cyrilzakka/clinical-trials huggingface dataset:
Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Type 2 diabetes is a risk factor of heart failure and cognitive decline. Heart failure at its early stage is often silent. At present, primary prevention for heart failure is not available. Our aim is to identify diabetic patients at risk of heart failure in order to develop personalized preventive strategies.

Type 2 diabetes is vascular and metabolic risk factor for cognitive decline though a direct lesional effect but also through an interaction with underlying neurodegenerative lesions. Our aim is to identify diabetic patients at risk of cognitive decline in order to develop personalized preventive strategies


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Persons able to understand and object to the information provided.
* Type 2 diabetic patient free of heart failure ≥stade B
* Patient affiliated with a social security scheme.
* Patient agreeing to sign the informed consent form

Exclusion Criteria:

* Patient with dementia
* Patient with at least one of the criteria for heart failure ≥stade B
Randomized Study Comparing Two Established Gastrointestinal Suture Techniques - One-layer-continuous Versus Double-layer-continuous Suture

The purpose of this study is to examine the frequency of postoperative complications depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer suture.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old,
* planned for elective surgery
* at least one hand-sutured ileo-colonic or colo-colonic anastomosis

Exclusion Criteria:

* ASA-Score \> 3,
* missing written consent of the informed patient
* no existing choice between suture-techniques according to the surgeon
* patient not able to cooperate/non-compliance
* rectal anastomoses
Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer

The current trial is intended to assess the efficacy of oral versus vaginal progesterone for luteal support in frozen IVF cycles.

Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF. Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone in frozen IVF cycles.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-39
* Modified natural cycle (induction of ovulation with HCG)
* Consent to participation

Exclusion Criteria:

* None
Risk Perception Associated With Covid-19 Among Anesthetists

Since the outbreak of the COVID-19 pandemic, the anesthesiologists are involved in the riskiest interventions e.g. airway management, endotracheal intubation, and resuscitation. So, they are subjected to a higher risk of infection compared to many other medical specialties. As a result, they are more subjected to psychological stresses. This study aimed to assess the level of stress associated with the COVID-19 pandemic among anesthesiologists.

This is a cross-sectional, hospital-based survey conducted using an online questionnaire after getting IRB approval. The primary outcomes are to evaluate the prevalence of anxiety, depression, and post-traumatic stress disorder (PTSD) among anesthesiologists working in Saudi Arabia. The secondary outcomes include the association of the socio-demographic and occupational characteristics with mental health in the study sample. The survey sent to the target participants using a web-based software platform (https://www.surveymonkey.com/r/ZJ98BTJ) though the Saudi Society of Anesthesia. The study sample included anesthetists and their allied health care providers (nurses and technicians) involved in the management of COVID-19 patients. Data were analyzed using SPSS version 21. Descriptive analyses were conducted, and the ranked data for each level for symptoms of depression, anxiety, and PTSD were presented as numbers and percentages. Multi-variable logistic regression analysis was used to explore potential influence factors on the outcomes. P-values of less than 0.05 were considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* The survey included anesthesia physicians, anesthesia technicians and nurses, and those involved in the management of COVID-19 infected patients in the OR, ICU, or ER.

Exclusion Criteria:

* The exclusion criteria include age \< 18 or \> 60 years, incomplete data, or those who were outside Saudi Arabia during the time of the COVID-19 pandemic.
Remote Physical and Cognitive Training Effects in Older Adults at Increased Risk of Clinical-functional Vulnerability

This study is a randomized, single-blind, parallel, controlled, superiority trial. The main objective is to verify the chronic effects of a remote 12-week low-intensity physical training program alone or in combination with cognitive training on functional, cognitive, and occupational capacity, as well as on the self-reported quality of life.

