cyrilzakka/clinical-trials huggingface dataset:
Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications

This study will test the relative efficacy of high-risk messages in increasing flu shot rates in patients at moderately high risk for flu and complications (those in the top 11-20% of risk). It will also examine whether informing patients that their high-risk status was determined by analyzing their medical records or by an artificial intelligence (AI) / machine-learning (ML) algorithm analyzing their medical records will affect the likelihood of receiving a flu vaccine.

Almost everyone age 6 months or older can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death by reducing the likelihood of contracting influenza. Flu shots are particularly important for patients at high risk of experiencing severe outcomes.

In the 2020-21 and 2021-22 flu seasons, the study team sent messages to Geisinger patients in the top 10% of risk for flu and complications according to an artificial intelligence algorithm. Messages that disclosed patients' risk status significantly increased flu vaccination rates. Additionally, messages that included risk information were most effective in patients at relatively lower risk (those in the top 4-10%) compared with those at the highest risk (top 3%).

The present work will test the effectiveness of high-risk messages in patients who are in the top 11-20% of risk, at high risk but lower than previous studies. These communications will inform patients they are at high risk with either (a) no additional explanation, (b) an explanation that this determination comes from an analysis of their medical records, or (c) the additional explanation that an AI or ML algorithm made this determination.

Eligibility Criteria:
Inclusion Criteria:

* Included on a list of active Geisinger patients (all patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the Electronic Health Record \[EHR\] since at least September 2021 and had at least one encounter in 2020-2022)
* Aged 18 or older
* In the top 11-20% of risk for flu and flu complications, according to Medial's flu complications machine learning algorithm (which operates on coded EHR data)
* Has a Geisinger PCP assigned as of August 2022
* Has had an encounter in the last 2 years as of August 2022

Exclusion criteria:

- Cannot be contacted via any of the communication modalities (e.g., letter, patient portal, SMS) being used in the study, either due to insufficient/missing contact information in the EHR or because they opted out of all modalities
Prospective Study of an Human Endometrial Receptivity Test

Evaluation of endometrial receptivity is a crucial step in in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) programs. Using "Omic technologies", such as transcriptomic and proteomic analyses, the investigators previously identified a specific molecular signature of human endometrial receptivity during the embryo implantation window. After validation of this signature in fertile women and in an ex vivo model (i.e., stromal and epithelial endometrium cells),the investigatorsdeveloped a diagnostic tool called Win-Test (Window Implantation Test) to evaluate the expression level of a set of endometrial receptivity-specific genes during the implantation window by quantitative RT-PCR. Based on their expression, each endometrial biopsy sample can be classified as receptive, partially receptive or non-receptive. Then, after the identification of the right cycle day within the implantation window where endometrium is considered as receptive, a customized timing for embryo transfer with respect of the synchronization of the embryo-maternal dialogue must be performed. A prospective study to validate the relevance of the Win-Test, is a necessary step to gauge its effectiveness. In this objective, patients with multiple implantation failures will be recruited. Embryo transfers were performed in double-arm: the intervention group had a customized timing of embryo transfer according to the Win-Test strategy and recommendation, the control group had their embryos transferred in a classical timing. Pregnancy and live birth rates (LBR) were compared between groups.


Eligibility Criteria:
Inclusion criteria :

* Infertile patients associated with multiple implantation failures.
* Signatures consent and non-opposition letter.
* Patients with a standard infertility assessment.
* Patients with a monitored cycle (ultrasound, hormonal markers) during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle.
* Patients with complete treatment information during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle.
* Patients with accurate transfer day information.
* Patients for whom we have the outcome (pregnancy, live birth).

Exclusion criteria:

More than 24 weeks of amenorrhea
Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )

In this pilot project Investigators propose to create annotated image data bank of patients suffering from cancer. The system will provide India's first comprehensive platform to upload annotated images with associated medical and demographic information of a patient. It will support flexible query from the users with appropriate choice from a set of attributes and design of various query filters using a GUI. Over the proposed period of 18 months, images and records related to radiation oncology including pretreatment images of at least 500 patients would be annotated and archived in the data bank. The imaging modalities to be covered are X-RAY mammograms, SPECT, CT, CBCT, MR, PET-CT, Ultrasound, digital histopathology, etc. In this phase, this study will include data sets of five types of cancers namely, breast, head and neck, brain, cervix and lung cancer.

Investigator propose to demonstrate the application of this data set in cancer research. Investigator will work on serial PET-CT based radiomics of breast and cervix cancer patients to extract appropriate features and correlate them with clinico-pathological variants.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing radiotherapy planned with volumetric imaging.

