cyrilzakka/clinical-trials huggingface dataset:
Improving Care of Patients With Heart Failure

Heart failure (HF) affects more than 5 million Americans and is a major source of morbidity and mortality. Despite optimal management, over half of patients with HF suffer from pain, dyspnea, fatigue, and depression that diminish quality of life (QoL). HF care also exacts a huge financial toll with yearly costs of $35 billion. Although consensus guidelines call for providing palliative care (PC) to patients with HF to relieve suffering and improve QoL, few receive it. The overall aim of this project is to conduct a randomized controlled trial (RCT) to determine if an interdisciplinary PC intervention (Symptom Management Service-HF \[SMS-HF\]) provided concurrently with standard cardiology care improves symptoms, QoL and satisfaction, and reduces resource utilization in outpatients with Class II-IV HF compared to standard cardiology care alone. Subjects assigned to the SMS-HF group will receive a 6-month interdisciplinary PC intervention based on the investigators successful SMS model of outpatient PC for oncology patients and focused on assessment and management of physical, emotional, social, and spiritual distress and discussion of treatment preferences. Innovations of this study are that it will rigorously assess the impact of the SMS-HF on patient outcomes and on resource utilization, a key component to ensuring program sustainability. The investigators research team of PC and HF experts is recognized for its PC research and has a proven record of collaborating, conducting RCTs of PC interventions, and studying outpatients with HF. The environment at UCSF is highly supportive of innovative research and of sustaining programs with demonstrated improvements in patient outcomes and operational effectiveness. The overall goal is to use the results from this study to support an application to the NIH for a multi-center RCT of the SMS-HF and to study similar models of concurrent PC for patients with other serious illnesses.


Eligibility Criteria:
* HF as primary Dx or symptomatic/active HF
* During index hospitalization or within the prior 6 months
* Age \> 18
* Admit from: hospital, skilled nursing, home
* Medicine, Cardiology, and Heart Failure Services
* Co-morbidities can include end-stage renal disease, metastatic cancer, ICU/CCU care patients if able to consent and complete survey
* English speaking

Exclusion Criteria:

* Non-English speaking
* Previous consult by Palliative Care Service
* Pulmonary HTN
* Right Heart Failure
* LVAD
* PCI or CABG patient within this admission
* AS with planned surgical intervention
* Pre/post heart transplant
* Pre/post organ transplant within this admission
* Dementia (unable to consent)
* Homeless
* Active drug user
* Hospice enrolled patient
* GeriTraCC patients
* Does not have a UCSF physician
* Lives outside of the SF Bay Area
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.

This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Paraffin-embedded tissue samples from patients clinically diagnosed with gastrointestinal stromal tumor (GIST), and a small number of other cancers or benign lesions in the gastrointestinal site were included as interference samples.
2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
3. The sample is a formalin-fixed paraffin-embedded gastrointestinal stromal tumor tissue sample, and each sample can provide 5 paraffin sections or 5 paraffin rolls with a thickness of at least 5 µm.
4. The content of tumor cells meets the requirements of assessment reagents and comparison methods.

Exclusion Criteria:

1. The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.
2. Samples that cannot complete the entire testing process.
3. Patients with incomplete sample information.
FSRT Combined With TMZ for Large BMs: a PSM Study

A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* (1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (MRI) ; (2) age 18 years or older (3) KPS ≥60, or KPS ≥50 but symptomatically caused by BMs; (4) the large lesions haven't treated with surgery or SRT.

Exclusion Criteria:

* (1) KPS \<60 but not caused by BMs; (2) the large lesions have been treated with surgery or SRT.
Determinants of Gestational Weight Gain in Obese Pregnant Women

The purpose of this study is to measure energy intake and energy expenditure during and after pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the Institute of Medicine (IOM) guidelines, 'High Gainers', will have increased energy intake but no evidence for changes in energy expenditure after adjustment for the weight gained when compared to women with appropriate gestational weight gain, 'Normal Gainers'. Additionally, the investigators will measure the babies born to the pregnant women enrolled in MomEE at one time point before 10 days of life.


