cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic

Pregnant patients in the UT Medical Branch outpatient obstetric clinic are screened for anemia via blood draw at first prenatal visit. Those who meet Center for Disease Control (CDC) criteria for anemia during pregnancy (hemoglobin less than 11g/dL in first and third trimesters and hemoglobin less than 10.5g/dL during the second trimester), will be approached for participation in this study. It is the protocol of the UT Medical Branch outpatient obstetric clinic to repeat a blood draw every 4 weeks in patients with anemia. At the time of their blood draw, patients who participate in our study will have the Masimo Spot Non-invasive Hemoglobin monitor placed on our finger. The primary aim of the study is to see how accurate the non-invasive monitor is compared with blood draw. With the potential benefit being earlier diagnosis of anemia and easier method to ensure improvement in the hemoglobin.

Pregnant women who are patients in the UT Medical Branch outpatient obstetric clinic will be screened for anemia using blood draw for CBC during the first prenatal visit. Those who are found to have anemia will be prospectively enrolled in this proof-of-concept study. Anemia will be defined according to the CDC guidelines (first and third trimesters hemoglobin level less than 11g/dL, and less than 10.5g/dL in the second trimester). Patients meeting these criteria will be approached for inclusion. If patients consent to participate, they will have their hemoglobin checked via the non-invasive monitor at the same time as their clinically indicated CBC testing. At the UT Medical Branch outpatient obstetric clinic, this is usually every 3-4 weeks and determined by the health care provider. The hemoglobin measured by the non-invasive monitor will be compared with the hemoglobin obtained via the complete blood count. Other data collected from the patient's medical record will include general characteristics such as demographics, medical history and hemoglobin levels obtained from blood draw.

Eligibility Criteria:
Inclusion Criteria:

pregnant women aged 18-50 with anemia (hemoglobin less than 11g/dL during first and third trimester and less than 10.5g/dL during second trimester)

Exclusion Criteria:

patients with normal hemoglobin levels patients with hemoglobinopathy (sickle cell disease) patients who are incarcerated patients unwilling or unable to give consent
TESTO-TRIAL: Use of Testosterone in Critically Ill Patients

The objective of this study is to evaluate whether the use of the anabolic agent testosterone cypionate in critically ill patients, compared to placebo, increases the number of ventilator-free days

It will be a randomized, controlled, double-blind, single-center clinical trial conducted in the Intensive Care Unit (ICU) of the State Hospital of Serrana (HE Serrana). Patients admitted to the ICU who meet the eligibility criteria and have given written informed consent will be randomized into control and intervention groups. Forty-seven patients will be included in each group, totaling 94 patients. The intervention group will receive 200 mg of testosterone cypionate intramuscularly every 5 days for a total of 3 doses. The control group will receive a placebo on the same schedule. After inclusion in the study, demographic and clinical data, laboratory results, ultrasonographic measurements, and functionality and muscle strength scores will be assessed on days 1, 5, 10, and 15 in the ICU and until hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation (MV) for seven days or more, or patients on MV with an unsuccessful weaning attempt for at least three days. An unsuccessful weaning attempt is defined as the patient undergoing a Spontaneous Breathing Trial (SBT) on three different days without success, according to the ICU protocol;
* Over 18 years old;
* Patients with optimized nutritional therapy, defined by caloric and protein goals met for at least three days;
* Signing the informed consent form (ICF).

Exclusion Criteria:

* Hypersensitivity to the medication, the vehicle of the medication, or the placebo (sesame oil);
* Venous or arterial thrombosis in the past six months, including acute myocardial infarction, ischemic stroke, acute arterial occlusion, mesenteric ischemia, venous thromboembolism, or pulmonary embolism;
* Left Ventricular Ejection Fraction (LVEF) below 35%;
* Glutamic-pyruvic transaminase/Alanine Aminotransferase (GPT/ALT) greater than five times the normal level and impaired bilirubin excretion;
* Patients with liver cirrhosis (CHILD \> B);
* Pregnant or lactating women;
* Women of childbearing age;
* Hematocrit \>52%;
* Refractory shock, defined as requiring a norepinephrine dose \> 0.5 mcg/kg/min or a vasopressin dose \> 0.04 IU/min;
* Thrombocytopenia \< 20,000/mm³ without a transfusion plan;
* Personal history of prostate or breast cancer;
* Active neoplasm of any site;
* Primary neuromuscular disease, including Amyotrophic Lateral Sclerosis (ALS), Duchenne muscular dystrophy, myasthenia gravis, or Guillain-Barré syndrome;
* Current or previous spinal cord injury above C4 (tetraplegia);
* Patients with total limitation of therapeutic measures;
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

