cyrilzakka/clinical-trials huggingface dataset:
Stanford PIPRA Validation Study in an Elderly Orthopedic Population

The purpose of this study is to determine the accuracy of an AI-based tool in the prediction of postoperative delirium (POD), in a population at moderately high risk of developing this syndrome (i.e., elderly orthopedic subjects). The population to be studied has already been enrolled in a parallel study regarding the likelihood of developing delirium, its relationship to the type of anesthetic, and the relationship between anesthetic type, development of delirium and risk for post-operative cognitive impairment (including risk for dementia) (Protocol ID#55169 \[David Drover-Principal investigator; José Maldonado-Co-investigator\]).

Study investigators would like to determine the real-life accuracy of a new tool developed for the prediction of delirium: Pre-Interventional Preventive Risk Assessment (PIPRA) Tool. The importance of assessing the risk for post-operative delirium (POD) includes: providing clinicians and patients with accurate predictive information regarding the patient's risk for developing delirium as part of the risk/benefit calculation for surgical procedures, and thus potential risk of subsequent cognitive impairment; as well as the ability to introduce timely prophylactic techniques that may prevent its onset.

The PIPRA tools consists of nine items commonly found in any presurgical patient's electronic medical record (EMR). The tool has been designed to run in the background of the EMR and automatically calculate the patient's risk for developing delirium upon admission for surgical intervention. For our study, we will be applying the PIPRA tool to the EMR of patients already enrolled in a parallel study as detailed above.

The PIPRA tool predicts the risk of developing POD delirium based on its algorithm that takes into consideration the following nine clinical variables: age, height/weight or body mass index, the American Society of Anesthesiologist physical status Classification system (ASA), past history of delirium, past history of cognitive impairment (including dementia), number of medications, preoperative C-reactive protein levels, surgical risk (as determined by the European Society of Anesthesiology), and type of surgery. The subsequent result predicts the risk (in percentage) of a patient developing POD following surgery.

The PIPRA tool is fully integrated into EMR systems, operating in the background, extracting relevant information, and automatically generating a delirium prediction score. In addition, this software possesses the flexibility to recalibrate the delirium risk based on the availability of the nine clinical variables.

Eligibility Criteria:
Inclusion Criteria:

* Surgical patients
* Greater than or equal to 65 years old
* ASA I, II or III
* Greater than 90 min of surgery
* Non-cardiac surgery

Exclusion Criteria:

* Dementia
* Alzheimer's
* Parkinson's
* Current Benzodiazepine use
* Alcoholism
* Previous surgery within the last 12 months or expected in the 12 months to come (except the expected surgery for which they are being enrolled).
* Color-blindness
Sensate II Utilization and Perceived Stress in Adults

Sensate® is A commercially marketed (FCC #: 2AS9ESEN231) stress management wellness device (BioSelf Technology; London, UK). This non-invasive wellness device is one component of a cross-modal (acoustic and aural) sensory experience designed to help an individual experience relaxation following a 10 to 30-minute session. The wellness device is paired with an in-app software program that offers infrasonic vibrations that are proprietarily synced to music or soundscapes. The wellness device is recommended in blogs, and online news articles as a possible modality for positive stress management (Bergland, 2017; Woodhall, 2018; Woolton, 2018), and anecdotal evidence from social media influencers suggest a relaxing response (Garth, 2021; Knight, 2021; Patterson, 2020). Moreover, a 2021 survey response from consumers of Sensate suggests an improvement in stress response during the COVID-19 pandemic (McDoniel \& Chmelik, 2022). However, it is unknown to what extent, if any, the use of Sensate II correlated with validated measures of stress, affect, or sleep quality in adults.

This study aims to assess the possible relationship between Sensate II utilization (Frequency, Duration, \& Time) and perceived stress, affect, and sleep quality in adults.

1. Is there a relationship between Sensate II utilization and perceived stress
2. Is there a relationship between Sensate II utilization and postive \& negative affect
3. Is there a relationship between Sensate II utilization and sleep quality. It is hypothesized that significant relationship existis between Sensate II utilization and perceived lower stress, higher postive affect, lower negative affect, and sleep quality.

References Bergland, C. (2017). Will stress-busting vagus nerve gadgetry be a game changer? Non-invasive vagus nerve stimulation reduces "fight-or-flight" stress responses. Psychology Today. http://www.psychologytoday.com/us/blog/the-athletes-way/201711/will-stress-busting-vagus-nerve-gadgetry-be-gamechanger

Garth, E. (2021). Review: Sensate stress and anxiety management. Longevity.Technology. http://longevity.technology/lifestyle/review-sensate/

Knight, S. (2021). Does the Sensate 2 do anything apart from vibrate your ribcage? http://www.makeuseof.com/sensate-review/

McDoniel, S., \& Chmelik, S. (2022). A non-invasive device for stress management. https://www.researchgate.net/project/A-Non-Invasive-Wellness- Device-for-Stress-Management

Patterson, B. (2020). Sensate Meditation Device Review. http://the-gadgeteer.com/2020/07/10/sensate-meditation-device-review/

Woodhall, V. (2018). Vagus nerve: The new key to stress relief and good health. The Times. https://www.thetimes.co.uk/article/vagus-nerve-the-new-keyto- stress-relief-and-good-health-b0778h20q

Woolton, C. (2018). Wellness: Fear of flight. https://www.vogue.co.uk/article/fear-of-flying-sensate-review

Eligibility Criteria:
Inclusion Criteria:

Inclusion for this study will be adults (18+ years of age) who have been using the Sensate II device for stress management for a minimum of 30-days or one month.

