cyrilzakka/clinical-trials huggingface dataset:
#iBeatCRC: A Community-based Intervention to Increase Early-onset Colorectal Cancer Awareness

Dr. Rogers' long-term goal is to better understand the etiology of an early-onset colorectal (CRC) diagnosis and to improve long-term survivorship and quality of life for early-onset CRC (EOCRC) survivors globally by studying the burdens accompanying this condition. The goal of this study is to better understand the reasons why people under age 50 in Utah and Wisconsin are being diagnosed with CRC. As a first step, the researchers identified the specific places in Utah and Wisconsin where diagnoses of CRC among younger people are increasing the most. Next, they conducted 1-hour recorded Zoom interviews over phone and/or video with 27 people across the United States diagnosed with CRC when they were under age 50. Thirdly, the researchers plan to create and test a program that will raise the awareness of residents in Utah and Wisconsin of the increasing risk of CRC among residents of the state who are aged under 50. This study is unique as CRC survivors are key to helping drive the study forward.

Colorectal cancer (CRC) is preventable when detected early. Because of effective screening, fewer Americans aged 50 and older are now being diagnosed with CRC or dying from it. Over the past 20 years, however, the number of Americans under age 50 who are diagnosed with CRC has doubled. Health experts estimate that the numbers of younger Americans with CRC will continue to increase rapidly over the next 10 years. The reasons for this increase are poorly understood. In addition, younger people are less likely to be diagnosed with CRC when the disease is still at an early stage. Also, of concern is that among men and women of all ages and all races, African-American men are the most likely to die of CRC.

Central hypotheses were: (1) Patients residing in hotspots-counties with high EOCRC incidence/mortality rates-will have significantly worse EOCRC survival juxtaposed to those in other Utah areas, specifically. (2) Rurality and county-level access to health care will contribute to an explanation of EOCRC incidence and survival.

Eligibility Criteria:
Inclusion Criteria:

Aim 1: No recruitment took place (secondary data analysis). These records were used to determine early-onset colorectal cancer hotspots in Utah.

Aim 2: 30 one-hour interviews were conducted with EOCRC patients and survivors who (1) resided in the United States, (2) were diagnosed with CRC at 18-49 years of age, (3) had a telephone, and (4) spoke English.

Aim 3: Individuals must: (1) reside in Utah or Wisconsin, (2) were diagnosed with CRC at 18-49 years of age, (3) have a telephone, and (4) speak English.

Exclusion Criteria:

Aim 1: No recruitment took place (secondary data analysis).

Aim 2: Individuals were excluded if they (1) did not reside in the United States, (2) were not diagnosed with CRC between 18-49 years of age, (3) did not have a telephone, and (4) did not speak English.

Aim 3: Individuals will be excluded if they (1) do not reside in the Utah or Wisconsin, (2) were not diagnosed with CRC between 18-49 years of age, (3) do not have a telephone, and (4) do not speak English.
Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.

Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7 months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and secondarily for the development of asthma.

Two other markers of airway aggression seem to increase during acute bronchiolitis: serum SP-D protein and serum soluble receptor sRAGE.

Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit. Secondary end-points: correlation with urinary CC16; correlation with risk factors for bronchial epithelial aggression, viruses, immediate morbidity and mortality. Study of serum SP-D and sRAGE levels.

Eligibility Criteria:
Inclusion Criteria:

* Infants under 1 year old hospitalized for acute bronchiolitis

Exclusion Criteria:

* Broncho dysplasia
* Preterm under 34 weeks
* Cystic fibrosis
* Immune deficiency
* Suspicion of primary ciliary dyskinesia
* Congenital heart disease
* Acute renal failure
THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: a Clinical Study

This study aims to explore the clinical effect of THRIVE in improving early postoperative atelectasis in patients undergoing long-term non-intubated anesthesia gastrointestinal endoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Multiple polyps resection, ESD(Endoscopic Submucosal Dissection) , EMR(Endoscopic Mucosal Resection), enteroscopy and other gastrointestinal endoscopic diagnosis and treatment were performed
2. The duration of anesthesia is more than 30 minutes, that is, from induction to withdrawal of anesthesia
3. ASA(American Society of Anesthesiologists) ≤ II 4.18kg/m2\<BMI\<30 kg/m2

5.Informed consent, voluntary participation in the experiment, and signed by the subject informed consent

Exclusion Criteria:

1. ASA classification ≥ III;
2. History of previous lung or nasal surgery;
3. History of chronic obstructive pulmonary disease (COPD) or restrictive lung disease;
4. History of obstructive sleep apnea syndrome;
5. History of upper airway obstruction;
6. History of head and neck radiation therapy;
7. Significant nasal septum deviation;
8. Active infection (defined as a white blood cell count \>10\*10\^9 or a body temperature \>38°C);
9. Gastrointestinal perforation;
10. Combined use of other anesthetic methods or inhalation anesthetics outside of non-intubated intravenous anesthesia;
11. Concurrent other medical procedures besides the prescribed gastrointestinal endoscopic procedures, such as ERCP(Endoscopic Retrograde Cholangiopancreatography);
12. Severe communication disorders due to conditions like severe hearing impairment or dementia;
13. Disagreement with participation in the study.
Intraaortic Balloon Pump in Cardiogenic Shock II

Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.