-

Exclusion Criteria:

* Informed Consent not given
Nutritional Practices and Outcomes in Non-Invasive Ventilation

The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a collaboration with lead sites from pediatric critical care units within US and Canada, and participating sites from multiple international regions. The goal of NPO/NIV is to understand how non-invasive ventilation (NIV) is used to treat critically ill children and, concurrently, how these children are fed while on NIV. Designed as a period prevalence study, NPO/NIV will collect observational, cross-sectional data over the course of five study weeks. Each study week will require two days of screening for eligible patients. On Mondays, study staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days after the initiation of NIV or until the patient is discharged from the pediatric intensive care unit. This study was granted exempt status by the University of Arizona Human Subjects Protection Program, including a waiver of informed consent. As no personal health information is transmitted during the course of the study, the University of Arizona does not require Data Use Agreements between sites to participate.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the Pediatric ICU
* in whom noninvasive ventilation (NIV) was initiated within previous 48 hours (NIV use includes any High Flow Nasal Canula \> 2 lpm flow , continuous positive airway pressure or bilevel pressure or neurally adjusted ventilatory assist)

Exclusion Criteria:

Patients with:

* chronic home NIV use for \>12 hours per day
* limitations of care decisions made
* Cardiac surgery during this admission
* Acute gastro intestinal bleeds
* Abdominal surgery in previous 48 hours
* Gut graft versus host disease
* Chronic parenteral nutrition
* Short Gut Syndrome
Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab

This study is to evaluate a commercial tool on the market (Fitbit®) that also quantifies sleep. No one has studied how pediatric patients perform with it and how accurate it is in measuring their quality of sleep. This study will use the obstructive sleep apnea (OSA) questionnaire completed by parents and Fitbit® together and evaluate how they perform against the polysomnography (PSG).


Eligibility Criteria:
Inclusion Criteria:

* Patients who consent/assent to wearing Fitbit® band over wrist overnight during sleep study and parents who consent to answering questionnaire.

Exclusion Criteria:

* None
An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.

This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301 (PARAGON-HF).

This study was an open-label extension study following the PARAGON-HF. Patients who have completed the PARAGON-HF were eligible to participate. During the study, open-label LCZ696 was taken in addition to background treatments of comorbidities. All subjects were treated with LCZ696 (sacubitril/valsartan) at maximally tolerated dosed with a target dose of 200 mg b.i.d (twice a day).

The subject were to continue to receive LCZ696 until it became commercially available, or for a period up to 24 months from the first patient enrolled in this study whichever came first. However, this study was terminated early based on the pre-defined early termination criteria of "the primary endpoint of PARAGONHF was not met" in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained before any assessment is performed.
* Patients who have completed LCZ696D2301 and are able to be safely enrolled into this study as judged by the investigator.

Exclusion Criteria:

* Patients who discontinued study drug treatment during LCZ696D2301 due to an event or intercurrent illness. Eligibility can be re-considered if the event has resolved and no longer represents a risk to the patient and the patient can safely tolerate the administration of LCZ696 per the investigator's assessment.
* Any medical condition that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.
* Patients who have experience of angioedema event(s) which occurred and reported by the investigator during LCZ696D2301.
* Pregnant or nursing (lactating) women.
* Women of childbearing potential unless they are using highly effective methods of contraception.

Other protocol-defined inclusion/exclusion may apply.
Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity

In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.


Eligibility Criteria:
inclusion criteria:

* Body mass index (BMI) \> 95th percentile
* Having insulin resistance
* Having a family history of Type 2 diabetes mellitus (T2DM)

exclusion criteria;

* Alcohol consumption and smoking
* Having T1DM and T2DM
* History of drug use
Virtual Reality for Improving Symptoms in Palliative Care

The objective of this study is to determine whether VR can ameliorate symptoms for palliative care patients within a hospice setting. We also aim to verify the efficacy with a larger sample size than previously shown, as well as extend the population to include non-cancer patients receiving Hospice care. We will further attempt to delineate whether there is a sustainability of symptomatic improvement one week after VR experiences.

Potential candidates will be provided with our assent and consent information form and the study will be explained to them in detail prior to gaining consent. As per standard practice at The Hospice of Windsor \& Essex County, palliative care ESAS symptoms will be measured at baseline during the week prior to the VR experience. The mean of these pre-VR scores will be calculated as a baseline, optimally 3 separate ESAS scores in the preceding week. ESAS symptoms and expectations/satisfaction will then be measured immediately before and after the VR experience. An average set of ESAS scores will then be calculated in the same manner for one week post VR as per baseline pre-VR scores above.

We expect to find a decrease in Palliative Care symptoms after the intervention of a VR experience.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years or older
* admitted to Hospice for Specialty Palliative Care

Exclusion Criteria:

* Palliative Performance Scale (PPS) ≤ 20%
* severe cognitive impairment leading to inability to provide ESAS scores for 5 key symptoms measured in this study
* severe visual and/or hearing impairment preventing use of VR (glasses and hearing aids may be worn during VR sessions and do not exclude participation)
* absolute inability to sit
* paralysis of an upper limb
* participant dies before VR experience
Lysine-specific Demethylase 1 and Salt-sensitivity in Humans

The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1.

The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure in African American and Caucasians, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1. This might help us understand why some people develop high blood pressure.

Healthy volunteers will be screened for eligibility and invited to participate in a 2 weeks study. Week 1 will be consumption of a low salt diet. Week 2 will be a high salt diet.

At the end of each week, participants will be admitted to a Clinical Research Center overnight and for one day.

On the CRC, participants will remain fasting and supine overnight and then next morning undergo hormonal and vascular testing. This will consist of blood drawing, echocardiogram, vascular tonometry, and assessment of renal blood flow before and after a low-dose Angiotensin II infusion.

