cyrilzakka/clinical-trials huggingface dataset:
Prognostic Relevance of Biological Subtype in Breast Cancer

Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. The aim of this study was to compare the prognostic relevance of the TNM staging system and intrinsic subtype in breast cancer patients who received curative surgery.

Identified patients who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008. Primary outcomes were recurrence-free survival (RFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* patients who received curative surgery
* stage I-III breast cancer
* between January 2004 and September 2008
* had available immunohistochemistry profiles.

exclusion Criteria:

* age \<18 years old
* microinvasive carcinoma of breast
Vilazodone for Corticosteroid-Induced Memory Impairment

The purpose of this study is to examine whether vilazodone attenuates the memory and mood effects of corticosteroids on the human hippocampus in 24 healthy controls.

In animals and humans, stress and corticosteroid excess are associated with changes in hippocampal structure and functioning. These findings have important implications to the millions of patients taking prescription corticosteroids and to patients with major depressive disorder or bipolar disorder who have elevated cortisol levels and memory impairment. The investigators believe that vilazodone may be a medication that can block the effects of hydrocortisone on the human hippocampus. The investigators propose to examine whether vilazodone attenuates the effects of corticosteroids in a randomized, double-blind, placebo-controlled pilot study using a within-subject crossover design.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women age 18-50 years
* Education of ≥ 12 years and baseline RAVLT total words recalled score ≥ 35 (normal baseline memory)
* BMI between 18.5-30 (not underweight or obese)

Exclusion Criteria:

* History of major psychiatric illness defined as major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, schizoaffective disorder, schizophrenia, eating disorders, or drug/alcohol abuse/dependence or current tobacco use
* History of neurological disorders including seizures, brain surgery, multiple sclerosis, Parkinson's disease
* Taking CNS-acting medications within 30 days of study
* History of allergic reaction or medical contraindication to vilazodone or hydrocortisone
* Significant medical conditions (e.g., myocardial infarction, cancer, diabetes)
* Vulnerable population including pregnant or nursing women, the incarcerated, and severe cognitive disorders
* Baseline HRSD (Hamilton Rating Scale for Depression) \> 7 or current suicidal ideation or history of suicide attempt
* History of systemic Corticosteroid (CS) use or recent (past 6 months) inhaled CS use
The Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).

This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). By reviewing clinical data, physical examinations, questionnaires, continuous glucose monitoring, and subcutaneous fat ultrasound, we aim to understand the current status of treatment and metabolism in Chinese T1DM patients and analyze the potential factors that may affect their blood sugar control and metabolic indicators. A cost-effectiveness analysis will be conducted on Chinese T1DM patients using continuous glucose monitoring systems to identify the groups that benefit most from these systems.

This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). This study will collect multicenter data on T1DM patients, including sociodemographic information, anthropometric measurements, glycemic indices (glycated hemoglobin, fasting blood glucose, postprandial blood glucose), acute and chronic complications, other important metabolic indicators (blood lipids, vitamin D), insulin treatment methods, blood glucose monitoring status, diabetes education, diet and exercise, social and psychological support, and extra-pancreatic autoimmune diseases. The aims are: 1. To understand the current state of treatment and glycemic metabolism in Chinese T1DM patients and to analyze the potential factors that may affect their glycemic indices. 2. To understand the current status of continuous glucose monitoring (CGM) usage in Chinese T1DM patients and to analyze the impact of CGM on blood glucose control, acute and chronic complications, and quality of life in T1DM patients. 3. Through cost-benefit analysis, to identify potential beneficiary groups for CGM, providing objective evidence for the demand of this technology to healthcare professionals and diabetes patients; to provide effective information for the formulation of medical insurance reimbursement policies for continuous glucose monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate and be able to sign informed consent
* Patients with type 1 diabetes
* At least one of the following three clinical characteristics must be met: The disease presents initially with diabetic ketoacidosis (DKA) or ketonuria; The presence of islet-related autoantibodies, such as islet cell antibodies, tyrosine phosphatase antibodies, or glutamic acid decarboxylase (GAD) antibodies, is detected positively; Both fasting and postprandial C-peptide levels are ≤0.6 ng/mL.

