Kornimate/medical-research-clean huggingface dataset:
resistive action video games enhance functional fitness of disabled workers in sheltered workshops

Conditions: Mental Disorder

Summary: aims: investigating the efficacy of resistive action video games on functional fitness (ff) of disabled workers in sheltered workshops (dwsws). methods: thirty-two dwsws participated in this study and were allocated as either experimental group (eg) or control group (cg). dwsws in eg underwent three 60-minute sessions each week for 12 weeks; those in cg maintained daily routine. the outcomes included all components ff and were measures at pre-, mid- and post-training.

purpose: to investigate the efficacy of a training program including resistive action video games on functional fitness (ff) of disabled workers in sheltered workshops (dwsws). material and methods: thirty-two dwsws participated in this study and were allocated as either experimental group (eg) or control group (cg). dwsws in eg underwent three 60-minute training sessions each week for 12 weeks. one of the session is group training and two of the sessions are individual session. in group session, the participants do aerobic exercise following a video which was launch by the health management ministry of city government. in the individual session, the participants play play two video games alternatively. the video games used are fitness boxing 2 and adventure ring-fit. in addition to the training program, the participants in the eg maintain work and leisure routine in addition to the added training. the participants in the cg maintained daily work and leisure routine.the outcome measures included body mass index, body weight, body fat percentage, skeletal muscle rate, muscle strength, cardiopulmonary endurance, flexibility, balance and agility. all participants must be evaluated of the outcome measures at pre-, mid- and post-training time point.

Eligibility criteria:
inclusion criteria: * (1) aged more than 20 years; (2) diagnosis of an intellectual disability, autism, or a psychiatric disorder; (3) employed for at least 6 hours per day and five days a week in the sheltered workshop; (4) capable of following verbal instructions to enable outcome measurement and of participating in the training program; and (5) voluntary agreement to participate and signed the informed consent form exclusion criteria: * (1) advisement against performing moderate- to high-intensity physical activities by a physician and (2) physical limitations preventing independent walking or standing without an assistive device.

Keywords: disabled workers sheltered workshops functional fitness physical activities resistive video games action video games
collect breast cancer patients' digital mammography images with corresponding reports for the development of software

Conditions: Breast Cancer

Summary: the purpose of this case collection effort is software design by r2 technologies, inc., the information received from women's imaging will be provided to the case collection, data management and algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of r2 technologies, inc., for computer aided detection (cad) and new digital image archiving software design.

the information is necessary for sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. the information will be used to develop algorithms that will foster development of cad software. the information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events

Eligibility criteria:
inclusion criteria: * subjects with known breast cancer ages 18 and over * case images originating from women's imaging or one of the affiliated screening centers. raw images must be available for each image * source documents or mammographic interpretation must be available exclusion criteria: * 17 or younger

Keywords: breast cancer digital archiver software
evaluation of sequential stent addition vs. incremental dilation & stent exchange for management of anastomotic biliary strictures after liver transplantation

Conditions: Anastomotic Stenosis; Biliary Stricture

Summary: prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.


Eligibility criteria:
inclusion criteria: 1. age 18 and older 2. clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist) 3. willing and able to comply with the study procedures and provide written informed consent to participate in the study. exclusion criteria: 1. age \<18 2. potentially vulnerable subjects including, homeless people, pregnant females, employees and students. 3. complex post-surgical anatomy e.g. choledochojejunostomy, billroth type ii anatomy, roux-en-y-gastrojejunostomy 4. participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit 5. other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture).
cardio training of older adults with central obesity

Conditions: Visceral Obesity

Summary: given the increasing prevalence of obesity, there is an urgent need to find better strategies to promote physical activity in the community. the present study will invite 70-year-olds with central (abdominal) obesity to participate in a 10-week aerobic exercise program. participants will be randomly assigned to one of two equally large groups. the first group will complete the exercise program in instructor-led groups. the second group will complete the program at home with the help of an on-line video.

central obesity means having a lot visceral fat, that is, fat located in the abdominal cavity. visceral fat is a well-established risk factor for cardiovascular disease and all-cause mortality. participants will be recruited from the healthy ageing initiative (hai), an ongoing population-based study that invites all 70-year-olds in umeå, sweden, to a health examination. the exercise program will focus is on station-based aerobic exercises and resistance exercises, predominantly with participants' own body weight as resistance. the program is progressive, starting at a moderate pace so that participants learn to perform the exercises properly. the intensity will be aimed at 60-80% of maximal exhaustion, and each exercise bout will last 60 seconds with 20 seconds of rest between bouts. the program was developed by seniors in the bachelor's program in exercise physiology at umeå university, sweden.

