Kornimate/medical-research-clean huggingface dataset:
investigation of the clinical performance of biatain fiber ag on burns

Conditions: Partial-thickness Burn

Summary: the goal of this study is to test a new gelling fiber wound dressing with silver on patients with a partial thickness burn wound, which is infected or at risk of infection. participants will be asked to wear the test dressing in a two weeks period(+/- 2 days) consisting of 3-4 study visits, and will have the dressing changed once pr. week at the research facility. the wound will be cleaned, assessed and photos will be uploaded to a digital software system.

the clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study. the test product, biatain fiber ag is a non-ce-marked gelling fiber wound dressing, containing silver. the product is intended for moist wound healing and exudate management of moderate to high exuding wounds. the product has a classification iii, as it contains the active ingredient silver. the overall purpose of this investigation is to obtain clinical data supporting effectiveness of biatain fiber ag to obtain the ce-mark in eu. the total study duration for the subject will be approximately two weeks (+/- 2 days), consisting of a two-week test period and 4 study visits (v0/v1, v2 and v3). v3 will also terminate the 2-week study period. the primary endpoint is percentage of wounds healed within 14 days (≥ 95 % reepithelialisation) the clinical investigation will be conducted in a total of 50 eligible subjects with a partial thickness burn wound that are infected or at risk of infection.

Eligibility criteria:
inclusion criteria: 1. has signed informed consent 2. is between 18 -65 years (both included) 3. is capable of following study procedure (assessed by investigator). 4. has a partial thickness burn wound 5. has a burn wound that is infected or at risk of infection (assessed by investigator) 6. the size of burn (including both study wound and non-study injuries) has a total body surface area (tbsa) less than 10% (assessed by investigator). 7. the wound should fit under a 20x30 cm dressing (600 cm2) or smaller 8. the shape and location of the wound should be suitable for photo capture (assessed by the investigator). 9. has a wound that has medium to high level of exudate (assessed by the investigator) 10. is suitable to use the test product for wound treatment (assessed by the investigator). exclusion criteria: 1. is pregnant/breastfeeding 2. is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area) 3. known history of skin sensitivity to any components of the test dressings 4. \>72 hours from time of injury 5. intake of antibiotics within one week before the start of the enrolment 6. use of chemical debridement 7. participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).

Keywords: infected or risk of infection
comparative evaluate the efficacy to acute and chronic bronchitis

Conditions: Acute Exacerbation of Chronic Bronchitis

Summary: the purpose of a multicenter, randomized, double-blind, placebo-controlled to evaluate the efficacy, safety and pharmacokinetics of n02rs1 600mg and 1,200mg per day in patients with acute and acute exacerbation of chronic bronchitis for 7 days.


Eligibility criteria:
inclusion criteria: * patients over 18, under 75 years of age * patients acute and chronic bronchitis exclusion criteria: * patients who have gotten a glucocorticoids treatment within 4 weeks. * patients who need treatments of antibiotic and acute bronchitis infection. * patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days. * bronchial asthma patient. * patients who have an indication of bleeding. * patients who have a serious heart and renal disease or liver ailment or immunosuppressive response. * patients who have history of over 3 phage of chronic obstructiv lung disease * bronchiectasis patients.
early access program of the safety of human anti-tnf monoclonal antibody adalimumab in subjects with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: multicenter early access program of the safety of human anti-tnf monoclonal antibody adalimumab in subjects with active rheumatoid arthritis


Eligibility criteria:
inclusion criteria: * eighteen years or older * females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control * females - negative pregnancy test at screening * confirmed diagnosis of active ra \>= 6 swollen joints and \>= 9 tender joints * met acr criteria for diagnosis of ra for at least 3 months * active ra defined by a das \>= 3.2 at study entry exclusion criteria: * subject had prior treatment with cyclophosphamide or chlorambucil * subjects previously treated with total lymphoid irradiation or anti-cd4 or campath 1h monoclonal antibodies resulting in cd4 lymphopenia * prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab * subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin
an innovative mental health virtual ward: evaluation of patient-centered outcomes

Conditions: Mental Health Disorder; Mental Health Impairment; Psychiatric Emergency; Crisis; Emotional

Summary: the goal of this study is to evaluate if admission to the mental health virtual ward (mh vward) for mental health crisis stabilization is having a meaningful positive impact on patient reported outcomes and healthcare utilization. the objectives of this study are: 1. prospectively measure demographic, recovery, service delivery, and systems use outcomes in a cohort of mh vward admissions. 2. establish this cohort for use in future research. as part of the intervention, participants will receive care in the mh vward for an average of 5 days following a visit to an emergency department or crisis centre for a mental health crisis. while admitted to the mh vward, participants will: 1. engage in individual therapy and care planning with a clinician or psychiatry team. 2. have engagement with formal (community providers) and informal supports (family, friends) for collateral and collaboration. 3. receive medication reconciliation and management. 4. participate in group programming. 5. receive referrals for follow-up services. 6. have access to after hours support. 7. have access to the telus home health monitoring (hhm) app, which is custom designed to complement the services provided by the program.


