cyrilzakka/clinical-trials huggingface dataset:
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping

The trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the NeuTrace System v1.0 for cardiac electroanatomic mapping.

Arrhythmias, or abnormal heart rhythms, are a major cause of morbidity and mortality worldwide. In patients with arrhythmias, electrophysiology (EP) studies are often performed to assess the electrical system of the heart. Since its introduction in the 1990s, electroanatomic mapping has become a cornerstone of EP studies. Electroanatomic mapping systems allow for non-fluoroscopic navigation of the heart and the creation of three-dimensional (3D) anatomic and electroanatomic maps. These maps facilitate diagnosing and treating arrhythmias.

The NeuTrace System is a cardiac EP mapping system that is intended to be used during catheter-based atrial and ventricular mapping procedures. The system is designed to acquire and analyze data points and use this information to display 3D anatomical and electroanatomic mapping of the human heart. The system is used with a compatible, marketed magnetic sensor-enabled catheter and compatible EP recording system to acquire the location information and local electrogram needed to create the cardiac maps. The purpose of the trial is to evaluate physician acceptance and feasibility of the NeuTrace System v1.0 for cardiac electroanatomic mapping.

Eligibility Criteria:
Inclusion Criteria:

* Patient with standard indications for an electrophysiology study and/or catheter ablation per European Heart Rhythm Association/Heart Rhythm Society) guidelines and/or judgement of the investigator
* Age 18 to 80
* Signed Informed Consent Form

Exclusion Criteria:

* Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/percutaneous transluminal coronary angioplasty, or coronary artery stenting which occurred during the 90-day interval preceding the date that participant signed the Informed Consent Form
* Unstable angina
* NHYA class III or IV congestive heart failure and/or known left ventricular ejection fraction less than 45%
* Thrombocytosis, thrombocytopenia
* Contraindication to anticoagulation therapy
* Active systemic infection
* Cryoglobulinemia
* Known reversible causes of arrhythmia
* Any cerebral ischemic event (stroke or transient ischemic attacks) which occurred during the 180-day interval preceding the date the participant signed the Informed Consent Form, or any known unresolved complications from the previous stroke/transient ischemic attack
* Pregnancy
* Unwilling or unable to comply fully with study procedures
Health Disparities in Prevalence of Hypertension Between Black and White Americans

This study will be the first to distinguish the relative contributions of sleep, circadian and behavioral mechanisms to the non-dipping BP profile in Black adults and will lay the groundwork for optimizing therapies dependent on mechanisms, such as targeting sleep, targeting circadian rhythmicity, or targeting behaviors, and raising the possibility that ideal therapy for hypertension (HTN) may differ by race. This research will ultimately help to improve health and survival in black populations with HTN.

By studying standardized behaviors and regulators of BP during sleep and behavioral stresses across all circadian phases, this protocol will allow us specifically to:

1. To determine if poor sleep, while controlling for circadian phase, contributes to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.
2. To determine if reduced BP responses to standardized behavioral changes across the day and night contribute to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.
3. To determine if reduced circadian amplitude of BP contributes to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified Black or White
* 'normotensive' (resting systolic blood pressure (SBP) \<140/90 mmHg) or uncomplicated stage 1 'hypertensive' (systolic BP between 140 and 160 mmHg or a diastolic (DBP) between 90 and 100 mmHg).
* free of all prescription and non-prescription drugs (including caffeine, nicotine, alcohol and herbal medications)

Exclusion Criteria:

* Currently treated with pharmacologic agents for hypertension
* Blood pressure \>160/100 mmHg
* Smoked within the last year
* Regular night work or rotating shift work for the three months prior to the study
* Travel across more than three time zones during the three months prior to the study.
* Any acute, chronic or debilitating medical conditions, other than mild hypertension (140\<SBP\<160 or 90\<DBP\<100 mmHg) and severe renal disease (glomerular filtration rate \<30)
* Moderate to severe obstructive sleep apnea (OSA)
* History of severe psychiatric illnesses or psychiatric disorders will be excluded, including alcoholism, drug dependency, major depression, manic depressive illness, schizophrenic disorders, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder.
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients

This research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may be a better treatment for patients with Richter's Transformation. Depending on fitness, the patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also called vincristine, and P= prednisolone or prednisone (corticosteroids).


