Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of iguratimod in the treatment of steroid-resistant/relapse immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: a phase 2, open-label, single-arm study to evaluate the efficacy and safety of iguratimod for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (itp)

the investigators are undertaking an open-label, single-arm study of 100 adults with steroid-resistant/ relapse itp in china. patients were received iguratimod treatment. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * primary immune thrombocytopenia (itp) confirmed by excluding other supervened causes of thrombocytopenia; * platelet count of less than 30×10\^9/l at enrollment; * patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation; * 18 years older; exclusion criteria: * secondary immune thrombocytopenia (e.g., patients with hiv, hcv, helicobacter pylori infection or patients with systemic lupus erythematosus) * congestive heart failure * severe arrhythmia * nursing or pregnant women * aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria * creatinine or serum bilirubin levels each 1•5 times or more than the normal range * active or previous malignancy * unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
multidisciplinary treatment of chronic vulvar pain

Conditions: Vulvodynia; Chronic Pain

Summary: vulvodynia (i.e. chronic vulvar pain without identifiable cause) is a heterogeneous clinical entity with a complex multifactorial causation. it is long lasting and difficult to treat, and the general consensus of current guidelines states that patients with vulvodynia benefit from a compound multidisciplinary intervention targeting mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. however, there is little empiric evidence to support this recommendation. this will be a randomized controlled trial comparing multidisciplinary treatment with standard care for women with vulvodynia.

patients with chronic vulvar pain constitute a heterogeneous group with regards to causes and moderators of pain. multidisciplinary teams simultaneously assess contributing factors such as infections and dermatoses and treat known mediators of pain, namely mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. treatment as usual, on the other hand, is primarily based on a sequential model applying one type of treatment at a time. the investigator's aim is to compare multidisciplinary treatment including multimodal physiotherapy (intervention group) with standard treatment (control group) in reducing pain, sexual dysfunction and related symptoms in women with vulvodynia. the study sample will be allocated randomly 1:1 to multidisciplinary treatment by a vulva team or to standard treatment by a specialist in gynaecology. the intervention will include a joint consultation by a gynaecologist and a dermatologist, tailored multimodal physiotherapy by a physiotherapist and guided imagery (mindfulness and relaxation) by use of a sound track during home sessions. the controls will receive standard care by a gynaecologist, who is free to offer any kind of non-standardized treatment. treatment effect will be measured at 3 months and at 6-12 months after inclusion.

Eligibility criteria:
inclusion criteria: * women aged 18 years and older * chronic vulvar pain for ≥3 months of duration exclusion criteria: * insufficient norwegian skills * intellectual disability or severe mental disorder * severe comorbidity making tailored care necessary (such as active cancer treatment)

Keywords: physical therapy modalities
simultaneous versus sequential antiretroviral therapy (arv) therapy and mycobacterium tuberculosis (mtb) treatment

Conditions: HIV; AIDS; Tuberculosis

Summary: the purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral therapy versus 2 month deferred anti-tb therapy upon the clinical course of tuberculosis and hiv infection in patients with aids and active tuberculosis.

aids and tuberculosis are two international and national priority public health problems. the best time for starting antiretroviral therapy in patients with aids and active tuberculosis is not clear, despite of the guidelines regarding cd4+ count. the debate surrounding this issue is mainly due to the difficulty among adherence of anti-mtb and anti-hiv treatment, the pharmacological interaction, the adverse events related to drugs and the risk of inflammatory reconstitution syndrome, especially in patients with advanced hiv infection. moreover, there is great debate upon the lack of knowledge of the degree of immune reconstitution throughout time against mtb induced by the anti-hiv therapy.

Eligibility criteria:
inclusion criteria: * hiv infected * \< 200 cd4+ cells/ml * active pulmonary tuberculosis (with or without extrapulmonary involvement) exclusion criteria: * meningeal tuberculosis * unable to attend 96 wk follow-up

Keywords: enzyme-linked immunospot deferred treatment immune recovery inflammatory syndrome
reflexology and quality of life

Conditions: Diabetic Foot

Summary: this is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients divided into 2 groups of 30 patients each, control group (cg) and treatment group (tg). the tg will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the cg will only receive the guideline.

