Kornimate/medical-research-clean huggingface dataset:
usability and acceptability study of a functional electro-stimulator controlled by electromyographic signal (fitfes)

Conditions: Stroke; Healthy Health Care Professionals

Summary: functional recovery of the upper limb after a cerebral stroke is one of the major critical issues in rehabilitation. the advent of innovative technologies can be helpful to rehabilitators and intervene where there is no other solution but a clear therapeutic indication. the use of functional electrostimulators can actively and functionally support movements, helping people affected by stroke to complete a motor gesture taking into account their residual capacities.

fitfes is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements. this study aims to assess the usability, acceptability, and satisfaction of this device by post-stroke subjects and healthcare workers. ten post-stroke subjects and ten healthy health care workers will be recruited. participants will take part in a single session where they are going to execute motor tasks of daily living with the support of the fitfes. at the end of session participants will fill out questionnaires. collected results will serve as input for further development of the fitfes device, based on the requests and opinions of participants, to obtain a final version of the device that will be used in a randomized controlled study.

Eligibility criteria:
stroke inclusion criteria: * age equal to or greater than 18 years * diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks stroke exclusion criteria * mini mental state examination (corrected for age and schooling) \< 24 * clinical evidence of visuospatial disorders, ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders that prevent the use of the device * major head trauma * cardio-respiratory or internal clinical instability * pregnancy * severe spasticity (ashworth scale \> 3) * skin integrity issues on the surface interfaced with the device * implanted electronic devices * epilepsy * severe peripheral neuropathies healthy health care professionals inclusion criteria: * age equal to or greater than 18 years healthy health care professionals exclusion criteria: * pregnancy * skin integrity issues on the surface interfaced with the device * implanted electronic devices

Keywords: stroke functional electrical stimulation feasibility usability medical device
the effects of jing si herbal tea liquid packets on fatigue in patients with inflammatory arthritis

Conditions: Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Fatigue

Summary: fatigue is a common feature in patients with rheumatic conditions. fatigue can lead to a decline in physical function, self-confidence, cognitive status, and work performance and significantly impact the quality of life. while pain and inflammation of arthritis can be well controlled nowadays attributed to the advances in anti-rheumatic medications, fatigue remains a challenge. even with proper therapies for arthritis, the prevalence of severe fatigue is more than 30%, which is a significant burden to both physicians and patients. however, there is no regimen to alleviate fatigue among patients with inflammatory arthritis. finding a way to combat fatigue will significantly help improve patients' physical and mental state and family society. to investigate the efficacy of jing si herbal tea liquid packets on fatigue in patients with inflammatory arthritis, the investigators propose a two-year research project to recruit approximately 150 patients with fatigue and inflammatory arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. this project is designed as a randomized, double-blind, placebo-controlled study. the recruited patients will be randomized to receive jing si herbal tea liquid packets or a matching placebo in combination with the background regular anti-rheumatic therapy. the severity of fatigue will be obtained by questionnaire. clinical parameters, including demographic data and disease activities, will be collected during each visit.


Eligibility criteria:
inclusion criteria: * inflammatory arthritis, any of the following diagnosis 1. rheumatoid arthritis, based on acr (american college of rheumatology) classification criteria 2. ankylosing spondylitis, based on modified new york criteria 3. psoriatic arthritis, based on 2006 caspar (classification criteria for psoriatic arthritis) criteria exclusion criteria: 1. active infection or chronic infection 2. uncontrolled disease status of inflammatory arthritis 3. unwilling to take herbal tea 4. with difficulty for return visits
possible new therapy for advanced cancer