Eligibility criteria:
inclusion criteria: * individuals admitted to the mental health virtual ward. exclusion criteria: * none.
cognitive-behavioral therapy for pediatric body dysmorphic disorder

Conditions: Body Dysmorphic Disorder

Summary: the purpose of this study is to develop and test the effectiveness of cognitive-behavioral therapy (cbt) for children and adolescents suffering from body dysmorphic disorder.

the main purpose of this trial is to develop and investigate the effects of a cbt protocol for children and adolescents with bdd. it is important to investigate cbt in this population given the disorder's early onset and poor trajectory if left untreated. in the first phase of this trial, we will develop the treatment manual, adapting the adult manual for use in a pediatric population. in the second phase of this trial we will test the effectiveness of the cbt treatment in 12 pediatric bdd patients. we intend to treat 12 children and adolescents with bdd. all patients will receive cbt. we will also examine treatment feasibility and acceptability (e.g., retention and reasons for treatment refusal and dropout, expectancy, and motivation), and we will explore predictors of outcome. therapeutic progress will be broadly assessed with measures of beliefs, behaviors, mood, functioning, and quality of life before, during, and after treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of dsm-iv bdd or its delusional variant, which must be present currently and for at least 6 months prior to study entry * total score of at least 24 on the 12-item bdd-ybocs, adolescent version, which includes a score of at least 2 on item 1 (1-3 hours/day of preoccupation with the perceived defect) * score of at least moderate on the clinical global impressions of severity (cgi-severity) * score of \< 60 on the child global assessment scale (c-gas) * ability to communicate meaningfully with the investigators and competent to provide written assent; both parental informed consent and adolescent assent must be obtained exclusion criteria: * alcohol or substance abuse or dependence within the past 3 months, bipolar disorder, psychosis, organic mental disorder, development disorder, body image concerns accounted for primarily by an eating disorder or weight concerns. if subjects have another comorbid diagnosis, the bdd has to be the primary concern. * recent (within the past 6 months) suicide attempt, or suicidal ideation as indicated by a k-sads score of 4 or higher that is active or warrants consideration of hospitalization * need for inpatient or partial hospital treatment * current psychotherapy and failure to benefit from ten or more sessions of previous cbt treatment * participants can be receiving psychotropic medication, but they must be on a stable dose for 2 months prior to the study baseline assessment and maintain this dosage throughout the course of the study

Keywords: pediatric body dysmorphic disorder bdd cbt cognitive-behavioral therapy
influence of systemic parameters in diabetic macular edema - lipsia study

Conditions: Diabetic Macular Edema; Macular Edema; Retinal Vein Occlusion

Summary: this study aims to evaluate the influence and prognostic value of systemic factors (such as the cardiovascular and metabolic status) on the treatment response to anti-vegf therapy in macular edema due to diabetes or retinal vein occlusion.

this study includes patients with macular edema (me) due to diabetes or retinal vein occlusion in the need of treatment. at baseline patients underwent an extensive ophthalmological examination (best-corrected visual acuity, oct, oct-angiography, fluorescein angiography, fundus photography). besides that, systemic work-up (including 24h blood pressure measurement, electrocardiogram, and serological blood testing) is conducted. patients underwent routine me treatment including at least 4 monthly anti-vegf injections, as first-line therapy. further injections will be conducted if needed. re-treatment criteria are: persistent intra- and/or subretinal fluid seen on sd-oct, central subfield thickness \> 300 µm. ophthalmological examination will be repeated at month 3, 6 and month 12. systemic work-up will be repeated at month 6. primary outcome is the correlation of systemic parameters with functional and anatomical response at month 6. secondary outcome is the correlation of systemic parameters with functional and anatomical response at month 12.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. diagnosis of diabetes mellitus (type 1 or type 2) and/or retinal vein occlusion 3. macular edema causing visual loss, with study eye va of 0.1 - 1.0 logmar (20/25 - 20/200 snellen equivalent) 4. macular edema defined clinically and by retinal thickness of \> 300 µm in the central subfield thickness (cst) with intra +/- subretinal fluid seen on spectral domain optical coherence tomography 5. last intravitreal treatment \> 3 months ago. exclusion criteria: 1. concomitant ocular disease that could cause macular edema (including choroidal neovascularization from any cause, uveitis or intraocular surgery less than 6 months ago). 2. any concomitant ocular or neurological condition that could affect vision except of cataract. 3. pregnancy.
comparison of the success rates of four different pulpotomy techniques

Conditions: Extensive Decay in Primary Molars

Summary: this randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including biodentine and two different mineral trioxide aggregate (mta) products (white proroot® mta and mta plus®). ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.