Eligibility Criteria:
Inclusion Criteria:

* Are pregnant
* Have a body mass index (BMI) greater than or equal to 30kg/m2
* Are 18-40 years old
* Medically cleared for participation by primary care obstetrician
* Medically cleared for participant by Medical Investigator
* Willingness to allow the study access to information in the participant's medical record
* Willingness to be notified of incidental findings from study procedures

Exclusion Criteria:

Clinical

* Hypertension (i.e. systolic blood pressure (SBP) \>160 mmHg \& diastolic blood pressure (DBP) \>110 mmHg)\*
* Diagnosis of diabetes prior to pregnancy
* Hb A1c ≥6.5 %\*
* Implanted metal objects that render MRI unsafe
* HIV or AIDS (self-reported)
* Severe anemia (hemoglobin \<8g/dL and/or hematocrit \<24%)\*\* Psychological
* History or current psychotic disorder or diagnosis of a current major depressive episode or bipolar disorder
* Past history of anorexia or bulimia by medical history or patient report (binge eating disorder is not an exclusion) or current eating disorder
* Actively suicidal defined as a value ≥2 on the Beck Depression Index (BDI-II) question 9\* Medications
* Current use of one or more of the following medications: metformin, systemic steroids, antipsychotic agents (e.g., Abilify, Haldol, Risperdal, Seroquel, Zyprexa), anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g., Depakote, Lamictal, Lithium, Neurontin, Tegretol, Topamax, Keppra), medications for attention-deficit/hyperactivity disorder (ADHD) including amphetamines and methylphenidate
* Continued use of weight loss medication including over the counter (OTC) and dietary supplements for weight loss (e.g., Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange) Other Exclusion Criteria
* Recent history of or currently smoking, drinking alcohol or abusing drugs (prescription or recreational)
* Plans to move out of the study area within the next 2 years or plans to be out of the study area for more than 4 weeks in the next 12 months
* Planned termination of pregnancy
* Unwillingness to avoid pregnancy for 12 months following delivery
* Claustrophobia
* Prior or planned (within 1 year of expected delivery) bariatric surgery
* Participant's unwillingness or inability to commit to a 1 year follow-up
Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D

The purpose of this study is to determine whether 8 weeks of Liraglutide or Golimumab can transiently improve beta cell function in patients with longstanding Type 1 diabetes (T1D) who secrete proinsulin and little/no C-peptide.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 3 years from Type 1 diabetes diagnosis
2. Males and females 18-50 years of age, inclusive
3. Peak MMTT stimulated C-peptide \<0.017 pmol/mL
4. Proinsulin levels ≥ 2 pM (either fasting or stimulated)
5. Females of child-bearing potential must be willing to use effective birth control for 12 weeks
6. Willing and able to give informed consent for participation
7. HbA1c ≤ 8.5%

Exclusion Criteria:

1. Concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of screening MMTT (V-2).
2. History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies.
3. Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT or AST\> 1.5 x the upper limit of age-determined normal (ULN) .
4. Females who are pregnant or lactating.
5. Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment.
6. History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac and stable thyroid disease.
7. Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin).
8. Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial.
9. For Study A (liraglutide)

   1. Any history of pancreatitis or elevated amylase or lipase.
   2. Any personal or family history of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
   3. Any personal or family history of multiple endocrine neoplasia syndrome type 2.
   4. Hypersensitivity to liraglutide.
   5. Previous treatment with liraglutide.
   6. Known history of clinically significant gastroparesis.
10. For Study B (golimumab)

    1. Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections.
    2. Any history of demyelinating diseases (such as multiple sclerosis), heart failure, or left ventricular dysfunction.
    3. Serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C.
    4. Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection.
    5. Active infection with EBV, defined by real-time PCR.
    6. Active infection with CMV, defined by real-time PCR.
    7. Any of the following hematologic abnormalities at screening:

       * White blood count \<3,000/μL or \>14,000/μL
       * Lymphocyte count \<500/μL
       * Platelet count \<140,000 /μL
       * Hemoglobin \<8.5 g/dL
       * Neutrophil count \<2,000 cells/μL
    8. Receipt of live vaccine (in the 6 weeks before treatment)
Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model

This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke.

The objectives of the study were as follows: first, to integrate the degree of carotid stenosis and plaque characteristics assessed by vascular ultrasound for a comprehensive assessment of plaque vulnerability; second, to develop an assessment tool for the risk of future ischemic stroke in patients with asymptomatic carotid stenosis by combining vascular risk factors, serologic markers, carotid ultrasound characteristics, and contrast-enhanced ultrasonographic parameters; and third, to incorporate vascular ultrasound parameters into existing predictive models of ischemic stroke recurrence risk to develop a risk assessment tool for atherosclerotic ischemic stroke.