Exclusion Criteria:

-
Treatment for Joint Pains Due to Aromatase Inhibitor Therapy in Breast Cancer

Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast cancer. However, approximately half of the women who take this drug will develop significant joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine should be taken for 5 years, the joint pain can be so troublesome that up to 13% may prematurely discontinue it because of the arthralgia, thus sacrificing their best chance of recurrence-free survival. Nonetheless, neither the etiology nor optimal management of AIA is clearly understood, leaving both doctor and patient rather frustrated.

The investigators therefore propose to test the hypothesis that AIA can be effectively treated by a new clinical algorithm, and that effective treatment of the problem will lead to improved compliance with Aromatase Inhibitor (AI) therapy. The algorithm is a clinical pathway for treating AIA which incorporates, in a rational and step-wise manner, a series of interventions based on the available evidence. Interventions include acupuncture, pain medication, weight bearing exercise, and other commonly used therapies for AIA.

The investigators will enroll 100 women who are beginning adjuvant AI therapy and assess each woman's baseline joint pains via a questionnaire as well as grip strength measurement. The investigators will then periodically repeat these tests during AI therapy in order to systematically quantify and characterize AIA. Those women who develop AIA during the course of the study will be placed on the clinical algorithm, and the investigators will observe whether their joint pains significantly improve (as measured by questionnaire and grip strength measurement) after institution of the algorithm. The investigators will also determine whether their compliance is improved compared to historical controls, and at least non-inferior to the women in the study who do not develop AIA. Finally, the investigators will measure serum estrogen level at baseline and then periodically during AI therapy to investigate whether more dramatic decline in estrogen level after initiation of an AI leads to significant AIA and earlier time to onset.

This study targets a very common cause of pain among breast cancer survivors and aims to offer an effective treatment strategy to alleviate pain and improve quality of life as well as medication compliance.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* stage I-III ER+ breast cancer
* beginning adjuvant AI therapy
* post-menopausal as defined by any of the following: age \>60 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and FSH concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomy

Exclusion Criteria:

* previous use of an aromatase inhibitor
Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD).

The maximum study duration per subject was anticipated to be up to 42 days.


Eligibility Criteria:
Inclusion Criteria:

* Estimated glomerular filtration rate (eGFR) of 20 to \<60 mL/min/1.73m2
* Serum bicarbonate level of 12 to 20 mEq/L

Exclusion Criteria:

* Any level of low serum bicarbonate that, in the opinion of the Investigator, requires emergency intervention.
* Severe comorbid conditions other than chronic kidney disease.
* Chronic obstructive pulmonary disease.
* Anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, H2-blockers, or proton pump inhibitors.
* Excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (NSAIDs), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.
Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia

The arterial blood pressure affects the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the hematocrit. During induction of anesthesia blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the decrease in hematocrit.

24 patients scheduled for coronary artery bypass surgery will be included and randomized to receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or to a control group and receive norepinephrine only if mean arterial pressure decreases below 60 mmHg. Arterial blood gas will be analysed every ten minutes. Equal anesthesia in both groups will be monitored. No fluids will be infused. Noninvasive continuous hemoglobin measurement (SpHb) will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Elective coronary artery surgery patients

Exclusion Criteria:

* Age under 18 years
* untreated hypertension
* a reduced left ventricular systolic ejection fraction of 45 % or less
* diabetes mellitus
* former stroke and/or a known carotid artery stenosis.
Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography

This project aims to establish a comprehensive artificial intelligence system for detecting and qualitative diagnosing breast lesions. Mammary images will be used to construct a diagnosis method based on deep learning. The system is proposed to automatically analyze the type of mammary glands, automatically identify and mark all breast lesions on the mammography images, provide the malignancy probability judgment of the lesions, the BI-RADS classification and the clinical suggestion, and also automatically generate the structured diagnosis report.

This is a multi-center study.The project contains a retrospective part(3000 samples anticipated) and a prospective part(7000 samples anticipated). In the retrospective part, investigators collected subjects with mammary images to design the deep learning method and construct a detective and diagnostic model for breast lesions. In the prospective part, investigators validate the accuracy of the constructed deep learning method, and established artificial intelligence system focusing on mammary diagnosis. Investigators will also explore the application pattern of the artificial intelligence system in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* the X-ray images of the breast were complete
* the results of pathological diagnosis or more than 2 years of mammography follow-up were available
* subject signs informed consent(this item was only for prospective study cases)

Exclusion Criteria:

* there exists pathological diagnosis of breast lesions when receiving mammography
* there lacks pathological diagnosis or 2 years of mammography follow-up
* subject withdraws(this item was only for prospective study cases)
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.


