Kornimate/medical-research-clean huggingface dataset:
tacrolimus plus glucocorticoid for severe thrombocytopenia in ss

Conditions: Sjogren Syndrome With Other Organ Involvement

Summary: this 12-week randomized, open-label study evaluates the efficacy and safety of tacrolimus combined with glucocorticoid for sjogren's syndrome patients with severe thrombocytopenia.

this study evaluates the efficacy and safety of tacrolimus combined with glucocorticoid for the treatment of severe thrombocytopenia in sjogren's syndrome patients.

Eligibility criteria:
inclusion criteria: * diagnosis of sjogren's syndrome according to the 2002 revised american-european consensus group (aecg) criteria. * baseline platelet counts less than 30×109/l. exclusion criteria: * concomitant other systemic autoimmune diseases. * other severe complications of sjogren's syndrome. * abnormal laboratory tests such as: white blood cell count \ 1.5 uln, serum creatine \> 1.5 mg/dl. * received glucocorticoids, immunosuppressants, or biological agents within 3 months. * active acute or chronic infections. * history of malignancy. * pregnancy or breastfeeding.

Keywords: sjogren's syndrome thrombocytopenia tacrolimus
researching the effectiveness of attexis, a digital health application for adults with attention deficit hyperactivity disorder

Conditions: Adult Attention Deficit Hyperactivity Disorder

Summary: in this randomized controlled clinical trial, 326 patients with adhd will be investigated regarding the effectiveness of a digital therapeutic for improved adhd symptomatology, the unguided online intervention attexis. inclusion criteria are: male, female or non-binary, age 18-65, diagnosis of adhd, elevated levels of adhd symptoms (score of ≥17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the asrs v1.1), stable treatment for at least 30 days at time of inclusion, sufficient german skills, and consent to participation. exclusion criteria are: diagnosis of any other severe psychiatric disorder and plans to change treatment in the upcoming three months. patients will be randomized and allocated to either an intervention group, receiving access to attexis in addition to tau, or a control group, receiving access to tau only. primary endpoint will be self-rated adhd symptomatology, assessed via the asrs v1.1, with three months post-allocation being the primary time point for assessment of effectiveness. six months post allocation will be used as a timepoint for follow-up assessment of endpoints. secondary endpoints will be depressive symptoms, self-esteem, work and social functioning, and health-related quality of life.


Eligibility criteria:
inclusion criteria: * women, men, non-binary * age 18-65 years * diagnosis of adhd (assessed via diva) * adhd severity score (cut-off): score of ≥17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the asrs v1.1 * stable treatment (psychotherapy, medication, no treatment, ...) for at least 30 days at the time of inclusion * consent to participation * sufficient knowledge of the german language exclusion criteria: * diagnosis of another severe psychiatric disorder (severe affective disorder, autism spectrum disorder, psychotic disorder, borderline personality disorder, antisocial personality disorder, substance use disorder, suicidality) * plans to change treatment (psychotherapy, medication, ...) in the upcoming three months after inclusion
safety and effectiveness of pulmonary vein isolation and posterior wall ablation with pulsed field energy in patients with paroxysmal and persistent af

Conditions: Atrial Fibrillation

Summary: the primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (pvi) and posterior la wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the varipulse™ catheter and the trupulse™ generator.


Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal and persistent af with at least one af episode electrocardiographically documented within 24 months prior to enrollment. electrocardiographic documentation may include, but is not limited to ecg, transtelephonic monitoring (ttm), zio patch monitor, telemetry strip, or consumer devices * age 18-80 years * willing and capable of providing written consent * able and willing to comply with all pre-, post- and follow-up testing and requirements. exclusion criteria: * previous surgical or catheter ablation for af * documented la thrombus by imaging within 48 hours before procedure (ct, tee, or intracardiac echocardiogram at the beginning of the procedure). * uncontrolled heart failure or new york heart association (nyha) class iv * history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) * significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * presence of implanted pacemaker or implantable cardioverter-defibrillator (icd) or other implanted metal cardiac device that may interfere with the pfa energy field * women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation * life expectancy less than 12 months * currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
bimodal stimulation compared to unilateral cochlear implant

Conditions: Hearing Impaired Children

Summary: the majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .

there are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. to avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. when bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. this is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.