The main questions it aims to answer are:

* How to screen high-risk patients and those eligible for revascularization from asymptomatic carotid stenosis patients for primary prevention of stroke.
* How to improve the prediction accuracy of atherosclerotic ischemic stroke based on existing prediction models for secondary prevention of stroke.

The data from January 2022 to December 2022 was obtained from the electronic medical record system, but there will be a two-year follow-up of the data. Therefore, this is a two-way cohort study, containing both a retrospective and prospective cohort.

Eligibility Criteria:
Inclusion Criteria:

* ① Patients aged ≥ 40 years old; ② Complete clinical data and serological indicators; ③ Carotid artery ultrasound examination was performed after admission.

Exclusion Criteria:

* ① Unilateral or bilateral carotid artery occlusion; ②Carotid stenosis caused by other reasons, such as entrapment, aortitis, radiculopathy and muscle fiber dysplasia; ③Previous carotid stenting or carotid endarterectomy; ④Carotid artery plaques are strongly echogenic with acoustic shadowing, resulting in unclear detection of the lumen.
Patient Positioning on Supraclavicular Nerve Block

Blockade of the brachial plexus using a supraclavicular approach provides excellent anesthesia for upper extremity surgery. The most serious complication specific to this block is pneumothorax. Subsequent modifications of this block including the use of ultrasound have lowered the risk from 6% to \<1%. Case reports remain and authors have described certain factors and strategies to reduce this risk. Most texts and journals describe the patient in a supine or semi-sitting position during the block. At the investigators institution the investigators perform the block in a semi-sitting position to facilitate needle tip visibility with ultrasound. The investigators plan to obtain ultrasound anatomic measurements in three different positions (supine, semi-sitting, sitting) using patients consented for supraclavicular nerve blocks.


Eligibility Criteria:
Inclusion Criteria:

* all patients, 18 y/o to 65 y/o, who are scheduled to receive an ultrasound- guided supraclavicular nerve block

Exclusion Criteria:

* patient refusal to be included in the study,
* the presence of language barrier that inhibits proper communication with the patient, contraindications to regional anesthesia (local infection, severe pulmonary disease, or preexisting neuropathy)
* history of allergy to amide local anesthetics or narcotics
* the presence of a progressive neurological deficit
* history of hepatorenal insufficiency
* the presence of a coagulopathy or infection
* pregnancy
* a history of psychiatric disorder
* inability to follow study protocol
Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)

A new fundus-guided microperimeter (MP-3S) has been developed by Nidek, Inc. to track the fundus of the patient and present stimuli in specific anatomically-defined locations. Furthermore, this tracking means that exactly the same locations can be tested on subsequent (follow-up) visits. The investigators will use a method called two-color perimetry to map rod and cone sensitivity on this device. With this technique, the sensitivity difference (blue-red) to chromatic test stimuli can be used to determine whether rods, cones or both photoreceptor systems mediate the threshold at a given location in the macula.

Despite recent advances in understanding the pathogenesis of retinitis pigmentosa (RP) and age-related macular degeneration (AMD), precise characterization of the disease phenotype remains elusive. In both diseases, much of the focus has necessarily been on the loss of cone function, since visual fields, acuity and contrast sensitivity are typically measured under photopic conditions. In RP, we need a greater understanding of patterns of rod loss since most disease-causing mutations affect primarily rods. In AMD, recent findings have shown that scotopic sensitivity can be much more affected than conventional photopic measurements such as visual acuity. For patients, however, it is difficult to maintain stable fixation, especially when central vision is compromised. A new fundus-guided microperimeter, the MP-3S, has been developed by Nidek, Inc. to circumvent this problem. The investigators will evaluate the value of this device for following rod and cone loss in patients with either RP or AMD.

Eligibility Criteria:
Inclusion Criteria:

* clear media
* diagnosis of RP or non neovascular AMD
* normal volunteers

Exclusion Criteria:

* exudative AMD
* other eye diseases that could cause vision loss
* physical ailments that would preclude comfortable testing
* unable to provide informed consent
SCGs as a Proxy for Determining the Cognitive Status of Older Adults

Detecting memory problems early is crucial for treating conditions like Mild Cognitive Impairment (MCI), which often leads to dementia. Currently, doctors use tests in clinics to check for these issues. However, there's a growing need for better methods to monitor our cognitive skills over time. Computer games emerge as a cost-effective solution for assessing the brain functions of older adults.