Participants over 60 years of age at increased risk of clinical-functional vulnerability will be recruited in the city of Pelotas/RS, Brazil and randomized to two different arms. The intervention group will receive low-intensity physical training combined with a cognitive training program using neurobic exercises, whereas the active comparator group will only receive the low-intensity physical training program. Participants from both groups will perform their training sessions remotely for a total of 12 weeks. Outcomes of interest include handgrip strength, functional and cognitive capacity, occupational performance, clinical-functional vulnerability level, self-reported quality of life, and depressive symptoms, which will be assessed in a pre-post fashion. The study hypothesis is that remote low-intensity physical training combined with cognitive training will result in additional benefits to those of low-intensity physical training alone in the physical and cognitive capacity outcomes, and as a consequence, improved quality of life, occupational performance, decreased level of clinical-functional vulnerability and symptoms of depression will be observed.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older,
* MMSE score equal to or greater than 19 points,
* Elementary school education complete or over,
* Sedentary (no current or previous participation in structured exercise (\>1x/week) in the past 6 months),
* Increased risk of clinical-functional vulnerability, as determined by the Clinical-Functional Vulnerability Index-20 (IVCF-20) questionnaire.
* Access to a cell phone or notebook with internet access,
* Resident in the city of Pelotas, Brazil.

Exclusion Criteria:

* Individuals who have been affected by COVID-19,
* Not retired, or those retired individuals who maintained continuous or sporadic work activities,
* Neuromuscular deficits or any medical diagnosis that prevents the individuals from performing physical exercises,
* Individuals with decompensated or untreated blood pressure (\> than 140x90 mmHg) and,
* Individuals with visual problems that prevent them from watching the training sessions on their cell phone or notebook screen.
Aromatase Inhibitor Host Factors Study

The purpose of this study is to examine how key patient factors, including body size affect how well letrozole suppresses circulating estrogen levels.

This study has two components: (1) Part A - an observational phase to evaluate the impact of vitamin D and obesity on estrogen suppression in post-menopausal women already receiving letrozole treatment, and (2) Part B - an interventional phase for women with body mass index (BMI) \> 25 kg/m2 to assess the effect of double AI dose on estrogen levels.

If BMI or other patient factors reduce the effectiveness of letrozole, modifications to treatment recommendations and studies to test higher dosing of letrozole may be needed to maximize the benefit of this treatment and minimize the risk of the breast cancer coming back.

The available evidence suggests that circulating estradiol levels play a critical role in determining effectiveness of aromatase inhibitor therapy, and that maximal suppression of aromatase activity and estrogen production is essential for optimal disease control. Host factors such as high 25-Hydroxy Vitamin D (25-OH D) levels and obesity, which might increase residual estrogen levels, could adversely impact outcome and lead to an increased risk of recurrence or death. The primary objective of Part A (which includes women regardless of BMI) is to directly evaluate the relationship between (i) 25-OH D levels and serum estrogen levels and (ii) BMI and serum estrogen levels in a cohort of postmenopausal women on standard dose letrozole therapy (2.5 mg/day). Part B (which includes only women with BMI \> 25 kg/m2) will determine whether an increased dose of letrozole (5 mg/day), which had no dose limiting side effects in a Phase I study improves suppression of estrogen in overweight/obese women.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female patients
* histological confirmed diagnosis of estrogen receptor and/or progesterone receptor positive breast cancer (Stage I-III) who have completed local therapy
* Currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months
* Willing to provide written informed consent to participate
* for the experimental arm: all of the above and body mass index (BMI) \> 25 kg/m2

Exclusion Criteria:

* Known abnormal liver or renal function defined by:

  1. Serum Creatinine \> 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance \< 40 mL/min
  2. Serum Bilirubin, Aspartate transaminase (AST) or alanine transaminase (ALT) \> 1.5 times ULN
* Presence of persistent local or known metastatic cancer
The Potentially Addictive Properties of Soda: A Feasibility Study

The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.


Eligibility Criteria:
Inclusion Criteria:

* Drinks more than 36 ounces of sugar-sweetened beverages per day
* Speaks fluent English
* Parent speaks English or Spanish
* Lives in San Francisco Bay Area

Exclusion Criteria:

* Pregnant or nursing
* Taking medication to address mental health issues
ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy

Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy

A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation

Eligibility Criteria:
Key Inclusion Criteria:

* Patient is willing to participate and to comply with the study procedures
* Patient present with gynecological disease that may be treated with surgical intervention

Key Exclusion Criteria:

* Life expectancy for less than 1 year
MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy

This study aims to assess changes in vascular permeability in the brain tumor, and in the surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histological confirmed malignancy and presence of intraparenchymal brain metastases
* Patients are treated by WBRT, SRS, or FSRT
* Age greater than or equal to 18 years
* A life expectancy of greater than or equal to 8 weeks
* Karnofsky performance status (an assessment of general well being and ability to do activities of daily living; scale ranges from 0 to 100 where 100 is perfect health) greater than or equal to 60
* Informed consent with signed study-specific informed consent form

Exclusion Criteria:

* Major medical or psychiatric illness, which, in the investigator's opinion, will prevent completion of the protocol
* Patients with lepto-meningeal metastases documented by Magnetic Resonance Imagine (MRI), Computed Tomography (CT), or Cerebrospinal Fluid (CSF) evaluation
* For patients that will undergo Whole Brain Radiation Therapy (WBRT), previous WBRT is not allowed. Patients who have had brain metastases managed by Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery are eligible
* For patients that will undergo Stereotactic Radiosurgery (SRS), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
* For patients that will undergo Fractionated Stereotactic Radiation Therapy (FSRT), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
* Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, etc).
* Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the University of Michigan.
* Women who are pregnant are excluded.
Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery

The purpose of this project is to develop and evaluate the effects of a computer-tailored intervention targeting pain barriers and catastrophizing in adults having cardiac surgery.

The hypotheses are that in the experimental group, in comparison to the control group, participants will show lower levels of pain, less pain interference in their activities, less attitudinal barriers, and less pain catastrophizing.

A pilot-RCT is privileged to assess the preliminary effects of the intervention on the following outcomes: pain intensity, analgesic consumption, pain interference, barriers and pain catastrophizing.


Eligibility Criteria:
Inclusion Criteria:

* first intention cardiac surgery
* 18 years old or more
* able to fill up questionnaires in french

Exclusion Criteria:

* participation to another psychosocial intervention
* cognitive or psychiatric disorder
Detection Dogs as a Help in the Detection of COVID-19

Canine olfactive detection has proven its efficacy in numerous situations (explosives, drugs, bank notes...) including for early diagnosis of human diseases: various cancers, alert of diabetic or epileptic people in immediate alarm of crisis.

Fighting such a viral outbreak requires a widespread testing, one of the key measures for tackling the pandemic. In June 2020, facing a decline of COVID-19, it is possible to say that countries that have mastered their outbreak, and were able to maintain the number of infected people low, need to perform fewer test to correctly monitor the outbreak, than those countries where the virus has spread more widely. And for the same reasons, the timing of testing is also crucial. A high rate of testing will be way more effective to slow an outbreak if conducted earlier on, at a time when there is fewer infectious

The aim of this study is to evaluate if the sweat produced by COVID-19 persons (SARS-CoV-2 PCR positive) has a different odour for trained detection dogs than the sweat produced by non COVID-19 persons. The study was conducted on 3 sites, following the same protocol procedures, and involved a total of 18 dogs. A total of 198 armpits sweat samples were obtained from different hospitals. For each involved dog, the acquisition of the specific odour of COVID-19 sweat samples required from one to four hours, with an amount of positive samples sniffing ranging from four to ten.

Eligibility Criteria:
Inclusion Criteria:

* Due to have a coronavirus swab test in the previous 24 hours
* Aged ≥ 18 years
* Suspected mild COVID-19 symptoms or have been exposed to COVID-19
* Written informed consent provided

Exclusion Criteria:

* Aged \< 18 years
* Written informed consent not provided
* Unable or unwilling to put a compresses for at least 4 h
Manual Versus AI-Assisted Clinical Trial Screening Using Large-Language Models

A prospective randomized controlled trial comparing manual review and AI screening for patient eligibility determination and enrollments. A structured query will identify potentially eligible patients from the Mass General Brigham Electronic Data Warehouse (EDW), who will then be randomized into either the manual review arm or the AI-assisted review arm.

Screening participants for clinical trials is a critical yet challenging process that requires significant time and resources. Traditionally, patient screening has been manual, relying on the diligence and judgment of study staff. However, manual screening is prone to human error and inefficiencies, contributing to high costs and prolonged trial durations.