Eligibility criteria:
inclusion criteria: * patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. the criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable. exclusion criteria: * the exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (pdl) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. teeth without permanent successor were not also included in the study.

Keywords: pulpotomy primary molars
evaluation of systane® balance in dry eye subjects with lipid deficiency

Conditions: Dry Eye Syndrome; Lipid Deficiency

Summary: the purpose of this study is to evaluate the repeated use of systane® balance on stabilizing the tear film of dry eye patients with an unstable tear film.


Eligibility criteria:
inclusion criteria: * non-contact lens wearer; * symptomatology as defined by the ocular surface disease index (osdi) questionnaire; * lipid deficiency; * best visual acuity of 6/9 or better in each eye; * willingness to adhere to the instructions set in the clinical protocol; * signature of the subject informed consent form; * other protocol-defined inclusion criteria may apply. exclusion criteria: * use of systemic medication which might produce dry eye side effects; * systemic disease which might produce dry eye side effects; * active or recent ocular inflammation or infection; * use of ocular medication; * significant ocular anomaly; * previous ocular surgery; * previous use of restasis; * any medical condition that might be prejudicial to the study; * pregnant or lactating; * other protocol-defined exclusion criteria may apply.

Keywords: dry eye ocular surface vision complaint tear film stability time controlled functional visual acuity tear film kinetics
computer-based balance training for people with parkinson's disease

Conditions: Parkinson's Disease

Summary: this study will be carried out to determine the effectiveness of in-home computer games played by a person with parkinson's disease for 50 minutes 3 times a week on measures of standing and walking balance.


Eligibility criteria:
inclusion criteria: 1. presence of bradykinesia along with at least one of the following: muscular rigidity, 4-6 hz rest tremor, and postural instability (gelb, oliver, \& gilman, 1999; hughes, ben-shlomo, daniel, \& lees, 1992). 2. hoehn \& yahr disease stage 1 (unilateral disease) to 3 (mild to moderate bilateral disease, physically independent) (fahn and elton, 1987). exclusion criteria: 1. history of strokes, repeated head injury, encephalitis, oculogyric crises, neuroleptic treatment, mptp exposure, more than one affected relative, sustained remission, strictly unilateral features after 3 years, supranuclear gaze palsy, early severe autonomic involvement or dementia, babinski sign, tumor, or a negative response to l-dopa (hughes et al., 1992). 2. other neurologic, orthopedic or cardiac problems, cognitive impairment as evidenced by 5 or more errors on the mini mental state examination (mmse) (folstein, folstein, \& mchugh, 1975) 3. visual or hearing impairments serious enough to interfere with their ability to interact with the computer-based training program.

Keywords: gait movement disorders balance function
cyfluatg in lower risk mds

Conditions: Myelodysplastic Syndromes

Summary: to evaluate the efficacy of the conditioning regimen with cyclophosphamide, fludarabine, and antithymocyte globulin (cyfluatg) for allogeneic hematopoietic cell transplantation (hct) in patients with lower risk myelodysplastic syndrome (mds). the efficacy of the treatment will be measured in terms of engraftment and non-relapse mortality (nrm).

* this is a prospective, phase 2 extension study * conditioning regimen a. cyclophosphamide 50 mg/kg/day i.v. daily on days -3 and -2 (for 2 days) b. fludarabine 30 mg/m2/day i.v. daily on days -7to -2 (for 6 days) c. antithymocyte globulin (thymoglobulin) 1.5 mg/kg/day (for hla-matched sibling donor hct) or 3.0 mg/kg/day (for other alternative donor hct) i.v. daily on days -3 to -1 (for 3 days) d. methylprednisolone 2 mg/kg i.v. daily on days -4 to -1 (for 4 days) * harvest and infusion of donor hematopoietic cells a. harvested peripheral blood mononuclear cells of donors via leukapheresis will be infused to recipients on day 0. additional infusion on day 1 can be made based on the judgement of attending physician. * gvhd prophylaxis a. cyclosporine: 1.5 mg/kg i.v. every 12 hours beginning on day -1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. b. methotrexate: 15 mg/m2 i.v. on day 1, and 10 mg/m2 i.v. on days 3 and 6.

