cyrilzakka/clinical-trials huggingface dataset:
Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

The goal of this study is to address surgical health equity in historically marginalized participants with primary hyperparathyroidism (PHPT). The main questions that this study aims to answer are, how does patient navigation impact:

* The proportion of PHPT participants undergo parathyroidectomy?
* The proportion of PHPT participants who complete surgical consultation?
* Time to surgical consultation?
* Time to surgery?

Patients historically marginalized in Medicine are at increased risk of delayed care and undertreatment of PHPT, which can result in end-organ damage and reduced quality of life due to fatigue, brain fog, pain and other constitutional symptoms due to imbalances in calcium levels. It can be easily treated with a highly curative, cost-effective, and low risk surgery but less than 40% of patients who qualify for surgery undergo treatment. Patients from historically marginalized populations such as black/Hispanic/Asian race, underinsurance, and older age are disproportionately impacted by lower rates of surgery and longer delays to surgery.

This pragmatic pilot trial aims to address surgical health equity in historically marginalized patients with PHPT by assessing the impact of navigation, specifically direct outreach and appointment scheduling, on conversion of surgical referral to consultation and conversion of surgical consultation to treatment in two dimensions, timeliness and clinical outcomes. Participants will be randomized to receive or not receive scheduling navigation at time of recruitment with a crossover design at 3 months for those who do not receive scheduling navigation at time of recruitment and have yet to complete surgical consultation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PHPT and not yet had parathyroidectomy who meet criteria for surgical treatment of PHPT (osteoporosis, fragility fracture, or evidence of vertebral compression fracture on spine imaging, renal involvement \[renal stone, silent nephrolithiasis on renal imaging, nephrocalcinosis, hypercalciuria (24-hour urine calcium level 400 mg/dL) with increased stone risk, or impaired renal function (glomerular filtration rate 60 mL/min)\], calcium 1 mg/dL above upper limit of normal, age less than 50)
* Qualify as a member of a racial or ethnic minority group (Black, Hispanic, Asian and Pacific Islander, Native American), lower socioeconomic neighborhoods (by zipcode), socially vulnerable (social determinants of health indicating financial strain, social vulnerability index in the top quartile 75%+ by zip code), or with underinsurance (Medicaid, Medicare, dual eligible, uninsured)

Exclusion Criteria:

* Prior Parathyroidectomy
* End-stage Renal Disease
* Renal Transplant
* Vitamin D Deficiency
* Metastatic Disease
* Familial Hypocalciuric Hypercalcemia
* No Indication for Surgery
* Unable/Unwilling to provide consent
Emergence of the COVID 19 Epidemic in the City of Nice

Descriptive analysis of the appearance of the first cases of COVID 19 diagnosed in the city of Nice. Analysis of the association of socio-demographic factors with the viremia attack rate according to the district of residence.


Eligibility Criteria:
Inclusion Criteria:

* People resident in city of Nice at the COVID diagnosis
Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions

Design: Single center, single-blind randomized controlled trial of patients with high risk native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will be randomized to either a combined intervention or conventional PCI. Cardiac biomarker measurements will be performed before PCI and 18-24 hours later.

Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible.

Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution in the two study groups.

The secondary endpoints are: (1) Reduction in the incidence of \>3x and \>10x upper limit of normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3) Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Willing and able to provide informed consent and able to comply with study procedures and follow-up.
3. Undergoing a clinically indicated left heart coronary catheterization
4. Need PCI of a high-risk native coronary artery lesion. High-risk lesions will be defined as lesions with ≥2 contiguous yellow blocks on block chemogram.

Exclusion Criteria:

1. Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol.
2. Positive pregnancy test or breast-feeding.
3. High risk for bleeding.
4. Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol.
5. Clinical presentation with ST-segment elevation MI.
6. Persistent (\>10 minutes) hypotension (systolic blood pressure \<90 mmHg)
7. Need for revascularization of multiple lesions during the index PCI.
8. Unprotected left main (\>50%) or equivalent left main disease.
Neuroimaging of Dystonia

The main purpose of this study is to investigate primary cervical dystonia as compared to healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by examining cognitive measures, physical measures, and structural and functional magnetic resonance imaging (MRI).

The secondary aim of this study is to investigate a specific drug therapy for primary cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug, trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by physicians as a treatment for symptoms of primary cervical dystonia.

To participate in this study, you will be asked to come to the University of Florida for one testing day. For your convenience, arrangements will be made by the study coordinator.

If you have a movement disorder, you will be tested in an "off" medication condition. We do not expect concerns or unwanted consequences arising from discontinuing medications for this duration.

We will review the informed consent and you will have the opportunity to ask questions before signing the informed consent. During the experiment, you may be asked to complete the following: (1) questionnaires about quality of life and depression; (2) tests to measure your strength and motor function; (3) tests to measure your cognition; (4) functional and structural MRI scan of your brain while performing a precision gripping task; (5) intravenous blood draw; (6) urine pregnancy test (if applicable); (7) trial of anticholinergic therapy drug trihexyphenidyl (if applicable - cervical dystonia only).

