cyrilzakka/clinical-trials huggingface dataset:
"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"

Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. There seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical department at Oslo University Hospital, Ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.

The investigators will include 150 patients with a stable cervical fractures of vertebra C3-C7 with a Subaxial Cervical Spine Injury Severity (SLIC) Score 1-3 and randomize them in to two similar groups. One group will be treated with a cervical collar for 6 weeks and the other group will be treated for 12 weeks. There will be a clinical check up and a CT scan at 1, 6, 12 and 26 weeks after the initial injury. The investigators will compare the results between the two groups when it comes to fracture healing (CT based), level of function, pain and the length of sick leave with a total of 6 months of follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a newly diagnosed (within 5 days of injury) fracture in vertebra C3-C7 with SLIC score 1-3
* Patients must be abel to give their consent to participate in the study

Exclusion Criteria:

* Unstable cervical fractures in need of surgery
* SLIC score \>3
* Fractures of the spinous process and the transverse process in the cervical spine
* Stable fractures in in the C3-C7 vertebra combined with fractures of the C0-C2 vertebra
* Pathological fractures in the cervical spine
The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)

The purpose of this study is to evaluate the relationship between fractionated exhaled nitric oxide, peripheral eosinophils, and plasma citrulline and ß-alanine in patients with eosinophilic esophagitis (EoE) compared to those without EoE.

The hypothesis is that a combination of elevated fractional exhaled nitric oxide, increased peripheral eosinophils, and elevated plasma citrulline and ß-alanine is associated with active EoE.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patient, ages 5-18 years old, who will undergo esophagogastroduodenoscopy with biopsies at Children's Memorial Hermann Hospital, as part of the standard of care in the evaluation of EoE
* Signed informed consent by a parent or legal guardian
* Signed assent form by the child/adolescent subjects 7-18 years of age

Exclusion Criteria:

* Past medical history of active asthma, active allergic rhinitis, inflammatory bowel disease (IBD), parasitic infection, hay fever and any exposure to smoking (including secondhand smoke) because these disorders are known to affect the FeNO levels
* Active respiratory tract infections at the time of FeNO evaluation because this can affect the result of the FeNO as well
* Asthma questionnaire and/or Spirometry test consistent with asthma
A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19

This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 18 years, signing the informed consent.
* SARS-CoV-2 infection by PCR ≤ 7 days
* One or more of COVID-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate COVID-19)

Exclusion Criteria:

* Recurring COVID-19 patients.
* Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent
* Receipt of convalescent COVID-19 plasma, SARS-CoV-2 mAb treatment, SARS-CoV-2 vaccine, or other investigational treatments prior to study entry.
Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers

This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Clinically significant infections within the past 3 months.
Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer

This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.

All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously (IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85 mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, followed by 2400 mg/m2 administered as a continuous infusion over 46 hours via a pump (outpatient) and leucovorin 350 mg IV (modified FOLFOX6). Cycles were 14 days.

Eligibility Criteria:
Inclusion Criteria:

To be included in the study, you must meet the following criteria:

* Metastatic colorectal cancer confirmed by a biopsy sample
* 18 years of age or older
* Evidence of disease progression at time of study entry
* At least one prior adjuvant chemotherapy regimen
* No prior therapy for metastatic disease
* Measurable disease
* Able to perform activities of daily living with minimal assistance
* Adequate bone marrow, kidney, and liver function
* Tumor tissue available for assessment of EGFR
* Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

* Treatment with a previous regimen for metastatic disease
* Prior treatment with any EGFR inhibitor or anti-angiogenic agents
* Brain or nervous system metastases
* History of severe thromboembolic event
* Clinical evidence or history of bleeding or coagulopathy
* History of stroke or heart attack within six months
* Poorly controlled hypertension
* Non-healing wound, ulcer, or bone fracture
* History of abdominal fistula, perforation, or abscess within six months
* Other uncontrolled or significant disease or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Automated Physician Notifications to Improve Guideline-Based Anticoagulation in Atrial Fibrillation

The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by preventing stroke. The investigators propose to implement an automated algorithm using electronic medical record (EMR) data to alert physicians in a large primary care practice network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated stroke risk that are not taking an anticoagulant for stroke prevention. The investigators hypothesize that interventions to notify physicians of such individuals may prompt reassessment for the need for anticoagulation, and thereby increase guideline-indicated anticoagulation rates. Additionally, in a survey component, physicians will characterize reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.

