cyrilzakka/clinical-trials huggingface dataset:
Racial Differences in the Coronary Microcirculation

To study mechanisms of excess coronary ischemia secondary to alterations in autoregulation and arteriolar vasoreactivity in Black Americans with hypertension, varying degree of left ventricular hypertrophy, and angiographically normal or mildly diseased coronary arteries.

BACKGROUND:

Although studies in 1992 with a sufficient number of minority patients were sparse, those available suggested that Black Americans had a higher case fatality from coronary heart disease, but lesser amounts of atherosclerotic coronary artery disease. A possible explanation for this apparent paradox was that myocardial ischemia might be more prevalent with less coronary artery atherosclerosis in Black Americans because of comorbid diseases or differences in coronary physiology. This could be secondary to excess hypertension and left ventricular hypertrophy in Black Americans but might also have been related to intrinsic or acquired differences in coronary artery autoregulation and vasoreactivity leading to depression in coronary blood flow and reserve.

DESIGN NARRATIVE:

The intracoronary Doppler flow velocity guidewire together with quantitative coronary angiography was used to study changes in coronary blood flow in blacks secondary to pharmacologic provocateurs known to induce arteriolar vasodilation. White Americans with similar demographic characteristics and equivalent amount of ventricular hypertrophy and coronary disease were similarly studied in a parallel fashion for comparison. A control group of normal white and Black Americans were studied to detect unexpected intrinsic differences. Both endothelium dependent and independent induction of coronary arteriolar vasodilation were studied. In 25 percent of patients with endothelium dependent defects in arteriolar vasodilation, retesting was performed after intracoronary infusion of L-arginine, the precursor of endothelium dependent relaxing factor. Finally, the possibility of a rightward shift in coronary artery autoregulation in chronic hypertension was investigated. This finding would necessitate that the lower limit of autoregulation occurred at higher diastolic pressures, resulting in a drop-off of coronary perfusion at normal physiologic pressures and ischemia.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus

Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.


Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ-Ⅱ
2. aged between 20 and 70 year
3. hydrocephalus
4. general anesthesia for undergoing drainage of cerebrospinal fluid

Exclusion Criteria:

1. an anatomical or functional abnormality in optic nerve
Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination

The purpose of this study is to provide emergency treatment of adult and pediatric patients:

* Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms or
* Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

Demographics, baseline disease information, prior disease-directed therapy including fluorouracil or capecitabine, and details of the fluorouracil or capecitabine overexposure (dose, cause, and timing) will be collected. Adverse events information will be collected and recorded. Patients will be followed for 30 days unless the patient expires or resumes chemotherapy within the 30 day period.

Eligibility Criteria:
Inclusion Criteria:

* The patient received a fluorouracil or capecitabine overdose (regardless of the presence of symptoms) or
* The patient is exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration
* Judged by the Investigator to have the initiative and means to be compliant with the protocol
* Able to take oral medications
* Able to start treatment with uridine triacetate within 96 hours after the end of fluorouracil or capecitabine administration
* Provides written informed consent (patient or legally authorized representative)

Exclusion Criteria:

* Has a known allergy to uridine triacetate or any of its excipients
* Unable to have the initiative and means to be compliant with the protocol
* Unable to be compliant with taking oral medications
* More than 96 hours have elapsed since the completion of 5-FU dosing
* Unable to provide written informed consent (patient or legally authorized representative)
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy

To determine the safety and efficacy of the ThermaRx heating device for the application of controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).

This study will assess the safety and efficacy of ThermaRx heat treatment in subjects who have urinary hesitancy.

The rationale for this approach is based on anecdotal evidence and case reports suggesting that urinary hesitancy can be effectively reduced by external skin heating (hot tub "Jacuzzi" effect, perineal hot water spray). However, to date, there have been no formal studies of this non-invasive form of treatment, and the mechanism of action is still unclear.

This is a two-day study in which each subject will receive an oral fluid load and then one (1) heating treatment with the device. Ultrasound-based measurements of bladder volume will be performed both before and after voiding. On Day 1, voiding will be performed in a standing position; on Day 2, voiding will be done in a sitting position.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects 25-80 years of age at the screening visit.
* Subject must have mild-to-moderate urinary hesitancy symptoms (shown as an American Urological Association Symptom Index (AUA-SI) score of 7-19).
* Symptoms include (not limited to):
* Leaking or dribbling of urine
* More frequent urination, especially at night
* Urgency to urinate
* Urine retention (inability to urinate)
* Hesitant, interrupter or weak stream of urine
* Inability or difficulty to urinate in public

Exclusion Criteria:

* History of prostate cancer or prostate surgery
* Currently (or within the past 30 days) on active treatment for prostate problems
Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care

Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. This is a prospective, single-arm feasibility trial that will explore the feasibility and acceptability of a music therapy intervention to decrease stress in the PICU among families of children receiving invasive or noninvasive mechanical ventilation.

