cyrilzakka/clinical-trials huggingface dataset:
Nutri Diet Goal Setting Software Pilot Trial

The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control.

In this pilot trial, the intervention group (N=10 primary care providers \[PCPs\], N=40 patients) receives collaborative diet goal setting via Nutri, and the control group receives usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when the Nutri workflow is available for a patient and asked to complete it during their visit with that patient.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes
3. Have a scheduled medical appointment with a study enrolled PCP within the study enrollment period
4. Fluent in either English or Spanish
5. Access to a computer, tablet, or smartphone and reliable internet
6. Stated willingness to comply with all study procedures and availability for the duration of the study
7. HIPAA authorization for Health Information Exchange

Exclusion Criteria:

1. Currently pregnant
2. Diagnosed with an eating disorder
Effect of Homocysteine and Asymmetric Dimethylarginine on Cardiovascular Events in Hemodialysis Patients

Homocysteine (Hcy) and asymmetric dimethylarginine (ADMA) have recently been recognized as potential risk factors for atherosclerosis in the general population, and the metabolism of each of these substances seems to be closely related. This study investigates the association between these substances, and whether elevated serum levels of Hcy and ADMA would be related to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (HD) patients.

Objective- Homocysteine (Hcy) and asymmetric dimethylarginine (ADMA) have recently been recognized as potential risk factors for atherosclerosis in the general population, and the metabolism of each of these substances seems to be closely related. This study investigates the association between these substances, and whether elevated serum levels of Hcy and ADMA would be related to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (HD) patients.

Methods- The subjects were recruited from both day-time and night-time HD patients at Maruyama Hospital. The study inclusion criteria were those patients who had been receiving hemodialysis therapy for more than 6 months, were in a stable condition and were under 70 years old. The degree of atherosclerosis was evaluated by four indices involving the carotid artery intima-media thickness (IMT), carotid artery plaque, percentile of calcification index in the abdominal aortic wall (ACI) and elongation of the thoracic aorta. At the same time, plasma Hcy and ADMA were measured. After the initial laboratory examination and evaluation of the degree of atherosclerosis, all the patients were followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* The study inclusion criteria were those patients who had been receiving hemodialysis therapy for more than 6 months, were in a stable condition and were under 70 years old.

Exclusion Criteria:

* Any patients showing signs of heart failure or a history of such apparent cardiovascular diseases as myocardial infarction, cardiac valve diseases and stroke were excluded.
Maintenance of Physical Condition and Physical Activity at One Year After Cardiac Rehabilitation Program

Maintaining physical activity post-cardiac rehabilitation (CR) has a major role in disease progression and patient prognosis, especially given its potential impact on physical condition. Unfortunately, during a nursing interview carried out 6 months after the CR at the Center Hospitalier de Cholet, we find that 40% do not maintain regular physical activity. This observation is in line with the literature since it emerges respectively at 2 months and 1 year post-CR that between 47% and 59% of patients do not comply with the recommendations in terms of physical activity (Guiraud et al, 2012).

However, data suggest that during the post-CR follow-up phase at 6 months, there could be a maintenance of the physical condition assessed via the distance at the 6-minutes walk test (Pavy et al, 2012; Racodon et al, 2019). There is a lack of data on the maintenance of physical condition beyond 6 months since no study has evaluated the maintenance of physical condition at 1 year post-CR by 6-minutes walk test.

The objective of this study is to examine the maintenance of physical condition at one year after cardiac rehabilitation program by the 6-minutes walk test.

Eligibility Criteria:
Inclusion Criteria :

* Patient participating in cardiac rehabilitation
* Patient who presented an acute coronary syndrome
* Patient having signed the written consent to participate
* Patient able to comply with the constraints of the protocol

Exclusion Criteria :

* Patient with heart failure
* Patient reluctant or unable to comply with the protocol
* Pregnant, parturient and nursing mothers
* Persons deprived of their liberty or under guardianship
Vaporized Nicotine and Autonomic Control

E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been reported: our purpose was to clarify this issue. Using a randomized crossover design, participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo e-cigarette (0 mg/ml).


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Individuals with a history of hyperthyroidism
* Women currently taking oral contraceptives, are pregnant or breast-feeding, or trying to become pregnant
* Individuals currently taking prescription drugs.
* Individuals with respiratory illnesses (e.g., asthma, chronic obstructive pulmonary disease, reactive airway disease, etc.)
* Individuals with hypertension (systolic \>130 and/or diastolic \> 80).
* Individuals with a history of tobacco or vaporized nicotine use.
* Individuals who have been diagnosed with diabetes
* Individuals who are under the age of 18 or over the age of 40
Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time

This research aims to assess the effect of low versus high dialysate sodium concentration during hemodialysis on dialysis recovery time