Eligibility criteria:
inclusion criteria: * patients with lower risk mds a. international prognosticscoring system (ipss) ≤ 1.0 and b. bone marrow blast percentage \< 5% during the disease course before hct * patients with appropriate hematopoietic cell donor a. hla-matched sibling b. hla-matched unrelated donor c. hla-mismatched familial donor * 18 years old or older, 70 years old or younger * adequate performance status (karnofsky score of 70 or more) * adequate hepatic and renal function (ast, alt, and bilirubin \< 3.0 x upper normal limit, and creatinine \< 2.0 mg/dl). * adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiogram) * signed and dated informed consent must be obtained from both recipient and donor. exclusion criteria: * presence of significant active infection * presence of uncontrolled bleeding * any coexisting major illness or organ failure * patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible * nursing women, pregnant women, women of childbearing potential who do not want adequate contraception * patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
chronic gastrointestinal sequelae of an acute outbreak of bacterial gastroenteritis in walkerton ontario

Conditions: Irritable Bowel Syndrome

Summary: acute bacterial dysentery leads to chronic symptoms of disturbed bowel habit in a minority of individuals. this condition known as post infectious irritable bowel syndrome (pi-ibs) remains poorly understood. this could allow material in the bowel to reach deeper tissues of the bowel wall leading to inflammation and changes in muscle and nerve function. this is also early evidence that genetic programming of people with pi-ibs prevents them from turning off inflammation once it begins. literature suggests that ibs may develop at greater rates in individuals with pro-inflammatory genotype and that these individuals may be at increased risk of inflammatory bowel diseases (ibd).

this research will study chronic gastrointestinal problems in the residents of walkerton, ontario region. determine whether acute bacterial infection is a risk factor for development of inflammatory bowel disease using the population of walkerton as a cohort. we hypothesize that exposure to bacterial infection leads to development of post infectious irritable bowel syndrome which is associated with an increase in intestinal permeability and immune activation with low grade intestinal inflammation and that this sequence of events will trigger inflammatory bowel disease in genetically susceptible individuals

Eligibility criteria:
inclusion criteria: * participants must be residents of the walkerton, ontario region at the time of outbreak who consented to the study exclusion criteria: * non residents of walkerton ontario at the time of outbreak

Keywords: residents of walkerton ontario at outbreak
investigation of the effect of conventional treatment on postural stability and balance in individuals with shoulder pain

Conditions: Shoulder Pain; Balance; Distorted

Summary: shoulder pain is one of the most common musculoskeletal complaints that people need treatment for. typical signs and symptoms include pain during reaching, muscle weakness, and interrupted sleep. the shoulder is one of the most common areas of pain, ranking third among musculoskeletal pains in the general population. there is a lack of information regarding the impact of shoulder-related problems on the general population, and therefore there is a growing interest in identifying adverse factors associated with shoulder problems. in our study, the postural stability and balance status of individuals with shoulder pain complaints will be evaluated and the effects of conventional treatment of shoulder pain on postural instability and balance parameters will be investigated.

the muscle that is important in lateral flexion of the trunk is the latissimus dorsi. there is a hypothesis that this muscle acts as a force transmitter from the gluteus maximus muscle to the upper extremity via myofascial connections. in the study of kaur et al., it was reported that the myofascial connection between the hip muscles and the lateral flexors of the trunk increases the serratus anterior muscle activation. therefore, deterioration in the performance of trunk muscles may affect the activation of the serratus anterior, resulting in decreased scapular upward rotation and posterior tilt, which may contribute to the development of pain and shoulder injury. decreased core endurance can result in poor transmission of force generated in the lower body to the upper body and may contribute to upper limb incorrect positioning. 40 individuals with shoulder pain symptoms were planned to participate in the study. the individuals included in the study were divided into two groups the treatment group and the control group. a 24-session physiotherapy program will be applied to the patients in the treatment group. pain, active joint range of motion, balance, and postural stability will be evaluated first week and eighth weeks.

Eligibility criteria:
inclusion criteria: * having a complaint of shoulder pain for at least 3 months * being between the ages of 19-60 exclusion criteria: * having had a surgical operation in the last 6 months, * having cognitive problems that prevent participation in exercises.

Keywords: shoulder pain balance postural stability