The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.


Eligibility Criteria:
Inclusion Criteria:

Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with

* intended revascularization (PCI or CABG)
* Systolic blood pressure \< 90 mmHg \> 30 min or inotropes required to maintain pressure \> 90 mmHg during systole
* Signs of pulmonary congestion
* Signs of impaired organ perfusion with at least one of the following:

  * Altered mental status
  * Cold, clammy skin
  * Urine output \<30 ml/h
  * Serum lactate \>2mmol/l
* Informed consent

Exclusion criteria:

* Resuscitation \> 30 minutes
* Cerebral deficit with fixed dilated pupils
* No intrinsic heart action
* Mechanical infarction complication
* Onset of shock \> 12 h
* Severe peripheral artery disease
* Aortic regurgitation \> II.°
* Age \> 90 years
* shock of other cause
* Other severe concomitant disease
* participation in another trial
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.
* Failed at least 2 lines of prior systemic therapy
* Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.
* At least one measurable tumor lesion by RECIST v1.1
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
* Life expectancy ≥3 months.
* Willing to participate in this study and sign informed consent form, able to read and understand the study, follow the procedures.

Exclusion Criteria:

* History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the study.
* Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
* Any known hypersensitivity to infigratinib or its excipients.
* History and/or current evidence of extensive tissue calcification.
* Current evidence of endocrine alterations of calcium/phosphate homeostasis.
* Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).14. Laboratory abnormality as defined in protocol.
* Considered unsuitable to participate in the study by Investigator
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population at particular risk is the growing number of patients who undergo autologous breast reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population of patients undergoing plastic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) women
* Scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous \[TRAM\] and/or deep inferior epigastric artery perforator \[DIEP\]) flap)
* Caprini score of 6 or greater.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Contraindication to the use of apixaban or enoxaparin
* Active bleeding
* History of bleeding disorder
* History of coagulopathy
* History of heparin-induced thrombocytopenia
* History of liver disease
* History of renal disease (creatinine clearance \<30 mL/min; serum creatinine \>1.6 mg/dL)
* Major neurosurgical intervention (brain/spine) within the past 90 days
* Ophthalmologic procedure within the past 90 days
* Uncontrolled hypertension
* History of alcohol and/or substance abuse
* Need for therapeutic anticoagulation
* Pregnant or Nursing
Food Additives - Do Processed Diets Impact on Gut and Metabolic Health

This dietary intervention study will assess the effect in healthy human volunteers of an E number which is a food additive and commonly used and consumed emulsifier, on gut function, gut inflammation and glucose metabolism. We will be using a powdered soy lecithin product in the food to compare a diet with and without this ingredient.

A dietary intervention study to investigate the effect, in healthy human volunteers, of dietary lecithin (soy lecithin), a commonly used/consumed emulsifier, on markers of gut function particularly bacterial translocation (assessed by measure of venous blood bacterial DNA, circulating lipopolysaccharide \[LPS\] binding protein and soluble CD14), gut inflammation (assessed by measurement of faecal calprotectin), gut microbiota activity/composition (faecal short-chain fatty acid \[SCFA\] profile and bacterial diversity \[16S ribosomal RNA genes\]) and glucose metabolism (measured by oral glucose tolerance test \[OGGT\], plasma fasted lipids and insulin).

Eligibility Criteria:
Inclusion Criteria:

• BMI ranging from 27-40 kg/m2

Exclusion Criteria:

* Antibiotic use within the past 3 months (due to impact on gut microbiota)
* Current Statin use
* Current Aspirin use
* Chronic inflammatory disorders (including rheumatoid arthritis, inflammatory bowel disease)
* Food allergies or self-reported food sensitivity or intolerance
* Diagnosis of diabetes
* Pregnant or breastfeeding
* Unsuitable veins for blood sampling
* Inability to speak, read and understand English
* Unable to comply to alcohol-free diet for 5 weeks
* Consumption of nutrition supplements
* Soy allergy or intolerance.
Evaluation of 3D-printed Space Maintainers Versus Conventional Space Maintainer : a Randomized Clinical Trial

This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.


Eligibility Criteria:
Inclusion Criteria:

* Lower first permanent molar in active state of eruption
* Patient and parent showing cooperation and compliance.
* Medically free children.
* According to space analysis available space is less than or equal to needed space
* Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss)
* Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines.

Exclusion Criteria:

* Children with previous allergies to stainless steel.
* There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
* The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)
STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI

The investigators propose to carry out an observational study of patients implanted with a pacemaker using AAI SafeR® mode after a TAVI procedure. This study aims to define the persistence or not of high-grade AVB beyond seven days after the procedure, based on the analysis of PM memories, and define definitive cardiac pacing indications after TAVI procedure.

Atrioventricular (A-V) conduction disorders are common after Transcatheter Aortic Valve Implantation (TAVI) and the average of a pacemaker implantation after TAVI is 15% to 17%.