Conditions: Adrenocortical Carcinoma

Summary: il-13-pe is a chemical similar to one made by the body that is connected to a toxin to specifically attack cancer cells. researchers want to look at different doses of il-13-pe to find one that may be safe and effective against cancer that has returned, spread to other organs, or that cannot be surgically removed. participants will receive physical exams and report side effects. blood and urine samples will be collected. imaging studies, tissue samples, and other tests will be used to study the tumor before the start of treatment and during the study. il-13-pe therapy will be given to each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles. the study will be done in two parts, with a six-month period between them. if the cancer continues to grow, participants will stop taking il-13-pe. if the cancer continues to shrink or not grow the study will continue, even into a follow-up period after the second part of the study. the first part of this study will determine how much il-13-pe can be tolerated. for this part, the study is recruiting adult patients with various types of cancer. after six participants have taken the lowest dose with no more than one experiencing dose-limiting toxicity, two participants may begin the study taking the medium dose. if they tolerate the medium dose for a month, up to four more may begin at that dose. when at least three participants have tolerated the medium dose, two may attempt the highest dose. when they have tolerated the highest dose for one monthly cycle, 1-4 more may begin the study, receiving the highest dose. adrenal cortex cancer (acc) is a rare tumor in the gland above the kidney. it affects only 1-2 people per million each year and causes hormone problems. this tumor affects children under age 5 and adults aged 30-40, causing death within five years for up to 80% of them. during the second part of the study, all participants will be acc patients. they will receive the highest dose tolerated during part 1 on days 1, 3, and 5 of each monthly cycle for up to four months.


Eligibility criteria:
inclusion criteria: * has measurable disease by response evaluation criteria in solid tumors (recist) criteria at presentation * has failed standard treatment * has met protocol-specified criteria for qualification and contraception * has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures exclusion criteria: * has history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters * has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: * the safety or well-being of the participant or study staff * the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) * the analysis of results

Keywords: adrenal gland cancer treatment refractory malignancies metastatic cancer
dose-finding study of glpg0634 as add-on to methotrexate in active rheumatoid arthritis participants (darwin1)

Conditions: Rheumatoid Arthritis

Summary: participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking glpg0634 (3 different doses - 50 milligram \[mg\], 100 mg and 200 mg daily -, each evaluated as once daily \[qd\] and twice daily \[bid\] regimen) or matching placebo for 24 weeks. •during the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of glpg0634 present in the blood (pharmacokinetics) as well as the effects of glpg0634 on disease- and mechanism of action-related parameters in the blood (pharmacodynamics) were determined. also, the effects of different doses and dose regiments of glpg0634 administration on participants' disability, fatigue, and quality of life were evaluated.

* treatment duration was 24 weeks in total. * however, at week 12, participants on placebo who did not achieve a 20% improvement in swollen joint count(sjc66) and tender joint count (tjc68) were re-randomized (automatically via interactive voice/web response \[ixrs\]) to treatment to receive glpg0634 100 mg qd or 50 mg bid doses in a blinded fashion, participants on 50 mg qd who had not achieved a 20% improvement in sjc66 and tjc68 were assigned to 100 mg qd and participants on 25 mg bid. who did not achieve a 20% improvement in sjc66 and tjc68 were assigned to 50 mg bid. all continued the study until week 24. * participants in the other groups maintained their randomized treatment until week 24.

Eligibility criteria:
inclusion criteria: * have a diagnosis of ra since at least 6 months and meeting the 2010 acr/eular criteria of ra and acr functional class i-iii, * have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at screening and at baseline, * screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (uln), * have received mtx for ≥6 months and have been on a stable dose (15 to 25 mg/week) of mtx for at least 4 weeks prior to screening and willing to continue on their current regimen for the duration of the study. stable doses of mtx as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses. exclusion criteria: * current therapy with any disease-modifying anti-rheumatic drugs (dmard) other than mtx, * current or previous ra treatment with a biologic dmard, with the exception of biologic dmards administered in a single clinical study setting more than 6 months prior to screening (12 months for rituximab or other b cell depleting agents), where the biologic dmard was effective, and if discontinued, this should not be due to lack of efficacy, * previous treatment at any time with a cytotoxic agent, other than mtx, before screening.

Keywords: methotrexate inadequate responders
protocol for rapid onset of mobilization in patients with traumatic spinal cord injury

Conditions: Spinal Cord Injuries

Summary: prompt-sci (protocol for rapid onset of mobilization in patients with traumatic sci) is a single-site single-arm proof-of-concept trial. forty-five patients aged 18 years or older who have sustained a severe traumatic sci (american spinal injury association impairment scale grade a, b or c) from c0 to l1 and undergoing spinal surgery within 48 hours of the injury will be included. participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. the feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. feasibility and patient outcomes will be analysed with descriptive statistics. patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.


