cyrilzakka/clinical-trials huggingface dataset:
Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines

Vaccination is the best way to mitigate the coronavirus disease 2019 (COVID-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. There is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. Thus, the investigators investigated the relationship between gut microbiota and humoral immune response after COVID-19 vaccination.


Eligibility Criteria:
Inclusion Criteria:

* People assigned to get either BNT162b2 or ChAdOx1 vaccines
* informed concents

Exclusion Criteria:

* Participants were excluded if they had a history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs.
System Accuracy of 12 Bloog Glucose Monitoring Systems

The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, with clinical indication for blood glucose measurement
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
Psycho-social Aspects After a Physiotherapy Intervention in Chronic TMD Pain

How patients psycho-social factors change after a physical intervention in patients with chronic TMD pain


Eligibility Criteria:
Inclusion Criteria:

* Chronic myofascial TMD pain

Exclusion Criteria:

* Neurologic pain
Radiological Analysis on Patients With Achondroplasia Disorder

Achondroplasia is a genetic disorder characterized by disproportionate short stature. It affects about 1 in 2500 live births in the world. The cause of Achondroplasia was identified to be a gain-of-function mutations in the fibroblast growth receptor 3 (FGFR3). In these children compression of the spinal cord at the foramen magnum stenosis can occur in early childhood which, can lead to central sleep apnea. It can lead to morbidity and mortality. A surgical intervention may be indicated in patients who present a foramen magnum stenosis. However, surgical indications are still under discussion. The objective of this retrospective study is to analyse the degree of stenosis and its clinical tolerance/evolution from radiological data monitored at the Hospital Femme Mère Enfant.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls.
* Aged from 0 to 18 years old.
* Subjects with an Achondroplasia diagnosis.
* Patients or parents/ legal guardian must provide non opposition prior to participation in the study.

Exclusion Criteria:

- Patients or patient's parents or legal guardian whose have an objection for using their data.
Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening

The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

Problem statement:

In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.

Research question/hypothesis:

Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?

Study design:

Parallel group, single blinded randomised controlled trial

Study participants:

Patients attending for colonoscopy under the bowel cancer screening programme

Planned sample size: 534

Planned study period: 12 months

Primary objective:

To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for colonoscopy under the national bowel cancer screening programme
* Able to provide written informed consent

Exclusion Criteria:

* History of Inflammatory bowel disease
* History of Hereditary non polyposis colorectal cancer
Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume

After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation.

The purpose of this study was objectively and subjectively to compare the effect of Subspinal Le Fort I Osteotomy and Conventional Le Fort I Osteotomy on nasal airway volume and septum deviation without additional modification such as Ans Reduction, Alar Cinch Suture, V-Y closure.

Surgical procedure; Patients were underwent general anesthesia for bimaxillary orthognathic surgery.

The mucoperiosteal flap was raised to expose the bilateral infraorbital foramina, aperture pyriformis, zygomaticomaxillary, and pterygomaxillary buttress. No dissection was performed between the nasal mucosa and the ANS of the patients in Subspinal Le Fort osteotomy group.A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery. In Conventional osteotomy group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation. In both groups, osteotomes and pterygoid plaques, nasal septum, and lateral nasal walls were separated.

Follow up:

septum deviation and nasal. airway volume value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-40, ASA I, without systemic disease, without any drug allergy, and without a history of NSAID use in the week before the operation.

Exclusion Criteria:

* ASA II or higher, hepatic or renal dysfunction, neuropathic disease, long-term use of NSAIDs or opioid-derived drugs, a history of allergic reaction to drugs, pain, swelling, inflammation in the head and neck region before the operation, pregnant and breastfeeding with a history of cleft lip and palate and rhinoplasty surgery
Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is:

Do patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery?

To address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.

This is a longitudinal observational study that seeks to evaluate for the prevalence and extent of cognitive dysfunction in adults with persistent and chronic ITP. Following enrollment, subjects will complete neurocognitive testing using the NIH Toolbox Cognition Battery (NIHTB-CB). In addition, subjects will complete surveys for patient-reported outcomes of quality of life, fatigue, self-reported cognitive function, and depression. Background characteristics and relevant clinical history will be obtained through an enrollment survey and chart review. The primary aim of the study is to describe the prevalence and extent of cognitive impairment in ITP and explore associated risk factors. This study will also assess the feasibility of longitudinal cognitive testing in patients with ITP and describe any observed changes in cognition over time.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years
* A clinical diagnosis of persistent or chronic ITP, as defined by a history of platelet counts \<50 x 109/L on two occasions in the preceding 3 to 12 months or \>12 months, respectively, and documented response to at least 1 prior ITP-directed therapy. ITP-directed therapies include corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. Other qualifying agents used for the treatment of ITP are permissible with approval of the principal investigator.
* Ability to follow instructions in English.