Objectives: The aims of this study are to: 1) Assess the feasibility of implementing a music therapy intervention in the PICU among children receiving invasive or non-invasive mechanical ventilation; 2) Determine the acceptability of the music therapy intervention in the ICU among caregivers, patients, and pediatric and cardiac ICU staff; 3) Explore the variability in child and caregiver stress outcomes throughout ICU admission. Hypothesis: The music therapy intervention will be feasible, as determined by recruitment, retention, protocol adherence, and data collection rates, and will be acceptable to participants and to PICU staff.

Sample: This study will recruit 20 families that include children aged 2 months - 17 years old admitted with an expected length of ICU stay greater than 72 hours. Of these 20 families, the investigators will specifically recruit 10 families whose child is admitted for a hypoxic brain injury. Eligible children are receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support settings. One primary caregiver will be enrolled along with the child admitted into the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Parent/caregiver aged 18 years or older.
* Children aged 2 months - 17 years admitted to the PICU with an expected length of stay greater than 72 hours
* Child is receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support setting

Exclusion Criteria:

* The legal guardian is unclear,
* Caregiver does not read, write, and speak English
* Child is not expected to survive that PICU stay or has care limitations in place
* Child has deafness in both ears, in foster care or justice system, or experiences musicogenic epilepsy.
Eccentric Motor Control After SCI

This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at slow to moderate speeds - targeted to rehabilitation eccentric function of the hip and knee.

Lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with SCI. This proposal aims to characterize eccentric motor control of the muscles about the hip and knee during locomotion and evaluate the efficacy of downhill gait training at slow speeds as an intervention to improve eccentric function of the hip joint and knee joint during walking.

Eligibility Criteria:
Individuals with SCI:

Inclusion Criteria:

* medically approved
* discharged from outpatient rehabilitation for 6 months
* incomplete SCI based on ASIA impairment score (AIS C or D) at neurologic level C1-T10
* ability to take some steps overground and on the treadmill
* 18-90 years old.
* ability to speak English. Note: the quality of life measures have not been validated yet in non-English speaking populations.

Exclusion Criteria:

* evidence of lower motor neuron injury in the legs
* use of botox in the past 3 months
* pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, HIV)
* acute deep vein thrombosis
* skin wounds in regions where harness or hands provide support
* pregnancy. Note: Persons who are pregnant will not be enrolled as exercise tolerance is unknown in these women with SCI.
* cognitive conditions that preclude providing informed consent
* ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment
* persistent orthostatic hypotension (drop of BP \>30mmHg in treadmill and harness equipment)
* hospitalization for myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study
* participation in any other concurrent exercise programs.

Note: Use of anti-spasticity and other medications (dose, frequency) will be monitored throughout training and used as a confounding variable in the analyses.
Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients

A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Subjects commonly shared a condition of overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Intra-Surgery complications, Previous surgery, Readmission Post Intervention, Location of surgery, Duration of Surgery, Re-intervention (yes), Clearance, and CRM were collected. Subjects commonly shared overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>25 Kg/m2
* Colorectal cancer (CRC)

Exclusion Criteria:

* Current emergency conditions (i.e., perforation and\\or occlusion)
* Pregnancy,
* Co-existing peritoneal carcinomatosis
* Contraindications to LS, such as cardiorespiratory comorbidities (CHD, CHF, and other severe CVD)
* Prior transverse resections
Dose Finding Study for Remimazolam in Children

This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.

We will administer remimazolam intravenously to the study participants. Remimazolam will be infused in 30 seconds to the participants, and we will wait for 2 minutes for the participants be sedated.

When a participant was not sedated in 2 minutes, dose of remimazolam in the next participant will be escalated by 0.05mg/kg. When a participant was sedated in 2 minutes, dose of remimazolam in the next participant will be decreased by 0.05mg/kg or maintained as same. The probability of decrement and maintenance will be 90% and 10% respectively. The dose of remimazolam in the first participant of the study will be 0.05mg/kg.

We will collect the results and obtain ED90 of remimazolam for loss of consciousness in children aged 2 to 8 years old.

