Kornimate/medical-research-clean huggingface dataset:
expanded access program (eap) for nusinersen in participants with infantile-onset (consistent with type 1) spinal muscular atrophy (sma)

Conditions: Infantile-onset Spinal Muscular Atrophy

Summary: to provide access to nusinersen to eligible patients with infantile-onset spinal muscular atrophy (sma) (consistent with type 1) to address a high-unmet medical need.

the nusinersen expanded access program (eap) is available at approved treatment centers in select territories. a doctor must decide whether nusinersen treatment is appropriate for each patient, based on the patient's medical history and program eligibility criteria. a full list of participating treatment centers is provided in the 'contacts and locations' section of this listing, and is regularly updated. following local approval and official reimbursement of nusinersen in each territory, the eap will close and patients will transfer to commercially available drug.

Eligibility criteria:
key inclusion criteria: * genetic documentation of 5q sma homozygous gene deletion, homozygous mutation, or compound heterozygote. * onset of clinical signs and symptoms at ≤ 6 months (180 days) of age, consistent with infantile onset, type i sma * patient whose care in the opinion of the treating physician meets, and is expected to continue to meet, the guidelines set out in the 2007 consensus statement for standard of care in sma key exclusion criteria: * patient is qualified to participate in an ongoing clinical trial with nusinersen * participation in a prior nusinersen study * previous exposure to nusinersen * history of brain or spinal cord disease that would interfere with the lp procedures or csf circulation * presence of implanted shunt for the drainage of csf or implanted cns catheter * previous or current participation in a clinical trial with an investigational gene therapy for sma * participation in a study with an investigational therapy for sma within 6 months or five half-lives of the investigational drug, whichever is the longer, prior to the first dose of nusinersen. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: spinal muscular atrophy sma smn smnrx isis-smnrx isis-smn rx isis 396443 isis-396443 endear ionis-smnrx ionis-smn rx embrace nurture ionis biogen shine nusinersen
clinical outcomes following surgical debridement of diabetic foot infection with borderline vascularity

Conditions: Chronic Limb Threatening Ischemia

Summary: observe timing to complete healing of wounds \& limb salvage in both cohorts those who are undergoing debridement only and those who are undergoing debridement plus pta

secondary aims of the study include length of hospital stay , necessity of further intervention(whether a revascularization procedure or more debridement sessions) , incidence of mace (major adverse cardiovascular events) in both groups

Eligibility criteria:
inclusion criteria: * patients will be included in this study are those suffering from dfus; and borderline ischemia (bli) / borderline vacularity with (rutherford grade "i" categories "2\&3") when they have a borderline ankle systolic pressure exclusion criteria: * all patients with (cli) and dfus as they are indicated for urgent re-vascularization. severely infected/ gangrenous wounds requiring amputation hindering possible limb salvage. lesions lying within or adjacent to an aneurysm; non diabetic cases with foot ulcers; arteritic lesions;(vasculitic patients). patients had prior major amputation, bypass surgery, and endarterectomy on any vessel of the ipsilateral (target) extremity
is the short physical performance battery a useful outcome measure in chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Pulmonary Emphysema; Bronchitis, Chronic; Lung Diseases; Disease Progression

Summary: patients with chronic obstructive lung disease (copd) often develop muscle problems, particularly in their legs which makes them more limited in what they can do. the short physical performance battery (sppb) is a simple test of standing balance, usual walking speed and ability to stand from a chair. the sppb may be a useful measure to predict leg function. this study aims to evaluate whether the sppb is comparable with current exercise tests used in copd patients, and whether it is useful in predicting disability, death and health resource usage over time.


Eligibility criteria:
inclusion criteria: * diagnosis of copd exclusion criteria: * any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause (eg. motor neurone disease), severe peripheral vascular disease or amputation * any patient whom is deemed unsafe to exercise * patients unable to complete the sppb, walking tests and leg strength assessments.

Keywords: cohort studies longitudinal studies
compliance of compression therapy in healed venous ulcerations

Conditions: Venous Insufficiency

Summary: this study seeks to determine if compliance with compression therapy is increased in patients with healed venous insufficiency ulcerations when lower levels of compression therapy are prescribed. this study will measure compliance with compression therapy at low levels of compression. it will also seek to determine if compression therapy aids in the prevention of venous insufficiency ulcer recurrence.

this study looks to determine if patients with a history of venous insufficiency and recently healed venous insufficiency ulcerations are compliant with lower levels of compression therapy. it also seeks to evaluate the efficacy of compression therapy in the prevention of recurrence of venous insufficiency ulcerations.