Eligibility criteria:
inclusion criteria: 1. the lack of middle-ear infection. 2. normative intelligence. 3. the lack of auditory neuropathy disorder . 4. residual hearing in the non-implanted ear. exclusion criteria: 1. middle ear infection.. 2. below average intelligence. 3. auditory neuropathy disorder.

Keywords: hearing loss
assessment of factors which predict improvement in children with pdd after a year of integrative therapy

Conditions: Pervasive Developmental Disorder

Summary: the aim of the current research is to assess the efficiency of the integrative therapy among children with pdd after a year of treatment in kindergartens in ashdod, israel. an additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. this analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

integrative therapy among children with pdd after a year of treatment in kindergartens in ashdod, israel. an additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. this analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Eligibility criteria:
inclusion criteria: * children with pdd * children aged from 2 years to 6 years exclusion criteria: * children with severe retardation

Keywords: children with pdd
regional distribution mapping of lymph node metastasis in epithelial ovarian cancer

Conditions: Ovarian Cancer

Summary: the goal of this observational study is to investigate the metastatic pathways of lymph node involvement in ovarian cancer patients. the main question it aims to answer is: • what are the sequential patterns of lymph node metastasis in ovarian cancer, and are there specific clinical factors associated with different metastatic pathways? participants diagnosed with ovarian cancer who have undergone lymphadenectomy as part of their standard treatment will have their postoperative pathological lymph node involvement analyzed. the study will retrospectively collect and analyze patient data, including lymph node metastasis patterns, to identify potential progression routes.


Eligibility criteria:
inclusion criteria:i) initial diagnosis and tumor cytoreductive surgery performed at the first affiliated hospital of sun yat-sen university; ii) confirmed postoperative pathology of epithelial ovarian cancer; iii) available lymph node status; and iv) accessible clinical features, including preoperative ultrasound and blood biochemistry tests exclusion criteria: i) initial diagnosis or surgical treatment conducted at other hospitals; ii) absence of imaging results (ct/pet-ct/mri) or postoperative pathology results for lymph node status. iii) presence of other cancers; and iv) incomplete medical history -

Keywords: lymph node metastasis
ct-guided adaptive radiation therapy combine with anti-pd-1 antibody adjuvant immunotherapy for thoracic cancer patients

Conditions: Thoracic Malignancies

Summary: this phase ii study is to evaluate the safety and efficacy of ct-based adaptive radiation therapy followed by adjuvant anti-pd-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (cartai)

primary objectives: i. to evaluate the safety and toxicity of anti-programmed cell death 1 (pd-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies. secondary objectives: i. to assess the efficacy of adjuvant anti-pd-1 antibody immunotherapy after radiotherapy. ii. to understand the dynamics and interactions of ido with others immune pathway biomarkers. iii. to evaluate whether ido immune status could predict the treatment outcomes of radiation and immune combined therapy.

Eligibility criteria:
inclusion criteria: 1. signed inform consent form 2. age \>= 18 years and \<= 75 years 3. histologically or cytologically confirmed advanced/metastatic thoracic malignancies 4. patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment 5. eastern cooperative oncology group performance status of 0 or 1 6. life expectancy \>= 8 weeks 7. adequate hematologic and end organ function exclusion criteria: 1. prior exposure to any immune checkpoint inhibitors including but not limited to anti-pd-1, anti-pd-l1 or anti-ctla-4 antibodies. 2. prior exposure to any other thoracic radiation therapy before this time radiation therapy. 3. prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment 4. no active second cancers 5. active or prior autoimmune disease or immunodeficiency. 6. active infections including but not limited to hepatitis b, c ,and hiv. 7. significant cardiovascular disease 8. active or untreated central nervous system (cns) metastases 9. any unresolved toxicity ctcae \>= grade 3 from the prior radiation therapy. 10. known hypersensitivity to humanized antibodies or fusion proteins or any of study drug excipients. 11. known psychiatric or physical impairments that would interfere with cooperation with the protocol of this trial.
adipose tissue function after pancreas transplantation

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; End Stage Renal Disease

Summary: clinical measures of adipose tissue mass (bmi, waist circumference, waist-to-hip ratio) do not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . there is a need to identify novel/universal markers of risk for diabetes (dm) and cardiovascular disease (cvd). these biomarkers also can become additional outcome measures for an intervention such as pancreatic/kidney transplant. if biological markers show an improvement with an intervention before anthropometric changes occur, intermediate outcomes can be an encouraging finding for practitioners. this study will focus on the central question of "adipose tissue dysfunction" as mediator of metabolic complications of positive energy balance, independent of body fat content and distribution. this study will address the question of effect of hyperglycemia on adipose tissue function independent of body fat mass. this project will take advantage of unique expertise of our investigators to perform detailed metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. the results of the proposed study will provide support to the novel approach of identifying adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of diabetes and cvd across all ethnic groups, age and gender. we will obtain necessary preliminary data for future grant submissions to support our central hypothesis and develop stronger interactions within and outside the university of texas medical branch (utmb) with clinical investigators in the area of dm and its complications.

detailed description is his protocol

Eligibility criteria:
inclusion criteria: 1. men and women of any ethnicity, and age between 18 and 65 years. 2. patients with diabetes and renal failure who have been scheduled kidney-pancreas or isolated kidney transplantation. 3. ability to speak read and understand english or spanish exclusion criteria: 1. any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as assessed by history and physical examination and laboratory testing. 2. any personal history of substance abuse (reported only). 3. alcohol intake above 7 grams/day. 4. pregnancy or lactation. 5. inability to give consent for this study. -
food and crohn's exacerbation study (faces)

Conditions: Crohn's Disease

Summary: the proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with crohn's disease (cd) in remission. at baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. disease activity will be assessed with the abbreviated crohn's disease activity index (acdai)59. self-reported disease status will be assessed during follow-up using an internet-based questionnaire. repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (ffqs) administered after 20 weeks. follow-up duration will be for 48 weeks. statistical analysis will compare the time to relapse using cox regression for patients in the two study arms. in the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.


Eligibility criteria:
inclusion criteria: 1. patients must have an established diagnosis of cd. 2. all patients must be in clinical remission at the time of entry into the study. remission is defined as an acdai of less than 150. exclusion criteria: inflammatory bowel disease (ibd) unspecified / indeterminate colitis total or sub-total colectomy, ileostomy, or colostomy unable to read and speak english no internet access steroids other than budesonide ≤6mg/day with the prior two weeks perianal fistula or abscess with more than scant drainage age less than 18 years pregnant or breastfeeding women unwilling to follow the study diet
evaluation of the initial prescription of ketamine and milnacipran in depression in patients with a progressive disease

Conditions: Depression

Summary: ketapal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. half of participants will receive ketamine and milnacipran in combination, while the other half will receive a placebo and milnacipran in combination.

ketamine, a molecule mainly used as an analgesic in palliative care, turns out to be an excellent fast acting antidepressant. by acting as an nmda receptor antagonist, its mechanism of action is complementary to classical and long acting antidepressants like selective serotonin reuptake inhibitors (ssri). in particular, ketamine is able to boost synaptogenesis in only a few hours whereas long-term prescription of ssri can stimulate neurogenesis. the purpose of this study is to evaluate a new therapeutic strategy that could integrate ketamine in the same time than ssri, to control depression symptoms faster and optimize patient's quality of life complementary to treatments of cancer.