Eligibility Criteria:
Inclusion Criteria:

* confirmed Richter's transformation in treatment naïve and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma patients
* may have had prior exposure to ibrutinib and other B-cell signaling receptor agents
* Adequate hematologic function
* Adequate liver and kidney function
* Willing and able to participate in all required evaluations and procedures in this study protocol
* Female subjects of childbearing potential must not be pregnant upon study entry
* Male and female subjects who agree to use highly effective methods of birth control

Exclusion Criteria:

* known allergy to any of medications
* chemotherapy taken within 21 days of study treatment
* targeted therapy within 10 days of study treatment
* BCR inhibitors within 24 hours of study treatment
* major surgery within 4 weeks of first dose of study treatment
* women who are pregnant
* known infection with HIV or Hepatitis C
* Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?

The aim of this project is to compare the effects of conventional, burst and modulated TENS primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in MAS treatment.

Myofascial pain syndrome (MAS) is a regional pain syndrome characterized by trigger points detected by one or several muscle groups and reflected pain manifestation caused by palpation of these points. Transcutaneous electrical nerve stimulation (TENS) is a physical therapy modality that provides an analgesic effect by delivering a controlled low voltage electrical current to the nervous system through electrodes placed on the skin. Knowledge on how modulation parameters such as frequency, wave width and form alter TENS activity are limited.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of myofascial pain syndrome according to the criteria defined by Travell and Simons

Exclusion Criteria:

* The onset of symptoms is less than 3 months
* Severe cervical disc hernia, radiculopathy or myelopathy
* Stage 3-4 cervical degeneration
* Tumoral, infectious, psychiatric, neurological, uncontrolled systemic disease
* Cardiac pacemaker
* Diagnosed with fibromyalgia syndrome
* Kyphoscoliosis
* Acute trauma history
* Having had previous brain or shoulder surgery
* Injections for MAS and / or physiotherapy programs in the last 3 months
* Pregnancy
Acupuncture Pilot Study for Cancer-related Cognitive Function

This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age 18 ≥ years old
* Diagnosis (breast, colorectal, prostate or gynecological cancer)
* Completed initial cancer treatment (surgery, chemotherapy, and/or radiation therapy) at least one month prior to study enrollment (patients receiving maintenance cancer treatment with hormonal or targeted therapies are permitted)
* Must report moderate or greater perceived CD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration (item #20) and memory (item #25) on the EORTC QLQ-C30 instrument (version 3.0)
* Must indicate that their cognitive functions have worsened since their cancer diagnosis by replying "Yes" to all of the following questions:

  * Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis?
  * Do you think your mind isn't as sharp now as it was before your cancer diagnosis?
  * Do you feel like these problems have made it harder to function on your job or take care of things around the home?
* Must be willing to adhere to all study-related procedures, including randomization to one of the 2 possible choices: acupuncture or sham acupuncture

Exclusion Criteria:

* Active disease
* Use of acupuncture for cognitive symptom management within the past 3 months
* Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
* Score of ≥10 on the Blessed Orientation-Memory-Concentration (BOMC) screening instrument
* Primary psychiatric disorder not in remission
* Initiation or change in medication (e.g., hypnotics, sedatives, and/or antidepressants) in the past 8 weeks
Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety

This is a prospective,randomized, cross over study comparing the efficacy and safety of nebulizedfurosemide with Intra Venous (IV)furosemide in preterm infants who areventilator-and oxygen dependent. Reviewing the patient census on Neo data by the Sub Investigator will identify the potential subjects. Subject will be randomized to either A arm or B arm. Subjects in the A arm will receive 1 mg/kg of inhaled furosemideQ 24 hours for 3 days. This will be followed by a washout period of a day followed by 1mg/kg of intravenous furosemide Q 24 hours for 3 days. Subjects in the B arm will receive 1 mg/kg of intravenous furosemide Q 24 hours for 3 days followed by a washout period, which is then followed by 1 mg/kg of inhaled furosemide Q 24 hours for 3 days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are born prematurely at\<34 weeks of gestation
* Subjects who are at least 14days old, on Oxygen and mechanical ventilation.
* Radiologic evidence of pulmonary parenchymal disease
* The NICU medical team to start furosemide administration as a part of the routine clinical management

Exclusion Criteria:

* Subjects who have received any diuretics;IV or PO for 48 hoursbefore the study initiation
* Subjects with congenital heart disease withR-L shunts.
* Subjects with acute sepsis.
* Subjects with kidney diseasedefined by creatinine \> 1mg/dl or oliguria, defined as urine output \< 0.6 ml/kg/hour
* Subjects with necrotizing enterocolitis (NEC)or suspected NEC
* Subjects with congenital malformations.Subjects who are receiving steroids, or have received steroids in the last 7 days(patients need to be off steroids for at least 7 days).
Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite

The purpose of this study is to determine the effect of carbohydrates of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and overweight or obese (OW/OB) children.

