cyrilzakka/clinical-trials huggingface dataset:
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I

The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. This study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently, the decision to continue with surgery in patients with a diagnosed concussion is based on clinical judgment by the patients.

Phase I's specific aim is to estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.

The first phase of this study requires a member of the research team to administer a paper questionnaire to all eligible, consented orthopedic surgery patients in either the Pre-operative Clinic or in the Day Surgery Unit over a period of four months. The research member will only approach adolescents that are scheduled for repair of orthopedic traumatic injury as defined in the inclusion criteria. The questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair. If the participant scores higher than a 0 on the SCAT3 the results will be conveyed to the surgeon prior to the start of the scheduled surgical procedure. A copy of the completed SCAT3 will also be placed in the medical record. The decision to continue with surgery and need to possibly refer the patient to the Boston Children's Hospital Sports Concussion Clinic after the SCAT3 will remain at the surgeon's discretion.

Information will be gathered from the questionnaire and the SCAT3, then entered into the REDcap database under a de-identified subject number.

Eligibility Criteria:
Inclusion Criteria:

All patients aged 5-21 years of age presenting for repair of orthopedic traumatic injury. Orthopedic traumatic injury will be defined as any traumatic injury resulting from a fall, collision (struck by or struck against), vehicle accident, assault or bike-related injury or fracture.

Exclusion Criteria:

Patients who do not speak English as their first language, or who are unable to respond to the survey's questions on their own will be excluded from study participation.
Study Of Sunitinib With Capecitabine In Breast Cancer

To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
* Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
* Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.

Exclusion Criteria:

* Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
* Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
* Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
Medical Cannabis During Chemoradiation for Head and Neck Cancer

The primary purpose of the study is to observe the adherence and health seeking behavior of patients with Head and Neck cancer (HNC) certified to obtain medically certified cannabis as part of their supportive care regimen undergoing treatment with definitive or adjuvant concurrent chemoradiation (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed squamous cell carcinoma of the head and neck region planned for definitive or adjuvant treatment with concurrent radiation therapy and systemic therapy
* Patients may receive platinum-based chemotherapy or cetuximab concurrently with radiation therapy
* Age \>18 years and ECOG performance status \<2 (Karnofsky \>60).
* Patients must be willing to use medically certified cannabis as directed after study enrollment
* Patients must be able to read English, Spanish, or French fluently
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior diagnosis of cannabis use disorder as defined in the DSM-V
* Current opioid use disorder on maintenance opioid therapy
* Current active use of smoked cannabis or cannabis derivatives AND unwillingness to cease use of non-medically certified cannabis for the duration of study participation.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cannabis derivatives
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Fructose Effect on Neuroinflammation and Feelings

Fructose is increasingly present in our food. The increase in its consumption is associated with the increase in the prevalence of several pathologies such as metabolic syndrome or hepatic steatosis. The effect of fructose consumption on brain health has been poorly studied. Studies in animal models show that diets enriched in fructose promote the development of emotional behavior disorders. Fructose malabsorption is also associated with changes in the microbiota that could also impact brain health. However, no human study to date has associated fructose malabsorption with changes in the gut microbiota and effects on brain health.

The objective of this study is to study the emotional behavior of a population of healthy volunteers according to the presence or not of fructose malabsorption. Patients with fructose malabsorption are susceptible to gut dysbiosis without necessarily consuming high amounts of fructose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18 to 35
* Male sex
* BMI between 18.5 and 25
* Affiliation to a social security scheme
* Adult patient having read and understood the information letter and signed the consent form

Exclusion Criteria:

* Presence of irritable bowel syndrome, celiac disease
* Presence of a psychiatric illness
* Presence of a neurodegenerative disease
* Presence of an eating disorder
* Presence of chronic disease, including inflammatory disease
* Presence of diabetes
* Presence of an acute infectious disease
* Presence of a surgical history of the digestive tract (excluding appendectomy)
* Taking long-term treatment
* Taking antibiotics within 6 months
* Taking probiotics within 3 months
* Typical diet low in lactose, FODMAP, gluten, vegetarian, vegan, vegan, chromonutrition .... in progress
* Smoker
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship
* Simultaneous participation in another interventional clinical trial
Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers

PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers for brain imaging:

* males or females, age 20 - 55 years
* assessment of the brain MRI as "normal (age-appropriate)"
* absence of any sign of CNS disease, no co-medi cation Patients for brain imaging
* males or females, age 20 - 55 years
* patients with previously diagnosed MS, presenting with acute relapse, without any current immunomodulating therapy for MS ("drug-naïve"), or patients presenting with first clinical episode suggestive of demyelinating disease (Clinically Isolated Syndrome, CIS)
* patients with previously diagnosed MS, presenting with acute relapse, receiving currently immunomodulatory therapy exclusively with interferon β
* MRI: \>/= 2 T2 lesions and \>/= 1 Gadolinium- (Gd-) enhancing lesion

Exclusion Criteria:

Exclusion criteria for all healthy volunteers and patients:

* Pregnancy or lactation
* Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
* other forms of diseases with neuroinflammatory components
The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder

"Social brain" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. The social brain is hypothesized to consist of a distributed network including the posterior superior temporal sulcus (pSTS), the dorsal and ventral medial prefrontal cortices (dmPFC and vmPFC), ACC and posterior cingulate cortex (PCC), the amygdala, the orbital frontal cortex (OFC), and the fusiform gyrus (FG), TPJ, inferior occipital gyrus (IOG), and the insula. Each region serves distinct role while works together to support social processing, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50
* diagnosed with ASD from licensed mental health or medical professional based on DSM5
* have social problems
* motivated to participate in the treatment
* fluent in chinese
* caregiver also fluent in chinese and motivated to participate
* had a full-scale IQ \> 70 on WAIS-IV
* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.

Exclusion Criteria:

* history of major mental illness, such as bipolar affective disorder, schizophrenia, psychosis, or neurological diseases
* visual impairment and/or hearing impairment
* any metal, electronic part that cannot be removed from the body, or being pregnant, which may not be able to use fMRI scan.
Fibrinogen Early In Severe Trauma studY Junior

1. Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in paediatric trauma patients
2. Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
3. Hypo/dysfibrinogenaemia plays an important role in TIC
4. Early replacement of fibrinogen may improve outcomes
5. Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
6. The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
7. Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
8. It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
9. Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
10. Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay

12. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in paediatric trauma patients before widespread adoption makes performing such studies unfeasible


Eligibility Criteria:
Inclusion Criteria:

1. Child affected by trauma (3 months to 18 years)
2. Judged to have significant haemorrhage OR predicted to require significant transfusion by the treating clinician
3. Activation of Local MHP or transfusion of emergency red blood cells (Pre-hospital or at Trauma Centre)

Exclusion Criteria:

1. Injury judged incompatible with survival
2. Randomisation unable to occur within 6 hours of hospital admission
3. Pregnancy
4. Known personal or parental objection to blood products
5. Known coagulation disorder (i.e. haemophilia, von Willebrand disease)
6. Previous dedicated fibrinogen replacement this admission
7. Pre-Trauma Centre dedicated fibrinogen replacement
8. Participation in competing study
Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe.

Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous origin is of utmost importance. Due to it's markedly favourable safety profile, a bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success rate), is sub-optimal.

There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be advanced more peripherally to obtain a biopsy.

Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield.

In this study, investigators compare these two types of probes in the ability to diagnose a PPL.

The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too small to accommodate an aspiration needle)


Eligibility Criteria:
Inclusion Criteria:

* Patient referred for R-EBUS as per routine management.
* Patient judged to be medically stable to give consent for this study.

Exclusion Criteria:-Unsuitable for flexible bronchoscopy and biopsy

* INR\>1.5
* Platelets\<150.
* Hb\> 80g/l
* Liver function tests (AST/ALT) \<2 times upper limit of normal
* Neutrophil count \>1.0
* EGFR \>30ml/kg/min
* On anticoagulation, that cannot be withheld for the procedure, due to medical reasons (e.g. On-clopidogrel with recent drug-eluting stent placement.)
Community Outreach for Palliative Engagement -- Parkinson Disease

The purpose of this study is to learn more about the effectiveness of palliative care training for community physicians and telemedicine support services for patients and carepartners with Parkinson's disease and Lewy Body Dementia (LBD) or related conditions and their care partners. Palliative care is a treatment approach focused on improving quality of life by relieving suffering in the areas of physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Telemedicine is the use of technology that allows participants to interact with a health care provider without being physically near the provider.