The duration of treatment is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee which requires treatment with medication for pain relief

Exclusion Criteria:

* Any known allergy to the study drug
Dawn Simulation and Postural Hypotension

One of the most physiologically demanding things that older people do every day is to get up in the morning. After spending a night laying flat, where the blood distributes evenly across the body, when they stand in the morning (and the blood rushes to their feet), their cardiovascular system may not be able to compensate and maintain blood flow to the brain. This phenomenon is known as orthostatic or postural hypotension. The investigators have found in a group of young individuals that use of a dawn-simulation light that gradually wakes the brain is able to increase cardiovascular tone prior to arising. The goal of this experiment is to determine whether this dawn simulation light is able to increase cardiovascular tone in older adults such that they would have reduced or absent postural hypotension when they awaken in the morning. This would greatly reduce the risks of falls and their associated morbidities in older adults.


Eligibility Criteria:
Inclusion Criteria:

* History of falls or dizziness at exit from bed in the morning (at least two incidents in the past year)
* At least 20/200 corrected visual acuity
* Stable health
* Normal hearing

Exclusion Criteria:

* Regular cigarette smoker
* Alcohol abuse
* Drug abuse
Assessment of Patients With Multiple Sclerosis (MS)

Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown, but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that cause the body's immune system and natural defenses to attack healthy cells. In the case of MS, the immune system begins attacking myelin, the cells that make up the sheath covering nerves. Without myelin, nerves are unable to transmit signals effectively and symptoms occur.

This study is directed toward a better understanding of the cause of Multiple Sclerosis (MS). Researchers will evaluate patients with a tentative diagnosis of MS or other neurological diseases possibly caused by a immunological reaction. Patients will undergo a series of three MRIs, taken once a month for three months and submit blood samples for immunological studies.

The Neuroimmunology Branch (NIB) conducts research into the cause of immunologically mediated diseases of the nervous system such as multiple sclerosis (MS). The studies in the NIB range for studies of the natural history of MS to trials of new experimental therapies. In order to recruit patients into the various NIB research studies, patients with a tentative diagnosis are initially seen by the NIB to assess the accuracy of the diagnosis and to assess the level of disease activity occurring in the patient. Patients seen under the NIB screening protocol are evaluated in clinic with a complete neurological examination. Blood studies necessary to eliminate the possibility of many other causes of disease that may resemble MS are performed. Spinal fluid examination may be preformed if uncertainty exists with respect to the diagnosis. Finally, patients will have at least one MRI preformed to assess the consistency with MRI findings expected in MS. Most patients will have a series of three MRIs done approximately one month apart in order to assess the frequency of new contrast enhancing lesions occurring in the patient. The level of disease on MRI is important both from the standpoint of diagnosis as well as determining if the patient may be eligible for any other NIB protocols. To assess the patient's eligibility for other NIB studies, the NIB may periodically follow patients in whom the diagnosis is uncertain or in whom the level of disease activity is not clear for the initial evaluation.

Eligibility Criteria:
* INCLUSION CRITERIA:

Diagnosis of possible MS.

Age between 18 and 75.

EXCLUSION CRITERIA:

Clinically significant medical condition other than MS that could cause neurological dysfunction.

Currently enrolled in an experimental study.

Medical contraindication for MRI.

Psychological contraindications for MRI.