Eligibility criteria:
inclusion criteria: * participated in the healthy ageing initiative (a population-based intervention study in umeå, sweden) * visceral adipose tissue mass \>1 kg (women) or \>2 kg (men) exclusion criteria: * physical disability that affects ability to perform the exercises * heart failure or severe degenerative condition (e.g. malignant cancer or multiple sclerosis) * myocardial infarction or stroke in the past year * heart condition that can worsen with aerobic exercise (e.g. angina)
registry of myelodysplastic syndromes and therapy-related acute myeloid leukemia

Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Summary: the registry mds is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health care interventions (hci) from patients with mds and therapy-related acute myeloid leukemia

the registry mds is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health care interventions (hci) from patients with mds and therapy-related acute myeloid leukemia. this registry was created in july 2003 by gfm group. it is conducted in accordance with the french law on data processing and freedom relating to the processing of personal data in the field of health (law n°78-17 of 6 january 1978 as amended). it has received the favorable opinion of the ethics committee for research and the authorization of the national commission on informatics and freedoms. (cnil) included in the registry are all patients over 18 years of age with mds or secondary chemo- and/or radio-induced leukemia diagnosed after july 2003. the registry allows, after obtaining the patient's consent, the anonymous recording of his or her demographic (sex, age), epidemiological (medical and family history, exposure to toxicants), clinical, biological, cytological and cytogenetic data. included in the registry are all patients over 18 years of age with mds or secondary chemo- and/or radio-induced leukemia diagnosed after july 2003. the registry allows, after obtaining the patient's consent, the anonymous recording of his or her demographic (sex, age), epidemiological (medical and family history, exposure to toxicants), clinical, biological, cytological and cytogenetic data. to date, 70 gfm centers participate in this registry, 5300 patients have been included. approximately 400 to 500 new patients are currently included per year. data are recorded and entered through the web-based e-crf by haematology centers in 70 centers of gfm at inclusion and follow-up of the patients every six months. data analyses are conducted by the sbim (medical and biostatistical computing at service of pr sylvie chevret, hospital saint louis). data quality control including monitoring of both clinical execution and data collection implemented from the initiation of the registry has resulted in high quality data. registry mds has included the most patients and has proven itself as a well-established operational, and constantly evolving project in an elderly population. the registration of new patients is still ongoing, and the follow-up of the project is unlimited.

Eligibility criteria:
inclusion criteria: * male or female * age \> 18 years * patients with myelodysplastic syndrome and therapy-related acute myeloid leukemia * able and willing to provide written informed consent exclusion criteria: * age \<18 years * patient is unwilling or unable to give consent

Keywords: mds t-aml
efficacy and tolerability of carbamazepine cr in diabetic neuropathy pain

Conditions: Neuropathic Pain

Summary: the trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients


Eligibility criteria:
inclusion criteria: * diabetes patients with diabetes neuropathy dn4 \> or equal to 4 * male or female aged from 21 to 65 years * informed consent * hba1c \< 11% exclusion criteria: * prior hospitalization for acido- cetosis * prior hospitalization for severe hypoglycemia * pregnancy * hepatitis * diabetes foot * avb (auriculo-ventricular conduction disturbance) * patient treated by antidepressant drugs * patient treated with other antiepileptic drug * patients with blood ion disturbance * patient with neutropenia * glaucoma * bladder adenoma * alcohol abuse * creatinin clearance \< 60 ml/ minute other protocol-defined inclusion/exclusion criteria may apply

Keywords: neuropathic pain brief pain inventory dn4 questionnaire electrocardiogram
oral neutralizing antibody booster for post-vaccinated people with covid19 vaccine

Conditions: COVID-19 Pandemic

Summary: this is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered bacillus subtilis spore extract which contain spike protein of the sars-cov2 on the spore coat.

covid-19 immunization reduces the risk of covid-19 and potentially serious complications. in clinical trials, all covid-19 vaccines currently authorized for use in the united states are beneficial in protecting adults and children 5 years and older against covid-19, including severe illness. so far, studies looking at how covid-19 vaccines work in real-world conditions (vaccine effectiveness studies) have shown that they work well. however, it has been reported that most of the antibodies in people who received the second dose of covid-19 vaccine had been dramatically decreased. bacillus subtilis (b. subtilis) is a generally regarded as safe organism and it is a common food source. the investigators have used an engineered bacillus subtilis spore which express and display the spike protein receptor binding domain (srbd) of the sars-cov-2 on the surface. the investigators have proved that it successfully increased the neutralizing antibody against srbd in unvaccinated mice and human individuals after oral administration. on this basis, the investigators designed and developed an oral antibody booster by extracting the spore surface of b. subtilis. this supplement has the advantage of being stable and effective, free of recombinant plasmid, and can be served as a potential antibody booster to existing vaccines. mice toxicity and efficacy test was conducted and the experiment proved that the b. subtilis spores extract was effective in inducing immune response, and it was safe and did not cause any significant adverse effect. the b. subtilis spore extract will be further studied in a human trials through oral administration to test its safety and the immune effect resulted in human body.

Eligibility criteria:
inclusion criteria: * healthy * age over 12 years * the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); * participant vaccinated with covid-19 over 6 months * anti-sars cov 2 neutralizing antibody is negative in serum. exclusion criteria: * pregnant women * history of covid-19 infection or showing covid-19 infection symptoms * having had contact to people with known covid-19 infection in the last 14 days * having fever (\> 37.4oc in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. * positive real time rt-pcr covid-19 test. * persons with autoimmune diseases * allergic diathesis or any clinically significant allergic disease (i.e. asthma) * any condition that might impair the immune response * recent or current immunosuppressive medication * any other vaccine application 5 months before the first dose
multicenter trial for adults with partial seizures

Conditions: Epilepsy

Summary: to compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (aeds) and to determine the safety of talampanel in this group of patients.

a randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (tlp) in 190 patients (18-65 years old) with refractory partial seizures.

