Kornimate/medical-research-clean huggingface dataset:
practice of treat-to-target on pediatric systemic lupus erythematosus: a two-center retrospective study

Conditions: Systemic Lupus Erythematosus

Summary: treat to target (t2t) strategies have proved to be useful in several chronic disorders, including rheumatoid arthritis. in systemic lupus erythematosus (sle), t2t strategy has been proposed in order to control disease activity, improve health-related quality of life, and reduce morbidity and mortality. remission would be the main target, but a low disease activity state (ldas) could be an acceptable alternative. however, due to sle protean manifestations, the operational definitions of both remission and ldas are still in progress. this clinical trial would like to assess the clinical value of t2t strategy in the treatment of children with sle, optimize the treatment of children with sle, andimprove the prognosis.

this two-center study retrospectively analyzed the follow-up data of children with systemic lupus erythematosus (sle) in our center (the children's hospital of chongqing medical university) and the children's hospital of nanjing medical university, grouping the patients into two observation groups-low disease activity status group (ldas group) and never reached low disease activity group (never ldas group). we would analyze the risk factors of sle that patients cannot reach ldas by comparing baseline data and treatment conditions of the two groups. meanwhile, we would evaluate the sle clinical indicators, sle disease activity, organ damage, and disease remission state at the end of the follow-up of the ldas group, in order to assess the clinical value of t2t strategy in the treatment of children with sle, optimize the treatment of children with sle, andimprove the prognosis.

Eligibility criteria:
inclusion criteria: (1）children with sle diagnosed by the slicc classification criteria for systemic lupus erythematosus (2012); (2) since diagnosed of sle to follow-up termination, inpatient and/or outpatient follow-up at the research centers shall be carried out at least twice a year, the interval of follow-up is ≤3-6 months, and the total follow-up time is ≥1 year; (3) all children or guardians signed an informed consent file before inclusion. exclusion criteria: 1. the treatment plan is unknown; 2. excluding deaths caused by other diseases 3. follow-up was interrupted; 4. follow-up time is less than 1 year, or interval is more than 6 months.

Keywords: pediatric sle treat to target
selective axillary lymph node dissection vs complete axillary dissection: a randomised clinical trial to assess the prevention of lymphedema in breast cancer treatment

Conditions: Breast Cancer

Summary: this is a pilot study at the national cancer institute (int) of milan evaluated the feasibility of selective axillary dissection (sad) which preserved the lymphatic drainage of the arm. lymph nodes draining the arm are identified following radiotracer injection and lymphoscintigraphy, a technique called axillary reverse mapping (arm). sad was found feasible in 75% of patients. furthermore only 9% had bcrl after sad compared to 33% after axillary lymph node dissection (alnd).

to evaluate the efficacy, safety and cost reduction of sad compared to standard alnd, we propose a prospective 2-arm randomised trial. the control arm consists of patients randomized to alnd, the study arm consists of patients randomized to sad.

Eligibility criteria:
inclusion criteria: * patients diagnosed with operable breast cancer who are candidates for alnd, irrespective of the type of breast surgery performed or adjuvant treatments administered. * patients who sign the informed consent form after explanation of trial aims by a senologist involved in the study. * patients able to attend int for regular follow-up as required by study protocol. exclusion criteria: * massive axillary metastasis (n2 ajcc). * previous surgery to controlateral axillary region. * previous radiotherapy to ipsilateral or controlateral regional lymph nodes. * non compliance with any inclusion criterion.
megestrol acetate plus lng-ius in young women with early endometrial cancer

Conditions: Endometrial Neoplasm Malignant Stage I

Summary: to see if megestrol acetate plus levonorgestrel-releasing intrauterine system (lng-ius) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate alone in patients with early endometrial cancer.