Exclusion Criteria:

* Other types of diabetes.
* Patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.
Interest in Electronic Applications for Patients With Glaucoma

To evaluation interest in use of smartphone- and tablet-based application (app) for participants with glaucoma, ocular hypertension, those at risk and their caregivers.

This study is designed to determine the amount of interest in an educational application (app) on social media for glaucoma patients and their caregivers.

The purpose of this App is to enhance understanding of glaucoma by using short video tutorials. The App will include glaucoma eye drop medication reminders, a short video tutorial which aims to improve understanding of how visual field testing should be performed, how to administer eye drops and a feature that will enable participants to store and organize testing results using a mobile device.

Eligibility Criteria:
Inclusion Criteria:

* Anyone affected by glaucoma
* Family and friends of someone with glaucoma

Exclusion Criteria:

* unable to complete survey
Multi-center Dynamic Investigation and Research on Nutritional Status of Inpatients

we use the tools of SGA and NRS2002 to understand the nutritional status of Chinese Han inpatients during hospitalization and discharge, and to dynamically analyze the changes in the process of internal medicine and surgery in many general hospitals across Zhejiang Province.

his study was conducted in parallel in a number of Grade-A hospitals across the country.

The researchers used SGA and NRS2002 and other data measurement tools to collect patient information.

1. General survey: initials, age, height, weight, gender, birthday, nationality;
2. Admission and discharge diagnosis: primary diagnosis and secondary diagnosis;
3. Laboratory indicators at admission and discharge: white blood cell, lymphocyte count, hemoglobin, platelet; Liver function (ALT and TBIL); kidney function (BUN and CR); protein (total protein, albumin and Prealbumin); blood lipids (cholesterol and triglycerides), etc.: The above results are subject to laboratory examinations within 3 days of hospitalization and discharge, and collect as complete as possible;
4. Anthropometric indicators at admission and discharge: hand grip, calf circumference or upper arm circumference, etc.
5. Comprehensive evaluation tools at admission and discharge: subjective comprehensive nutritional assessment (SGA) and nutritional risk screening (NRS2002);
6. Description of nutritional support during hospitalization: no nutritional support, pure enteral nutrition support, pure parenteral nutrition support, enteral + parenteral nutrition support;
7. Clinical outcome indicators at discharge: 30-day hospitalization mortality, total complications, infection complications, length of stay, total medical expenses, etc.

Eligibility Criteria:
Inclusion Criteria:

* Newly hospitalized patients ≥ 18 years old;
* The length of hospital stay is 7-30 days;
* Those who have not undergone surgery before 8 o'clock the next day;
* Consciousness;
* Willing to accept the assessment and sign the informed consent form.

Exclusion Criteria:

* Age \<18 years old;
* The hospital stay is less than 7 days or more than 30 days;
* Those undergoing surgery before 8 o'clock the next day;
* Unconsciousness;
* Inpatients who refuse to be assessed.
The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting

The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation, occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH), this frequently performed procedure is currently done without anesthetic, making it a painful and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a relatively new effective and "needle-free" topical anesthetic. The investigators were interested in examining its effectiveness in pain reduction in children undergoing Perc Pin removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded, randomized placebo-controlled clinical trial with 281 patients (140 patients each in the Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children) and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to randomization and immediately after Perc Pin removal. Data was analyzed using a Student's t-test and the Wilcoxon signed ranks test.


Eligibility Criteria:
Inclusion Criteria:

* Children between 3 and 16 years of age (i.e. up to but not including the 17th birthday) who present to the Pediatric Plaster Room at the SCH for Perc Pin removal were eligible for inclusion in this study.