Exclusion Criteria:

* Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease.
* Active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse.
* Active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer.
* Brain tumor or cranial surgery within the past year.
* Significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.
Elucidate Outcomes of Elective High-grade/Total Occlusion Intracranial Arteries Using Low-profile Self-expanding Stent

Intracranial atherosclerotic disease (ICAD) is a high prevalent cause of stroke, especially in Asian population and can be categorized as either symptomatic (resulting in acute ischemic stroke) or asymptomatic. Treatment for patients who failed with optimal medical therapy (OMT) is still elucidating.

In symptomatic ischemic stroke due to intracranial large severe stenosis or occlusive artery, the choice for treatment has remained controversial after results of the Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial because it demonstrated that the efficacy of medical treatment was superior to intracranial stenting (IS) in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of IS in the secondary prevention of ischemic stroke and recovery time for a long time because of the improper patient selection of this trial such as no evidence of medical failure, IS in case of moderate intracranial stenosis and IS in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about IS, the Wingspan Stent System Post Market Surveillance (WEAVE) trial, reported not only 97.4% patients with no complication at 72 hours, but also a relatively low 8.5% recurrent stroke and death rate during 1 year in the Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) study about Wingspan stent (Stryker, Kalamazoo, MI). In case of the symptomatic stenosis greater than 70%, the probability of recurrent stroke and transient ischemic attack in the territory of the symptomatic stenotic artery in 1 year was 23% and 14%, respectively, despite treatment with antithrombotic therapy and standard management of vascular risk. Given a lot of patients with symptomatic ischemic stroke who have some adjustable indications for intracranial stenting deployment with Wingspan stent in the world and a paucity of evidence from the comprehensive stroke centers about other self-expanding stents, Credo stent (Acandis GmbH, Pforzheim, Germany), our purpose was to compare the periprocedural complication and rate of 1-year recurrent ischemic stroke associating to the IS between beyond 7 days from acute stage and the progressive ischemic stroke time.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of severe intracranial stenosis
* Target intracranial artery ≥ 2 mm
* Absence of intracranial hemorrhage
* Procedure treated with the Credo stent (Acandis, Pforzheim, Germany)

Exclusion Criteria:

* Premorbid modified Rankin Scale (mRS) score ≥ 2
* Intracranial rescue stenting for acute ischemic stroke within 24 hours
* Loss to follow-up after discharge
* Systemic lupus erythematosus
* More procedures at the same time
Non-invasive Monitor in Endoscopic Invasive Procedure

Investigators include the patients who need painless invasive endoscopic procedure, investigators collect the demographic data and apply the non-invasive device ICON on participants during the who procedure.

Invasive endoscopy procedure including Endoscopic Retrograde Cholangio-Pancreatography (ERCP), endoscopic ultrasound guided fine needle aspiration (EUS-FNA), Endoscopic Retrograde Biliary Drainage (ERBD) and others is more and more popular which become the standard treatment before surgical intervention. However; the elder group who need this procedure is getting more common. The painless endoscopic sedation for elder group who has more comorbidity is not easy. During the procedure, the investigators found that the anticholinergic medication-buscopam which in order to suppress intestine mobilization can cause obvious tachycardia. Tachycardia makes the stroke volume decrease which enhance the perioperative hypotension, and the vasodilation effect of the analgesics make it worse.

Investigators are trying to find the non-invasive predictor of perioperative hypotension in geriatric group. Investigators collected the patients who need painless endoscopic invasive procedure, investigators will record their hemodynamic data including estimated cardiac output (CCO)，index of contractility (ICON)，NBP，HR，and saturation. Investigators also add the evaluation of frailty to evaluate the relationship between frailty and perioperative complications.

Eligibility Criteria:
Inclusion Criteria:

* patient who need painless endoscopic invasive procedures
* age above 50 y/o

Exclusion Criteria:

-
fMRI in Blood Phobia Syncope

We plan to study patient who faint in response to the sight of blood and compare them to healthy subjects who do not. We are going to use a special type of MRI scan (functional MRI) to determine if there are differences in brain activation in response to seeing bloody or gory pictures that occur before the fainting occurs.