the purpose of this study is to evaluate the effects of reflexology on the quality of life and functional capacity of patients at risk for diabetic neuropathy. this is a randomized, controlled and blind clinical trial with type 2 diabetes patients. the eligibility criteria are 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the primary health care unit of são joão or in the diabetes education center in minas gerais state, brazil. as exclusion criteria, it will be considered the presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology. for the calculation of the sample size, a pilot test will be conducted with 8 diabetic patients. it will be used the statistical software biostat® 5.3. the sample found was of 60 patients who were divided into 2 groups of 30 patients each, control group (cg) and treatment group (tg). the tg will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the cg will only receive the guideline. for the evaluations, it will be applied the instrument for quality of life (sf-36) and for functional capacity, the stanford health assessment questionnaire. this research will follow the standards set by resolution 466/12 of the national health council, for research with human beings and will be conducted in accordance with the ethical recommendations of the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the primary health care unit of são joão or in the diabetes education center in minas gerais state, brazil. exclusion criteria: * presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology

Keywords: reflexology,diabetes, quality of life
revlite laser system compared to the candela alex trivantage system refractory mixed type melasma

Conditions: Melasma

Summary: this proof of concept study will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two fda 510k approved devices: q switched nd: yag laser vs. alex trivantage


Eligibility criteria:
inclusion criteria: 1. subjects with fitzpatrick skin type iii-vi 2. subjects with mixed (epidermal and dermal) type melasma diagnosed by wood's lamp. 3. subjects who are over the age of 18 years of age 4. the subject is willing and able to comply with study instructions and return to the clinic for required visits. 5. the subject's melasma has persisted for greater than 6 months and has failed to respond to conventional treatment with hydroquinone cream or other topical lightening agents. exclusion criteria: 1. the subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 2. the subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis. 3. the subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy. 4. the subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy). 5. the subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. the subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering this study. 7. the subject has used photosensitizing drugs (e.g., declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present. 8. the subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. the subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. the subject has diabetes type 1 or 2. 11. the subject has a sensitivity to hydroquinone or retin-a. 12. the subject has evidence of a compromised immune system or hepatitis. 13. has had microdermabrasion in past 3 months, other laser or intense pulsed light treatment or chemical peels to the face in past 6 months, injectable fillers, topical retinoids, over-the-counter anti-aging products past 2 weeks. 14. has a history of keloids or hypertrophic scarring 15. has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study
assessing the right heart remodeling after transcatheter tricuspid edge-to-edge repair

Conditions: Tricuspid Regurgitation

Summary: in the recent years, secondary tricuspid regurgitation (str) has gained interest due to its high prevalence and impact on outcomes. transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter tv replacement systems using orthotopic valve implantation. (5) among leaflet approximation techniques, the tricuspid transcatheter edge-to-edge repair (t-teer) using the triclip™ (abbott vascular, santa clara, ca, usa) or leaflet approximation with the pascal systems (edwards lifesciences, irvine, ca, usa) are approved in europe for minimally invasive tv repair.the purposes of the present study are: i. to use 3de and cct to evaluate the effect of t-teer on the geometry and function of the right heart chambers in patients with str; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and tr jet; iii. to compare the accuracy of 3de assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by cct, in the setting of t-teer; and iv. to assess patients' outcome.


Eligibility criteria:
inclusion criteria: * age\> 18 years * severe str, amenable to percutaneous treatment with t-teer * acceptance to be part of this study by signing the informed consent * good enough acoustic window and ability to cooperate in order to obtain 3d echo data sets of cardiac structures with a minimum temporal resolution of 20 fps * availability for clinical, cct and, echocardiography follow-up visits exclusion criteria: * pregnancy * severe chronic kidney disease (gfr \&lt;30 ml/min) * hypersensitivity reactions to contrast media * cardiovascular implantable electronic device-related (cied) tricuspid regurgitation. * bad acoustic window with inadequate echocardiographic images.
accelerating newborn survival in ghana through a low-dose, high-frequency health worker training approach

Conditions: Stillbirth; Neonatal Death

Summary: this study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in ghana.

in-service training for skilled birth attendants (sbas) is one of the most common interventions to address lack of knowledge and skills. however, these training interventions are seldom evaluated for effectiveness in improving learning or performance. this study study is a cluster-randomized waitlist trial implemented in 40 public and mission hospitals in ghana. it assesses the effect of a low-dose, high-frequency (ldhf) training approach to update hospital-based sbas in key evidence-based intrapartum and immediate newborn care practices, using current global guidelines.the ldhf approach includes two 4-day onsite sessions (low dose) with weekly practice sessions, sms quizzes and reminders, and mentoring via mobile phone and onsite visits between trainings (high frequency). the low-dose sessions include competency acquisition through simulation, case-based learning, and small content packages spread over short time intervals. eligible hospitals will be stratified by geographic region and caseload, and then randomly assigned to one of four implementation waves. the pipeline randomization allows for rigorous evaluation while the program is rolled out to all facilities.