Investigators propose to conduct a pragmatic stepped-wedge comparative effectiveness trial comparing a novel model of providing community-based palliative care for persons living with Parkinson's disease (PD), Lewy Body Dementia (LBD) and related disorders through online communities to usual care. Our intervention includes support for both community neurologists (using the ECHO model of clinician support) as well as family caregivers and patients. Investigators hypothesize that this model of care will improve patient quality of life and caregiver burden as well as other important secondary outcomes such as patient symptom burden and clinician burnout. This study will recruit neurology providers (MD and APPs) from 24 community neurology practices. These practices will identify participants for the study who have PD, LBD or a related condition and moderate to high palliative care needs. Under usual care, community providers will deliver their usual care and center coordinators will collect data on our outcomes every 3 months. After one year of baseline data collection, 6 practices will be randomized to the intervention, which will include clinician training and coaching as well as access to online services for their patients. Per the stepped-wedge design an additional six practices will be randomized 18 months into the data collection period, six at 24 months, and the final six will enter the intervention 30 months into the data collection period to allow for 12 months intervention recruitment for all practices.

Eligibility Criteria:
Inclusion Criteria:

PATIENT INCLUSION CRITERIA:

• Over age 40 years and diagnosed with PD or other causes of parkinsonism, such as progressive supranuclear palsy, multiple system atrophy and Lewy Body Dementia by their community neurologist.

Exclusion Criteria:

PATIENT EXCLUSION CRITERIA:

* Potential patient subjects who are unable or unwilling to commit to study procedures
* Presence of additional medical illnesses which requires palliative services (e.g. metastatic cancer)
* Already receiving palliative care or hospice services.
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma

To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma


Eligibility Criteria:
Inclusion Criteria:

* Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis
* Sarcoma not originated from bone structure, abdominal or gynecological viscera
* All disease can be included safely within one radiotherapy field
* Absence of extension through the sciatic notch or across the diaphragm
* Histologically proven, excluding the following subtypes: Gastro-intestinal stromal tumors (GIST), rhabdomyosarcoma, PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma
* ECOG performance status 0 to 2
* American Society of Anesthesiologist (ASA) score ≤2
* Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan
* Normal bone marrow and hepatic function.
* Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age
* expected life expectancy longer than 5 years
* Written consent form was given prior to treatment
* Can safely be treated by radiotherapy and surgery

Exclusion Criteria:

* metastatic disease
* Tumor was previously treated by radiotherapy
* Involvement of liver, pancreatic head or duodenum
Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI

The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if a brain tumor has recurred or if the person has radiation injury following their treatment.

After a patient has been treated for a brain tumor by radiation the area of the brain that has been treated changes in appearance. These changes in appearance can make it hard to determine if a brain tumor has come back at the same site or if it is radiation injury. The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if the tumor has come back or if it is radiation injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously treated with radiation therapy (including radiosurgery), with or without previous surgery or chemotherapy, with a new contrast enhancing lesion(s) with the size of 1 cm or more on conventional brain MRI examination are eligible
* Patients must have a previously histological confirmed brain tumor
* Patients must be 18 years of age or older
* Patients must sign a study-specific consent form approved by the Institutional Review Board of the University of Michigan indicating prior to study entry

Exclusion Criteria:

* Pregnant woman
* For the purpose of this radiological study and in collecting data from the patient but not from receiving the MR Spectroscopy if it is clinically indicated.
* Patients unable to undergo MRI imaging because of non-compatible devices such as cardiac pacemakers, other implanted electronic devices, or foreign body in the eye
* Also patients with metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and surgical pins/clips in the face or skull region), or patients with braces since these devices may cause metal artifacts which may obscure the images and result in artifacts on the MR spectroscopy.
* Prisoners