cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System

Quality assurance of the laboratory examinations. Retrospective non-interventional study with ThinPrep slides collected as part of the German Co-Screening Program for routine diagnostic. These slides will retrospectively be used to validate the Hologic Genius Digital Cytology (DC) system vs. the ThinPrep Imaging system (TIS).

The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to retrospectively validate the Hologic Genius Digital Cytology (DC) system selected slides earlier measured with TIS will be additionally reviewed with the Genius Digital Diagnostic System in order to demonstrate clinical performance and efficiency.

Hologic's Digital Image Analysis Algorithm uses AI to identify diagnostically relevant objects of interest.Only anonymized results will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory CytoMol as part of the German Cervical cancer screening program.
Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder

The aims of this research are to validate and develop of therapeutic strategies for patients with colorectal lesions in real time through pCLE(probe-based confocal laser endomicroscopy). Endomicroscopy is a technique for obtaining histology-like images from inside the human body in real-time. Total objections are 311 patients.

Specific research topics are as below.

1. Diagnosis and classification of colon polyps through pCLE
2. Evaluation of the depth of invasion of colorectal cancer or lateral growth type tumor through the pCLE
3. Differential diagnosis of colorectal submucosal tumor through the pCLE
4. Differential diagnosis of ileocecal ulcers through the pCLE

The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions Check diagnostic agreement of technical phrases which are derived, the matching degree between observers, and will develope a new classification method based on this.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years old
* Patients with colorectal polyps
* Patients who undergo endoscopic submucosal dissection (ESD) due to lateral spreading tumors or early colorectal cancer
* Patients with submucosal tumor in colorectal cancer
* Patients with ileocecal ulcers
* Patients who consented to research

Exclusion Criteria:

* Patients who are impossible to biopsy or polypectomy due to underlying diseases.
* Patients who are not able to end the ESD because of a complication
* Patients who are already known the cause of ileocecal ulcers before the pCLE.
* Patients with contraindications to the use of disease fluorescent contrast agents
* Patients who did not consent to research
* Patients who are unsuitable for clinical trials in charge of the attending physician.
Application of Digital Impression Technology in Children's Dental Trauma

We will Choose patients with tooth loosening caused by tooth trauma and requiring fix in the department of Pediatric Dentistry and emergency of Stomatology Hospital, Zhejiang University School of Medicine, from July 2022 to May 2025. These patients will be randomly divided into digital impression module (experimental group) and ordinary impression group (control group).The operation time, comfort index and efficacy index of the two groups were compared to investigate the advantages of digital impressions in the application of traumatic dental injuries in children.

1. Information on medical history, physical examination, and ancillary tests were collected and recorded by the pediatric dentistry and emergency department to determine the inclusion subjects, and the grouping was determined according to a randomized controlled design.
2. In the experimental group, digital impressions + 3D printed models were used and fitted pads were made; in the control group, alginate impressions + plaster model infusion were used to make models and fitted pads were made. The included subjects were routinely examined intraorally before and after treatment. Patients were instructed to wear the hinge pad for 24 hours and X-ray films were taken and intraoral examination was performed at 2 weeks and 4 weeks.
3. The observation indexes included： (1) operation time: operation time for the child's chair position, (2) comfort index: pain assessment of patients using visual analog scale, (3) efficacy indexes: a. tooth sensitivity, gingival margin irritation, and lip irritation were assessed using visual analog scale (VSA); B. fixation efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years old ② Loosening or dislocation of anterior teeth caused by trauma; ③ Degree I, II and III of tooth mobility, excluding normal physiological mobility; ④ No jaw fracture, root fracture, avulsion injury and individual malocclusion; ⑤ Children can cooperate with treatment and follow up on time

Exclusion Criteria:

① Children have clear systemic disease factors (various syndromes, hormone level disorders, metabolic diseases, etc.); ② Patients with periodontal disease; ③ Children or family members do not agree to participate in the study; ④ Uncooperative or intolerable examination and treatment
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent
* Body mass index (BMI) between greater than or equal to 30.0 kg/m\^2 and less than or equal to 40.0 kg/m\^2 at screening
* Except for obesity, otherwise healthy or medically stable per protocol
* Have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening
* Other Inclusion criteria may apply
* Stable on liraglutide, depending on cohort

Exclusion Criteria:

* History or clinical evidence of diabetes
* Inadequate organ function at screening
* Currently receiving treatment in another investigational device or drug study
* Women who are pregnant/lactating/breastfeeding or who plan to become pregnant/breastfeed while on study through 5 months after receiving the last dose of investigational product
* History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* A family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma; confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for cohorts receiving liraglutide
* History of major depressive disorder
* Other Exclusion criteria may apply
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other LLTs under conditions of routine clinical practice.

