cyrilzakka/clinical-trials huggingface dataset:
Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software

The upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed by Wuhan ENDOANGEL Medical Technology Co., Ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. The aim of this study is to evaluate the safety and effectiveness of the software in clinical use.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18, male or female；
2. Cases with complete, clear imaging data, including images under white light and magnified stained images；
3. Complete pathological diagnosis of upper digestive tract lesions;
4. The included cases were excluded from the software development.

Exclusion Criteria:

1. Cases whose image data did not meet the evaluation requirements;
2. The investigator considered the case unsuitable for the clinical trial.
Pilot Feasibility Study of a Sjögren's Syndrome Self-management App

This study investigates the feasibility of a fully remote effectiveness evaluation of a self-management smartphone application for those with Sjogren's syndrome.

The aim of this study is to pilot and assess the feasibility of a fully remote effectiveness evaluation of a smartphone self-management app for those living with Sjogren's syndrome.

The fully-remote evaluation will involve minimal contact with researchers. Potential participants will be recruited internationally online through social media and mailing lists for Sjogren's syndrome support groups. Adverts will direct people to download the self-management app on app stores (Apple App Store and Google Play). The app has been designed to automate all study procedures, by guiding users through the following processes: screening, informed consent, randomisation, and the collection of outcome data through in-app surveys sent at 0, 5, and 10 weeks. Users will be randomised to receive the full intervention or a control:

* Intervention group: full version of the app containing multiple behavioural components: Symptom and Lifestyle Information, Energy Management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills.
* Control Group: minimal version of the app containing only the Symptom and Lifestyle Information component.

To pilot and assess the feasibility of the planned methodology, and inform the design of a future definitive randomised control trial of the app, the primary objectives of this study are to: characterise users (i.e. international recruitment and consent rates), and test screening, randomisation and data collection procedures (i.e. outcome measure completion rates and score variability). The secondary objectives are to explore app engagement patterns (using log data) and the acceptability of the study procedures and the app (using remote semi-structured interviews).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosed with either Primary or Secondary Sjogren's syndrome (self-report)
* Own an iPhone or Android smartphone

Exclusion Criteria:

* None
Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems

To evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of 35 patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on 105 Class V restorations.A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from may 2023 to may 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.

Clinical evaluation for all restorations will be done at baseline (after insertion) and after 6, 12 and 24 months of clinical service by two calibrated independent examiners that will not share in restorations placement. It will be designed depending on modified USPHS criteria and FDI criteria

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will be fair oral hygiene patients with 30-60 years. Patients with at least three similarly sized non-carious cervical lesions (NCCLs) in vital teeth that need for restoration and depth of NCCLs will be 1-3 mm with at least 50% of margins without enamel.

Exclusion Criteria:

* Exclusion criteria will be patients with severe periodontitis, mobile teeth, fractures, severe bruxism, carious teeth, poor oral hygiene, teeth with irreversible pulpitis and endodontically treated teeth.
Body Composition Analysis for Patient With Lung Cancer Using Computed Tomography Image Analysis

Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, it has been mainly studied from several assessment methods which do not usually differentiate muscle from other tissues.

Aim: To analyze body composition of patients with lung cancer at diagnosis using computed tomography (CT-Scan) image analysis.

Methods: This is a retrospective study extending over a period of 3 years conducted at the Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in our institution. Following the collection of clinical data from patient records, we used SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area from a single abdominal cross-sectional image at the level of the third lumbar vertebra.


Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Between 40-80 years of age
* Primary lung cancer diagnosed between 2009 and 2012
* CT-Scan done at the time of the diagnosis

Exclusion Criteria:

* Chemotherapy, radiotherapy or surgery at the time of the first Ct-Scan image
* History of other cancer (during the last five years)
Small Intestinal Bacterial Overgrowth: a Prospective Registry

The purpose of this study is to investigate the prevalence of small intestinal bacterial overgrowth (SIBO) in patients who will be undergoing an enteroscopy as an outpatient procedure with symptoms of functional dyspepsia. In addition, the investigators would like to identify the types of bacteria that are present in the small intestines in patients with SIBO and compare two different diagnostic tools: microbiologic culture and DNA sequencing of bacteria.

The aim is to compare the microbiota between patients with and without the clinical complications of SIBO

Same as above

Eligibility Criteria:
1.Study Subjects Inclusion Criteria i. All patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology.

Exclusion Criteria i. Use of colon cleansing prep in the past 1 month ii. Treatment with antibiotics in the past 30 days (antibiotics are allowable for patients undergoing clinical indicated repeat aspiration to determine bacteria clearance) iii. Use of probiotics in the past 30 days iv. Contraindication for upper endoscopy for any reason v. Prisoners vi. Pregnant vii. Unable to give own informed consent

2 Control Subjects Inclusion Criteria i. Patients who are undergoing double balloon enteroscopy or upper enteroscopy for another medical reason.

Exclusion Criteria i. Diagnosis of SIBO ii. Diagnosis of functional dyspepsia iii. Established risk factors for SIBO (ANY of the following)

1. Connective tissue disorder (scleroderma, polymyositis, mixed connective tissue disease, or systemic lupus
2. Resection of ileocecal valve for any reason
3. Chronic intestinal pseudo-obstruction
4. Small bowel blind limb, diverticulum or fistula
5. Surgery with decreased gastric acid exposure for small bowel a. Gastric surgery with vagotomy (Bilroth I, Bilroth II, vagotomy/pyloroplasty) or gastric bypass iv. Use of colon cleansing prep in the past 1 month v. Use of antibiotics in the past 30 days vi. Use of probiotics in the past 30 days vii. Contraindication for upper endoscopy for any reason viii. Prisoners ix. Pregnant x. Unable to give own informed
Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

The investigators carried out a multi-center comparative study, involving hospitals including the Second Affiliated Hospital of Zhejiang University School of Medicine, Peking Union Medical College Hospital, West China Hospital, Wenzhou First Hospital, and Li Huili Hospital. This study aimed to compare the efficacy of medication and surgery for specific subtypes of microadenomas and clearly defined macroadenomas (Knosp grades 0-2), in order to determine which is more effective and which has fewer benefits, thereby enhancing the evidence base.


Eligibility Criteria:
Inclusion Criteria:

* Prolactin level greater than three times the normal upper limit
* MRI indicates Knosp Grade 0-2 pituitary adenoma

Exclusion Criteria:

* MRI indicates Knosp grade 3-4 pituitary adenoma
* Taking antidepressants or other psychotropic drugs
* Patients allergic to bromocriptine or cannot tolerate surgery
* Women defined as surgical infertility (i.e. hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or amenorrhea for more than 2 years
* Critical illness patients, such as those with progressive consciousness disorders, cerebral hernias, and other emergency situations
Skin Samples of Diabetic Patients and Healthy Volunteers Collection

The main objective of this study is the Obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients diagnosed for type 2 diabetes, with a BMI between 20 and 25, without familial history and known genetic cause of diabetes.
* Diabetic patients diagnosed for MODY diabetes (1, 2, 3, 4, 5 or 6), with a BMI between 20 and 25.
* Healthy volunteers, siblings of MODY patients (1, 2, 3, 4, 5 or 6).
* Healthy volunteers without familial history of diabetes.
* Patients over 18 years old.
* Patients with social insurance coverage
* Patients who signed a consent form

Exclusion Criteria:

* Type 1 diabetic patients.
* Pregnant women or women who might get pregnant
Assessing Ovarian Function During Prolonged Implant Use

The study will evaluate how the ovaries may be functioning while using the the Implanon®/Nexplanon® during the three years beyond the FDA approved duration. Ovarian function will be assessed with weekly serum progesterone levels. Participants will undergo weekly venipuncture for a total of four draws. Participants will be followed for 30 days.

This prospective cohort will evaluate the ovarian function of 210 ENG users during the three years beyond the FDA approved duration. Participants enrolled in the current study, EPIC (Evaluating the Prolonged Use of IUD and Implant for Contraception, NCT02267616), will be contacted via telephone, screened and scheduled to enroll in person. After the signed consent is obtained participants will be asked to complete a brief questionnaire on demographic information and bleeding patterns. Participants will undergo a blood draw to assess serum etonogestrel and serum progesterone levels.

Follow up visits will include a weekly blood draw for three weeks to assess serum progesterone levels. Participants will also complete a bleeding diary to assess daily bleeding patterns for the 30 day study period.

The investigators will enroll participants at seven time points; at method expiration (3 years of use), and in six-month intervals through six years of use.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the prospective EPIC Prolonged Use Study
* 18-45 years of age
* At expiration or beyond the end of the FDA-approved duration of use of the etonogestrel-releasing subdermal implant (ENG implant =3 years)
* Ability to consent in English
* Willing and able to complete required follow-up for the study.

Exclusion Criteria:

* Have history of female sterilization procedure
* Desire for conception in the next 12 months
* Had their ENG implant removed
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfast in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* All participants are healthy males
* Age range from 21 to 50 years
* Broca-Index: within +- 20% of normal weight

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\> 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study
* Use of any drugs which might influence the results of the trial (\>= one week prior to administration or during the trial)
* Participation in another study with an investigational drug (\>= tow months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation (\>= 100 mL) within four weeks prior to administration or during the trial
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance
Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848

The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test)
* Patients with need of treatment for their nasal symptoms during the pollen season

Exclusion Criteria:

* Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis
* Symptomatic perennial allergic or non-allergic rhinitis
* A history of asthma
Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control

Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention - grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.

The objective of this study is to conduct the RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) for 12 weeks among Black women who are obese and hypertensive living Chicago. We propose to 1) Pilot the RN-CHEFRx intervention and measures that will be used to assess blood pressure, BMI status, and sodium intake with 20 Black women diagnosed with hypertension and BMI ≥ 30. We will assess the efficacy of the evaluation tools to be used in a future clinical trial at three-time points (baseline, 12 weeks, and 6 months); and 2) Assess the feasibility and acceptability of the RN-CHeFRx intervention using interviews, surveys, and documentary analysis. Findings from this study will inform a larger efficacy trial of RN-CHeFRx to improve dietary behaviors and blood pressure control among Black women with hypertension and obesity.

Eligibility Criteria:
Inclusion Criteria:

* self-identified as Black or of African descent
* female
* ≥ 18 years old
* baseline blood pressure ≥130/85 or diagnosed with hypertension and BMI ≥ 30

Exclusion Criteria:

* inability to cook in their homes
* cognitive deficits impeding the ability to participate or provide informed consent
* current treatment for cancer
* liver or renal disease
* pregnancy
* lack of English language proficiency
Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study

This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Length of stay in ICU ≥24h;
* Age ≥18 years old;
* Conscious when leaving ICU, communicating with investigators without barriers;
* Informed consent.

Exclusion Criteria:

* had been admitted to ICU for more than 24h within 3 months prior to this admission;
* Transferred to another ICU;
* There was cognitive impairment before ICU admission (BDRS \> 4);
* Serious hearing impairment, dysarthria, etc., can not be followed up;
* Serious illness can not cooperate to complete the questionnaire.
A Mobile Personal Health Record for Behavioral Health Homes

Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with SMI receive coordinated medical and mental health care. However, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations.

This application proposes to develop and test a mobile Personal Health Record (mPHR) to overcome this problem while more fully engaging patients in their health care. The study will develop, test, and disseminate the mPHR. The investigators will develop the app building on experience and preliminary data from a PC-based PHR project, and link it to the medical and mental health EHR in a behavioral health home. Next, the investigators will conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.


Eligibility Criteria:
Inclusion Criteria:

* one or more of the following conditions: hyperlipidemia, hypertension, diabetes
* able to give consent
* patient in the behavioral health home

Exclusion Criteria:

* Unable to give consent
High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy

The investigators seek to test the hypothesis that the improved version of high definition white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments than current versions of these endoscopes.

Information will be collected. Images will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Patients with Barrett's esophagus (BE) dysplasia as the original indication for treatment
* Undergoing any type of endoscopic BE resection or ablation treatment including RFA, cryotherapy, photodynamic therapy, or EMR, or combinations of these.
* \<1cm of circumferential, peninsular, or island-type BE on prior endoscopy or ablation
* Ability to provide written, informed consent

Deferral Criteria: This category is for patients in two specific situations, 1) Erosive esophagitis, and, 2) presence of a nodule suspicious for the presence of neoplasia.

1. Erosive esophagitis: patients found to have erosive esophagitis, will be deferred for up to 3 months from their Index study procedure, to permit more aggressive medical therapy to heal the erosive esophagitis. After healing, the Index study procedure will be performed up to 3 months later, and the follow-up endoscopy (and study closure) performed 3 to 6 months after that (total of no more than 9 months).
2. Presence of nodule suspicious for neoplasia: for patients found to have such nodular lesions, the Index study procedure will be deferred for 3 months, while Endoscopic Mucosal Resection is performed and subsequently heals.

Note: Only one deferral per patient is permitted, and this one deferral is allowed only for these specific criteria. The end of the study will be defined by the time of follow-up of the last patient who was not deferred; any deferred patients who have not completed follow-up procedures by that time, may miss their follow-up visit as part of the study. (This is to prevent the possibility of delaying the close of the study due to deferral of a procedure late in the study.)

Exclusion Criteria:

* Current participation in another clinical study
* Complete eradication of BE documented by biopsies in 3 or more previous endoscopic procedures performed after resection/ablation
* Inability to obtain biopsies due to anticoagulation, varices, etc.
* Pregnancy
* Worse than Grade C erosive esophagitis
* Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (ablation or resection).