The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by preventing stroke. The investigators propose to implement an automated algorithm using electronic medical record (EMR) data to alert physicians in a large primary care practice network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated stroke risk that are not taking an anticoagulant for stroke prevention. Using a medical record algorithm, there are an estimated 2,000 to 3,000 such patients in the primary care practices at MGH. The investigators hypothesize that interventions to notify physicians of such individuals may prompt reassessment for the need for anticoagulation, and thereby increase guideline-indicated anticoagulation rates.

The investigators define the following three Specific Aims to address the primary study hypothesis:

Specific Aim 1: Implement an automated alerting system within the EMR to notify primary care physicians (PCPs) of patients with AF at elevated stroke risk that are not being treated with anticoagulants. To maximize efficiency of the effort, the alert will not require a concurrent clinic visit, but rather will occur with existing data aggregated from the medical record independent of any clinical encounter.

Specific Aim 2: Test whether the alerting system increases the rate of anticoagulation at 3 months after implementation.

Specific Aim 3: Characterize the reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.

Specific Aim 4: Assess how PCPs want to be alerted about anticoagulation status in the future and what types of support they find helpful

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 and older seen in Massachusetts General Hospital primary care practices in the past 3 years
* Diagnosed with atrial fibrillation
* Increased risk of stroke (CHA2DS2VASc score ≥ 2)
* Not currently taking an anticoagulant

Exclusion Criteria:

* Patients who are subsequently identified as having died prior to or during the course of the study intervention using the Social Security Death Index
* Listed in the Massachusetts General Hospital system as having a PCP outside of the network
PET/MRI Study on Changes of Fat and Muscle Metabolism.

False positives for Brown Fat \& Muscle（F\&M） always affect the evaluation of metabolic disease treatment. Recently, using PET/CT，international journals such as Journal of Nuclear Medicine reported that the amount of active brown fat was correlated with renal creatinine clearance and subject to regulation by atrial natriuretic peptide in addition to association of season and temperature. At present，studies based on PET/CT have shown that elimination of the above factors, brown fat(even muscle) will still appear false positive metabolism in tumor patients. In view of the basis of Positron emission computed tomography/Magnetic resonance (PET/MRI) brain function research，our team speculate that it may be related to psychological or cortex metabolism. And there is a lack of studies on the correlation between the psychosocial，cortex structure and metabolism. Therefore, it suggests that，combination of structure and metabolism，PET/MRI will play a role in studying the effects of psychological on F\&M false-positive metabolism in malignant patients. In this project, the investigators intend to observe the changes of F\&M metabolism with psychological and cortex metabolism after comprehensive treatment in malignant patient by combining PET/MRI. The relationship between F\&M metabolism and psychological will be deeply analyzed to provide scientific basis for the development of the differential diagnosis and assessment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of malignant tumor
* Have not yet been receiving comprehensive treatment and should begin within one month
* Fasting glucose of diabetic patients is controlled below 11.1 mmol/L.

Inclusion Criteria for Healthy Control Participants:

• Clinical diagnosis of Healthy Control

Exclusion Criteria:

* Fasting glucose ≥11.1mmol/L
* History of endocrine disease (such as chronic glomerulonephritis, Addison's disease)
* Neurological signs and/or history of neurological disease
* Have begun comprehensive treatment
* Presence of magnetically active objects in the body
* Claustrophobia or any other medical condition that would preclude the participant from lying in the PET/MRI scanner for approximately 40 mins.
the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis

1. Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy；
2. On baseline, 6 months after treatment and 24 months after treatment, the AAV patients will accomplish the Birming-ham vasculitis activity score(BVAS) besides DTI；
3. The new serum biomarkers of AAV associated peripheral neuropathy will be measured by ELISA； (4) Another cohort with 50 patients with AAV associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using DTI by cost-benefit analysis


Eligibility Criteria:
Inclusion Criteria:

* age between 18-80 years old；
* must fulfill 2012 criteria of ANCA associated vasculitis
* presented with peripheral neuropathy diagnosed by specialists

Exclusion Criteria:

* the ANCA associated vasculitis is already in the stable stage after treatments
* any vital organ dysfunction
* active infection or cancer
* can not finish DTI scan
Impact of COPD on Muscle Regeneration

Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD) and can affect both respiratory and peripheral muscles. Impaired muscle regeneration is thought to be implicated in the process of muscle atrophy. In this study the investigators will evaluate muscle regenerative potential of the Vastus Lateralis (VL) and diaphragm of patients with COPD, compared to patients with normal lung function.

