Kornimate/medical-research-clean huggingface dataset:
transitional care program in stroke patients with hemiplegia.

Conditions: Ischemic Stroke; Transitional Care; Hemiplegia

Summary: this study examines the effects of a transitional care program in stroke patients on self-care behavior, quality of life, and hospital readmission. the research conceptual framework is based on the transitional care model by naylor. sixty participants with stroke patients at charoenkrung pracharak hospital will be recruited. these participants are stratified by block randomization using nihss score and divided into 2 groups; a control group (n=30) and an intervention group (n=30). the program consisted of 2 phases: 1) phase i during hospital admission and 2) phase ii following hospital discharge

this study is to examine the effects of a transitional care program in stroke patients on self-care behavior, quality of life, and hospital readmission. the research conceptual framework base on transitional care model by naylor. sixty participants with stroke patients at charoenkrung pracharak hospital will be recruited. these participants are stratified block randomization using nihss score and divide into 2 groups; control group (n=30) and intervention groups (n=30). the program consisted of 2 phases: 1) phases i during hospital admission and 2) phases ii following hospital discharge for 4 weeks. the instruments used in this study for collecting the data are 1) the personal data form, 2) the self-care behavior questionare and 3) the stroke impact scale (sis) 3.0. data will be analyzed using descriptive statistics and two-way repeated measures anova. the result of this study will be used to develop guideline for nursing care in stroke patients during the transition from hospital to home. this program will help the patients improve their self-care, quality of life, and reduce hospital readmission

Eligibility criteria:
inclusion criteria: * age from 18 years old. * the first diagnosis is acute ischemic stroke. * hemiplegia * nihss 5-14 point (moderate impairment) * telephone and line application used. * can read and communicate in thai language * accept participants to research and inform consent. exclusion criteria: * aphasia * the six item cognitive impairment test: 6cit from 8 points in age from 60 years old. * participants with illness severity or dead during the study. * reject the study

Keywords: quality of life self-care behavior hospital readmission transitional care stroke patients
humoral immunodeficiency with rituximab and therapy with subcutaneous ig

Conditions: Secondary Immune Deficiency

Summary: to study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy) and have an abnormal immune system putting them at increased risk of infection.

the investigators propose evaluating patients with b cell non-hodgkin's lymphoma treated with rituximab within the past 2 years with baseline immunoglobulin levels and vaccine responses to polysaccharide (pneumococcus, meningococcus) and peptide (tetanus, diphtheria) antigens. patients with impaired vaccine responses may benefit most from immunoglobulin prophylaxis and will be proactively started on 20% subcutaneous replacement therapy. this study is novel in that it will stratify patients according to their humoral response to polysaccharide and peptide vaccines, and will proactively initiate therapy with the new 20% subcutaneous immunoglobulin in those with impaired humoral response rather than starting it after infections occur. this will potentially lead to decreased infections and improved quality of life.

Eligibility criteria:
inclusion criteria: 1. diagnosis of b cell non-hodgkin's lymphoma 2. medically stable 3. able to understand and willingness to sign a written informed consent 4. able to comply with study procedures exclusion criteria: 1. previously diagnosed primary immunodeficiency 2. additional immunosuppressive states 3. ongoing therapy with ig replacement

Keywords: rituximab non hodgkin's lymphoma subcutaneous immunoglobulin
4sc-202 in combination with pembrolizumab in patients primary refractory/non-responding to prior anti-pd-1 therapy

Conditions: Malignant Melanoma

Summary: phase ib/ii open-label, multi-center study with a priming cycle of 4sc-202 to evaluate the safety, tolerability and preliminary efficacy of combination treatment with 4sc-202 and pembrolizumab. a dose expansion cohort at the recommended phase two dose (rptd) will be added. adult patients with advanced (unresectable or metastatic) cutaneous melanoma primary refractory or non-responding to anti-pd-1 therapy as most current systemic anti-cancer therapy and for whom no standard therapy is available, will be enrolled. the last administration of anti-pd-1 therapy must have been performed within 6 months prior to screening.