Recent advancements in natural language processing (NLP) and large language models (LLMs), such as GPT-4, offer potential solutions to improve the accuracy, efficiency, and reliability of the screening process. Retrieval-Augmented Generation (RAG)-enabled systems, like RECTIFIER, have shown promise in enhancing clinical trial screening by automating the extraction and analysis of relevant data from electronic health records (EHRs).

In the investigators' previous study, RECTIFIER demonstrated high accuracy in screening patients for clinical trials, aligning closely with expert clinician reviews and outperforming manual study staff in several criteria. It underscored the potential for LLMs to transform clinical trial screening, making it more efficient and cost-effective while maintaining high standards of accuracy and reliability. However, before RECTIFIER is scaled to be used across many domains of clinical trials, it should be validated prospectively in the real-world setting to enroll patients.

In the Co-Operative Program for Implementation of Optimal Therapy in Heart Failure (COPILOT-HF) trial (NCT05734690), the investigators will identify potential participants through EHR queries followed by manual review, which provides an opportunity for RECTIFIER to improve the screening process. By leveraging RECTIFIER, this study aims to evaluate the effectiveness of automated AI screening compared to traditional manual methods for enrollments of patients into an ongoing clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of heart failure (e.g., ICD-9 codes 428 ICD-10 codes I50 or Problem list in the electronic health record)
* Most recent left ventricular ejection fraction (LVEF) assessed within the past 24 months
* Seen Mass General Brigham provider within the last 24 months

Exclusion Criteria:

* LVEF \<50% currently prescribed or intolerant to an evidence-based beta-blocker, ARNI, MRA, and SGLT2i at least 50% goal dose
* LVEF\>50% currently prescribed or intolerant to SGLT2i
* Systolic blood pressure (SBP) \<90 mmHg at last measure
Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase

The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.


Eligibility Criteria:
Inclusion Criteria:

* male or female, aged 18 to 60 years
* intact normal skin without potentially obscuring features on both anterior thighs in the area intended for infusion
* agreeing to no fluid intake for 12 hours prior to start of study infusion
* vital signs within normal range or, if outside normal range, deemed not clinically significant
* metabolic panel, hematology, virology and standard 10-test urine dipstick tests within normal range, or if outside normal range, deemed not clinically significant
* if female of child-bearing potential,negative serum pregnancy tests
* negative urine drug screens
* written informed consent for participation

Exclusion Criteria:

* lower extremity edema
* lower extremity pathology that could interfere with study outcome
* history of cardiovascular disease
* rales on lung auscultation
* known allergy to hyaluronidase or other ingredient in the formulation of hylenex
* pregnancy or breast-feeding a child
* exposure to any experimental drug within 30 days prior to study participation
* previous participation in this study
Improving Lactation Success in Mothers of Critically Infants

The purpose of this study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit

Although compelling evidence exists that breast milk (BM) improves infant health, mothers of critically ill infants frequently produce insufficient amounts BM which is likely due to inadequate daily breast pumping frequency. BM sodium levels are an easy to measure biomarker of pumping frequency and providing this information to mothers via text messaging may increase their pumping frequency and BM production. Therefore, the overall objective of this pilot study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit (NICU) at University of Florida Health. Specific aims include (1) evaluate the feasibility of a mHealth intervention to increase BM pumping frequency and BM production and (2) assess whether results indicate a signal of effectiveness supporting a subsequent adequately powered randomized clinical trial (RCT). Following delivery, 50 mothers of critically ill infants admitted to the NICU will be randomized to one of two groups. The Enhanced Intervention Group will receive text messages including both general lactation information and a personalized message consisting of the mother's BM sodium level, pumping frequency and feedback regarding pumping frequency. The Standard Intervention Group will receive only general lactation information. Results will be used to revise the intervention and study processes and to estimate outcome measurement variability and effect sizes needed for sample size calculations for an adequately powered RCT.

Eligibility Criteria:
Inclusion Criteria:

* stated intent to provide BM to the infant
* infant not expected to be stable enough to bottle/breastfeed for \> 14 days
* owns a mobile phone with unrestricted SMS capability.
* English speaking

Exclusion Criteria:

* known illicit drug use
* breast reduction or augmentation
* positive HIV status
* does not anticipate being able to bring BM to the NICU at least 4X/week
* infant not expected to live \> 7 days following delivery
* COVID-19 positive