Kornimate/medical-research-clean huggingface dataset:
a wearable morning light treatment for postpartum depression

Conditions: Post Partum Depression

Summary: this study will test a consumer health light therapy device (re-timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock). eligible participants will be enrolled and randomized after baseline assessments. in addition to using the re-timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results. the hypotheses regarding the bright light versus the placebo dim light of the study are: * morning bright light therapy will produce greater improvement from pre- to post-treatment on the hamilton rating scale for depression * morning bright light therapy will lengthen the phase angle difference (pad) and this will mediate change in depression symptoms. * morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.

please note this project added a sub-study (hum00235787, irb approved on 7/31/2024) to the main study. however, the sub-study only applies to some of the participants and there are only exploratory outcomes, therefore, this will not affect the main study registration.

Eligibility criteria:
inclusion criteria: * less or equal (≤) to 26 weeks postpartum * meet criteria for current major depressive disorder per the structured clinical interview for diagnostic (scid) and statistical manual of mental disorders version 5 (dsm-v) * not currently receiving treatment for depression (for example, prescription medications or psychotherapy). exclusion criteria: * current diagnosis of posttraumatic stress disorder (ptsd), obsessive compulsive disorder if the onset is outside of the perinatal period, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per scid. * current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy. * retinal pathology or history of eye surgery * current use of photosensitizing medications, * current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (nsaids) if used daily, and beta-blockers) * medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures). * nightshift work * currently pregnant

Keywords: post partum depression light therapy
develop and implement methods for diagnostic and treatment of hormonal disorders in patients with chronic kidney disease

Conditions: Hyperprolactinemia; Thyroid Dysfunction; Bone Diseases, Metabolic; Chronic Kidney Diseases

Summary: methods of diagnostic and treatment of hormonal disorders in patients with chronic kidney disease (ckd) will be developed and implemented in real clinical practice. as a result of the project, new scientific data will be obtained on the relationship of hyperprolactinemia and impaired functioning of the pituitary-gonadal axis, changes in functioning of the renin-angiotensin-aldosterone system will be revealed, and the characteristics of the thyroid and parathyroid status in patients with ckd will be determined, including receiving renal replacement therapy (rrt) and after kidney transplantation, which will improve the efficiency of diagnosis and treatment of hormonal disorders in the early stages of the disease, reduce the direct financial costs of the diagnostic and treatment process primarily due to the optimization of hormonal studies and treatment of the revealed disorders, as well as will prevent the progression of ckd and the severity of the condition of this category of patients due to the development of hormonal dysfunctions.

1. assessment of prevalence, clinical manifestations and pathological significance in a cohort of patients with ckd: * hyperprolactinemia, hormonal disorders of a pituitary -gonad axis ; * disorders of renin-angiotensin-aldosterone system; * pathology of the thyroid and parathyroid glands. 2. analysis of ckd impact on the development of structural changes in the thyroid gland and parathyroid glands according to the results of ultrasound examination. 3. assessment of relationship of hormonal dysfunctions in patients with ckd and adipocytokines, markers of renal impairment. 4. to study the effect of renal replacement therapy on thyroid hormones clearance . 5. investigate hormonal status in patients with ckd after kidney transplantation.

Eligibility criteria:
inclusion criteria: * patients at ckd 1-5, including renal replacement therapy and renal transplantation exclusion criteria: * patients with impaired thyroid function before the onset of ckd; * pregnant women; * patients with acute diseases; * patients in the acute phase of comorbid chronic diseases; * patients in the acute period of myocardial infarction, after acute cerebrovascular accident; * patients with mental illness; * patients undergoing treatment for various cancer types.

Keywords: hormonal alterations, rrt, ckd, kidney transplantation
evaluation of screening for visual disorders of the old subject in consultation memory

Conditions: Visual Disorders

Summary: visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. the main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of nantes clinical gerontology as part of the consultation geriatric memory. secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. the results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.