Eligibility criteria:
main inclusion criteria: * patients with unresectable stage iii or stage iv cutaneous melanoma, as per american joint committee on cancer (ajcc) (version 8) staging system (must have been histologically confirmed at least once during course of disease). patients with metastatic tumor of unknown primary site and histology of melanoma are eligible. * patients must be primary refractory or non-responding to anti-pd-1 therapy (either as monotherapy or in combination with ipilimumab) * measurable disease by computer tomography (ct) or magnetic resonance imaging (mri) per immune-related response evaluation criteria in solid tumors (irrecist) 1.1 criteria, with longest diameter for non-nodal lesions ≥ 10 mm and ≥ 15 mm in short axis for nodal lesions * at least one tumor site (either primary site or metastasis) must be accessible for sequential biopsies and patient must consent to the 2 mandatory biopsies. this requirement is not applicable for continuous dosing schedules and may be waived by the sponsor in other individual cases. main exclusion criteria: * patients who achieved a cr or pr, during or after prior anti-pd-1 mono- or anti-ctla-4/anti-pd-1 combination therapy * patients with symptomatic brain metastases/central nervous system (cns) involvement * patients with inadequate organ function * therapy with agents known to prolong the qt interval and increase the risk for torsades de pointes

Keywords: cutaneous melanoma
a study of herceptin (trastuzumab) monotherapy in patients with metastatic urothelial cancer

Conditions: Urinary Tract Cancer

Summary: this study will evaluate the efficacy and safety of intravenous herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. the anticipated time on study treatment is until disease progression.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * metastatic urothelial cancer; * disease progression during or after 1 prior platinum-based chemotherapy; * measurable disease; * her2 overexpression (ihc \[2+\] or \[3+\]). exclusion criteria: * concomitant chemotherapy or immunotherapy; * active or uncontrolled infection; * solely cns metastases; * clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea; * co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
periodontal disease and cardiovascular disease

Conditions: Periodontal Diseases

Summary: to access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease.


Eligibility criteria:
inclusion criteria: * a minimum of 12 uncrowned teeth other than 3rd molars * age 18 to 75 years * informed consent exclusion criteria: * prosthetic heart valves * prosthetic joint replacement * previous infective endocarditis * requirement for antibiotic cover for dental treatment * current treatment with warfarin
corticosteroids for immune reconstitution inflammatory syndrome (iris)

Conditions: Immune Reconstitution Inflammatory Syndrome; Leukoencephalopathy, Progressive Multifocal

Summary: the objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (pml) while on natalizumab as measured by time-course change in functional status based on karnofsky performance status index through 6 months following the completion of plasma exchange (plex; or equivalent), survival at 6 months following the completion of plex (or equivalent), and incidence and severity of adverse events (aes) and serious adverse events (saes); to characterize the evolution of immune reconstitution inflammatory syndrome (iris) as measured by time course changes in global clinical impression of improvement (gci-i), symbol digit modalities test (sdmt), brain magnetic resonance imaging (mri), magnetoencephalography (meg), chemokines, cytokines, c-reactive protein (crp), john cunningham virus (jcv) load and cell count in cerebrospinal fluid (csf); and to characterize the time course elimination of serum natalizumab concentrations in the study population following the last plex (or equivalent) procedure.


Eligibility criteria:
key inclusion criteria: * must have been receiving natalizumab for multiple sclerosis (ms) prior to the diagnosis or suspicion of progressive multifocal leukoencephalopathy (pml). * subject must be willing to undergo or have completed plasma exchange (plex) prior to initiating study treatment. key exclusion criteria: * history of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ivmp corticosteroids iris progressive multifocal leukoencephalopathy immune reconstitution inflammatory syndrome pml
dx-8951f in treating women who have advanced or recurrent cancer of the cervix

Conditions: Cervical Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of dx-8951f in treating women who have advanced or recurrent cancer of the cervix.

objectives: * determine the antitumor activity of dx-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix. * evaluate the quantitative and qualitative toxic effects of this regimen in these patients. * evaluate the pharmacokinetics of this regimen in these patients. outline: this is a multicenter study. patients receive dx-8951f iv over 30 minutes daily for 5 days. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months until death. projected accrual: approximately 37 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy * measurable disease * no known brain metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm3 * platelet count at least 100,000/mm3 hepatic: * bilirubin no greater than 1.5 mg/dl * sgot or sgpt no greater than 2 times upper limit of normal (uln) (5 times uln if liver metastases present) renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no active congestive heart failure * no uncontrolled angina * no myocardial infarction within the past 6 months other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no concurrent serious infection * no other malignancy within the past 5 years except nonmelanomatous skin cancer * no other life threatening illness * no psychosis, mental disability, or incompetence prior concurrent therapy: biologic therapy: * no concurrent biologic therapy chemotherapy: * at least 4 weeks since prior chemotherapy * no more than 1 prior chemotherapy regimen (except chemotherapy for radiosensitization) * no prior camptothecin * no other concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy * no concurrent radiotherapy surgery: * at least 4 weeks since prior surgery * no concurrent surgery other: * at least 4 weeks since other prior investigational drugs (including analgesics or antiemetics) * no other concurrent investigational drugs during or within 28 days after final dose of study drug * no concurrent drugs that induce or inhibit cyp3a enzyme