Eligibility criteria:
inclusion criteria - facilities: * public or faith based hospital * at least three skilled birth attendants on staff * at least 30 births per month exclusion criteria - facilities: * private hospital * public or faith based hospital with less than three skilled birth attendants on staff * public or faith based hospital with less than 30 births per month inclusion criteria - service providers: \* health providers who attend births in participating health facilities and consent to be assessed at the time of enrollment and at several points in time over the study period exclusion criteria - service providers: \* health providers who decline to participate

Keywords: institutional delivery
extension study of ec145 (vintafolide) for subjects enrolled in a previous study with ec145 (mk-8109-010)

Conditions: Solid Tumors

Summary: this extension protocol is for those subjects that have completed the allowed duration of participation in an endocyte-sponsored clinical trial of ec145 (vintafolide) and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.

this extension protocol is for those subjects that have completed the allowed duration of participation in an endocyte-sponsored clinical trial of ec145 and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study. following confirmation of eligibility, subjects will receive intravenously-administered ec145 at a dose of 2.5 mg. dosing will occur on monday, wednesday, and friday of weeks 1 and 3 of each 4-week cycle. no therapy will be administered during weeks 2 and 4. subjects randomized to non-ec145-containing treatment arms of ec145 trials are not eligible for this study.

Eligibility criteria:
inclusion criteria: * must have received prior treatment with ec145 within the context of an endocyte-sponsored, irb-approved clinical trial. * disease (i.e., cancer) that was considered "stable" at the last evaluation while participating in the previous ec145-containing study. "stable" is defined as not having progression of disease per standard criteria (recist, etc). stable disease may be indicated by previously attained complete or partial tumor shrinkage that has not progressed per standard criteria. * no more than 10 weeks have elapsed since the last evaluation of "stable disease". * eastern cooperative oncology group (ecog) performance status of 0 to 2 * must have recovered (to baseline/stabilization) from prior ec145-associated acute toxicities. * adequate bone marrow reserve, hepatic, and renal function. * negative serum pregnancy test for women of childbearing potential * willingness to practice contraceptive methods for men and women of childbearing potential. exclusion criteria: * pregnancy. * development of a secondary malignancy requiring treatment. * symptomatic central nervous system (cns) metastasis. * history of receiving any investigational treatment or other systemic therapy directed at controlling cancer since the subject's last dose on the parent ec145 study.

Keywords: cancer adenocarcinoma phase ii lung non-small cell lung cancer nsclc extension ec145 prior exposure to ec145
effect of pechakucha (pk)presentation method on nursing students' satisfaction level with deep breathing and cough exercise skills and education method

Conditions: PechaKucha Presentation; Traditional PowerPoint Presentation

Summary: abstract aim: the aim of this study is to examine the effect of the pk presentation method on nursing students' deep breathing and cough exercise skills and the students' level of satisfaction with this method. design: the sample of the study consisted of students studying in the 2nd year of the nursing department of a foundation university and taking the fundamentals of nursing course (n=96). experimental (n=48) and control (n=48) groups were determined using a randomization program. while the students in the experimental group were taught deep breathing and cough exercises with the pk presentation method, the control group was trained with a traditional power point presentation. as data collection tools, student information form, deep breathing and cough exercise skill checklist and visual analog scale measurement tool were used to determine the level of satisfaction with the training method. keywords: pechakucha, nursing students, respiratory exercise, satisfaction


Eligibility criteria:
inclusion criteria: * inclusion criteria taking the fundamentals of nursing course for the first time attending the course on the day of the course exclusion criteria: * students taking the course for the second time and those who did not attend the course on the day of the training were excluded from the study.

Keywords: pechakucha nursing students breathing exercise satisfaction,
sintilimab and bevacizumab biosimilar combined with pld in mtnbc

Conditions: Breast Cancer

Summary: to evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer


Eligibility criteria:
inclusion criteria: * patients aged 18-70 years old. * metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage iv breast cancer, and recurrent metastatic breast cancer. * er and pr negative, her2 negative breast cancer. * received one or two lines of systemic treatment in metastatic setting * measurable disease based on recist 1.1. * ecog performance status 0-1 * adequate hematological, renal and hepatic function according to all of the following laboratory values exclusion criteria: * has received any prior therapy with an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent * has received any prior therapy with bevacizumab. * has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) * has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy * has known active central nervous system (cns) metastases and/or carcinomatous meningitis * has a known history of hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipient * has an active autoimmune disease that has required systemic treatment * has a history of (non-infectious) pneumonitis that required treatment with steroids; or current pneumonitis. * has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. * has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * has been pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment. * failure to comply with the study procedures, restrictions and requirements of the study