Patients will be enrolled over a period of \~31.5 months, and followed for up to 24 months to assess for study outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who are 18 years or older
2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
4. Participants who per physician's criteria need to optimize their LLT
5. Participants who provide written informed consent to participate in the study
6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.

Exclusion Criteria:

1. Participants that have received inclisiran previously
2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children

Primary:

* To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children

Secondary:

* To evaluate the safety of Enterogermina® in acute diarrhea in Indian children


Eligibility Criteria:
Inclusion Criteria:

* Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (\>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration

Exclusion Criteria:

* History of presence of blood, pus, or mucus in stools
* Severe dehydration (World Health Organization criteria)
* Severely malnourished patients
* Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
* History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
* Known hypersensitivity to Bacillus clausii or other probiotics.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)

A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).


Eligibility Criteria:
Key Inclusion Criteria:

* Participant with a body mass index (BMI) within the 5th to 95th percentiles for the age and gender (based on World Health Organization BMI charts). Participant must have a minimum weight of 15 kg.
* Participant must meet the International League of Associations for Rheumatology classification for 1 of the following categories and have, according to the investigator's judgment, moderately to severely active disease that is not adequately controlled with his/her current therapy.

  * Rheumatoid factor (RF)-positive polyarthritis
  * RF-negative polyarthritis
  * Oligoarthritis
  * Psoriatic arthritis
  * Enthesis-related arthritis (ERA) Note: Historical Human leukocyte antigen B-27 (HLA-B27) results are considered appropriate for ERA diagnosis during screening.
  * Systemic JIA with active arthritis without active systemic features, or with active systemic features that are stable in the prior 6 months of time of enrollment
* Participant with intolerance or a history of inadequate response to at least one of the following medications for the treatment of JIA, administered for at least 12 weeks, based on current treatment guidelines: conventional synthetic disease-modifying antirheumatic drugs and biological disease-modifying antirheumatic drugs (including methotrexate) and non-steroidal anti-inflammatory drugs for ERA and psoriatic arthritis.
* Female participants of childbearing potential (i.e. who have passed menarche) must have a negative highly sensitive urine pregnancy test.

Key Exclusion Criteria:

* Participant with persistent oligoarthritis.
* Participant with undifferentiated arthritis.
* Participant with any other any other rheumatic, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, systemic lupus erythematosus, or uncontrolled uveitis).
* Active infection that is clinically significant, as per judgment of the investigator.
* Participant with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
* Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, or atypical mycobacteria).

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Assessment of Wall Thickness in Hypertrophic Cardiomyopathy

Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and prognostic importance given its known association with sudden cardiac death. However, data regarding comparison of imaging modalities for this key measurement is lacking. This study seeks to compare assessment of maximum wall thickness between clinically indicated echocardiography (with and without contrast) and clinically indicated cardiac magnetic resonance imaging.

Patients receiving clinically indicated echocardiograms and cardiac magnetic resonance imaging at Mayo Clinic will be eligible.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically and echocardiographically defined hypertrophic cardiomyopathy.
2. Clinically indicated transthoracic echocardiography as part of the medical evaluation.
3. No contradiction to administration of ultrasonic echocardiography contrast.
4. Planned clinically indicated cardiac magnetic resonance imaging as part of medical evaluation.
5. No contraindication to cardiac magnetic resonance imaging (such as cochlear implants, central nervous system aneurysm clips and other implanted medical devices).
6. Age 18 years and older

Exclusion Criteria:

1) Insufficient image quality for determination of maximal wall thickness.
Exercise Challenge in a Cold Chamber

The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured.

Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest. To provoke asthma symptoms a provocation test is necessary, e.g., by bronchial methacholine testing or by a standardised exercise test on a treadmill. The correlation between methacholine and exercise test is fair, possibly because both methods measure different kinds of bronchial hyperresponsiveness. Moreover, the sensitivity and the repeatability of the exercise test is fair.

The value of the methacholine test to predict a positive exercise test will be measured. We hypothesize that the exercise test in a cold chamber, a combination of two provocation methods cold air and exercise, is more sensitive to detect EIB and that the test has a better repeatability.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patients: Age \>6 and \<18 years
* Subjects: Age \>/=18 and \<45 years
* sportive, 1-2x exercise per week
* bronchial hyperresponsiveness in the medical history

Exclusion Criteria:

* lung function Forced vital capacity (FVC) \<80% and Forced expiratory volume in 1 second (FEV1) \<75%
* chronic diseases or infections (e.g. HIV, Tbc)
* pregnancy
* systemic corticosteroid-treatment
* inhalative corticosteroid therapy or leukotriene antagonists \<14d
* alcohol, substance or drug abuse
* smokers
* inability to capture extend and consequences of the study
Student Outcomes in Fitness and Nutrition ISEO

The study is designed to examine whether curriculum, designed in partnership with teachers at Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able to influence the behavior and health literacy of students. This information will be collected in surveys before and after the students are given the curriculum during the school day.