Exclusion Criteria:

* Any patient with Perc Pins that are threaded (not smooth), as these pins require a more difficult removal process, oftentimes in the operating room instead of the orthopedic clinic.
* Infection around the Perc Pins: This is considered a relative contraindication to the use of topical anesthetic as it is usually less effective in this situation.
* Any parents/patients unable to exhibit understanding of the Oucher/VAS -- due to language barriers or developmental delay in the patient (e.g. severe cerebral palsy).
* The presence of an open wound in the vicinity of the pins that could not be excluded from the area to which the topical anesthetic cream is to be applied.
* Present use of analgesic or anxiolytic medications (within 24 hours prior to pin removal)
* Known allergies or adverse reactions to Maxilene
Stratafix Vs. Vicryl OAGB / MGB Suture Study

To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* adult patients selected for primary Mini-Gastric bypass to treat obesity (BMI\>30)
* laparoscopic access feasable (intention to treat laparoscopically)
* failed conservative treatment (accepted by health insurance companies)
* relevant co-morbidities in cases with BMI \<40
* age 18 years or elder

Exclusion Criteria:

* severe language problems
* revisional or redo-procedures
* operation intended as open procedure(extensive previous surgeries),
* operation performed under corticoid-medication
* operation performed under full-dose anticoagulants
* operation performed by another surgeon than one of the 3 experienced MGB-surgeons of the Department
COVID-19 Close Contact Self-Testing Study

Widespread testing and contact tracing are critical to controlling the COVID-19 epidemic. Distribution of COVID-19 self-test kits can augment public health contact tracing efforts, as individuals with COVID-19 can distribute self-testing to close contacts. This approach can increase case detection by facilitating testing among exposed individuals, and potentially ameliorate stigma, fear, and medical mistrust associated with COVID-19 among vulnerable populations.

The central hypothesis of this study is that distribution of SARS-CoV-2 self-tests to close contacts of among individuals with COVID-19 infection can increase case detection compared with a standard contact referral strategy.

Strategies to increase testing among individuals exposed to COVID-19 are needed. One approach to increase testing and case detection is to distribute home test kits to close contacts of individuals with COVID-19. This approach decreases logistic barriers to testing, potential exposures to COVID-19, and reduces potential stigma and fear associated with facility-based COVID-19 testing.

The investigators will conduct a cohort study of individuals diagnosed with COVID-19 in the C-STRAND trial (NCT04797858), in order to determine if distribution of self-test kits to close contacts of of individuals with COVID-19 can increase case detection compared with a standard contact referral strategy among. Individuals diagnosed with COVID-19 who were randomized to the self-test (intervention) arm or received self-test kits will be assigned to receive additional self-test kits to distribute to close contacts. Individuals diagnosed with COVID-19 who were randomized to the test referral (control) arm or received test referrals will be assigned to receive text message referrals to give their close contacts to seek testing if needed. COVID-19 case detection and test uptake will be measured in both arms.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Has a working telephone number
* Willing and able to provide informed consent

Exclusion Criteria:

* Severe symptoms requiring immediate medical attention
* Younger than 18 years of age
* Does not have a working telephone number
* Unable or unwilling to provide informed consent
Dose-response Study of OPC-12759 Ophthalmic Suspension

The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatient.
2. Subjective complaint of dry eye that has been present for minimum 20 months.
3. Primary ocular discomfort severity is moderate to severe.
4. Corneal - conjunctival damage is moderate to severe.
5. Unanesthetized Schirmer's test score of 7mm/5minutes or less.
6. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
2. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
3. Anticipated use of contact lens during the study.
4. Any history of ocular surgery within 12 months.
5. Female patients who are pregnant, possibly pregnant or breast feeding;
6. Known hypersensitivity to any component of the study drug or procedural medications.
7. Receipt of any investigational product within 4 months.
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer

Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.