Unable to provide informed consent.
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)

The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* intubated and mechanically ventilated on a volume controlled mode
* head injury or other intracranial pathology and compromised cerebral perfusion
* arterial line in place or alternative with continuous pressure monitoring
* SpO2 ≥90%
* mean arterial pressure \>55
* admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor
* inclusion presents no significant delays to planned emergent neurosurgery
* prior written informed consent

Exclusion Criteria:

* cardiac or pulmonary injury
* confirmed pneumothorax or hemothorax
* serious neck injury resulting in neck swelling with jugular venous compression
* evidence of ongoing uncontrolled bleeding
* respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
* marked hypertension at time of device use defined as systolic blood pressure \>180 mmHg
* congestive heart failure
* women with positive serum or urine pregnancy test or breast feeding
The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Mechanical ventilation, although life-saving, damages the lungs through what is known as ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as a ventilation method that may be less injurious to the lungs than conventional mechanical ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress syndrome randomized to high frequency oscillation ventilation vs conventional lung protective ventilation. The present study is a substudy of the OSCILLATE trial looking at biomarkers of ventilator-induced lung injury in blood samples drawn from patients enrolled in OSCILLATE. The objective is to look for biochemical evidence of decreased ventilator-induced lung injury in patients treated with high frequency oscillation ventilation relative to conventional ventilation.


Eligibility Criteria:
Inclusion Criteria:

* enrollment in OSCILLATE (NCT01506401)

Exclusion Criteria:

* inability to provide blood samples
Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 years and older
* Patients referred for a assessment of a newly diagnosed multiple myeloma
* Patients for who the initial therapy proposed is either melphalan-prednisone-thalidomide or melphalan-prednisone-bortezomib or included in a phase 3 trial.
* Patients who provide informed written consent

Exclusion Criteria:

* Patients who refuse the study
* Patients who won't have therapy
* Patients can't respond to geriatric assessment because of severe cognitive disorder
* Patients with a legal guardian
An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases

This trial studies how well a magnetic resonance imaging technique called Displacement Encoding with Stimulated Echo (DENSE) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. Researchers want to learn if the DENSE technique improves the standard MRI method.

PRIMARY OBJECTIVE:

I. This is an exploratory study to collect Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.

SECONDARY OBJECTIVES:

I. Estimate sensitivity of MR DENSE (determine degree of 2 dimensional \[2D\] vector displacement with cardiac cycle and variability of measurements with cardiac ventricle contraction).

II. Determine detection of sinusoidal injury (sinusoidal fibrosis, necrosis of pericentral hepatocytes, narrowing and fibrosis of central veins) on biopsy with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.

III. Determine correlation of intra-operative surgical scores (liver color and texture) with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.

OUTLINE:

Patients undergo standard of care magnetic resonance imaging (MRI) and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy.
* No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
* Patient who is able to undergo informed consent.
* Men and non-pregnant women.
* Metastatic disease limited to liver.
* Metastases involving no more than 6 liver segments.
* No radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.

Exclusion Criteria:

* Contraindication to MRI.
* Inability to comply with study and/or follow-up procedures.
* Unable to provide informed consent.
* Presence of extrahepatic metastatic disease.
* Metastases involving more than 6 liver segments.
* Radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
* Pregnant women.
Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy

Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more hemorrhages in the brain cortex in individuals 55 years of age or older. This study will examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30 and 60. Subjects will be followed for 6 months after receiving the last dose of study medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with probable CAA using the Boston criteria; with no clinical cognitive impairment
* In general good health

Exclusion Criteria:

* Co-morbid diagnosis of clinically documented Alzheimer's disease or significant cognitive impairment
* Clinically significant syncope, epilepsy, head trauma or clinically significant unexplained loss of consciousness within the last 5 years
* Subject's body weight exceeding 100kg
* Women of childbearing potential.
Vitamin D Deficiency Still Growing

Vitamin D deficiency has become one of the most prevalent health problems in modern society. However, there has been no study that has reported the trend of vitamin D status in Asia. This study investigated the trend of vitamin D status in Korea between 2008 and 2014.

This study is based on a representative national database acquired from the Korea National Health and Nutrition Examination Surveys (KNHANES) conducted from 2008 to 2014. Serum 25-hydroxyvitamin D \[25(OH)D\] levels were measured by radioimmunoassay among those aged 10 yrs or older. The temporal change of vitamin D status will be statistically analyzed.