The research will implement a short battery of two survey inventories to measure student outcomes under InSciEd Out Fitness and Nutrition curriculum that is currently administered in 3rd and 4th grade at Lincoln K-8 Choice School. One is a grade-level adapted version of the National Youth Physical Activity and Nutrition Survey (NYPANS) authored by the United States Center for Disease Control (CDC). The other is a grade-level adapted version of the Newest Vital Sign (NVS) health literacy assessment authored by Pfizer and adapted by Dr. Linda Aldoory at the University of Maryland.

These assessments will help inform the health promotion activities of the InSciEd Out partnership within Lincoln K-8 Choice in Rochester, Minnesota (MN) and Moreland Elementary in West St. Paul, MN who originally wrote the curriculum. These assessments will be key to curricular revision and expansion to other schools that partner with InSciEd Out. As such, this study is a single cohort, internally controlled pre-post assessment of an existing behavioral intervention. Pending pilot study success, future follow-up studies are projected to be parallel-group, nonrandomized clinical trials of a treatment school versus a control school with grade levels expansion. This study will inform activities within the InSciEd Out network inside Rochester Public Schools (RPS), where grades Kindergarten through 2nd and 5th through 8th curricula is currently being built. Previously RPS-approved Mayo Clinic Institutional Review Board (IRB) #13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and Lincoln K-8 Choice/Moreland Elementary administrators, teachers, students, and parents.

IRB#13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and administration, teachers, and students at Lincoln K-8 Choice Elementary.

Eligibility Criteria:
Inclusion Criteria:

* Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN who assent to the study

Exclusion Criteria:

* Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN whose parents chose to opt-out of the study or who do not assent to the study
Virtual Reality Activity-based Training for Preventing Falls for Older Adults With Mild Cognitive Impairment

Using a Virtual Reality (VR) games-based application is as an innovative falls prevention technology in an aged care service. The VR intervention has promising effects on improving the physical and balance performances in the older adults.The study explored and evaluated the effects of VR activity-based training on falls prevention among community-dwelling older adults with mild cognitive impairment.

A pilot randomized control trial study was applied to compare the effects on falls prevention between participants who experienced a full-immersive VR training and group-based exercise (Baduanjin) training. Eighteen participants were recruited from ausing convenience sampling and were randomly assigned into the VR group and the exercise group (non-VR). The participants in both wo groups' participants attended 16 falls prevention training sessions over eight weeks. Eligible participants identified with a higher risk of mild cognitive impairment and early dementia undertook three measurements, pretest (T1), post-test (T2) and follow up (T3). The primary outcomes assessed included changes in physical risks factor of falls, and the secondary outcomes assessed included changes in cognition and fall efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. aged 65 years to 85 years inclusive;
2. had a history of a fall within the past 2 years;
3. community-dwelling older adults;
4. at a higher risk of mild cognitive impairment and dementia, assessed by a validated screening tool of Hong Kong Montreal Cognitive assessment test (HK-MoCA score=21/22);
5. walk independently e.g. able to access publicly - VR research center centre or local community aged care facilities.

Exclusion Criteria:

if they had a medical diagnosis of unstable health conditions

1. dizziness;
2. Meniere's disease;
3. Epilepsy;
4. Parkinson's disease;
5. Severe hearing impairment and visual impairments;
6. Mental illness.
Healthy Human Control Blood Collection for Validation of Biomarker Assay

Human blood will be collected to serve as control in validating clinical studies studying the detection and levels of circulating tumor cells and microvesicles in cancer patients. Targeted population is cancer-free 18-60 year old men and women. Volunteer selection will rely upon a short health questionnaire. About 20 mL blood will be collected from volunteers up to 20 different timepoints. The Procedure involves minimal risk of harm (eg discomfort, bruising) to the volunteer.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-60 years old Gender: Male and Female

Exclusion Criteria:

* No previously diagnosed malignancy Age: It is important to obtain a healthy, cancer-free volunteer population to serve as negative controls for this detection assay.
The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

This is a prospective, randomized, double-blind, placebo-controlled study about the effect of metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months after withdrawal of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. Patients should not have diabetes (HbA1c level at screening should be lower than 6.5)
3. Mild Graves' ophthalmopathy according to EUGOGO statement.
4. Clinical activity score lower than 4
5. Being euthyroid for at least 2 month before the enrollment
6. No previous specific therapy for GO in 6 month before the enrollment except for local measures (e.g. eye drops)

Exclusion Criteria:

1. Moderate-severe Graves' ophthalmopathy
2. Clinical activity score ≥ 4
3. Contraindication for metformin use as following: renal dysfunction (creatinine level should be within normal range), liver dysfunction (AST and ALT levels should be within normal range), severe concomitant illness
4. Pregnant women
5. Current use of metformin or containing preparations
6. Metformin intolerance
7. Inability to comply with the study protocol