This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means)
* Operated for an invasive breast cancer (histologically proven)
* Surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed
* Treated with aromatase inhibitor
* Osteopenic (-2.5\<T score\<-1) without osteoporotic fracture
* With written informed consent signed
* With social security

Exclusion Criteria:

* Women presenting a history of osteoporotic fracture or a T score less than -2.5 at at least one measure site
* Women presenting clinical signs of metastases
* Having received other hormonal treatment in the last 3 months
* Having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year
* Presenting a known and untreated hyperthyroid
* Presenting a known hyperadrenocorticism
* Patients treated and followed for Paget's disease of bone
* Presenting a untreated primary hyperparathyroid
* Presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min)
* Patients presenting malabsorption syndrome for glucose/galactose
* Person participating in another clinical trial concerning a medicine susceptible to influence bone mass
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)

The primary purpose of this study is to determine whether empagliflozin, a medication in a class known as sodium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, may reduce symptoms of depression. Since this medication helps the body make metabolites known as ketone bodies which can serve as an alternate energy source for the brain, the investigators can also test whether ketone bodies help with depressed mood.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB).
* Patients ages 18-65;
* Current/acute Major Depressive Disorder (MDD) diagnosis, per MINI psychiatric interview;
* At least moderate severity of depression (Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 at initial screen);

Exclusion Criteria:

* DSM-5 diagnosis of Bipolar disorders, Cyclothymia, Schizoaffective disorder, Schizophrenia; any psychotic disorder or affective psychosis;
* Subjects that have had more than two failures of adequate anti-depressant trials in the current MDD episode;
* Subjects on psychotropic medications other than SSRIs, NDRIs, SNRIs, or mirtazapine (occasional use of sleep agents, equivalent to lorazepam 1 mg or zolpidem 10 mg, will be allowed);
* Those that have previously been on SGLT2 inhibitors;
* A significant history of non-adherence to treatments;
* History of neurologic / seizure disorder;
* A significant history of non-adherence to treatments;
* History of dementia/cognitive dysfunction (MOCA \< 22);
* A primary diagnosis of a personality disorder, in the opinion of the screening clinician;
* DSM-5 substance use disorder (drug/alcohol) active within the past 12 months, or positive urine toxicology at screening;
* History of diabetic ketoacidosis;
* History of recurrent genital mycotic infection;
* GFR \<45;
* HgA1c.\>8.0%
* History of an allergic reaction to an SGLT2 inhibitor.
* Pregnancy or lactation (women of reproductive age, ie \<50 years old, should be on licensed hormonal or barrier method contraception).
* Any known pancreatic disease resulting in insulin deficiency (T1D, history of pancreatitis, pancreatic surgery);
* History of liver or kidney disease;
* Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.
SASH: Sodium Accumulation Study In Haemodialysis

Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates. The pathogenesis of CVD in patients on HD is multifactorial and complex but hypertension is thought to be a major contributing factor. Sodium balance is normally regulated by the kidneys in health but has to be achieved by sodium removal during HD for those with ESKD. Recent evidence suggests that accumulation of sodium in the skin and / or muscle may be a critical factor impacting the development of hypertension and CVD in patients with ESKD and non-invasive methods are therefore required to study tissue sodium accumulation in this context. This study aims to determine the change in skin and muscle sodium content in patients undergoing haemodialysis. Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis).

It has been proposed that tissue sodium accumulation in skin and/or muscle is a key factor in hypertension. 23Na MRI allows the assessment of skin and muscle sodium storage and will therefore be a valuable tool in elucidating the role of tissue sodium accumulation in the pathogenesis of salt-sensitive hypertension and cardiovascular morbidity and mortality. Moreover, if haemodialysis in patients with end-stage kidney disease (ESKD) results in changes in tissue sodium, the development of 23Na skin and muscle measures would allow for a method to correlate skin tissue sodium content with detailed cardiovascular and functional assessments.

Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis), in conjunction with clinical data collection (eg. blood samples, bioimpedance analysis, skin autoflorescence).

Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years inclusive
* Male patients with CKD stage 5 receiving chronic haemodialysis
* Patient has been dialysis dependent for at least 3 months
* Must be able to follow simple instruction in English (on safety ground for MRI scans) and be able to understand the nature and requirements of the study

Exclusion Criteria:

* Active infection or malignancy
* Amputee
* Pregnancy
* Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
* Unable or unwilling to provide informed consent
* Medical conditions or overall physical frailty precludes scan session in opinion of investigator
* Any condition which could interfere with the patient's ability to comply with the study