Eligibility criteria:
inclusion criteria: * elderly over 65 years, * subject to consultation from memory clinical gerontology ambulatory center nantes university hospital * current use of spoken french * patient (or legal guardian, if applicable) has given its written consent * patient affiliated to a social security scheme exclusion criteria: * life expectancy lower 1 year * mobility limitation preventing the installation retinal * major disorders and productive behavior does not allow participation in diagnostic procedures. * inability to respond to instructions when performing ophthalmological examinations.
effect of spacing of anti-tnf drugs in ankylosing spondylitis with low disease activity

Conditions: Spondyloarthritis

Summary: patients with spondyloarthritis, already treated by tnf blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.


Eligibility criteria:
inclusion criteria: * adult patients with spondyloarthritis according to asas criteria * stable low disease activity for at least 6 months * already treated by tnf blocking drug (adalimumab, etanercept or infliximab) exclusion criteria: * raised acute phase reactants * participation in another clinical trial * structural progression of peripheral joint damage * scheduled surgery within 12 months * pregnancy

Keywords: spondyloarthritis anti-tnf adalimumab etanercept infliximab
anlotinib combined with chemotherapy for the treatment of her2 negative advanced breast cancer

Conditions: HER2-negative Breast Cancer

Summary: the study is being conducted to evaluate the efficacy and safety of anlotinib combined with chemotherapy treatment for patients with her2 negative advanced breast cancer previously received anthracyclines and taxanes

breast cancer is the most frequent malignancy in women worldwide. treatments on her2 negative breast cancer are still under exploration. therefore, it is imperative to find a novel therapy to treat these patients. anlotinib is an anti-angiogenic small-molecule butyrate kinase inhibitor, and preliminary phase ii study results show that anlotinib has good efficacy and tolerability in the treatment of her-2-negative advanced breast cancer. this study is a prospective, multicenter, observational clinical study that will collect and report anlotinib in combination with anlotinib in patients with her2-negative advanced breast cancer treated with anthracyclines and taxanes in a real-world clinical setting efficacy and safety data for chemotherapy treatments.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old (calculated on the day of signing informed consent); 2. histologically diagnosed advanced breast cancer, including inoperable locally advanced breast cancer or recurrent/metastatic breast cancer; 3. immunohistochemical detection of her-2 (-) or (1+), of which her-2 (2+) must be tested by fish and the result is negative; 4. all patients have previously underwent chemotherapy containing anthracyclines and taxanes (adjuvant, neoadjuvant or rescue therapy) , and treatment failure or disease progression received at most two chemotherapy regimens after recurrence/metastasis. hr+/her2- breast cancer patients need to complete endocrine drug therapy; 5. physical condition ecog ps: 0-1; 6. there is at least 1 measurable lesion of metastasis according to recist 1.1; 7. the patients voluntarily joined the project and signed the informed consent. exclusion criteria: 1. pregnant or lactating women; 2. patients with a previous history of breast cancer were excluded, except for ipsilateral dcis who received only local therapy ≥5 years ago; patients with a history of any other cancer (except non-melanoma skin cancer or cervical carcinoma in situ) were excluded; 3. allergic to anlotinib; 4. received eribulin, capecitabine treatment or anti-angiogenic drug treatment in the past; 5. uncontrolled brain metastases (except asymptomatic, or patients with stable brain metastases receiving local treatment); 6. according to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
clinical study of platelet-rich plasma promoting tendon-bone healing in anterior cruciate ligament reconstruction

Conditions: Sports Injury

Summary: anterior cruciate ligament (acl) injury is a common knee injury, which seriously affects the living ability and sport level of the injured. acl reconstruction is the main method to treat acl injury. due to the reconstructive ligament needs a tendon bone healing and ligament maturation, therefore, in the acl anatomical study, reconstruction surgery and reconstruction materials under the condition of constant progress, how to improve the acl reconstruction of tendon bone healing and shorten the time of the ligament mature, improve the clinical effect of acl reconstruction, has become the focus in the acl reconstruction. autologous platelet-rich plasma (prp) is full of growth factors and bioactive factors, which has the function of promoting tissue healing, anti-inflammatory and analgesic effects. at the same time of anterior cruciate ligament reconstruction, using autologous prp in the bone channel might promote tendon bone healing and ligament maturing after acl reconstruction, promote the recovery of proprioception, prevent bone channel expanding, shorten the postoperative recovery time, speed up the patients recovery exercise ability, improve the clinical effect of acl reconstruction. in this study, patients with acl injuries were randomly divided into two groups: one group underwent acl anatomical reconstruction, and the other group underwent acl anatomical reconstruction with prp. various clinical scores, kt-2000, biodex and imaging tests were used to evaluate the differences in the clinical effects of the two surgical methods in terms of postoperative pain, joint swelling, knee function, joint stability, muscle strength recovery, bone channel expanding, ligament vasinization, and ligament maturation.