Chronic kidney disease (CKD) is a general term for heterogeneous disorders affecting the structure and function of the kidney. The variation in disease expression is partly related to the cause, pathology, severity and the rate of progression. Fatigue is a well-known and frequent symptom in HD patients with a reported association with the decrease in health-related quality of life commonly found in this population. The prevalence of fatigue ranges from 60% to as high as 97% in patients on long-term renal replacement therapy. Despite this fact, health care providers are still unaware of both its presence and severity. Several methods have been proposed as a way to assess post-HD fatigue with the "time to recover (minutes) from HD" being one of them. Lindsay et al.assisted patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?". Although post-HD fatigue commonly exists in dialysis patients, it is usually underestimated by physicians. For this reason, appropriate and early identification of symptoms and associated factors might improve the patient's quality of life. Rayner et al. found that dialysate Na was inversely associated with DRT where lowering the Na concentration in the dialysate (to 140 mEq/L) was linked to a longer DRT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage renal disease who have been prescribed long term hemodialysis and undergo four-hour HD treatments three times a week for more than 90 days.
* Patient must be at least 18 years old. They must be able to read and write, as well as be in complete mental health.

Exclusion Criteria:

* Inability to complete the surveys due to reading or hearing difficulties, actual instability of clinical condition that necessitate hospitalization, dementia, active malignancy or liver failure.
Memantine for Agitation in Dementia

We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks

Agitation is a cause of morbidity and mortality in Alzheimer's due to distress and use of medication with side effects. Memantine has beed shown to be associated with less agitation and a recent study by forrest pharmaceuticals failed to recruit. We will perform a 12 week rct in 164 patients to test this hypothesis in a locality with no competing studies and in a clinical setting where the drug is not often used. We will compare with placebo and also use a rescue protocol derived from international best practice.

Eligibility Criteria:
Inclusion Criteria:

1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score\<=4.
3. Moderately severe to severe Alzheimer's Disease (baseline MMSE \</=19).
4. Clinically significant agitation that requires treatment.
5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) \> /=45.
6. Age \>/= 55.

Exclusion Criteria:

1. Memantine usage in the 4 weeks prior to the start of the study.
2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
3. Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
4. Antiparkinsonian medication.
5. Hypersensitivity to memantine or any of the excipients in the formulation.
6. Severe renal impairment.
7. Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.
8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
10. Severe, unstable or poorly controlled medical illness.
11. Any disability that may interfere with the patient completing the study procedure.
12. Active malignancy.
13. Delirium, pain or any medical illness as a clear cause of agitation.
14. Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorphan, Dopaminergics- amantadine, Warfarin due to theoretical INR prolongation.
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data related to other treatment modalities.

The present study will be a prospective, multicentric, non-randomized and non-controlled trial involving 112 patients followed for 24 months. The study will be conducted in France in 7 investigational centres.

The study will be prospective, multicentric, single-arm observational (non-interventional) to evaluate the safety and performance of the CELLIS Breast membranes used in breast reconstruction following mastectomy.

All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.

The study will be conducted in France in 7 investigational centres including 112 patients scheduled for a breast reconstruction following mastectomy.

Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.

Patients will return for ambulatory visits on day 10 (+/- 5 days) and/or on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.

CELLIS Breast is available in one thickness, in a variety of size and forms addressing multiple surgical techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥18 years,
* Patient with an indication of breast reconstruction after mastectomy (therapeutic or prophylactic),
* Patient being informed of her participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
* Patient being informed of the porcine origin of the device in advance of the procedure.

Exclusion Criteria:

* Patient with known hypersensitivity to porcine materials,
* Patient with an existing infection at the site of implantation,
* Patient having refused to participate to the study,
* Patient refusing to return for the follow-up visits,
* Patient who is pregnant.
Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?

Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and near total thyroidectomy some unilateral injuries are not clinically evident and asymptomatic.

The aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic examination of larynx to detect laryngeal nerve injuries.

100 patients were randomly divided into two groups, group I for whom mandatory post thyroidectomy endoscopic laryngoscopic examination and the other group of only symptomatic patients selected for direct laryngoscopic examination.

Eligibility Criteria:
Inclusion Criteria:

* all post thyroidectomy patients

Exclusion Criteria:

-
The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty

The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:

* Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.
* Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).

The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 65 years
* BMI between 30 to 45 kg/m2
* Willingness to participate in the study and ability to comply and understand the study protocol.

Exclusion Criteria:

* Active gastric gastro-duodenal during the last 6 months
* Helicobacter pylori infection.
* Organic or motility disorder of the stomach and / or esophagus
* Anticoagulant treatment
* Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
* Ongoing or active malignancy during the last 5 years.
* Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
* Drug or alcohol abuse
* Bulimic or binge eating pattern
* Continuous glucocorticoid or anti-inflammatory treatment
* Uncontrolled thyroid disease.
* Pregnancy, breastfeeding
* Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
* Hiatal hernia ≥ 5 cm
* Known allergy or hypersensitivity to the active substance or any of the other excipients
* Liver cirrhosis of any Child-Phugh stage or MELD\> 15
* Chronic Severe Renal Insufficiency (eGFR \< 30 ml/min/1.73 m2 based on CKD-EPI equation)
* Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
* Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD.