Most epidemiologic studies that assessed vitamin D status in various populations have been performed in a cross-sectional design. Some studies from western countries have assessed the trends of vitamin D status over the past decades. However, there was no study that investigated the trend of vitamin D status in Asian population.

In the present study, an assessment of the seven-year trend of vitamin D status and the prevalence of vitamin D deficiency in the Korean population, based on the KNHANES conducted from 2008 to 2014 was performed.

The KNHANES is an ongoing surveillance system that has been conducted by the Division of Health and Nutrition Survey within the Korea Centers for Disease Control and Prevention to evaluate the health and nutritional status of the civilian non-institutionalized population of South Korea. Since the KNHANES was initiated in 1998, surveys for the KNHANES I (1998), KNHANES II (2001), KNHANES III (2005), KNHANES IV (2007-2009), KNHANES V (2010-2012), and KNHANES VI (2013-2015) have been executed, and the survey for KNHANES VII (2016-2018) is still in progress. The present study is based on the data acquired from the KNHANES IV-VI, conducted between 2008 and 2014. Among those participants, serum 25(OH)D levels were measured from 39,759 individuals (6,925 in 2008; 8,303 in 2009; 6,815 in 2010; 6,704 in 2011; 6,308 in 2012; 2,355 in 2013; and 2,349 in 2014) aged 10 years and older. Serum 25(OH)D concentration was categorized into 4 levels (\<25, 25 to \<50, 50 to \<75, and ≥75 nmol/L) and the vitamin D deficiency was defined as the Serum 25 (OH) D concentration \< 50 nmol/L.

Statistical analyses were conducted to evaluate the effects of participant characteristics (age, season, and residential region) on serum 25(OH)D concentrations, and the temporal change in the mean concentration of serum 25(OH)D over years 2008-2014.

Eligibility Criteria:
Inclusion Criteria:

* Participants in the KNHANES from 2008 to 2014
* Participants who were examined for serum 25-hydroxyvitamin D level

Exclusion Criteria:

* Participants without serum 25-hydroxyvitamin D level data
Occyo Tele-ophthalmology Study

The prospective, (observer) blinded clinical trial at the University Hospital for Ophthalmology includes patients routinely scheduled for cataract surgery at the Medical University of Innsbruck.

Patients are enrolled one week prior to their planned cataract surgery. The participants will undergo a screening in which, in addition to the ophthalmological standard examinations, Occyo One images of the anterior segment of the eye are taken. After surgery, a post-operative follow-up visit takes place and a second set of Occyo One images will be generated.

During the postoperative check-up, the study team at the trial center decides-based on defined criteria (medical history, slit lamp examination results)-whether a change in the subsequent patient management is necessary due to the presence of postoperative complications (unexpected management changes = UMC).

Up on completion of all patient visits/study-specific measurements and data collection, information regarding diagnostic criteria and the Occyo One images are sent to an external, blinded ophthalmologist for telemedical assessment. Based on the available information and images, the blinded ophthalmologist decides whether a change in patient management should have been made or not.

The difference in the detection of an event resulting in a UMC is the primary objective of this clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

1. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature
2. Patients scheduled to undergo cataract surgery
3. Male or female patient aged ≥ 50 years at time of consent

Exclusion Criteria:

1. Woman of childbearing potential (WOCBP)
Disease Modifying Genes in Severe Asthma

Gene and protein bank to study disease modifying and susceptibility genes and proteins in urban patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and above

Exclusion Criteria:

* Greater than 10 pack year tobacco history
* Lung diseases other than asthma
Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk

The goal of this educational clinical trial is to identify Black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. The main question\[s\] it aims to answer are:

* How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?
* How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?

Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum patients who have delivered a baby at the Hospital of University of Pennsylvania
* Ages 18 or older
* Self-identify as Black (listed on chart)
* Speak English
* Able to read
* Other characteristics defined by our risk prediction model (algorithm)

Exclusion Criteria:

* Unable to provide informed consent
* Speaks a language other than English