after diagnosed of endometrioid endometrial cancer (eec) by hysteroscopy, patients will be enrolled. age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. blood tests, including fasting blood glucose (fbg), postprandial blood glucose (pbg), fasting insulin (fins), shbg, sex hormone levels, blood lipids and anti-müllerian hormone(amh) will be performed before treatment to evacuate their metabolic conditions. patients are randomized to 1 of 2 treatment groups. patients will receive ma (megestrol acetate) 160 mg by mouth daily for at least 3 months on arm i. patients will receive ma 160 mg plus lng-ius insertion for at least 3 months on arm ii. then an hysteroscope will be used to evaluate the endometrial condition every 3 months, and the findings will be recorded. for patients with eec, complete response (cr) is defined as the reversion of endometrial disease to proliferative or secretory endometrium; partial response (pr) is defined as regression to simple or complex hyperplasia without atypic or atypical hyperplasia; no response (nr) is defined as the persistence of the disease; and progressive disease (pd) is defined as the progression of endometrial lesions. continuous therapies will be needed in pr, nr or pd. as the reason of the low response rate of lng-ius alone in ec patients (nearly 50%), and the potential limitation of lng-ius to focal cancer lesion in endometrial cavity, the investigators did not add lng-ius alone as a single control group. after completion of study treatment, 2 months of maintenance treatment will be recommended for patients with cr, and participants will be followed up for 2 years.

Eligibility criteria:
inclusion criteria: * primarily have a confirmed diagnosis of endometrioid endometrial cancer based upon hysteroscopy * mri parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes * have a desire for remaining reproductive function or uterus * need to be able to undergo correlative treatment and follow-up exclusion criteria: * acute liver disease or liver tumor (benign or malignant) or renal dysfunction * pregnancy or suspicion of pregnancy * have a history of eah or ec and have disease relapse during merina insertion * under treatment of high-dose progestin therapy more than 3 months in recent 6 months * congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity * confirmed diagnosis of malignant tumor in genital system * acute severe disease such as stroke or heart infarction or a history of thrombosis disease * hypersensitivity or contradiction to any component of this product * ask for removal of the uterus or other conservative treatment * smoker(\>15 cigarettes a day)
mesenchymal stromal cells for the treatment of non-union fractures of long bones

Conditions: Atrophic Nonunion of Fracture

Summary: the present study evaluates the effect of xcel-mt-osteo-alpha in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest. xcel-mt-osteo-alpha is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by xcelia (blood and tissue bank of catalonia). the working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.

a phase iia, single center, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (xcel-mt-osteo-alpha) in non hypertrophic pseudoarthrosis of long bones.

Eligibility criteria:
inclusion criteria: * 18 to 85 years of age (male and female) * atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically. * signed informed consent form * the patient is able to understand the nature of the study exclusion criteria: * suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis. * positive serology for hiv (anti-hiv i/ii-ac), hepatitis b (hbsag, hbcac), hepatitis c (anti-hcv-ac) or syphilis lúes (tp-ac). * significant abnormal laboratory tests that contraindicates patient's participation in the study. * pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding * smoker of more than 15 cigarettes a day * congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism. * badly managed diabetes mellitus. * patients diagnosed with peripheral arterial disorders * previous therapeutic radiation (5 previous years) of the affected bone. * neoplasia within the previous 5 years, or without remission * the patient is legally dependent * participation in another clinical trial or treated with an investigational medicinal product the previous 30 days * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria * the patient does not accept to be followed-up for a period that could exceed the clinical trial length

Keywords: nonunion fracture long bones pseudoarthrosis cell therapy tissue engineering mesenchymal stromal cells
prostate cancer - comparative outcomes of new conceptual paradigms for treatment

Conditions: Prostate Cancer

Summary: this study will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk prostate cancer at high-volume centers in southern california (sca) and new york state (nys). complications of contemporary treatments for prostate cancer and quality of life outcomes, such as general health, urinary, sexual, and bowel function, cancer anxiety, and treatment regret will be compared and tracked over the course of this study.

prostate cancer remains the most commonly diagnosed, solid organ tumor and the second most common cause of cancer death in u.s. men. technological advances have enabled new treatment options, such as stereotactic body radiation therapy (sbrt) and partial gland ablation (pga). although heavily marketed as more convenient with fewer side effects, there is an absence of high-level, comparative effective research (cer) to discern relative outcomes to traditional therapies such as active surveillance (as), radical prostatectomy (rp) and intensity modulated radiation therapy (imrt). investigators hypothesize that pga will be associated with less reduction of urinary and sexual function compared to before treatment than both rp and imrt. sbrt is hypothesized to be associated with less reduction of urinary and sexual function before treatment compared to rp and imrt. sbrt is hypothesized to be associated with less reduction in bowel function compared to imrt. pga hypothesized to be associated with better overall quality of life at 12 months compared to as. investigators hypothesize pga and sbrt will be associated with fewer adverse events compared to rp and imrt. the investigators will conduct a pragmatic, population-based cohort study of men with newly diagnosed low and intermediate risk prostate cancer in southern california (sca) and new york state (nys) surveillance epidemiology and end results (seer) regions to bridge the evidence gap concerning adverse events and patient reported outcomes. this study will inform multiple stakeholders, who contributed to the study design. stakeholders include prostate cancer survivors, payers, medical device manufacturers, professional organizations, community and academic prostate cancer experts and the food and drug administration (fda).

Eligibility criteria:
inclusion criteria: * pathologically-confirmed clinically localized prostate adenocarcinoma with national comprehensive cancer network (nccn) low (t1-t2a, gleason 6, grade group 1, psa \<10 ng/ml) or intermediate risk (t2b-t2c or, gleason 7, grade group 2 or 3 or psa 10-20 ng/ml)72 at one of the selected hospitals in sca and nys * diagnosis date during the 18 month recruitment window * able to read/speak english or spanish * agree to participate by completing the baseline questionnaire exclusion criteria: * clinically metastatic disease or high-risk pca (t3a-t4, gleason grade group 4 or 5 or psa \>20 ng/ml * unable to read/speak english or spanish * unwilling or unable to give informed consent.
clomiphene in males with prolactinomas and persistent hypogonadism

Conditions: Hypogonadotropic Hypogonadism; Prolactinoma

Summary: prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes. clomiphene citrate is a well known selective estrogen receptor modulator that increases gonadotropin secretion via hypothalamic-pituitary action. we conducted a prospective, open label clinical trial of cc to evaluate its effects in reverting persistent hh in male patients with prolactinomas under dopaminergic agonist treatment.


Eligibility criteria:
inclusion criteria: * a minimum follow-up of 6 months under da therapy with normal serum prolactin or with maximum da dose (3.5 mg/week of cabergoline or 10 mg/day of bromocriptine for at least 2 months) * serum total testosterone less than 300ng/dl with normal or low lh and fsh levels after discontinuing testosterone replacement for at least 2 months. exclusion criteria: * impossibility to attend scheduled visits and irregular compliance to da treatment.

Keywords: hypogonadotropic hypogonadism prolactinoma
clinical and radiological effect of platelet rich fibrin on the healing of periodontal intrabony periodontal defects

Conditions: Chronic Periodontitis; Intrabony Periodontal Defect

Summary: the aim of this split mouth, single-center, controlled study is to compare the healing of intrabony defects treated with a combination of anorganic bovine bone mineral (abbm)/platelet rich fibrin (prf) or anorganic bovine bone mineral alone. the hypothesis being tested in the study was that prf would augment the regenerative effects of abbm in human intrabony defects.

anorganic bovine bone mineral (abbm) is extensively used in the treatment of intrabony defects. platelet rich fibrin (prf) is a new generation platelet concentrate with a simplified technique. although there are some studies on the use of prf in the treatment of intrabony defects, to date none of them evaluate its additive effects with abbm. therefore, a randomized, split mouth clinical trial was conducted to compare the healing of intrabony defects treated with a prf/abbm combination and to those obtained with abbm alone. using a split mouth design, 15 paired intrabony defects were randomly treated with either abbm alone (control group) or with abbm- prf combination (test group). the following clinical parameters and radiographic measurements were recorded at baseline and six months postoperatively: plaque index (pi), gingival index (gi), probing depth (pd), gingival recession (gr), clinical attachment level (cal), vertical bone loss, the depth of the defect and defect angle

Eligibility criteria:
inclusion criteria: * no systemic diseases; * a good level of oral hygiene (oh) (plaque index\<0.15); * presence of two paired two-wall or three-wall intrabony defects with probing depth ≥6mm and an intrabony component ≥3mm as detected on radiographs; -no intrabony defects extending into the furcation area; * tooth mobility ≤1; * tooth and adjoining teeth testing vital and without symptoms or signs of endodontic involvement; * tooth and adjoining teeth free of caries or inadequate restorations. exclusion criteria: * patients with compromised immune systems; * pregnant and/or lactating women; * patients taking any drug known to affect the periodontal status or affect the coagulation system * smokers.

Keywords: anorganic bovine bone mineral; graft intrabony periodontal defect platelet rich fibrin
physiological impact of cloth mask during exercise

Conditions: Fatigue

Summary: mask wearing during the covid-19 pandemic has been proven substantially effective in containing the spread of infection, with cloth masks being the most universally used. however, cloth masks may be uncomfortable and have physiological repercussion during exercise. this study aims to investigate the impact of cloth masks during exercise.


Eligibility criteria:
inclusion criteria: * healthy individuals * active, non-active and athletic individuals; exclusion criteria: * preexisting chronic conditions * obesity * physical limitation precluding exercise.
diagnosis of bacteremia/septicemia and culture negative endocarditis by the karius sequencing-based infectious disease diagnostic assay

Conditions: Bacteremia; Septicemia

Summary: prospective study at duke university hospital comparing the karius infectious disease diagnostic sequencing assay to blood culture results in admitted patients with bacteremia/septicemia.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. a positive blood culture 3. a suitable residual blood sample collected within 24 hours of the positive blood culture or 4. a blood sample obtained for the study obtain within 48 hours of the positive blood culture for endocarditis cohort: 1. all criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the duke criteria exclusion criteria: 1. inability to understand instructions and comply with study-related procedures 2. any condition that in the opinion of the treating physician will prevent the subject from completing the study

Keywords: sepsis infection culture sequencing non-invasive ngs
studying patterns in patient engagement among treatment resistant depression patients

Conditions: Treatment Resistant Depression

Summary: clinical studies, with a distinct focus on treatment resistant depression, play a crucial role in evaluating the safety and effectiveness of novel treatments. these trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption. the primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.


Eligibility criteria:
inclusion criteria: * diagnosis of treatment resistant depression * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * no prior treatment for treatment resistant depression exclusion criteria: * enrolled in another research study * inability to provide written informed consent * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Keywords: treatment resistant depression
the use of sensory or motor cues using electrical stimulation to reduce gait freezing in patients with parkinson disease

Conditions: Parkinson Disease

Summary: some individuals with parkinson disease experience "freezing" during walking which results in their inability to move their feet. they often have difficulty starting to move once they have stopped. freezing often results in loss of balance and falling. oral medications for parkinson disease aren't as effective in treating freezing as it is in reducing other symptoms. another treatment for freezing is instruction in walking using visual targets or auditory cues (thinking of a rhythm or beat). these cues can be initially effective for some individuals, but the effects do not last. other types of cues have not been studied. we want to examine the effects of two other cues, tactile (touch) or motor (muscle contraction), on the effects of freezing.

we will use a device (tens unit) that provides electrical stimulation to a nerve in the lower legs. electrodes will be placed on the skin of your lower legs and a box that delivers electrical current will cause a tingling feeling in the legs. subjects will be asked to perform three gait tasks with the device on and off to compare the effects of the sensory cue on the speed/time to complete gait tasks and the frequency and duration of any freezing events. this use of the device (tens unit) is investigational. while it has been approved by the food and drug administration for the treatment of pain, it has not been approved for the treatment of freezing. because the tens unit can provide a sensory cue, it may help to prevent or reduce freezing. if it is found that this cue works, it could lead to new treatments for the treatment of freezing.

Eligibility criteria:
inclusion criteria: 1. pd diagnostic criteria include those used for clinically defined "definite pd", as previously outlined22 based upon established criteria.22, 23 2. history of consistent freezing with ambulation in a straight line and/or when turning. 3. normal central and peripheral neurological function 4. at least grade 4 strength and normal joint ranges of motion in both legs 5. normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa. 6. each must have had clear benefit from levodopa for at least some of his/her pd symptoms 7. all subjects with pd must be able to walk independently for 10 feet. exclusion criteria: 1. serious medical problem that would impair the ability to undergo testing. 2. use of neuroleptic or other dopamine-blocking drug 3. use of drugs that might affect balance 4. history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease 5. participants who are unable to provide informed consent

Keywords: parkinson disease individuals frequent freezing during gait
improvement effect of transcranial direct current stimulation (tdcs) applied during exercise training in stroke patients with upper limb and hand motor function

Conditions: Stroke

Summary: the purpose of this study was to improve the effect of transcranial direct current stimulation (tdcs) applied during exercise training in stroke patients with upper limb and hand motor function.


Eligibility criteria:
inclusion criteria: * patients aged 19 to 80 years * less than 58 fma upper scores * patients whose lesions do not include stimulation regions * patients with stroke with more than 3 months of onset exclusion criteria: * difficult to communicate due to severe language impairment. * accompanied by an existing serious neurogenic disease * existing significant psychiatric disorders such as major schizophrenia, bipolar disorder * if there are difficulties in conducting the research * any patients who are judged by the investigator to be difficult to participate in this study * patients with contraindicated mri scans