This is a pragmatic pilot for a Stage IV effectiveness, embedded pragmatic clinical trial (ePCT) studying the feasibility of PAINAD assessment implementation via simple EHR prompts for PLWD presenting to the ED with hip pain at the University of Chicago Medicine (UCM) and the University of North Carolina at Chapel Hill (UNC-CH). Identification of subjects with hip pain and dementia contains the level of specificity needed for a pragmatic trial, and occurs on ED arrival, prompting an electronic health record clinical decision support (CDS).

The Pain in Advance Dementia (PAINAD) Score is a behavioral score based on observation of the person. The score depends on observation of five behaviors, breathing, negative vocalizations, facial expressions, body language, and consolability. Each observed behavior is scored from zero = none, to two = most, for a total score from zero to ten.

The design is an interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale. Pre-intervention data from most immediate year to date prior to the intervention start defines the baseline state. The intervention, the EHR prompt to document the PAINAD first on patient arrival to the ED treatment area, and second one hour after delivery of first pain treatment. Prospective evaluation of EHR data will be used to evaluate use of the PAINAD.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 65 years old
* ED arrival complaint of hip pain
* History of dementia by past medical history or problem list in EHR

Exclusion Criteria:

* Patients do not meet inclusion criteria
Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer

This is a real world study to evaluate the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression in HER2-positive metastatic breast cancer.

HER2-positive breast cancers account for 15%-20% of all breast cancers. Despite trastuzumab has significantly improved the survival of patients with HER2-positivie metastatic breast cancer as the first-line standard treatment, the selection of drugs after trastuzumab treatment failure remains difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has shown great effectiveness in treating HER2-positive metastatic breast cancer, but therapies subsequent to trastuzumab progression are still controversial. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. Here, investigators studied the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression, so as to provide new ideas for the treatment of patients with HER2-positive metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Female and 18-80 years old;
2. The patient was diagnosed as HER2-positive breast cancer by histopathology (HER2 positive (IHC +++ or IHC++ but FISH/CISH+ ));
3. All patients have previously received ≤ 2 lines chemotherapy for metastatic breast cancer;
4. Patients received inetetamab combined with pyrotinib and vinorelbine after trastuzumab failure;
5. According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;
6. ECOG score of physical status was less than 2, and the expected survival time was not less than 3 months;
7. Complete and traceable medical data.

Exclusion Criteria:

1. Incomplete medical data;
2. The investigator believes that the patient is not suitable to enter this study.
The Behavioral and Brain Mechanism of IGD

This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for IGDs were:

  1. a score of 67 or higher on the CIAS;
  2. engagement in Internet gaming for over 14 hours per week for a minimum of one year; and
  3. reporting of Internet gaming as their primary online activity;
* Inclusion criteria for HCs were:

  1. a score \< 60 on the CIAS;
  2. never having spent more than 2 hours per week engaged in Internet gaming

Exclusion Criteria:

* for all participants:

  1. current or history of use of illegal substances and gambling;
  2. current or history of psychiatric or neurological illness; and
  3. current use of psychotropic medications
Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique

Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught the orbit to be successful and has a relatively high failure rate. This study will examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion of local anaesthetic by using a dual quadrant injection technique. The study will assess the feasibility of this technique, how successful it is and whether any obvious safety issues arise with its use.

Peribulbar anesthesia is widely used for anterior and posterior chamber ophthalmic procedures. It is a blind technique which is traditionally carried out by inserting a needle in the infero-lateral aspect of the orbit below the globe and injecting a volume of 8 - 12 mL of local anesthetic in the periorbital space. The goal of this inejction is to achieve akinesia and anesthesia of the eye sufficient for surgery. The technique has a relatively high failure rate of up to 30%. A failure or insufficient block requires a second or rarely a third peribulbar injection to achieve success. Ultrasound can be used to guide needles in the human body and has been successfully used in many anatomic locations for anaesthesia. This study will assess whether ultrasound can guide the block needle in ophthalmic anesthesia to deliver local anesthetic via a single entry into two discrete locations within the periorbital space - the first in the infero-lateral quadrant and the second in the infero-medial quadrant. If this can be done the investigators may achieve a higher success rate for this block with a lower volume potentially improving the quality of the block and its safety.

Eligibility Criteria:
Inclusion Criteria:

* ASA score less than III and ability to provide a written informed consent
* 22 patients presenting for opthalmic surgery

Exclusion Criteria:

* Coagulation disorder or anticoagulated with INR \> 1.5
* Platelet count \< 75 X 10\*9/L
* Significant Myopia (axial length \> 28mm)
* Patients unable to lie supine for 2 hours
* Patients with recent gas or silicone injections in/around the eye