Eligibility criteria:
inclusion criteria: * recently healed venous insufficiency ulcerations * history of venous insufficiency * patient from uh richmond wound care center (recently discharged/healed venous ulcerations) exclusion criteria: * children * patients with diagnosed arterial insufficiency or abi less than 0.5 * patients that are diagnosed with congestive heart failure and not cardiac cleared * patients with paralysis or incapacitated physically or mentally (due to inability to apply compression stockings)

Keywords: venous insufficiency venous stasis ulcerations compression stockings compression stocking compliance
the natural history of viral upper respiratory infections in children aged 6 to less than 14 years

Conditions: Upper Respiratory Infection; Common Cold

Summary: this study examines the cold processes of children aged 6 to less than 14. children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. nasal secretions will be examined for chemicals that the body creates during a cold. skin cells will be collected by brushing the inside of the child's cheek with a small brush. the cells will be examined for genes that may hold control the creation of these chemicals.

leukotrienes are chemicals that are naturally made by your body. leukotrienes are increased in the bodies of adults and children with asthma and allergies and cause some of the symptoms of these diseases. leukotrienes are increased in the bodies of adults who have common colds and are believed to cause some of the symptoms of the common cold. it is not known if increases in leukotrienes are related to the symptoms of the common cold in children. there are also genes that may control levels of leukotrienes and other chemicals in your body during the common cold. if you enroll your child in this study, he/she will be tested for allergies and for genes that may control the levels of leukotrienes and other chemicals. study design: there will be 40 subjects enrolled into the study between the ages of 6 to \< 14 years of age. however, approximately 80 participants may have to sign the consent form and undergo screening activities in order enroll these 40 subjects. the study will last approximately 1 month and will require you and your child to return to our clinic approximately 7 times over the study duration. you and your child will be required to return to our clinic six days in a row for testing. testing will include skin testing for allergies, nasal secretion collection, and skin cell collection.

Eligibility criteria:
inclusion criteria: * children 6 to \< 14 years of age. * common cold symptoms for less than 24 hours. * at least 2 of the following 8 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, and sneezing. exclusion criteria: * investigational medication in past 30 days. * history of persistent asthma or other chronic diseases. * patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction. * patients with evidence of significant nasal septal deviation. * patients with a positive rapid antigen test for streptococcal infection. * common cold symptoms for more than 24 hours.

Keywords: upper respiratory infection common cold
"diagnostic yield and safety of transbronchial lung biopsy using cryoprobes versus conventional forceps.

Conditions: Interstitial Lung Disease

Summary: transbronchial lung biopsy (tblb) is a bronchoscopic procedure used to obtain peripheral lung tissue. small size and artefacts cause variable, and usually poor, diagnostic yield. the use of cryoprobes may allow for larger size and better quality biopsy samples. objectives:to analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with tblb obtained by conventional forceps and to assess the safety and complications of tblb with cryoprobe versus the conventional method. methodology: prospective randomized study of 80 patients. the transbronchial lung biopsy was indicated for diagnoses of a interstitial lung disease. in both procedures the videobroncoscopy used will be a olympus 260-t. the transbronchial lung biopsy will be carried out with conventional forceps (boston ® biopsy forceps, ref 1556 and olympus ® fb-19e) and cryoprobe (erbokryo ac ®). tblb will be performed by fluoroscopy guided and the cryoprobe or forceps will place in an area of the peripheral lung previously selected according to ct findings. lung biopsies will be processed: the samples submitted for histological analysis will be fixed in formalin and embedded in paraffin. staining will perform with hematoxylin-eosin and masson's trichrome and the samples will be analyzed by a pathologist according to a protocol. the samples submitted to immunohistochemical study will be frozen (liquid nitrogen) for later transport.the specifical monoclonal antibodies will be used for immunohistochemical analysis.


Eligibility criteria:
inclusion criteria: * patients with interstitial lung disease. exclusion criteria: * respiratory failure,haemodynamic instability, haemoptysis.
zanubrutinib combined with rituximab and chemotherapy for newly-diagnosed pcnslbcl patients intolerant to hsct

Conditions: PCNSL

Summary: this single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing zanubrutinib on the basis of rituximab and methotrexate (mtx) \[or temozolomide (tmz), if intolerant to mtx\] in treating patients newly diagnosed with primary cns large b-cell lymphoma and intolerant to hsct.

participants will receive zanubrutinib in addition to first-line therapy consisting of rituximab and either mtx or tmz. after treatment of 6 cycles with the new regimen, the patients achieving cr or pr would go on to receive zanubrutinib maintenance of 1 year (if tolerable).