Eligibility criteria:
inclusion criteria: * history of knee injury * history of knee instability * anterior drawer test (+), or / and lachman test (+) * the tear of anterior cruciate ligament was confirmed by mri exclusion criteria: * the injury of other ligaments of knee joint, such as complex posterior cruciate ligament injury, lateral collateral ligament injury and medial collateral ligament injury above iii degree * patients with meniscus removed * patients with moderate to severe articular cartilage injury * patients with complex nerves and blood vessels injury * patients with compound intra - and periarticular fractures of the knee * patients with intra or periarticular fractures of the knee * patients with contralateral knee instability * patients with severe cardiovascular and cerebrovascular diseases

Keywords: anterior cruciate ligament tear platelet-rich plasma
external validation of two prediction models for independent gait after stroke

Conditions: Stroke

Summary: regaining independent gait is one of the main goals in stroke rehabilitation and early prediction of gait outcome is important to guide discharge planning at acute stroke units, design rehabilitation and inform patients and relatives. in the last decade, two easy-to-apply prediction models for gait were developed: the epos model in the netherlands and the twist model in new zealand. although the models' performance in the development cohorts was good, this does not automatically mean that the models are ready for application in clinical practice, as it is unknown whether their performance is also good in an independent cohort from a different country and with different patient characteristics. such external validation is an essential step towards clinical implementation of prediction models. a mobility-related problem is the occurrence of falls after stroke. walking is among the top 3 activities during which stroke patients fall, with the other two activities being transferring or sitting in a wheelchair. especially soft tissue injuries after a fall are common and in 1-15% of the patients, the fall results in a fracture. apart from the costs that arise from these injuries, falls have a negative impact on the patient's physical functioning and psychological status, with an increased dependency and fear of falling, resulting in a reduced quality of life. a systematic review found 12 studies that developed fall risk prediction models for either inpatient rehabilitation stroke patients or those living in the community. important predictors for falls are the presence of hemi-inattention, fall history and balance deficits. however, none of the models had an acceptable performance and predictors were not always captured by a validated assessment, which is an important prerequisite for an unbiased prediction model. the primary aim of this study is to externally validate the epos and twist models for independent gait after stroke in a heterogeneous sample of subjects admitted to the hospital with an acute stroke. it is hypothesized that the performance of both models in this independent cohort will be lower than in the development cohorts, but still be adequate. the secondary objective is to investigate the occurrence and predictability of falls within the first six months after stroke and its relationship with the prognosis for independent gait within this sample.


Eligibility criteria:
inclusion criteria: * first-ever or recurrent stroke as confirmed by computerized tomography and/ or magnetic resonance imaging * not able to walk independently within the first 72 hours after stroke (functional ambulation categories \<4) * age ≥18 year * written informed consent exclusion criterion: • not able to walk independently before hospital admission (functional ambulation categories \<4)

Keywords: gait prognosis external validation epos model twist model falls
albumin-bound paclitaxel combination with capecitabine versus capecitabine monotherapy in paclitaxel/docetaxel-resistant advanced breast cancer

Conditions: Breast Cancer

Summary: albumin-bound paclitaxel combination with capecitabine versus capecitabine monotherapy in paclitaxel/docetaxel-resistant advanced breast cancer

a phase ii, single-center, randomized study of albumin-bound paclitaxel combination with capecitabine versus capecitabine monotherapy in paclitaxel/docetaxel-resistant advanced breast cancer.