Eligibility Criteria:
Inclusion Criteria:

* All aims, aged ≥18 - \< 99 years old admitted to UCH Burn Center with frostbite injury
* Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
* Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound

Exclusion Criteria:

* Pregnant patients
* Prisoners
* Anticipated death within 48 hours of admission
* Inability to obtain consent from patient, legally authorized representative, or proxy
* Aim 1:Patients admitted five days and later from frostbite injury. Patients who have a clinical infection at baseline. Any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy).
* Aim 2: Any patients that have a contraindication for use of dalbavancin, including known history of hypersensitivity to dalbavancin, vancomycin, or other glycopeptide antibiotics. Patients with infections known to be caused by vancomycin-resistant Enterococcus; or those with Stage IV or V chronic kidney disease, or with cirrhosis (Childs-Pugh C); or those with anticipated death within 48 hours of infection.
* Aim 3: Anuria due to chronic kidney disease (CKD)
Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time \>50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.

NOTE: The study never started.

Eligibility Criteria:
Inclusion Criteria:

1. Exclusively breastfed Infants
2. Infant aged of 29 days to 3 months
3. With a diagnosis of infantile colic as defined by the Rome III criteria
4. Birth at term and eutrophic (weight, height, head circumference)
5. Apgar score\> 7 at 5 minutes
6. Consent to the study signed by the two parents.
7. Availability during the study period

Exclusion Criteria:

1. Associated severe chronic disease
2. Acute infectious disease
3. Personal or family first degree history of allergy to milk proteins
4. Several infants of the same family from a multiple pregnancy
5. Infants who received antibiotics one week prior to randomization
6. Infants who received probiotics one week prior to randomization
7. Mother who received antibiotics 1 week before randomization
8. Regular consumption of probiotics by the mother 1 week before randomization
9. Infants-included in another clinical study
10. Lack of insurance coverage by the french social security
11. Non exclusively breastfed infants
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids

Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size)
* Cadaveric or living donor (related or unrelated)

Exclusion Criteria:

* Patients who are recipients of multiple solid organ transplants and/or who have previously received transplanted organs
* If cold ischemia time of the transplanted organ is \>12 hours
* Auxiliary liver transplant recipients
* Fulminant hepatic failure
* Autoimmune hepatitis
* Primary sclerosing cholangitis
* Severe acute systemic infections
* Hepatitis B surface antigen/HCV/HIV positive
* Known contraindication to intravenous (i.v.) or per os (orally) (p.o.) cyclosporine or corticoids
* Non-ability to comply with the protocol
* Relevant abnormal physical or laboratory findings within 2 weeks of inclusion
* Relevant severe allergy, hypersensitivity to basiliximab or similar drugs
* History/presence of relevant malignancy
* Pregnancy/breastfeeding
* Use of any investigational or immunomodulatory/immunosuppressive drug within 4 weeks prior to transplantation.
FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries

Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.

Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary stent guided with pressure into coronary arteritis comparing 2 strategies with patients having a coronary procedure with stent, excluded patients with myocardial infarction.

It is a randomized study, intending to treat, comparing the optimisation of the opening out of a stent into a coronar artery either guided with angiographic images only or with the assistance of pressure measurements plus angiographic control.

Several French centers participate to demonstrate superiority of one strategy. The criterion of principal judgement is the whole of cardiac events, criterion made up with the cardiac death, myocardial infarction, revascularisation by coronary bridging and/or angioplasty and positivity of the effort test.

Secondary criterions are :

* comparing cost to efficacy of the two strategies
* evaluating the angiographic restenosis into an under group of 200 patients (100 patients into each group)
* determining the optimal threshold of measurement of intra coronary pressure in a multicentric population
* comparing the ability of the different stents used to optimised the intra coronary pressure measurements

Eligibility Criteria:
Inclusion Criteria:

* patient sent to coronal angioplasty with putting of an active stent to treat a restenosis

Exclusion Criteria:

* acute myocardial infarction
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.

There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SPMS
* Age 40-70 years
* Able to understand English and able to give informed consent

Exclusion Criteria:

* Unable to undergo MRI testing
* For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
* For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
* Pregnant or breast-feeding.
* Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
* Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
* Other immunosuppressants or chemotherapies taken in the last 12 months
* Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
* IV or oral steroids taken in the past 60 days.
* Lipoic acid taken in the past 60 days.
* Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications
Immediate Effects of Dry Needling and Tens in Chronic Neck Pain

The aim of this study is to determinate the effects of percutaneous electrical nerve stimulation in the short-term for pain in patients with myofascial chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain for more than six months of evolution.
* Active Myofascial Trigger Point number 2 on Trapezius muscle.
* Score of more than 2 points in a Visual Analog Scale.

Exclusion Criteria:

* Neck pain specific.
* Radiculopathies.
* Whiplash.
* Dizziness and migraines
* Cervical surgical intervention
* Previous treatment of Dry Needling