The study outcome will compare how variants in the LSD1 gene affect hormonal and vascular responses according to race. This information will help us determine why some races and genetic profiles are more susceptible to detrimental effects of salt in the diet while others are protected against these effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-45 years
* Caucasian or African American
* No gender preference (anticipate 50% female)
* Normotensive (screening blood pressure \<140/90 mmHg)
* No history of hypertension, diabetes, stroke, coronary artery disease, kidney disease, cancer, thyroid disease, preeclampsia, or hospitalizations in 6 months
* Normal screening laboratory values (CMP, TSH, A1c)
* Normal ECG
* BMI \<25 kg/m2

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Any medication or herbal preparation
* \>6oz alcohol/week
* Tobacco use
* Illicit drug use
* Chronic NSAID use
* Recent steroid use (injected, inhaled, oral)
* Decongestant use in the past 2 weeks
* Known sensitivity to infused Angiotensin II or para-amino hippurate
Feasibility Study Assessing the Effect of Carbidopa/levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease.

This study is aimed at patients with multi-system atrophy - parkinsonian type (P-MSA) or Parkinson's disease (PD) receiving dopaminergic drugs and suffering from orthostatic hypotension (OH).

OH is a drop in blood pressure when standing, which can lead to symptoms of dizziness, lightheadedness, a black veil in front of the eyes and, when severe, can lead to fainting. HO is one of the symptoms present in AMS-P and PD.

The standard treatment for parkinsonian symptoms of slowness and stiffness is the administration of antiparkinsonian drugs containing dopamine. These dopaminergic drugs always contain 1) levodopa (which is the precursor of dopamine) and 2) an enzyme inhibitor, which may be either benserazide (in the case of Madopar® and its generics) or carbidopa (in the case of Sinemet® or Stalevo® and their generics) and whose role is to potentiate the effect of levodopa.

It has long been known that dopaminergic drugs aggravate HO. Through various mechanisms, this worsening of HO is linked as much to levodopa as to the enzyme inhibitor with which it is combined. However, investigators do not know the respective effects of these two molecules on HO.

In this study, investigators examine how the ratio of Carbidopa to levodopa affects HO in the various assays of the dopaminergic drug under study.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form signed.
2. Patient over 18 years and under 80 years of age.
3. Patient with Multiple System Atrophy- Parkinsonian type (MSA-P) (confirmed by diagnostic criteria for clinically established and clinically probable multiple system atrophy (11); OR Patient with Parkinson Disease (PD) (12) presenting OH symptoms (getting at least one point at the 3 questions - n° 14, 15 and 16 - of the SCOPA-AUT scale that address orthostatic hypotension symptoms).
4. Patient currently receiving Dopamine-Replacement Therapy (i.e. Levodopa combined with Carbidopa or Benserazide).

Exclusion Criteria:

1. Patient unable to stand an overnight (at least 12 hours) withdrawal of their immediate-release DRT (last extended-, delayed-, or controlled-release dosage must be taken minimum 24 hours prior to the test).
2. Patient with known congestive heart failure, grades C and D, NYHA III and IV.
3. Patient with dementia (i.e. major cognitive impairment) associated to MSA-P or PD,
4. Patient with mild cognitive impairment, and unable to provide or understand informed consent, i.e. who does not have full capacity for discernment.
5. Current participation to other clinical trials.
6. Pregnant or lactating woman or willing to become pregnant.
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

* Evaluate the safety and tolerability of sevelamer carbonate
* Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.

Eligibility Criteria:
Inclusion Criteria:

* The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) \<60 mL/min/1.73 m\^2 based on central laboratory results.
* The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.

Exclusion Criteria:

* The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.
* The participant had a non-renal case of hyperphosphatemia.
Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder

A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device.

In this investigation, the following indicators is also evaluated:

1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
2. Waveform qualitative assessment
3. Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54 subjects with atrial fibrillation diagnosis in phase II) are enrolled in the investigation according to the criteria.


Eligibility Criteria:
Inclusion Criteria:

* - All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.

Phase 1:

* Health conscious individuals
* \> 18 years of age

Phase 2:

* \> 18 years of age
* non critical patients ever diagnosed with atrial fibrillation

Exclusion Criteria:

* • \< 18 years old

  * Unable to consent

Phase 1:

* \> 80 years of age
* Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
* current status of non-sinus heart rhythm

Phase 2:

- Critical patients
Simulated Surgery Rehearsal (MIPN)

The purpose of the study is to evaluate patient-specific surgical simulation by permitting pre-operative rehearsals, in the form of the surgeon completing a dry run of the procedure on a model constructed from the patient's radiological studies that replicates every aspect of their organs. The investigators' aim is to evaluate the effectiveness of this form of practice in optimizing intraoperative and postoperative outcomes . The investigators hope eventually to use these rehearsals as a standard study tool for surgical training.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled to undergo MIPN surgery at the University of Rochester Medical Center
* Ability to give informed consent
* Willing to participate in the study
* Any racial or ethnic origin

Exclusion Criteria:

* Inability to give informed consent