Eligibility Criteria:
Inclusion Criteria:

* Children scheduled to undergo general anesthesia or sedation
* American Society of Anesthesiologist Physical Status of 1 or 2

Exclusion Criteria:

* Presence of Upper respiratory tract infection or any pulmonary disease
* Presence of subglottic stenosis, laryngomalacia, or tracheomalacia
* History of hypersensitivity to benzodiazepines or propofol
* History of hypersensitivity to beans or peanut
* History of seizure
* Presence of arrhythmia, tachycardia, or bradycardia
* Presence of acute closed-angle glaucoma
* Patients with unstable vital sign
* Presence of sleep apnea
* Presence of galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
* History of hypersensitivity to dextran 40
* Refusal to enroll by one or more parents or legal guardian
* Other conditions the researchers regarded as inappropriate to enroll
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 years or older
* Bilateral hearing aid user
* Able to consent in English
* Having access to a phone capable of running the mobile app required for the study
* Screen for fall risk ("Yes" to any question: Feels unsteady when standing or walking? Worries about falling? Has fallen in past year? If the participant has fallen: how many times? were they injured/hurt?)
* Ambulatory without need for a wheelchair

Exclusion Criteria:

* People with mobility restrictions (e.g., wheelchair bound) that would prevent the performance of the functional assessments.
* People with severe movement (e.g., Advanced Parkinson's disease) or cognitive (e.g., advanced dementia) disorders that would prevent the individual from either performing the functional assessments, or would lead to restricted activities that would prevent motion data from being collected according to the goal of the study.
* Inability to understand, consent, and complete requirements including verbal instructions and non-ambulatory/wheelchair-dependent.
First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction

It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥18 years and ≤80 years.
* LVEF ≤35% as assessed by echocardiography, confirmed by MRI if there are no contraindications for this procedure.
* History of revascularised or nonrevascularisable coronary artery disease as the cause of ventricular dysfunction.
* NYHA functional class III for dyspnea under optimal medical treatment.
* Ability to perform the exercise test with respiratory gas consumption. MVO2 should be ≥ 10 and ≤ 18 ml/kg/min in the exercise test.
* Ability to perform a 6-minute walk test \> 100 m and ≤ 400 m.
* Haemodynamic stability (blood pressure \> 100/40 mmHg, heart rate \< 110 bpm and oxygen saturation at rest in room air \> 95%).

Exclusion Criteria:

* Participation in another clinical trial within 30 days prior to inclusion.
* Prior treatment with cell or gene therapy.
* Diagnosis of acute myocardial infarction with 3 months prior to inclusion.
* Significant coronary artery disease eligible for revascularization.
* Significant valvular disease eligible for surgery.
* Presence of uncontrolled ventricular arrhythmias (VR or VF) at the time of implant surgery.
* Women who are pregnant or breastfeeding.
* Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent.
* Advanced dementia according to the Barthel index.
* Active systemic infection.
* History of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow-up).
* Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated nonmelanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy) are permitted.
* History of autoimmune disease.
* Stroke within 12 months prior to inclusion.
* Respiratory compromise or need for home oxygen therapy.
* Life expectancy of less than 1 year for any reason.
A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers

This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants between 18 and 55 years of age, inclusive,
* Body mass index (BMI) between 18.5 to 32 kg/m2, inclusive,
* Healthy, as determined by no clinically significant findings from medical history, ECG, and vital signs, and who are able to swallow and tolerate a tethered Heidelberg pH Capsule and have gastric pH measurements taken

Exclusion Criteria:

* Any medical condition or history of such condition that may, in the opinion of the investigator, contraindicate participation in this study
Red Light Treatment in Peripheral Artery Disease

Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle brachial index (\<.9 or \>1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and subsequent acquisition of ultrasound images. 2 blood samples will be collected for measurement of nitric oxide metabolites.

The intent of this protocol is to measure blood flow in the gastrocnemius muscle in patients with documented peripheral artery disease before and after exposure to 670 nm light energy. The study consists of one visit. Blood flow measurement will be performed using contrast enhanced ultrasound, a method by which ultrasound contrast is continuously infused into the blood stream. Ultrasound records images in the area of interest and flow is related to the intensity of the contrast in each image. Blood will be drawn to measure nitric oxide metabolites. The study is designed to consist of one visit. However, if the protocol changes or the data quality initially collected is uninterpretable, subjects may be asked to return to allow for a standard methodology across all participants. In this case, the subjects who are asked to return will be subject to the same informed consent process a second time. The two visits will be at least one week apart to further reduce the already minimal risks of the study. This will also limit the number of study participants required to gather the necessary data to complete the study, thereby limiting the risks of the study to a smaller number of participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be subjects between the ages of 18 and 85 who have been diagnosed with peripheral artery disease. Men and women will be recruited for participation. All ethnicities will be included in this study.

Diagnosis of peripheral artery disease is defined as an Ankle Brachial index of \<0.9 or greater than 1.1 either at rest or during treadmill exercise.

Exclusion Criteria:

* Exclusionary criteria include age under 18 years and over 85 years, those who are unable to understand the consent process , those who cannot read or speak English, active pregnancy, hypersensitivity to perflutren contrast agents, pulmonary hypertension, active illicit drug use, untreated blood pressure over 160/95, sickle cell disease, or a history of intracardiac shunt. Additional exclusion criteria neurological diseases such as spinal stenosis, unspecified pain disorders, and any uncontrolled medical conditions.