Eligibility criteria:
inclusion criteria: * 18 to 80 years old; * histopathologically confirmed cd20 positive primary large b-cell lymphoma of the central nervous system (cns) or primary vitreoretinal lymphoma according to the 5th edition of the world health organization (who) classification of haematolymphoid tumours \[primary large b-cell lymphoma of the cns previously named as primary diffuse large b-cell lymphoma (dlbcl) of the cns in the revised 4th edition\]; * life expectancy of \> 3 months (in the opinion of the investigator); * creatinine clearance rate (ccr) ≥ 50 ml/min or estimated glomerular filtration rate (egfr) ≥ 60 ml/(min·1.73 m\^2); * international normalized ratio (inr) ≤ 1.5 and activated partial thromboplastin time (aptt) ≤ 1.5 times the upper limit of normal; * left ventricular ejection fraction (lvef) ≥ 50%; * agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative. exclusion criteria: * pregnant or lactating women; * known hepatitis b virus (hbv) and/or hepatitis c virus (hcv) infection (hbv infection refers to hbv-dna \> detectable limit); * with acquired or congenital immunodeficiency; * with congestive heart failure in 6 months before enrollment, new york heart association (nyha) heart function class iii or iv, or lvef \< 50%; * known to be allergic to the test drug ingredients; * diagnosed with or being treated for malignancy other than lymphoma; * with severe infection; * substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; * deemed unsuitable for the group.

Keywords: pcnsl zanubrutinib
decompression and drainage seton in the treatment of high complex anal fistula

Conditions: High Complex Anal Fistula

Summary: this study aimed to compare the efficacy of the decompression and drainage seton (dads) and cutting seton (cs) in the treatment of high complex anal fistula.


Eligibility criteria:
inclusion criteria: * high trans-sphincteric cryptoglandular anal fistulas (involving \>30% of the eas muscles evaluated through magnetic resonance imaging (mri) scan, endoanal ultrasonography) * suprasphincteric fistulas were enrolled exclusion criteria: * low anal fistula; -non-glandular anal fistulas, such as tuberculous anal fistula and crohn's anal fistula; - * patients with symptoms of fecal incontinence; * a previous history of anal fistula surgical treatment; * patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
the efficacy and safety of shr-1314 in the treatment of pediatric patients of age 6 to <18 years with moderate to severe plaque psoriasis

Conditions: Children and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque Psoriasis

Summary: the purpose of this study is to assess efficacy, safety of subcutaneous shr-1314 in pediatric patients of age 6 to \<18 years with moderate-to-severe plaque psoriasis


Eligibility criteria:
inclusion criteria: 1. between 6 and 18years of age at time of screening. 2. chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization. 3. moderate to severe psoriasis as defined at baseline/ randomization by: pasi score of 12 or greater, and spga score of 3 or greater (based on a static scale of 0 - 5), and body surface area (bsa) affected by plaque psoriasis of 10% or greater. exclusion criteria: 1. forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or baseline/randomization. 2. drug-induced psoriasis. 3. had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (week 0). 4. presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the investigator could interfere with assessment of psoriasis. 5. history of inflammatory bowel disease or have other ongoing active autoimmune diseases. 6. at screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. history of congestive heart failure (new york heart association \[nyha\] functional classification ≥iii), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the investigator prevents the subject from participating in the study. 8. active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization. 9. history of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the columbina suicide severity rating scale (c-ssrs) at screening and baseline (posner k et al, 2011), the subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide. 10. all subjects will be tested for tuberculosis status using igra and x-ray test. 11. have evidence of positive test for hepatitis b, hepatitis c antibody, or human immunodeficiency virus (hiv) antibodies. 12. have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
auricular stimulation for relief of stress and anxiety

Conditions: Stress and Anxiety

Summary: the aim of the study is to evaluate whether auricular stimulation (percutaneous sensory stimulation of cranial nerves) as compared vs. no intervention (waiting list) reduces stress and anxiety in health care providers, working at the time of covid-19 pandemic at the university medicine of greifswald.