Regular breakfast eating NW and OW/OB children, 9-14 years of age, will participate in the experiment. Four isocaloric (450 kcal) breakfasts (eggs with a side of French fries, mashed potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping will be examined. On five separate mornings, 7 days apart and after a 12 hour overnight fast, each participant will receive one of the four breakfasts or skip breakfast, in a randomized counterbalanced order. Participants will be given an ad libitum lunch 3 hours after breakfast and parents will report the rest of day food record for food intake analysis. Blood glucose will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after breakfast consumption. Subjective appetite will be measured with a visual analogue scale at baseline and every 15 minutes for 1 hour, and every hour for 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* be between 9 and 14 years of age
* be healthy, and have been born at term
* not be taking any medications
* not have allergies or sensitivities to potatoes, eggs, gluten, dairy, or beans
* NW (between the 5th and 85th BMI percentile for age and gender)
* OW/OB (\>85th BMI percentile for age and gender)

Exclusion Criteria:

* food sensitivities, allergies, or dietary restrictions
* health, learning, emotional, or behavioural problems
* receiving any medications
Food Insecurity Reduction & Strategy Team

This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:

1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.
2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.
3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 or Type 2 Diabetes Mellitus
* Admitted to Stanford Healthcare inpatient unit
* Residence in California at time of enrollment
* Positive Screening for Food Insecurity
* On a Healthcare Plan covered by Mom's Meals.

Exclusion Criteria:

* Plans to be discharged to a skilled nursing facility.
* Patients who prefer a language for which a short-form consent is not available.
* No Home Address
* Pregnant Participants.
* No access to refrigerator.
Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol

Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.

Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.

The project aims to :

* develop the bio-sensor necessary to measure islet membrane electric potential
* develop interface between bio-sensor and user
* correlate analysis data collected by bio-sensor with metabolic results of islet graft

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP

Exclusion Criteria:

* Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.
VEGF Gene Transfer for Diabetic Neuropathy

This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.


Eligibility Criteria:
Inclusion criteria:

To be eligible to enroll and remain in the study, patients must meet the following criteria:

* Be at least 21 years old.
* Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin.
* Have peripheral neuropathy related to diabetes.

Exclusion criteria

Patients are to be excluded from the trial if any of the following conditions are met:

* Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.
Phase 1 Study of PRX019 in Healthy Adult Volunteers

The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period
* Participant is willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted
* Participant was exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or within 7 times the elimination half-life, if known (whichever is longer)

NOTE: Other protocol-defined inclusion/exclusion criteria apply
Exploratory Assessment of the Quantra® System in Adult ECMO Patients

This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.

Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years.
* Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours.
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria:

* Subject is younger than 18 years of age.
* Subject is pregnant.
* Subject is incarcerated at the time of the study.
* Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
* Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
The Effect of Calcium on Fecal Fat and Energy Excretion

The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.

Several reports have found inverse associations between calcium intake and body weight. Few intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. The mechanism is not clear, but one possible explanation is reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps or binding of bile acids which impairs the formation of micelles.

The aim of this study is to examined if a high calcium intake from dairy products, in diets high or normal in fat content, have an effect on fecal energy and fat excretion, concentrations of substrates involved in energy metabolism and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* healthy meals
* BMI 24-31 kg/m2
* age between 18-50 years

Exclusion Criteria:

* donation of blood 6 months before and under the study
* milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease
* use of dietary supplements 3 months before and under the study
* smoking
* elite athletes
* use of medication
Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

Our study investigated the effect of using a known drug used in intermittent claudication (named pentoxifylline) as an adjuvant to erythropoietin stimulating agents to improve anemia of hemodialysis patients.

Fifty out of 57 hemodialysis anemic patients were finally included. They were assigned to two groups of equal numbers. Oral Pentoxifylline 400mg once daily was added to the treatment group which was compared to the control group over a six months period regarding hemoglobin, hematocrit, serum albumin and CRP.

Inclusion criteria: (Patients with ESRD on HD who have hemoglobin \<11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio \>65%.). There were 57 patients who met the inclusion criteria out of 158 patients.

Exclusion criteria: Iron deficiency anemia with transferrin saturation \<30%, intact PTH\>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* (Patients with ESRD on HD who have hemoglobin \<11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio \>65%.). There were 57 patients who met the inclusion criteria out of 158 patients

Exclusion Criteria:

* Iron deficiency anemia with transferrin saturation \<30%, intact PTH\>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.