Participants with DYT 1 dystonia and healthy controls are not eligible to receive the trial drug. All women of childbearing potential will be given a urine pregnancy test. The questionnaire about depression will not be given to subjects under the age of 18.

If you have any metal in your eye or eyes, the researchers may require additional screening to ensure that it is safe for you to enter the MRI environment. If additional screening is determined to be necessary, you will be referred to Radiology at Shands UF for an orbitofrontal x-ray.

Blood will be collected for all subjects, including healthy control subjects. The blood may be analyzed, at the University of Florida, to assess potential biomarkers for cervical dystonia and DYT 1 dystonia. Biomarker testing is another way to say genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary cervical dystonia and between the ages of 18-70, OR
* Diagnosis of DYT 1 dystonia and between the ages of 7-50, OR
* Healthy control and between the ages of 7-70

Exclusion Criteria:

* Neurological impairment from: seizure disorders, stroke, hypertension, heart disease, diabetes, traumatic brain injury (TBI), drug abuse, nerve disorders, dementia, Parkinson's Disease, dementia
* Not a candidate for magnetic resonance imaging (MRI)
* Deep brain stimulation (DBS) surgery
* Any implanted electrical device
* Pregnant or planning pregnancy
* Breastfeeding
* Claustrophobia
Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.

Within the epidemic context of phase 3 that currently exists in Mexico, implementation of new treatments that have shown to be beneficial for patients in a critical state in other countries is an urgent need. Adipose tissue derived-mesenchymal stem cells for could favor the regulation of patient immune system to reduce the proinflammatory state and promoting the regeneration of damaged tissues.

Patients diagnosed COVID-19 and confirmed positive with the virus by PCR, will be treated with two intravenous infusions MSCs on the day 1 (D1) and the day 3 (D3) of the treatment consisting of 1X106/kg each.

We will assess the pulmonary lesion area by chest x-ray or computed axial tomography at baseline and days 2, 3, 5, 10, 15, 20, and 25.

Days to clinical improvement (to be evaluated on days 2, 3, 5, 10, 15, 20, 25), considering temperature and other vital signs measurement, arterial oxygen saturation, blood chemistry (including liver function tests), creatine phosphokinase, C reactive protein, immune cells (CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes), pro-inflammatory cytokines (IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10), immunoglobulins (IgA, IgG, IgM, and IgE), HLA profile expression, and weaning from mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65.
* RT-PCR positive for SARS-CoV-2 (Berlin protocol).
* Moderate to severe acute respiratory insufficiency (100 mmHg \<PaO2/FiO2 ≤ 200 mmHg).
* Confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography.
* Being under standard therapy for COVID-19.
* Informed consent signed by the patient or a legally acceptable representative (in the case of the legal representative, informed consent could be obtained by a phone call or email with the subsequent written confirmation).

Exclusion Criteria:

* Reserved prognosis (survival expected by the physician of fewer than three days).
* Being under immunosuppressive drug treatment.
* Severe kidney failure (estimated glomerular filtration rate \< 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.
* Immunosuppressed patients (except when the cause is corticosteroid treatment).
* Pregnant or lactating women.
* Patients who plan to become pregnant during the study period or within six months after the end of the study period.
* Participation in another clinical trial with an experimental drug during the last 30 days.
* Pathologies that in medical judgment constitute a contraindication to participate in the study.
Rosiglitazone Effect on Mitochondria and Lipoatrophy

The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).

This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Lipoatrophy
* Thymidine sparing ARV for at least 24 weeks
* Prior thymidine NRTIs for at least 12 months

Exclusion Criteria:

* Diabetes
* Heart failure
* Liver disease
* Hormonal therapies
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19

The main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in combination with standard of care (SOC) in adult patients with mild COVID-19 (coronavirus disease 2019). The trial will also define the recommended phase 2 dose (RP2D) of bempegaldesleukin in patients with mild COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, age 18 years or older on the day of signing the informed consent form.
* Agrees to admission to an in-patient facility for monitoring from Days 1 to 8, inclusive.
* Symptoms of mild illness with COVID-19 without shortness of breath, dyspnea, or clinical signs indicative of more serious COVID-19.
* Laboratory confirmed SARS-CoV-2 infection within 4 days prior to the screening visit or during the 7-day screening period.
* Respiratory rate \< 20 breaths per minute, heart rate \< 90 beats per minute (bpm).
* Oxygen saturation by pulse oximetry \> 93% on room air.
* Body mass index \< 35 kg/m2.
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
* Alanine transaminase (ALT) or aspartate transaminase (AST) \< 2 x upper limit of normal (ULN) and total bilirubin \< 1.5 x ULN.
* Agrees to not participate in another clinical trial for the treatment of COVID-19 while on study unless the patient's condition has worsened and is considered to be moderate, severe, or critical by the Investigator.

