate in this research study, which includes completion of quantitative measures at baseline, 1 year (primary endpoint) and 2 years (study endpoint), participation in qualitative interviews, and collection of feasibility data. implementation science frameworks will be applied to assess participants' perceived individual- and contextual-level barriers and facilitators to implementing calm through qualitative interviews. sites involved in the global calm program will conduct pilot studies of calm in their setting to evaluate calm at the patient- and caregiver-levels. we will not be involved in the collection of prospective patient- and caregiver-level data, however data will be pooled and analyzed to assess the cross-cultural generalizability of the calm intervention.

Eligibility criteria:
inclusion criteria: the research team will approach clinicians who: * have expressed interest in taking part in the global calm program; * able to deliver psychotherapeutic care according to the legislation/organizational policy that regulates their profession; * ≥18 years of age; * able to provide informed consent; * fluent in english (or other language(s) in which training and supervision will be offered); * fluent in the main language spoken in the country where their centre is located (to be able to deliver calm sessions); and * willing/able to engage with training in the calm therapy and attend in-person or online supervision meetings (based on feasibility). exclusion criteria: -

Keywords: psychosocial behavioural intervention implementation science
use of cyclobenzaprine after vaginal surgery

Conditions: Postoperative Pain

Summary: the management of post-operative pain in patients after vaginal surgery provides many unforeseen challenges. although vaginal surgery is considered a minimally invasive approach for the repair of pelvic floor prolapse and urinary incontinence, patients may still experience varying degrees of discomfort and post-operative pain. narcotics, however, can introduce a host of problems in addition to the potential addictive properties of the medication. a vicious cycle ensues as patients seek better pain control at the expense of worsening constipation, but without adequate control of pain after surgery, voiding dysfunctions are often exaggerated. cyclobenzaprine (flexeril®) in conjunction with nsaids has long been the basis for management of acute musculoskeletal injuries, but the practice of prescribing this centrally acting muscle relaxant for post-operative patients has also been successful in the management of pain. an online search of medical databases revealed that there are currently no published retrospective or prospective studies determining the efficacy of cyclobenzaprine in post surgical patients in conjunction with traditional pain management. the investigators hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic floor muscle attributable to surgery and thereby reduce the use of narcotics. consequently, the reduction of narcotics and the control of post-surgical pain may also hasten the return of normal urinary and defecatory function.


Eligibility criteria:
inclusion criteria: * ages 18-70 years old * undergoing vaginal surgery with apical or posterior repair requiring hospitalization * willingness to participate in the study * normal neurological exam * english speaking exclusion criteria: * contraindication to nsaids * allergy to hydrocodone, hydromorphone, or cyclobenzaprine * renal disease * use of any antidepressants including ssri, snri, maoi in the last 3 months * glaucoma * diabetes * hyperthyroidism * uncontrolled hypertension (\>160/100 mm hg) * history of chronic narcotic use in the last 3 months * history of pelvic pain
assessment of rheological parameters of human sputum.

Conditions: COPD; Asthma; Cystic Fibrosis

Summary: this is a proof of concept study. the aim of this study is to assess a device measuring rheological properties of human sputum of four populations : * 10 patients with broncho chronic obstructive pulmonary disease (copd) * 10 patients with asthma * 10 patients with cystic fibrosis * 10 healthy volunteers.

this study includes two visits to 48 hours apart. during the first visit : * patients with copd or cystic fibrosis will have a spontaneous expectoration * then all study participants will have an induced expectoration with hypertonic salin solution (4.5%). during the second visit : * patients with copd or cystic fibrosis will have a spontaneous expectoration * then, patients with copd, asthma and healthy volunteers will have an induced expectoration with hypertonic salin solution (4.5%). patients with cystic fibrosis will have a spontaneous expectoration 1 hour after an rhdnase nebulization. a control spirometry will be perform before each expectoration and during induced expectoration if necessary. all sputum sample collected will be homogenized and then divided into two equal volumes in order to perform two separate rheological measurements of 15 minutes.

Eligibility criteria:
inclusion criteria of healthy volunteers: * 18\>bmi\>29 * no smoker * no acute disease in the previous month exclusion criteria of healthy volunteers: * asthma, copd, cystic fibrosis * contraindications for spirometry * pregnant woman * legal exclusion criteria inclusion criteria of patients with cystic fibrosis: - cystic fibrosis with bronchial disorder. diagnosis confirmed by a reference center exclusion criteria of patients with cystic fibrosis: * forced expiratory volume in 1 second (fev1 ) ≤ 40%, contraindications for rhdnase, patient with chronic impairment of lung function (pao2\<60 mmhg at rest). patient who is unable to perform a spontaneous expectoration. * case of acute exacerbation during the last month * contraindications for spirometry * pregnant woman * legal exclusion criteria inclusion criteria of patients with copd: - copd with fev1/forced vital capacity (fvc) \<70% after administration of a beta-2 agonist exclusion criteria of patients with copd: * patient with chronic impairment of lung function and/or fev1≤ 40%. patient who is unable to perform a spontaneous expectoration. * case of acute exacerbation during the last month * contraindications for spirometry * pregnant woman * legal exclusion criteria inclusion criteria of patients with asthma: - diagnosis of asthma confirmed by a pulmonologist exclusion criteria of patients with copd: * patient with chronic impairment of lung function and/or fev1≤ 50%. * very unstable asthma * case of acute exacerbation during the last month * contraindications for spirometry * pregnant woman * legal exclusion criteria