Keywords: stage iii cervical cancer stage iv cervical cancer recurrent cervical cancer cervical squamous cell carcinoma
efficacy and safety of vildagliptin as add-on therapy to insulin in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: to assess the efficacy and safety of vildagliptin add-on therapy to reduce hba1c in patients with t2dm inadequately controlled by insulin, with or without concurrent metformin therapy.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of t2dm * on a stable dose of insulin as defined by the protocol * on a stable does of metformin (if applicable) as defined by the protocol * age 18 to 80 years * hba1c of 7.5 to 11.0% * body mass index (bmi) 22 to 40 kg/m2 exclusion criteria: * type 1 diabetes * short-acting or rapid-acting insulin * pregnancy or lactation * evidence of serious diabetic complications * evidence of serious cardiovascular complications * laboratory value abnormalities as defined by the protocol * other protocol-defined inclusion/exclusion criteria may apply

Keywords: add-on to insulin
evaluation of the effect of dapagliflozin in combination with metformin on body weight in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment * inadequate glycemic control, defined as hba1c ≥6.5% and ≤8.5% * ≥30 years for males * ≥55 years for females exclusion criteria: * type 1 diabetes * body weight change \>5% within 3 months prior to enrolment * renal and liver impairment

Keywords: dapagliflozin metformin type 2 diabetes body weight
the effect of environmental pollution on the prognosis of gastric cancer

Conditions: Gastric Cancers

Summary: gastric cancer is one of the common malignant tumours worldwide, with a high incidence especially in east asia. although the occurrence of gastric cancer is closely related to genetic factors, lifestyle and dietary habits, in recent years, environmental pollution, especially air pollution, has received more and more attention as a potential carcinogenic factor. numerous studies have shown that harmful substances in the air such as including passive smoking, soot and oil smoke exposure, incense burning exposure, occupational exposure and outdoor work, pm2.5, pm10, nitrogen oxides, sulphur dioxide, etc. may not only induce the occurrence of gastric cancer, but also affect the prognosis of gastric cancer patients. this experiment intends to determine the extent of the influence of air pollution on the prognosis of gastric cancer by analysing the survival data of gastric cancer patients in areas with different pollution levels. in addition, the association between air pollution levels and postoperative recurrence in gastric cancer patients was investigated to find possible mechanisms.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years; * patients diagnosed with gastric cancer by pathological biopsy before surgery; * patients without chemotherapy, radiotherapy, targeted and immunotherapy before enrolment; * willing to participate in this study and sign the informed consent; * complete clinical data. exclusion criteria: * patients with other primary malignant tumours other than gastric cancer; * patients with systemic diseases such as severe cardiopulmonary insufficiency that affect the choice of treatment plan; * patients who are not suitable for enrolment as assessed by the investigator; * incomplete clinical data.

Keywords: gastric cancer air pollution environment
evaluation of association between testosterone levels, dementia, and adverse mental health outcomes

Conditions: Anxiety Disorder; Depression; Genetic Disorder; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study evaluates the association between testosterone levels and risk of dementia and adverse mental health outcomes (e.g. depression and anxiety). it is not known whether low testosterone levels may be associated with an increased risk of dementia. learning about the association between testosterone levels and risk of dementia may help determine the long-term effects of androgen deprivation therapy and may help improve quality of life.

primary objective: i. to use a mendelian randomization study design to determine whether genetically predicted decreased testosterone levels are associated with an increased risk of dementia. secondary objective: i. to examine whether genetically predicted decreased testosterone levels are associated with worse cognitive function and adverse mental health outcomes. outline: patients' records from institutional or national biobanks are reviewed.

Eligibility criteria:
inclusion criteria: * have volunteered to participate in institutional or national biobanks, mainly the uk biobank and the kaiser permanente research bank, and those that have previously participated in studies that resulted in de-identified clinical and genetic data being make available on public archives, mainly the database of genotypes and phenotypes (dbgap) * no special populations (adults unable to consent, individuals not yet adults, pregnant women, or prisoners)
assessment of measurable residual disease in allo-hsct using digital polymerase chain reaction

Conditions: Acute Leukemia; MDS; MDS/MPN; CML

Summary: a research investigation into the efficacy of digital polymerase chain reaction (dpcr) for monitoring measurable residual disease (mrd) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (mds), and related hematological conditions.

this prospective clinical study focuses on patients diagnosed with leukemia, myelodysplastic syndromes (mds), and related hematological conditions post-allogeneic hematopoietic stem cell transplantation. the primary objective is to assess the efficacy of digital polymerase chain reaction (dpcr) in monitoring measurable residual disease (mrd), including markers such as bcr::abl, kmt2a, etc., as compared to other mrd monitoring methods such as conventional quantitative pcr or multicolor flow cytometry (mfc). key endpoints include the recurrence of mrd using conventional methods, hematological relapse, disease-free survival, overall survival, and non-relapse mortality.