Eligibility criteria:
inclusion criteria: * blunt traumatic spinal cord injury * neurological level of injury from c0 to l2 * american spinal injury association impairment scale grade a, b or c * spine surgery performed within 48 hours of injury exclusion criteria: * condition limiting patient's ability to engage into cycling * medical condition that might interfere with patient's safety if cycling * moderate or severe brain injury * inability to walk independently prior to injury * pre-existing neurological disorder * complete spinal cord transection * unwilling or unable to comply with scheduled follow-up
multicenter trial of ecmo in children with severe cardiac failure using the cardiohelp system

Conditions: Heart Failure; Cardiogenic Shock; Congenital Heart Disease; Cardiomyopathies

Summary: the goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the cardiohelp system for va-ecmo in children with cardiac failure. the main question\[s\] it aims to answer are: * what is the safety and effectiveness of the cardiohelp device for pediatric ecmo? * what are the optimal performance specifications of the cardiohelp device in children? should the cardiohelp device be fda-cleared for children? children who are receiving the cardiohelp device will be approached and consented to participate if interested. participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. outcomes will be compared to performance goals (pg) derived from the ecmo literature. funding source -- fda oopd (office of orphan products development)

this is a multicenter clinical trial to evaluate the safety and effectiveness of the cardiohelp system for up to 30 days of support in children with severe cardiac failure. despite more than 50 years of use and significant mortality, no standalone ecmo device has ever been fda-cleared for ecmo. all ecmo use in children is off-label and this may explain why there is significant center-based variation in ecmo use that is not evidence driven. this study seeks to change that by collecting systematic safety and effectiveness data on a single standardized ecmo circuit (cardiohelp device). the goal is to provide the data necessary to secure fda clearance of the first pediatric ecmo system, to determine the optimal performance range of the cardiohelp device in infants and children, and to provide the fda with a predicate device to support fda clearance of other ecmo systems.

Eligibility criteria:
inclusion criteria: 1. age 0 to 16 years of age 2. body weight 3 to 80 kilograms 3. va-ecmo use for primary cardiac failure using the cardiohelp system. 4. first ecmo run during any hospitalization 5. written informed consent from the parent or legally authorized representative. exclusion criteria:children must not meet any of the following exclusion criteria within 48 hours prior to device implant: 1. gestational age \<37 weeks 2. bleeding or coagulopathy that is a contraindication to anticoagulation 3. irreversible renal, hepatic or lung failure 4. stroke or uncertain neurological status within the past 30 days 5. severely malnourished 6. use of an ecmo system other than the cardiohelp 7. vv-ecmo or ecmo for primary respiratory failure 8. goals of patient to focus on comfort measures only. 9. failure to separate from cardiopulmonary bypass
acute, affective, organic disorders.

Conditions: Depressive Disorders

Summary: the purpose of the study is to investigate whether patients with brief depressive periods together with other fluctuating psychiatric symptoms, have this condition due to epilepsy or an other organic brain disorder.

a limited number of patients admitted to psychiatric acute wards or psychiatric intensive care units are admitted with a fluctuating array of psychiatric symptoms including brief depressive episodes. these patients do not fit into the present diagnostic systems due to short duration of affective symptoms and the fluctuating arrays of other symptoms. case histories indicate that these patients have psychiatric conditions due to epilepsy or organic brain dysfunctions. in the study acutely admitted patients filling criteria for two recent dsm-4 axis 1 diagnoses (one is a brief depressive period) during the last two weeks are compared to age- and sex-matched patients acutely admitted with a major depressive disorder. the patients are rated with a number of rating scales at admittance, day 5, after two weeks and three months. eeg and qeeg are taken three times the first week. mri, drug screening and blood screening of medication-concentrations are taken.