Another aim of the study is to determine whether or not differences in personality traits among people with blood phobia is associated with differences in BOLD signal responses during fMRI.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* 1. History of at least one syncopal episode upon exposure to viewing blood (Case Group)
* Negative urine pregnancy test on study day

Exclusion Criteria:

* Vasoactive medications (within 2 weeks of study day)
* antihypertensives
* beta blockers
* vasoconstrictors
* Psychotropic medications (within 4 weeks of study day)
* History of psychostimulant or opiate use
* History of alcohol, benzodiazepine or cannabis abuse or dependence
Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia

The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

The REPAIR trial is a multicenter randomized controlled trial of 618 postpartum patients with hypertensive disorders of pregnancy randomized to intensive blood pressure control versus usual care during the first 6 weeks postpartum. The intervention group will receive intensive blood pressure (BP) control with nifedipine extended-release initiation when BP is ≥ 140/90 mmHg. The active control group will receive usual care with nifedipine ER initiation when BP is ≥ 150/100. The study will take place at two clinical sites: Medical College of Wisconsin (MCW) and Northwestern University (NU). All participants will undergo BP monitoring, cardiovascular function assessment, and collection of cardiovascular biomarkers at baseline, 6 weeks, and 12 months postpartum. Specifically, cardiac function and structure will be assessed with transthoracic echocardiogram, endothelial dysfunction with brachial artery flow-mediated dilation, and arterial stiffness with carotid-femoral pulse wave velocity. The primary outcome is the incident diagnosis of stage I hypertension at one year postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension or preeclampsia, according to ACOG guidelines
* Postpartum day 0-4
* Able to communicate in English or in Spanish
* Has an established OBGYN at an MCW or NU health system practice that has access to Epic electronic medical records.

Exclusion Criteria:

* Pre-gestational hypertension
* Type 1 or type 2 diabetes mellitus
* Admitted to intensive care unit at the time of screening
* Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization
* Getting discharged on the day of screening
* Known allergy or contraindication to nifedipine ER
* Inability or unwillingness to provide informed consent
Position Changes During Colonoscope Insertion Increases Patient Comfort

The investigators wish to study the effects of position changes during colonoscope insertion on patient comfort. The investigators hypothesize that early position changes would reduce colonoscope loop formation and patient discomfort.


Eligibility Criteria:
Inclusion Criteria:

* age 19 years or older
* outpatient colonoscopy

Exclusion Criteria:

* inpatient
* unable to provide informed consent
* previous bowel resection, inflammatory bowel disease
* musculoskeletal disorder or other mobility issues limiting effective patient position changes.
* inadequate bowel preparation
Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)

This is phase III trial to evaluate whether edoxaban, a direct factor Xa inhibitor, is noninferior to warfarin in preventing worsening of chronic thromboembolic pulmonary hypertension (CTEPH).


Eligibility Criteria:
Inclusion Criteria:

1. Patient who once\* diagnosed with CTEPH based on at least 2 imaging study (VQ scan, CT pulmonary angiogram, or catheter-based pulmonary angiogram) and hemodynamic criteria (MPAP \>=25 mmHg and PAWP =\< 15 mmHg). \*Patients treated with PEA, BPA, or vasodilators, who do not meet hemodynamic criteria at the registration, are eligible.
2. Patients who are not planned to require increased / changed / discontinuation of PEA, BPA, or pulmonary vasodilators within 12months
3. Stable administration of vitamin K antagonists
4. WHO functional class I-III
5. Patients who meet A) B)and C) by 90 days prior to baseline. A)No addition, reduction, or change of endothelin antagonists, soluble guanylate cyclase stimulants, phosphodiesterase-5 inhibitors, prostacyclin, and its derivatives, or calcium antagonists. B)Appropriate anticoagulants have been continued. C)No BPA has been done.
6. Patients who have not undergone PEA from 180 days prior to baseline right heart catheterization to the start date of study drug administration
7. Patients with a 6-minute walking distance \>=150m

Exclusion Criteria:

1. Patients with severe lung disease (FEV1.0/FVC \< 60% or %TLC \< 60%)
2. Patients with acute or chronic disabilities that interfere with clinical trial requirements
3. Patients with acute symptomatic PE within 180 days prior to the start of study drug administration
4. Patients with congenital heart disease who have not undergone radical surgery
5. Patients who cannot provide informed consent due to mental disorders, dementia, or other illnesses
6. Patients with advanced cancer
7. Patients with a life expectancy of less than 1 year
8. Patients with active hemorrhagic lesions
9. Patients with comorbidities requiring vitamin K antagonist
10. Patients receiving other study drug within 30 days prior to randomization
11. Patients with renal dysfunction (Ccr 15 mL/min)
12. Patients with liver dysfunction (Child-Pugh B or C)
13. Females of reproductive age not using an acceptable form of contraception/Pregnant/Breastfeeding
14. Patients contraindicated for edoxaban or warfarin
15. Patients with hypersensitivity to any of the drug
Prediction of Expected Length of Hospital Stay Using Machine Learning

This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict length of stay throughout a patient's admission. This algorithm was then validated in a validation cohort.


Eligibility Criteria:
Was a subject in the Brigham and Women's Home Hospital study and has a completed record in the study's database.