Keywords: sputum rheology
new genes involved in molecular etiology of rett syndrome through dna microarray comparative genomic hybridization

Conditions: Rett Syndrome

Summary: rett syndrome (rtt) is a genetic encephalopathy and the typical form is caused by mutations in the gene mecp2. it is a genetically heterogeneous pathology. cdkl5 and foxg1 have been recently discovered being involved in other forms of rtt. however, at least 5% of typical forms and more other atypical forms are not linked to any of 3 genes known to be involved in the disease. the purpose of this study is to identify new genes involved in molecular etiology of typical and atypical forms of rtt.

search for pathogenic chromosomal imbalance through comparative genomic hybridization (acgh) on dna microarrays will be done in a group of patients having typical or atypical forms of rtt without known mutations in mecp2, cdkl5 et foxg1b genes. after imbalance confirmation by qpcr, the pathogenic potential of the segmental aneusomy will be assigned according to the interpretation of acgh technique-dedicated decepher, bach and gvd databases. analysis of parents will allow distinguishing between inherited polymorphic variants and potentially deleterious new imbalances. in case of a new imbalance, a bioinformatics approach will look for candidate genes that will be possibly confirmed by classic mutation screening (sequencing and pcr) in all typical and atypical cases of rtt present in the cohort. the identification of new genes involved in rtt will ameliorate the molecular diagnosis of the disease and genetic counseling for families. this project will allow progression in comprehension of physiopathological mechanisms of cerebral development abnormalities

Eligibility criteria:
inclusion criteria: * patients: rett syndrome * patients: female * parents: parent of a patients
in vivo dosimetry for brachytherapy study

Conditions: Prostate Cancer; Gynaecological Cancer

Summary: the main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).

a dosimeter is a small device that is able to record the dose of radiation received. it can provide an independent check that the dose of radiation delivered matches the dose calculated for patients receiving radiotherapy as part of their cancer treatment. the purpose of this study is to investigate the clinical use of in vivo dosimeters for brachytherapy. two types of dosimeters will be used; micro metal oxide field effect transistors (micromosfets) and thermoluminescent detectors (tlds). these will be placed into the rectum (back passage), urethra (the tube through which urine leave the body from the bladder) and within or near (typically within a few centimetres) to the cancer itself. these devices will record the dose of radiation received at the time of brachytherapy at each of these sites and we will compare that measurement with the expected measurement based on the calculations we made in planning the patient's treatment.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and above * patients receiving hdr brachytherapy using iridium-192 (192ir) radioactive source either as a monotherapy or in combination with external beam radiotherapy for: 1. histologically/radiologically proven primary or locally recurrent prostate cancer 2. locally advanced gynaecological malignancy in the primary and recurrent setting * primary cervix carcinoma (squamous, adenocarcinoma, adenosquamous) figo ib2-iva * primary vulval figo i-iva * primary vaginal figo i-iva * primary endometrial cancer figo stage i-iva (not suitable for surgery) * endometrial cancer receiving adjuvant vaginal vault brachytherapy * recurrent cervix, vulval, vaginal or endometrial cancer suitable for brachytherapy as discussed in a regional gynae-oncology multidisciplinary meeting. * world health organisation (who) or eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * previous brachytherapy exposure to the treatment site * patients unable to give informed consent * patients unable to have a regional or general anaesthetic * patients with the following medical conditions: coagulopathies, history of another primary malignancy, known allergy or sensitivity to study materials; previous or current fistulae * not able to understand the implications of participating in the study in english * patients with recent (within the last 6 months) or currently participating in interventional research
post intravitreal injection topical nsaid vs. patching

Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Summary: a prospective randomized trial, to evaluate post-injection comfort measures comparing topical nsaid (nepafenac 0.3% suspension) and patching.

this is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment). study participants will then complete the visual analog scale immediately following injection and then after 1 hour, and, 24 hours. the vas data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * already scheduled for anti-vegf injection based on standard of care for disease process. * ability to provide written informed consent * capable of complying with study protocol. * volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care exclusion criteria: * history of past intraocular injection of steroid medication. * experiencing baseline eye pain * monocular; non-study eye with va\<20/100. * unwilling or unable to follow or comply with all study related procedures
generation of heparin-induced thrombocytopenia (hit)-antibodies without prior heparin exposure

Conditions: Heparin-Induced Thrombocytopenia; Thrombosis

Summary: the purpose of this study is to determine the hit-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.


Eligibility criteria:
inclusion criteria: * major orthopedic surgery exclusion criteria: * heparin exposure * infection

Keywords: hit