Preliminary results suggest that the activation and differentiation processes of satellite cells isolated from the VL of patients with COPD could be altered. The investigators propose to compare the regenerative potential of the VL and the diaphragm in 15 patients with COPD and 15 individuals with normal lung function undergoing a thoracic surgery. From muscle biopsies, satellite cells will be isolated and cultured to assess their proliferation and differentiation rates, and the expression level of myogenic effectors (MyoD, Myf5, myogenin, and MRF4). Alterations in these measurements will confirm the hypotheses that the regenerative potential is lower in both muscle groups in patients with COPD compared to controls and that in COPD, the regenerative potential is lower in VL compared to the diaphragm.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a scheduled thoracic surgery
* ≥ 40 years
* Smoking cessation ≥ 1 month
* Smoking history ≥ 10 pack-year

Exclusion Criteria:

* Subjects who received either chemiotherapy or radiotherapy
* Hypoxemia
* Body weight loss ≥ 10%
* Use of systemic corticosteroid in the last month
Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit

Exclusion Criteria:

* Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental
* Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262
* Current infection requiring the use of oral or intravenous antibiotics

Other Inclusion/Exclusion criteria may apply
Cardiovascular Responses to Heat Waves in the Elderly

The purpose of this study is to assess the cardiovascular responses of the elderly to heat wave conditions

Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. It is important to note that such deaths are primarily cardiovascular, not hyperthermia itself, in origin. Nevertheless, we know relatively little about the effects of aging on cardiovascular function during actual heat wave-like conditions. The central hypothesis of this work is that the elderly exhibit greater cardiovascular stress during heat wave conditions. Aim 1 will test the hypothesis that recognized impairments in thermoregulatory capacity in the elderly will culminate in heightened cardiovascular stress during prolonged exposure to heat wave conditions. Comprehensive cardiovascular and thermal responses in the elderly, relative to younger adults, will be evaluated during exposure to two prolonged heat wave conditions: hot and humid (replicating the 1995 Chicago heat wave), very hot and dry (replicating the 2018 Los Angeles heat wave). The expected outcome from this body of work will re-shape our understanding of the consequences of aging on cardiovascular function during heat waves

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female individuals
* 18-35 years or 65+ years of age
* Free of any underlying moderate to serious medical conditions

Exclusion Criteria:

* Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
* Taking of any medications (such as beta blockers and non-dihydropyridine calcium channel blockers) that have known influences on either cardiac function or sweating responses.
* Abnormalities detected on routine screening.
* Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
* Current smokers, as well as individuals who regularly smoked within the past 3 years.
* Body mass index of greater than 30 kg/m\^2
* Pregnant individuals
Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds

The repair of large osseous defects remains still unsolved. Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.


Eligibility Criteria:
Inclusion criteria:

* German-speaking patients aged 18-70 admitted to the Clinic of Reconstructive surgery for reconstructive surgery and fat-excision.

Exclusion criteria:

* Drug-abuse, neoplasia and metabolic disorders
Application of High-flow Nasal Oxygen in Cesarean Section

The study propose that the using the high-flow nasl oxygen to provide oxygen for maternal can improve the fetal acidemia and the neonatal outcomes during cesarean section with combined spinal-epidural anesthesia.

Maternal oxygen supplementation is widely used intrauterine resuscitation technique in clinical, which can improve fetal oxygenation and prevent fetal acidemia. The incidence of hypotension is high in cesarean section with combined spinal-epidural anesthesia. Hypotension contributes to insufficient perfusion of uterus and placenta, resulting in decreased fetal oxygen supply and neonatal acidemia. High flow nasal oxygen have a better improvement oxygenation of patients by providing high flow oxygen airflow with heating and humidification through nasal cannula.

Eligibility Criteria:
Inclusion Criteria:

* An elective cesarean section in Beijing Tongren Hospital
* ≥37 weeks' gestation
* American society of Aneshesiologists（ASA） I-III
* Aged 18 to 45 years old
* The fasting time is 6-8h, and the water restriction time is ≥2h
* Anesthesia: combined spinal-epidural anesthesia
* Agree to the study and sign the informed consent

Exclusion Criteria:

* Fetal or placental abnormalities are known
* Maternal has complications
* Maternal BMI ≥40 kg/m2
* History of difficult intubation or known difficult airway
* Contraindications for HFNO such as nasal lesions or structural changes
* Gastric reflux disease
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers.


Eligibility Criteria:
Inclusion Criteria:

* Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology \[ACR\] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
* If female, a digital XRM is required if any of the following criteria is met:

  1. patient is younger than 50 years;
  2. patient has heterogeneously or extremely dense breasts;
  3. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
* If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
* Has an estimated glomerular filtration rate (eGFR) value \>/= 60 mL/min/1.73m\^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.

Exclusion Criteria:

* Is a female patient who is pregnant or lactating
* Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
* Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
* Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\< 48 hours)).
* Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate \< 60 mL/min/1.73m\^2).
* Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
* Has received hormone replacement therapy within 4 weeks prior to study drug administration.
* Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
* Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM