cyrilzakka/clinical-trials huggingface dataset:
Otitis Treatment with OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.

Mixed method, multi-center, pragmatic, cluster-randomized effectiveness-implementation investigation focused on pediatric subjects presenting with ear complaints at the office setting.

For the prospective randomized component, eligible clinicians at a given site will be randomized to one of two groups: the OtoSight intervention group or the usual care control group. There will be three (3) periods of post-intervention assessment: 10 days (optional), 6 months, and 12 months.

Eligible subjects will be automatically enrolled (or invited to enroll) in the clinical trial and will receive information. Because this is a non-interference design, frontline care clinicians randomized to either arm will be asked to: (1) assess the presence or absence of fluid in the middle ear; (2) record a diagnosis; and (3) treat the patient as they would according to the information available to them.

A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems. Randomization of clinicians (and not children) will decrease contamination in the usual practice group (i.e., so clinicians are not asked to flip between intervention and usual care practices).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects between 6 months and 17 years of age
* Pediatric subjects presenting for an office visit with ear-related pain (otalgia)/otic complaints/earache indicative of potential Otitis Media with Effusion (OME) or Acute Otitis Media (AOM)
* Pediatric subjects where otoscopy would traditionally be indicated
* Pediatric subjects whose parents or legally authorized representative (LAR) have signed an informed consent

Exclusion Criteria:

* The parent or guardian who attends visits does not speak the same language as their physician
* Pediatric subjects enrolled in another clinical trial
* Pediatric subjects with:
* Signs of severe chronic illness (e.g., immunodeficiency, congenital heart disease, encephalopathy, pulmonary disease other than asthma, and disorder of the ear, nose and throat) or any clinically significant illness or condition that, in the opinion of the investigator, would prohibit the subject from participating in the trial
* Anatomical conditions that would affect their ability to undergo an otoscopy.
Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC

The purpose of this study is to explore the safety and feasibility of laparoscopic spleen-preserving No. 10 lymph node dissection for patients with advanced middle or upper third gastric cancer.

Radical resection is the primary treatment for patients with advanced middle or upper third gastric cancer. And D2 lymphadenectomy, including No. 10 lymph node dissection, should be performed according to the Japanese treatment guidelines for gastric cancer. Because of the complexity of the anatomy around the spleen, spleen-preserving No. 10 lymph node dissection is difficult. Although Professor Huang from Fujian Medical University Union Hospital has proposed the "Huang's three-step maneuver" to dissect No. 10 lymph node with preserved spleen laparoscopically, such method is far from popularized, especially in North China. In addition, the safety, feasibility and oncological efficacy of this method was not confirmed in such area, either.

In this study, a prospective, single center, single-arm, non-inferiority clinical trial will be conducted to evaluate the short and long-term outcome of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced middle or upper third gastric cancer in Beijing.

Eligibility Criteria:
Inclusion Criteria:

* Patients age older than 18 years (including 18 years old);
* The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
* Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma);
* Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
* The Eastern Cooperative Oncology Group performance status of 0 or 1;
* The American Society of Anesthesiology classes of I, II or III;
* Signed Informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* Suffering from severe mental disorder;
* Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection;
* Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
* Siewert I type adenocarcinoma of the esophagogastric junction;
* Other malignant diseases (within 5 years);
* Other illnesses needed operation concurrently;
* Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy;
* Pulmonary function tests FEV1 less than 50% of predicted value;
* Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep vein thrombosis.
* Patients with obvious tumor infiltration in the spleen and splenic vessels which require splenectomy.
Mechanistic Clinical Trial of Advanced Imaging for CRT

This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.

At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic systolic HF
2. LVEF 35% or less
3. Guideline-based class I or II indication for CRT

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy
3. Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
4. Cerebral aneurysm clips
5. Cochlear implants
6. Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
7. Severe claustrophobia
8. Acute kidney injury
9. Acute renal failure or chronic kidney disease with GFR \< 45 cc/min/1.73m2
10. Liver transplant
11. Gadolinium allergy
12. \>10% premature ventricular contraction (PVC) burden; and 13) estimated \>10% atrial fibrillation (AF) burden based on available clinical data.
Real-World Study of Ceftazidime Avibactam in China

This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.

The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.

Eligibility Criteria:
Inclusion criteria：

* Initiate ≥1 dose of ceftazidime-avibactam during hospitalization.
* Aged ≥ 18 years old at the time of the informed consent signature.
* Provide signed informed consent. Exclusion criteria：
* Are enrolled in any clinical trial, including enrollment in non interventional studies.
* Pregnant women.
Inhibiting COMT in Parkinson's Disease

The overall aim of this observational study is to investigate the impact of COMT inhibition on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or computer-based.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 - 75 years,
* Caucasian ethnicity,
* diagnosed PD by UK brain bank criteria,
* Hoehn \& Yahr scale 2 - 3,
* fertile females have to use contraception
* Group 1: medication with Stalevo® (L-DOPA/DDI + Entacapone)
* Group 2: medication with Madopar® or Sinemet® (L-DOPA/DDI)

Exclusion Criteria:

* methotrexate therapy during the last 12 months,
* treatment with Tolcapone
* vitamin B6, B12 and/or folic acid supplementation during last 6 months,
* pregnancy,
* intention to become pregnant during the course of the study,
* breast feeding,
* other clinically relevant concomitant disease states by discretion of the investigator
* known or suspected non-compliance, drug or alcohol abuse,
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
* participation in another study with investigational drug within the 30 days preceding and during the present study,
* enrolment of the investigator, his/her family members, employees and other dependent persons.
Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities

The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.


Eligibility Criteria:
Main Inclusion Criteria:

* Presenting a DVA requiring hyperselective catheterization
* Having sign an informed consent form

Exclusion Criteria:

* Presenting a contraindication to the realization of hyperselective cathterism
The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP

Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.

In this multicentre, open-label, randomized controlled trial, about 118 new-diagnosed ITP patients will be enrolled from five tertiary medical centres in China. Eligible participants are randomly assigned (1:1) to 2 groups: group DEX2 and group DEX3. In group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14). In group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be at least 18 years of age at the time of the screening.
* Participant may be male or female.
* Participant has a confirmed diagnosis of newly diagnosed ITP according to the 2019 International Working Group assessment at screening, and has a baseline platelet count of less than 30 × 10\^9 cells per L or had bleeding manifestations, or both.

Exclusion Criteria:

* Participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated H. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. Evan's syndrome.
* Participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin).
* Participant has a history of coagulopathy disorders other than ITP.
* Participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment.
* Participant has 12-lead ECG with changes considered to be clinically significant upon medical review at baseline.
* Participant has severe renal impairment (glomerular filtration rate less than 45ml/min/1.73 m2).
* Participant has 3 × upper limit of normal of any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
* Participant with any of the following conditions: severe immunodeficiency, active or previous malignancy, human immunodeficiency virus (HIV), hepatitis B or C virus infection, pregnancy or lactation.
Breath Monitoring of Propofol (Observational Study)

This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath and blood in patients undergoing general anesthesia for elective surgery. The main goal of this study is to develop a population pharmacokinetic model for propofol in exhaled breath.

Propofol is a hypnotic drug commonly used for induction and maintenance of general anesthesia. Propofol is adiministered intravenously and has a comfortable side effect profile. Patients recover fast after propofol anesthesia and are less likely to suffer from post-operative nausea and vomiting compared to general anesthesia with inhalational anesthetics. However, titration of propofol can be challenging and patients may suffer from over- or underdosing during propofol anesthesia. Recent work has demonstrated that propofol is exhaled during anesthesia. Monitoring of propofol concentrations in breath gas during anesthesia may help to titrate propofol anesthesia more effectively. Yet, it is unclear how propofol concentrations vary among patients. This study aims to investigate this variation in a cohort of patients undergoing general anesthesia for elective surgical procedures. Propofol will be measured in breath gas continuously from the induction of anesthesia until recovery. Blood samples will be drawn from the start of anesthesia up to 24 h after the end of the anesthesia procedure and assayed for propofol blood concentrations. We will built a pharmacokinetic model from breath and blood measurements in order to describe the variability of propofol breath concentrations among study participants.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for routine surgery
* age ≥ 18 years
* planned duration of intervention \> 1 hour
* written informed consent

Exclusion Criteria:

* propofol administration within 3 days prior to planned intervention
* pregnancy
* inability to give informed consent
* retraction of informed consent
Food and Microbiome Longitudinal Investigation (FAMiLI)

The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease


Eligibility Criteria:
Inclusion Criteria:

* Age \> 40

Exclusion Criteria:

* Use of long term antibiotics.
* Pregnant
Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer

Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria (Cohort 1):

* Male ≥ 18 years of age
* Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease.
* PSA ≥ 0.2 ng/mL
* Patients must give informed consent for the research study, and agree to allow investigator access to clinical results following treatment plan implementation such as description of the treatment plan and PSA values following implementation of treatment plan as part of standard care, typically determined 3-4 months after treatment.

Inclusion Criteria (Cohort 2):

* Male ≥ 18 years of age
* Histologically confirmed prostate cancer with following Gleason scoring at biopsy:

  * Gleason ≥ 4+3 OR
  * Gleason 3+4 with \>30% pattern 4 or ≥3 cores positive
* Scheduled for radical prostatectomy (expected to occur within 60-days of scanning)
* Patients must give informed consent for the research study, and agree to allow investigator access to the clinical results such as SOC imaging (mpMRI, e.g.) for surgical planning if done, or biopsy data following prostatectomy including lymph node dissection biopsy data, if available.

Exclusion Criteria (Cohorts 1\& 2):

* Inability to give informed consent.
* Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia.
* Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)

The main questions it aims to answer are:

1. How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will

1. measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.
2. measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.

4. completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with RA
* diagnosed thumb deformity: butonier finger, type I or II
* female
* age 18 - 65 years
* patient's consent to the study

Exclusion Criteria:

* other deformity of the thumb
* less than 1 year since surgical intervention in the hand
* less than 6 months since delivery injections within the thumb
* change in treatment during the study and 3 months before the study
Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)

The purpose of this study is to determine whether using a mobile app increases adherence to a heart healthy prescription after discharge from a cardiac rehab program.

Ongoing maintenance of physical activity after cardiac rehab is an important part of preventing secondary cardiac events in patients with ischemic heart disease. Our central hypothesis is that monitoring and promotion of health-related behaviors by increasing patient-provider communication through a mobile device after discharge from cardiac rehab increased adherence to a heart healthy prescription over time. Participants will be randomly assigned to use a mobile app or serve as the control group. All participants will have an activity tracker to track their activity for two months.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* History of cardiovascular disease that qualified patient for cardiac rehab (i.e. ischemic heart disease, history of unstable angina, systolic heart failure with ejection fraction at 35% or less, and Class II to IV symptoms, coronary artery bypass graft surgery, valve replacement)
* Own a smartphone or tablet

Exclusion Criteria:

* Cognitive impairment
* Lack of English proficiency/literacy
* Clinical conditions including: unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm, symptomatic anemia, active infection, uncontrolled hypertension (resting diastolic \> 100 mmHg, systolic \> 180 mmHg), decompensated heart failure NYHA class 3-4, current unstable angina, 2nd or 3rd degree heart block, or uncontrolled high grade exercise-induced ventricular ectopy
Radiocontrast Media Induced Hyponatremia

Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention.

Radiocontrast media after percutaneous coronary interventioncan lead to increased osmolaliry of plasma, which results in translocational hyponatremia.

The investigator will exam the incidence of hyponatremia after percutaneous coronary intervention, and will evaluate the underlying mechanism related to hyponatremia including translocational hyponatremia, or osmotic natriuresis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive contrast media during percutaneous coronary intervention

Exclusion Criteria:

* Patients who have sensitivity to contrast media.
* Liver cirrhosis
* Hypothyroidism
* SIADH
* Patients who receive IVIG or mannitol.
Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* ER+ or TN Breast Cancer
* Progression on an aromatase inhibitor if ER+
* Prior treatment with taxane if TN
* 18 years or older
* Adequate organ function
* Measurable lesion

Exclusion Criteria:

* symptomatic pulmonary disease
* brain metastases
* pregnant females