Eligibility criteria:
inclusion criteria: * acutely admitted psychiatric patients who have at different times the last 2 weeks filled criteria for at least two new dsm-4 axis 1 psychiatric diagnoses. one of them has to be a depressive episode (madrs\>20) exclusion criteria: * patients not speaking norwegian or english. * patients not willing to participate. * patients with dementia or mental retardation to an extensive degree.

Keywords: brief depressive episodes affective disorders eeg and qeeg epilepsy organic brain disorders acute psychiatry
use of gcsf in patients with recurrent ivf/icsi failure

Conditions: Fertility Disorders

Summary: evaluate the effectiveness of granulocyte colony-stimulating factor (gcsf) in the treatment of thin endometrium or in women with recurrent implantation failure in icsi cycles

prospective analytical study which will be conducted at a private ivf center starting from june 2016. the study will be recruited from both the fertility clinics and centers by fulfilling inclusion and exclusion criteria , all patient will be subjected to complete history taking medical and fertility history including previous induction or implantation failure. patients will be randomized into two groups, group a will be treated with neupogen 30 international unit (iu) and group b will be treated with clexane 40mg and estrogen. study procedure: ovaries were stimulated with standard protocol (long gnrh agonist) or gonadotrophic releasing hormone (gnrh antagonist, when at least 3 follicles achieved 18 mm diameter, human chorionic gonadotrophic (hcg) (10000 iu) was administered for ovulation triggering, transvaginal oocyte retrieval was performed at 36-38 hours after injection of hcg . the oocytes were fertilized by intracytoplasmic sperm injection (icsi) method. the thickness of endometrium was evaluated on the day of oocyte retrieval and syringe which containing (300 mcg/1 ml) gcsf (neupogen) was infused slowly in the uterine cavity and after 5 days (before embryo transfer) endometrial thickness was evaluated again. all patients received oral and parenteral progesterone for luteal phase support.

Eligibility criteria:
inclusion criteria: * male partner with normal semen analysis according to world health organization (who) 2010. * female partner under the age of 36 presented with: a-thin endometrium (less 7 mm on transvaginal ultrasound) or b- previous history multiple unexplained * female with no history of asherman's syndrome , fibroids, and polyps in diagnostic hysteroscopy exclusion criteria: * women with sickle cell disease, renal insufficiency, upper respiratory infection or pneumonia, chronic neutropenia, known past or present malignancy
topical tacrolimus for breast cancer-related lymphedema

Conditions: Lymphedema

Summary: the goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage i or ii breast cancer-related lymphedema. the main question it aims to answer are: * how tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life). * if maintenance treatment is effective. participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. assessments will be performed at baseline, three, six, nine and 12 months.


Eligibility criteria:
inclusion criteria: * age over 18 years * bcrl isl stage i or ii * pitting edema * postmenopausal or use of contraceptive drugs * healthy opposite arm * l-dex score over 10 exclusion criteria: * pregnant, breast-feeding, or aiming to conceive within the next year * bilateral breast cancer * contralateral lymphadenectomy * allergy to tacrolimus, macrolides, or iodine * pacemaker * known kidney or liver disease
a specialized diet for the unique metabolic characteristics of peripubertal african american girls

Conditions: Obesity; Type 2 Diabetes

Summary: a diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal african american girls (hyperinsulinemic, low insulin sensitive) will be more effective in maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)


Eligibility criteria:
inclusion criteria: * african american girls aged 9-14, * overweight \< 90th percentile exclusion criteria: * on medications known to affect metabolism prior disease diagnosis

Keywords: obesity, puberty, diabetes,insulin dynamics
efficacy and safety study of gevokizumab to treat moderate to severe acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe acne vulgaris * acne vulgaris unresponsive to oral antibiotics * willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study exclusion criteria: * use of medications or treatments from specified pre-treatment time periods through the end of the study * beard, moustache, sideburns or other facial hair that may interfere with evaluation * other forms of acne * history of malignancy within 5 years * history of allergic or anaphylactic reactions to monoclonal antibodies * history of tuberculosis * history of chronic systemic infections * female subjects who are pregnant, planning to become pregnant other protocol-defined inclusion/exclusion criteria may apply

Keywords: acne acne vulgaris