Exclusion Criteria:

* Shortness of breath, hypoxia, or signs of serious lower airway disease.
* C-reactive protein, lactate dehydrogenase (LDH), or interleukin-6 (IL-6) \> 1.5 x ULN.
* D-dimer or ferritin \> 1.5 x ULN.
* Imminently requiring, or currently on, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
* Systolic blood pressure \< 90 mm Hg or diastolic blood pressure \< 60 mm Hg.
* Evidence of acute respiratory distress syndrome (ARDS) or systemic inflammatory response syndrome (SIRS)/shock.
* Known cardiovascular history, including unstable or deteriorating cardiac disease.
* Autoimmune disease.
* History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-cerebrovascular accident/transient ischemic attack arterial thromboembolic event.
* Central nervous system disease or dysfunction.
* Requirement for \> 2 anti-hypertensive medications.
* Unwilling to refrain from alcohol consumption from Day 1 of admission to the in-patient facility until discharge from the facility.
* Adrenal insufficiency.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>18 years of age
* Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

Exclusion Criteria:

* Contra-indications for RoActemra/Actemra
Incidence and Risk Factors of Symptomatic Epidural Hematoma After Cervical Spine Surgery

The incidence and correlation of symptomatic epidural hematomas after cervical spine surgery was reviewed and analyzed, then it will provide reference to avoid the occurrence of this complication for the future clinical work.

43 patients with symptomatic epidural hematoma after cervical spine surgery were enrolled in the Peking University Third hospital from January, 2009 to February, 2017. 86 patients without symptomatic epidural hematoma after cervical spine surgery during the same period were randomly selected as the control group. Demographic information (including gender, age, previous history, smoking history, etc.)，disease parameters (diagnosis, mJOA(modified Japanese Orthopaedics association) score, NDI(neck disability index) score)，laboratory and imaging parameters (including platelet, coagulation function, albumin, and OPLL)，segments，treatment parameters (surgical method, number of surgical segments, operative time, intraoperative blood loss, anesthesia time, whether to use implants) and postoperative conditions (including the time of hematoma occurrence, diagnostic method, emergency debridement operation time, patient improvement before and after debridement) were collected.Firstly, risk factors for symptomatic epidural hematoma after cervical surgery were selected by univariate analysis,then independent risk factors were screened by multiple Logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically and radiologically confirmed cervical spondylosis.
* Cervical spine surgery was performed in our hospital

Exclusion Criteria:

* Cervical trauma combined with fracture and dislocation.
* Cervical cancer.
* Cervical spine infection
* Upper cervical spine surgery alone
Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)

Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902)


Eligibility Criteria:
Inclusion Criteria:

Disease Characteristics:

* Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
* Stage T1c-4b, N0-1, M0

Hormone receptor status:

* Not specified
* No bilateral breast cancer

Prior/Concurrent Therapy:

* No previous treatment for breast cancer

Biologic therapy:

* Not specified

Chemotherapy:

* No previous chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Core needle biopsy or fine needle aspiration within 21 days prior to entry
* Repeated core needle biopsy permitted

Patient Characteristics:

Age:

* 16 to 70

Sex:

* Women only

Menopausal status:

* Not specified

Performance status:

* WHO 0-2

Hematopoietic:

* WBC at least 4,000
* Platelets at least 100,000

Hepatic:

* Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)

Renal:

* Creatinine no greater than 1.3 mg/dL (120 micromoles/L)

Cardiovascular:

* No congestive heart failure
* No significant arrhythmia
* No bilateral bundle branch block
* No recent myocardial infarction
* No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)

Other:

* No male breast cancer
* No pregnant or nursing women
* No second malignancy except adequately treated:

  * Nonmelanomatous skin cancer
  * Cervical cancer
High Risk Crack Use Settings and HIV in El Salvador

This project will first increase the accessibility and acceptability of rapid HIV testing in health clinics located in or near four low-income communities in San Salvador, El Salvador. The investigators will use crack users' social networks and small incentives, as recommended by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network Intervention among 400 crack users to change norms supporting HIV protective behaviors. The intervention will include monthly meetings open to crack using and non-crack using community residents to reinforce HIV risk reduction skills, and discussion of other topics related to HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness events. Our hypothesis is that these two intervention features will singly, and in combination, reduce HIV risk behaviors among Salvadoran crack users.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* used crack cocaine in the last 2 weeks

Exclusion Criteria:

* not giving informed consent
* under 18 years of age
* considered by research staff to be unfit or unable to give informed consent
* engages in continued disruptive behavior while participating in the project
* not using crack or cocaine in the last month
Real-time Ultrasound Guidance for Thoracic Epidural Blocks

Various modalities have been proposed for real-time confirmation of loss of resistance (LOR) for thoracic epidural blocks. With real-time ultrasound (US) guidance, the anesthesiologist attempts to visualize the sonographic advancement of the epidural needle and penetration of the epidural space (as detected by LOR)

This observational study is set out to confirm the reliability of real-time ultrasound guidance as an adjunct to LOR for thoracic epidural blocks.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

* Adults who are unable to give their own consent
* Sepsis (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. leukocytosis, increased c-reactive protein, increased procalcitonin)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Allergy to local anesthetics (LAs)
* Prior surgery in the thoracic spine