Eligibility criteria:
inclusion criteria: 1. medical care workers at the university medicine of greifswald 2. experiencing stress and anxiety in connection with covid-19 pandemic 3. participants without previous anxiolytic medication 4. ability to understand and fill in the structured questionnaire (appendix d \& e) 5. written informed consent exclusion criteria: 1. recidivist alcoholics 2. local auricular skin infection 3. pregnant or lactating women 4. participants with prosthetic or damaged cardiac valves and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of aha) 5. participants who are unable to understand the consent form 6. history of psychiatric disease
midas: minimal-dataset for the assessment of surgical outcomes - potential in hip surgery

Conditions: Hip Injuries

Summary: swiss legislation requires health service providers to collect such information. of medical quality indicators as part of the quality and performance audit (article 22a kvg). in addition, comparisons of clinics or specialist specialists on cost and quality of results are required (art. 49 (8)). currently, the quality of a medical therapy is evaluated rather negatively on the absence (or occurrence) of complications. in contrast, however, the goal of therapy must be to improve or maintain the health-related quality of life (hrqol). accordingly, the swiss society of surgery (sgc-ssc), in collaboration with the association for quality assurance in surgery (aqc), has developed a minimum dataset designed to assess the quality of life of patients after surgical intervention. in order to enable switzerland to be comparatively independent of the discipline, generic (in the research plan - midas -v2, date 24.05.2017 page 5/57 contrary to disease-specific) survey instruments proposed that cover the general quality of life in its different facets, regardless of the function of individual organ systems. the complication documentation was not completely abandoned in this proposal, but is only a quality indicator among many due to patient-related outcome measurements. however, the development of a minimal data set with quality indicators that are applicable across all surgical sub-disciplines for evaluating the quality of treatment of acute and chronic diseases raises a number of fundamental questions that can only be answered to a limited extent without empirical studies. five essential questions are: i. is it sufficient to work with generic quality of life tools or is it necessary to use disease / indication specific instruments or functional tests? ii. which is the best, solid time for a follow-up? iii. is it possible and useful to make a third-party determination of the quality of life in patients with limited cognitive abilities? iv. which preoperative risk factors should be documented so that sufficient adjustment for case mix differences in hospital comparisons can be made? v. which perioperative and postoperative factors, in particular complications, must be raised beyond the quality of life, as they reflect an independent aspect of quality?


Eligibility criteria:
inclusion criteria: - standard therapy of one of the following diagnoses * femoral neck fracture after low-energy trauma (implantation of a head endoprosthesis) * coxarthrosis (implantation of a total hip prosthesis) exclusion criteria: * rejection of study participation or standard therapy * patients who are unlikely to attend routine follow-up (e.g., tourists) * patients in palliative care * malignancy (known or diagnosed in the course of time) * patients with a limited knowledge of german, who can answer the questionnaire even with the help of a study nurse seems unrealistic * participation in an interfering clinical intervention study within the last three months * persons unable to consent (long-term incapacity to consent)
effectiveness of theobromine toothpaste

Conditions: Dental Plaque; Dental Care

Summary: since plaque control forms the basis for caries prevention, the type of toothpaste and its constituents becomes more important. toothpaste containing fluoride are widely popular and fluorides have been historically reported to have effects against dental caries. however, the fluoride safe doses are still discussed ,because fluoride has toxicity and causing fluorosis. the aim of the current research is to find alternative agent that can be used without side effects.

participants will be examined to ensure that they have met the smple entrey criteria,then the participants will be randomly assigned to four groups each one according to a group: 1. a group of children using low-fluoridated toothpaste (500ppm) 2. a group of children using fluoridated toothpaste (1450ppm) 3. a group of children using theobromine toothpaste (2%) 4. a group of children using low-fluoridated toothpaste (4%) the researcher will teach the participants how to brush using (tell-show-do)technique. * the brushing method that will be used is the fones technique. * brushing duration must be 2minutes. * frequency of brushing must be twice a day * the amount of toothpaste used is pea size. mechanism of examination and follow up: a thorough scaling and plaque removal was conducted and the children were advised to brush their teeth using their regular toothpaste for a week before starting the research. gingival will be evaluated with gingival index (loe and silness)

Eligibility criteria:
inclusion criteria: * children of age group 6to 9 years. * participant must have least 20 teeth free from dental cries on both buccal and lingual surfaces of the teeth. * cooperative children having behavioral rating (positive or definitively positive)according to frankel's behavior rating scale. * children who are not on any medication prior or during the study period exclusion criteria: * children with systemic diseases and medically compromising conditions. * children undergoing orthodontic treatment or with an intraoral prosthesis. * children who could not brush their teeth or rinse on their own. * allergic to any of the toothpaste ingredient used the study.

Keywords: dental primary prevention theobromine toothpaste fluoridated toothpaste