Eligibility criteria:
inclusion criteria: 1. females with age between 18 and 70 years old 2. histological proven unresectable recurrent or advanced breast cancer 3. negative for human epithelial receptor-2 (her2) by immunohistochemistry. a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator. 4. patients who developed disease progression within 12 months of previous paclitaxel-containing chemotherapy regimens. 5. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1) 6. performance status no more than 1 7. all patients enrolled are required to have adequate hematologic, hepatic, and renal function 8. life expectancy longer than 12 weeks 9. no serious medical history of heart, lung, liver and kidney 10. be able to understand the study procedures and sign informed consent. 11. patients with good compliance. exclusion criteria: 1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound) 2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study 3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy 4. treatment with an investigational product within 4 weeks before the first treatment 5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration 6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 8. uncontrolled serious infection

Keywords: breast cancer albumin-bound paclitaxel paclitaxel/docetaxel-resistant
systolic pressure intervention trial factors affecting factors affecting atherosclerosis study

Conditions: Hypertension; Chronic Kidney Disease

Summary: systolic pressure intervention trial (sprint) is a large scale randomized trial of \~ 9250 adults aged 50 years or older with high cardiovascular risk sponsored by nih. the study is designed to recruit 45% of the study population with chronic kidney disease (ckd). the trial will test the effects of low systolic blood pressure (sbp) goal of \< 120 mm hg versus the standard goal of \< 140 mm hg on the primary composite of cardiovascular events and death. one of the pre-specified secondary outcome is the progression of kidney disease. in this ancillary named sprint - factors affecting atherosclerosis study (fast), the investigators plan to take advantage of the unique opportunities afforded by the parent study to examine issues that are of significant public health importance. this is an observational study in sprint participants. this study will examine mechanistically, the factors affecting the progression of atherosclerosis in ckd.


Eligibility criteria:
inclusion criteria * systolic pressure intervention trial (sprint) participants exclusion criteria * contraindications to mri (such as intracranial metal prostheses, weight \> 300 pounds, claustrophobia and certain types of hardware used in pacemakers, prostheses, etc.)
three-dimensional assessment of craniofacial structures

Conditions: Malocclusion

Summary: the goal of this project is to reduce the radiation exposure in orthodontic patients by the use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital dental models, three-dimensional photograph) the first step in this process is to develop and validate an orthodontic analysis able to assess craniofacial proportions, dental, skeletal, and facial soft tissue. the investigators working hypothesis is that data from three-dimensional facial photographs and from digital dental casts can be registered accurately and consistently, and the diagnostic information about tooth position and facial soft-tissue derived from them are comparable to x-ray derived data


Eligibility criteria:
inclusion criteria: * full permanent dentition * complete set of digital orthodontic records * must be able to follow directions exclusion criteria: * incomplete orthodontic records
naples federico ii intensive cardiac care unit registry (naples fed2-iccu registry)

Conditions: Acute Cardiovascular Disease; Acute Coronary Syndrome; Acute Heart Failure; Cardiogenic Shock

Summary: this protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our iccu.

this study is designed as a single-center, investigator-initiated prospective observational study. our iccu is located at the department of "scienze cardiovascolari, diagnostica per immagini, e rete tempo dipendente delle emergenze cardiovascolari" of the azienda ospedaliera universitaria federico ii. all scientific activities are performed in the department of advanced biomedical sciences of the university of naples federico ii. this is a prospective observational study which does not include pharmacologic or invasive treatments different from daily and guideline-directed management, but only collects data of patients for research purposes, therefore no specific treatments or procedures are included in this research protocol. the clinical trial unit at the university of naples "federico ii" will oversee all study procedures and data management. the study data will be anonymized and managed using redcap electronic data capture, which is hosted at the university of naples "federico ii". once the patient is admitted to our iccu, the informed consent will be signed and all data will be collected: demographic, clinical, procedural, therapeutic, and outcome data. clinical outcomes will be assessed in the in-hospital period, at 30 days, at 1-year and at the longest available follow-up (telephone or follow-up visit). main clinical outcomes will be adjudicated by an independent clinical events committee (cec).

Eligibility criteria:
inclusion criteria: 1. acute cardiovascular disease admitted at our iccu 2. age ≥18 years; 3. written informed consent. exclusion criteria: 1) patients not providing consent to data collection