In our study, we are investigating the potential of computer games to reflect the cognitive skills of older adults. We developed the VibrantMinds platform, featuring five games: Whack-a-Mole, Bejeweled, Mahjong Solitaire, Word Search, and Memory Game. We have evaluated these games for ease of use, enjoyment, and their impact on brain functions. Now, our goal is to determine whether these games can offer valuable insights into the cognitive skills of older adults.

We are collecting demographic data, game-playing data, and cognitive test results. Our analysis will determine the correlation between game data, cognitive test outcomes, and demographic information. Additionally, we will assess both the perceived and observed engagement of older adults as they play the games.


Eligibility Criteria:
Inclusion Criteria:

* Reside in Calgary and/or Edmonton, Alberta, Canada
* sufficient English language skills to converse in English with research staff

Exclusion Criteria:

* Moderate or severe limitations in the control or movement of the upper extremity (e.g., severe arthritis, amyotrophic lateral sclerosis, multiple sclerosis)
* Visual and hearing impairments
* Attention deficit
A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects

This is a first in human Phase 1 study in two parts with healthy volunteers receiving a single dose of PU AD in three small cohorts and a multiple ascending dose in two small cohorts.

This is a Phase 1, double-blind trial in two parts. A single ascending dose study in approximately 3 cohorts receiving a single oral dose of PU-AD or placebo and a multiple ascending dose study in 2 cohorts. Each subject in all cohorts will be administered an oral solution of PU AD or placebo under fasting conditions. Each cohort will contain subjects randomized to active treatment or placebo, evaluating safety and tolerance.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female (Women of non-child bearing potential)
2. 18 to 60 years of age for part one, \>/= 60 years of age for part two

Exclusion Criteria:

1. Women of child bearing potential or Female with positive pregnancy test or who is lactating.
2. History or presence of conditions, which in the judgment of the PI, are known to interfere with the absorption distribution, metabolism, or excretion of drugs.
3. History or presence of conditions that may place the subject at increased risk as determined by the PI.
4. Has taken other investigational drugs or participated in any clinical study within 30 days.
5. Any other condition or prior therapy that, in the PI's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures
The LEARN Study for CVD Prevention

The investigator is testing a virtual environment to address prevention of HIV-related comorbidities.

The primary aims of this study are to test the feasibility, acceptability and preliminary effects of a VE to address prevention of HIV-related comorbidities. A waitlist control feasibility clinical trial will be conducted. We will assign (N=80) eligible participants and ensure balanced allocation to intervention and control groups over the intervention period. We hypothesize that the VE will be feasible and acceptable to persons living with HIV, and that they will apply their VE learning to real-life situations and health behaviors for prevention of HIV-related comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* identify as an ethnic/racial minority with HIV
* identify as gay, same-gender-loving, or MSM
* able to read and understand English
* access to a computer capable of downloading and running the VE software
* no medical history of serious cardiovascular or cognitive complications

Exclusion Criteria:

Anything outside of inclusion parameters, including history of:

* myocardial infarction (MI)
* congestive heart failure (CHF)
* coronary artery bypass graft (CABG)
* cerebral vascular accident (CVA)
* cognitive impairment
Comparison of Scar Results and Time for Closures of Scalp Defects Via Pulley Sutures or Layered Repairs

Surgical defects on the scalp require closure via various techniques of suture placement. A traditional technique requires both dermal (deep) and epidermal (superficial) placement of sutures to close the defect; this is referred to as intermediate or complex linear repair. However, the scalp is a location with high tension, and thus the closures take an hour or longer to perform. A type of suture placement referred to as the "pulley stitch" requires placement of a few stitches along the defect. The pulley stitch can be used in areas of high tension to close a large defect. The purpose of this study is to compare the scar results and time taken to perform scalp closures via only pulley stitches or via intermediate/complex linear repairs.

To my knowledge, no such study has been performed to compare the two techniques. Such a study would be useful in demonstrating comparable scar appearance and reduce the time to perform scalp closures.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Ability to understand risks, benefits, and alternatives to the study and to be able to give an informed consent
3. Lesions such as skin cancer or benign lesions on the scalp amenable to surgical excision or to MOHS surgical technique
4. Frontal scalp defects defined as frontal hair line to crown of scalp
5. Scalp defect size of 2cm - 8 cm

Exclusion criteria:

1. Patients who tend to form keloids or hypertrophic scars
2. Patients with a history of scleroderma or morphea
3. Pregnant or breast-feeding females
4. Patients whose surgical defects require flap closures