Eligibility criteria:
inclusion criteria: * inpatient * supported by a functional palliative care unit * having a severe and progressive disease diagnosed * meet the criteria for major depressive disorder as defined by dsm in its version 5 * madrs \> 19 ( moderate to severe) * no antidepressant treatment or treatment introduced for more than four weeks * in ability to receive clear information and give consent * beneficiary of a social security scheme exclusion criteria: * upper weight or equal to 100 kg * ultimate phase (about 24 to 72 hours prior to death) * unstable patient on cardiovascular diseases, including uncontrolled hypertension * severe renal impairment (renal clearance less than 15 ml / min) * psychiatric comorbidity: schizophrenia and schizoaffective disorder * neurological comorbidity: recent cerebrovascular accident (less than one month), parkinson's disease, dementia * treatment with ketamine received in the four weeks preceding the inclusion * impaired judgment, cognitive or massive sensory impairment not allowing to receive clear information * oral antidepressant treatment introduced less than four weeks ago * dosage of oral antidepressant treatment upper than the marketing authorization for more than four weeks * patient not covered by the social security system * refusal to sign the consent * minor patient or guardianship * pregnant women (implementation of a urine pregnancy test before inclusion for women of childbearing age) * lactating women * intolerance or allergic reaction to ketamine or milnacipran. * contraindications to the association of ketamine or milnacipran with the patient's usual treatment

Keywords: ketamine palliative care supportive care early palliative care fast acting antidepressant end of life care cancer psychological distress antidepressant serotonin norepinephrine reuptake inhibitors
multiple myeloma outcomes based on maintenance therapy post autologous stem cell transplant

Conditions: Multiple Myeloma

Summary: the purpose of the study is to determine outcomes for multiple myeloma patients on maintenance single agent vs. doublet (imid + pi) combination chemotherapy post autologous stem cell transplant (asct).

this non-interventional, cohort prospective research study will assess outcomes for multiple myeloma patients on maintenance single agent vs. doublet (imid + pi) combination chemotherapy post asct.

Eligibility criteria:
inclusion criteria: * all mm patients (18 years or greater) receiving autologous transplantation given as first line therapy (melphalan at least 140 mg/m2) will be screened and enrolled in the study if they qualify and willing to participate. * ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. * histologically confirmed diagnosis of multiple myeloma. * received high dose melphalan (≥ 140 mg/m2) followed by asct based on the institutional guidelines and within +60 and +180 after asct at the time of maintenance initiation. * disease status must be very good partial response (vgpr), complete remission (cr), or stringent complete remission (scr) per imwg response criteria at time of study entry. * measurable disease at diagnosis per imwg criteria serum m spike ≥ 1g/dl, or urine m protein ≥ 200 mg/24h or involved free light chain ≥ 100 mg/l with an abnormal ratio. * patients must have the clonoseq id sample showing a trackable clone in bone marrow. exclusion criteria: * patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of bence-jones protein in the urine defined by use of electrophoresis and immunofixation) * prior evidence of disease progression * patients who have other malignancy associated with a high risk of progression in the next 2 years.
thyroxine replacement in organ donors

Conditions: Brain Death

Summary: to compare oral versus intravenous administration of thyroid hormone: 1) for reversibility of hemodynamic instability in organ donors, and, 2) the pharmacokinetics of oral vs iv thyroid administration

disruption of the hypothalamic-pituitary axis following brain death may lead to hemodynamic instability, peripheral vasodilation, and diabetes insipidus in organ donors, requiring the use of high doses of inotropes. inotropes may cause ischemic injury to organs and intramyocardial atp stores, resulting in organs unsuitable for transplantation, as well as, a reduction in post-transplant organ function. therefore, some clinicians advocate the use of triple hormonal therapy in potential organ donors. since intravenous t3(the intracellular active form of thyroxine) is unavailable, oral or intravenous t4 must be used, requiring the conversion of t4 to t3at the cellular level. this conversion is impeded by glucocorticoids which also are administered to organ donors for their immunomodulating effects. since oral t3 is readily available, our first question is whether oral versus intravenous administration of t4 is comparable. if so, our next study is to determine the efficacy of oral t3 versus oral t4. our hypothesis is oral t3 is superior to oral t4. our study therefore will determine whether or not the oral route is suitable for administration of thyroid replacement therapy. the study will compare the pharmacokinetics of oral versus intravenous t4 administration in organ donors, as well as, determine its ability to wean intropes in this patient population.

Eligibility criteria:
inclusion criteria: 1. brain death criteria established 2. consent for organ donation received exclusion criteria: 1. immediate (\< 4 hrs) organ retrieval anticipated

Keywords: organ donation thyroid replacement