The European Society of Cardiology recommends to implant a permanent pacemaker (PM) in case of persistant high-grade A-V block (AVB) within 7 days of a TAVI procedure (class I recommendation, level of evidence C).

Some conduction disturbances are transient and might not need a definitive indication for pacemaker implantation. A recent study, based on dependency of patients to pacing, estimate that in half the patients, conduction disturbances that led to the implantation of a pacemaker after TAVI procedure would have disappear 30 days after the procedure.

Many studies tried to better define the indications of these devices. However, their evaluation criteria do not allow to prove these pacemakers were useful, because these studies are mainly based on the rate of implantation of pacemakers, or on the percentage of ventricular pacing. These studies may overestimate the usefulness of the pacemaker because of unnecessary ventricular pacing, or underestimate it in patients with high grade paroxysmal AVB, that could have been responsible for syncope or death.

Today some pacemakers allow a better occurrence of spontaneous A-V conduction and monitor precisely the atrioventricular conduction.

The AAI SafeR® mode from Sorin® allows the pacemaker to switch from a single to a dual chamber mode in case of AVB; these switches are stored in the memories of PM as endocardial electrogram (EGM) which can be validated afterwards. The use of this algorithm could allow an accurate assessment of the persistence of high level conduction disturbances in patients implanted with a pacemaker after a TAVI procedure. A study published in late 2014 using this tool in monitoring post TAVI conduction disorders on a small number of patients, other studies used the same tool in other cardiac pathologies.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.

Exclusion Criteria:

* Patients with life expectancy at hospital discharge estimated as less than 1 year
* TAVI procedure failure
* Patients refusing to be involved in the study
* Patients implanted with a PM of a brand different than Sorin® during the hospital phase or implanted Sorin® PM but not set in a AAI or AAI SafeR SafeR-R mode
* Patients with PM implant before TAVI
* Permanent AF at the implantation time
* Patients with Single or Triple chamber PM
Effect of Global Postural Reeducation (GPR) Program With Hamstring Stretch for Patients With Low Back Pain

The purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.

Low back pain (LBP) is a very common health problem worldwide and a major cause of disability which affecting performance at work and general well-being. LBP is a complicated condition which affects the physiological and psychosocial aspects of the patient. The muscles of the low back provide the strength and mobility for all activities of daily living. The purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Females
* 18-35 years
* Low back pain \> 3 month
* no exercise for last 6 months

Exclusion Criteria:

* Any diagnosed pathology (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis)
* Any lower limb abnormality
* Congenital deformities
* Central or peripheral neurologic signs
* Systemic illness (tumor and rheumatologic diseases),
* Psychiatric and mental deficits
* Diabetic neuropathy
Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients

The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.


Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years
* Use of nitrous oxide/oxygen analgesia/anxiolysis
* Any type of dental care

Exclusion Criteria:

* Use of midazolam
* Use of general anesthesia
Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI

The goal of this observational study is to develop AI that detects and classifies Acid-Fast Bacilli from microscope images using anonymized and fixed glass slides.


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom acid-fast bacilli(AFB) smear test was ordered

Exclusion Criteria:

* No exclusion criteria
miRNA Profile in Aneurysmal Subarachnoid Haemorrhage

The investigators aim to investigate and understand the circulating miRNA profiles after acute aneurysmal subarachnoid haemorrhage and underlying pathological significance.

1. The investigators aim to investigate the miRNA classifier for delayed cerebral infarction after aneurysmal subarachnoid haemorrhage;
2. The investigators aim to investigate the corresponding circulating and CSF miRNA profiles.

Eligibility Criteria:
Inclusion Criteria:

Aneurysmal subarachnoid hemorrhage patients within the first 72 hours or Healthy volunteers

Exclusion Criteria:

Previous neurological diseases such as stroke or dementia
Nexplanon Observational Risk Assessment Study (NORA)

This study characterises the frequency of specific insertion-, localization- and removal-related events and clinically significant consequences thereof among Nexplanon users in the US during routine clinical use.

Nexplanon is a subdermal contraceptive implant containing the progestogen etonogestrel. It provides contraceptive protection for three years. In addition to the progestogen, Nexplanon contains barium sulfate and a Next Generation Implanon Applicator (NGIA). Nexplanon was developed to further facilitate correct insertion of the implant by using the NGIA, and to extend the diagnostic modalities for localization of the implant by making it radiopaque and visible via X-ray imaging and X-ray Computerized Tomography (CT).

A large, descriptive, prospective, non-interventional, observational cohort study is planned to follow a cohort of new users of the contraceptive implant Nexplanon. Women will be recruited through health care professionals who have completed the Nexplanon Clinical Training Program. Baseline and follow-up information will be collected via a self-administered questionnaire. Data analysis will include characterizing the frequency of specific insertion-, localization- and removal-related events via point-estimates of the event rate as well as 95% confidence intervals. The impact of potential prognostic factors will be analyzed using multivariate regression models and/or stratified analyses.

Eligibility Criteria:
Inclusion Criteria:

* Women prescribed a new Nexplanon implant
* Women who are capable of understanding the major aspects of the study and can complete the self-administered questionnaire in English

Exclusion Criteria:

* Women who are not willing to sign the informed consent form