Eligibility criteria:
inclusion criteria: * the presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by ngs or real-time pcr provided for posttransplant mrd monitoring. * neutrophil engraftment * received at least one mrd monitoring by digital pcr after hsct exclusion criteria: * patients who relapsed or died before the first digital pcr monitoring * patients only with mutations in dnmt3a, tet2, and asxl1 ("dta mutations") or only germline mutations

Keywords: dpcr mrd allo-hsct leukemia
nettopp: the development and evaluation of an app-based selective intervention for adolescents exposed to cyberbullying

Conditions: Cyberbullying

Summary: the aim of the project is to develop and evaluate an app-based intervention for adolescents who have been exposed to cyberbullying. the overarching goal is to offer a low-threshold intervention, called nettopp, that is easy accessible and free to use for every junior high school student who has experienced cyberbullying in norway.

the main aim of the intervention is to increase coping strategies for adolescents who have been exposed to cyberbullying. more specifically the aims are to increase 1) knowledge about cyberbullying, 2) help-seeking behavior, 3) coping strategies with cyberbullying, 4) to reduce mental health problems, and 5) cyberbullying, and 6) to increase self-esteem and the 7) sleeping quality of the adolescents. to evaluate the mobile application three studies will be conducted: a lab test, a pilot study, and a larger effectiveness study with a follow-up examination after 3 months. the lab test will be conducted to examine the quality of the prototype of the app in order to find out if adjustments have to be made. thereafter, a pilot study will be conducted with adolescents that were exposed to cyberbullying in the past six months. the pilot study will use a pre-post design.the effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.

Eligibility criteria:
inclusion criteria: * adolescents whose guardians have given consent and who agree to take part in the study exclusion criteria: * severe developmental or cognitive challenges

Keywords: cyberbullying cyberaggression mobile application
umbilical cord blood-derived mesenchymal stem cells for the treatment of steroid-refractory acute or chronic graft-versus-host-disease

Conditions: Graft-Versus-Host Disease; GVHD; Allogeneic Hematopoietic Transplant; Disorder Related to Transplantation

Summary: graft-versus-host-disease (gvhd) is a major complication following allogeneic hematopoietic stem cell transplantation (allo-hsct) which may cause acute life-threatening morbidity or chronic disabilities. although corticosteroid, the primary agent to treat gvhd, may be effective for some patients, outcomes of those who are refractory to corticosteroid are dismal. secondary agents can be used for steroid-refractory cases; however, their efficacy is variable and usually limited. the quality of life issue of chronic gvhd is especially important for pediatric survivors who have longer life expectancy than adults. many in-vitro and in-vivo data support immunoregulatory properties of mesenchymal stem cells(mscs)and possibilities of treating diseases caused by immune dysregulation such as gvhd. recent data revealed that bone marrow-derived mscs were very useful to treat steroid-refractory acute gvhd, which led to improved overall survival compared with controls. more recently, a number of reports suggest mscs may also be useful in treating chronic gvhd as well as acute gvhd. it has been also reported that third party mscs are also useful as well as those from autologous or hla-matched donors. the investigator recently demonstrated that mscs obtained from umbilical cord blood (ucb) have similar immunosuppressive properties as bone marrow-mscs. ucb-mscs can be obtained without doing any harm to donors that it may be more appropriate source of mscs than bone marrow for off-the-shelf use. however, little is known about the safety and efficacy of ucb-mscs in treating gvhd. therefore, the investigator designed this study to evaluate the safety and efficacy of ucb-mscs in treating pediatric patients with steroid-refractory acute or chronic gvhd.


Eligibility criteria:
inclusion criteria: * steroid-refractory acute or chronic graft-versus-host-disease * acquisition of consent form * 0-30 years of age exclusion criteria: * withdrawal from the study * progression of underlying hematologic diseases * severe adverse effects related to the investigational drug

Keywords: graft-versus-host disease gvhd hematopoietic stem cell transplantation stem cell transplantation allogeneic hematopoietic transplant mesenchymal stem cells unrelated donors cord blood stem cell transplantation