Eligibility criteria:
inclusion criteria: * must weigh greater than or equal to 40kg * patients must have diagnosis of partial seizures * at least 3 observable partial seizures a month * are currently being treated with 1 and no more than 2 marketed anti-epileptic drugs. exclusion: * patients on valproic acid, and felbamate
a dose escalation trial of an intravitreal injection of sirna-027 in patients with subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd)

Conditions: Age-Related Macular Degeneration; Choroidal Neovascularization

Summary: the purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of sirna-027 (agn211745) and to assess the anatomical changes in the retina, changes in cnv, and changes in visual acuity. escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.


Eligibility criteria:
inclusion criteria: * active amd with subfoveal cnv (classic and/or occult cnv) * cnv lesion thickness \>/= 250um by oct assessment * visual acuity in study eye of \</= 20/100 but not worse than 20/800 * not eligible for or refused standard treatment exclusion criteria: * females of childbearing potential * other causes of cnv including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis * any intraocular surgery or treatment of amd with visudyne within 3 months of study entry * cnv lesion \>/= 12 mps disc area
brief pain exposure therapy (bpet) for nociplastic pain

Conditions: Fibromyalgia; Lupus Erythematosus, Systemic

Summary: this study is intended to test whether a brief zoom-based behavioral treatment can help adults with fibromyalgia (fm) and lupus learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia and lupus (such as depression or anxiety).

this project was amended and approved by the university of michigan medical school institutional review board. these changes include a title update and adding lupus participants on to the study.

Eligibility criteria:
inclusion criteria: * able to read, write and speak english * internet access and audio-visual conferencing capability (e.g., zoom meetings by phone or computer) in the home fibromyalgia participants must have: * physician diagnosis of fibromyalgia * or: meet 2016 american college of rheumatology (acr) criteria for fm: widespread pain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread pain index score is 4 to 6 and symptom severity score is ≥ 9 * or: have pain self-reported in 4 out of 7 body regions in the general sensory sensitivity (gss)-brief body map and opioid use disorder diagnosis by a physician. lupus participants must have: * physician diagnosis of systemic lupus erythematosus * and: have pain self-reported in 4 out of 7 body regions in the gss-brief body map * and: no change in medications or steroid dose for one month prior to entry (to avoid oscillation of steroid dosing during the study due to active disease). exclusion criteria: * indication of a co-occurring (non-fibromyalgia or non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other autoimmune disorders, spinal cord injury, cancer) * currently receiving cognitive-behavioral therapy or other psychological therapies for pain * open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening. * inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols. * pregnant or breastfeeding * any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. * lupus group only: taking \>10 mg prednisone (or equivalent steroid) dose per day as an indicator of ongoing disease activity (with no other strict exclusions based on medications)

Keywords: pain exposure therapy telehealth-based behavioral intervention
phase 3 clinical study for the treatment of cold sore

Conditions: Herpes Labialis

Summary: to demonstrate the efficacy of a single dose of acyclovir lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.


Eligibility criteria:
inclusion criteria: * history of recurrent herpes labialis lesions where: * at least 50% of previous episodes produced classical lesions to the vesicular stage (i.e. episodes that progressed through macula, papule, vesicle, crust and healed); * prodromal symptoms (itching, tingling, pain etc.) should precede herpes labialis lesions in at least 50% of the previous herpes episodes * good general health (ecog \< 2), immunocompetent * signed and dated written informed consent * women of childbearing potential must have effective contraception method exclusion criteria: * more than 50% of recurrences that aborted spontaneously in the past 12 months * primary herpes lesion outside the lips (e.g. nose, chin, etc.) * abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g. eczema, psoriasis...) * oral diseases whose prodromal symptoms may mimick those of herpes labialis, including recurrent oral aphthous disease * oral diseases that might interfere with the evaluation of the efficacy or safety of the treatments, including gingivitis, parondotis, mucositis, oropharyngeal candidiasis... * history of infection known to be resistant to acyclovir family agents * previous vaccination against herpes * concomitant treatment likely to interfere with acyclovir * allergy to any acyclovir containing agents * immunocompromised condition, including hiv+ * unability to properly understand protocol requirements, to follow the study procedures, to complete the patient diary or to start the self-initiation of the treatment * upper full or partial dentures with acrylic border in the canine fossa * milk allergy or known history of hypersensitivity to one of the components of the products * rare hereditary problems of galactose intolerance. * lactase enzyme deficiency or glucose galactose malabsorption * clinically significant abnormal level of serum creatinine * patients whose occupations make them unlikely to return to the clinic within 24h of treatment initiation * pregnancy or breast-feeding * investigational drug or immunomodulator treatment in the 30 days prior randomisation * prior enrollment in this study * participation in another therapeutic trial evaluating new drugs or which could interfere with the evolution of herpes labialis or the evaluation of the drug in the study within preceding 30 day.