cyrilzakka/clinical-trials huggingface dataset:
Influence of Platelet Concentrates on Wound Healing

Chronic soft tissues defects can extend into the fat layer or even deeper and can cause functional disadvantages. Split-thickness skin grafts (STSGs) used to cover these wounds have varying success rates. To improve wound healing in chronic wounds the authors have studied the application of autologous platelet concentrates in a human keratinocyte culture model in vitro and in a combination with surgical procedures in vivo as second line therapy in patients with initially failed wound closure.

For in vitro testing on keratinocytes a platelet-mediator concentrate (PMC) was processed with a commercially available bed-side system (ATR®, Curasan, Germany). In a clinical study soft tissue defects (n=5) were treated using a combination of surgical debridement and autologous platelet rich plasma (PRP). Time of healing as determined by epithelization as well as Laser Doppler Imaging to visualize blood flow were analyzed. Additionally, changes in "ease of surgical wound closure" were determined. Finally, the quality of life of patients was assessed using a validated questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* exposed tendons, ligaments or bone for \>3 weeks
* no healing tendency

Exclusion Criteria:

* sepsis
* intensive care treatment
* continuous smoking
* pregnancy or breast feeding women
* participants of other studies.
Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions

vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester


Eligibility Criteria:
Inclusion

* missed abortion under 8 weeks by sac diameter over 18 years old informed concent given

Exclusion Criteria:

* missed abortion over 8 weeks hypersensitivity for PG vaginal bleeding suspected EUP IUD heart disease, HTN, cerebral vascular disease, epilepsy intrauterine infection clooting disorder under 18
Predicting Local and Distant Recurrence in T1 Colorectal Cancer

Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.

This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.

The incidence of invasive submucosal colorectal cancer (T1 CRC) is increasing, likely as a reflection of improved screening and endoscopy use. Current treatment options for T1 CRC focus on less invasive methods (i.e., endoscopic submucosal dissection), and treatment decisions are based on the risk of lymph node metastasis (LNM). Up to 70-80% of T1 CRC patients may undergo surgery, with adjuvant chemotherapy recommended only for those with LNM.

However, current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone. This results in the overtreatment of many patients, especially those that are currently defined as 'high-risk' T1 CRC. Existing surveillance methods may not adequately predict the prognosis of T1 CRC, lacking established biomarkers for assessing disease-free survival.

This study seeks to validate tissue-based biomarkers (micro-RNA and messenger RNA) that are associated with tumor recurrence after curative resection. The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy. Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC, highlighting their potential as biomarkers for disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Stage I, pT1 colorectal cancer (TNM classification, 8th edition).
* Received standard diagnostic, staging, and stage-specific curative-intent resection (endoscopic or surgical, as per local guidelines).
* Confirmed cancer-free survivorship at the time of study inclusion.

Exclusion Criteria:

* Lack of informed consent.
* Induction of neoadjuvant systemic therapy before colorectal cancer resection.
* Synchronous colorectal and non-colorectal cancer diagnosed at or before surgery.
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female ages 30 to 80
* Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening

Exclusion Criteria:

* Participant has human immunodeficiency virus (HIV), Hepatitis B or C
* Participant uses illegal drugs
* Participant has Type I diabetes
* Participant has a history of claustrophobia
A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood

IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of recently discovered medical conditions.

The properties that bind them are: lesions similar to tumors in the mixed organs, lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and often, but not always, a high level of IgG4 in the serum.

This disease has been on the rise for the past two decades and since its recognition in 2001 there has been impressive progress in understanding its various manifestations, so that today almost every body system can be involved.

One of the conditions associated with this disease is oritis / periortitis and aneurysms

IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of recently discovered medical conditions.

The properties that bind them are: lesions similar to tumors in the mixed organs, lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and often, but not always, a high level of IgG4 in the serum.

This disease has been on the rise for the past two decades and since its recognition in 2001 there has been impressive progress in understanding its various manifestations, so that today almost every body system can be involved.

One of the conditions associated with this disease is oritis / periortitis and aneurysms

It is common to divide the aortic aneurysms according to the following etiologies:

1. Inflammatory-Aortic Aneurisms (IAA) The internal division in this category is whether IgG4RD is related / not related.
2. Atherosclerotic infrastructure.

Differences between the etiologies: IAA - greater thickness of the wall, fibrosis and adhesion to nearby retroperitone structures. Also, younger age and non-specific symptoms. In addition, the laboratory findings are usually white counts and increased CRP.

In this context, the investigators will examine the level of IgG4 in the blood of a population of patients with aortic aneurysms and try to understand the proportion of patients whose IgG4 level is higher than normal and their aneurysm can be attributed to IgG4 Related Disease.

the investigator chose the blood IgG4 level because it is the most important diagnostic variable for the disease (it is customary to place the incision point at \> 135mg / dL).

Eligibility Criteria:
Inclusion Criteria:

* Patients after aneurysm in the aorta
* Men and women aged 18-100 (not including special populations)
* Those who are able to read understand and sign a written consent to participate in the research

Exclusion Criteria:

* Any patient who does not meet the inclusion criteria
Study of Laparoscopic Inguinal Hernia Repair

Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* unilateral hernia
* uncomplicated hernia
* medical fitness for general anesthesia

Exclusion Criteria:

* unfit for general anesthesia
* complicated hernia
* uncorrectable coagulopathy
* BMI \> 35
* concomitant pathologies requiring simultaneous surgery
* bilateral hernia
AI-Agent for Automated Diagnosis and Predicting Using EHR and Multimodal Data

The goal of this clinical study is to evaluate the effectiveness of an AI agent in diagnosing and predicting diseases using electronic health records (EHR) and multimodal imaging data. The AI agent leverages advanced machine learning algorithms to process and analyze diverse health data sources, aiming to assist healthcare providers in making more accurate diagnoses and predictions.

This multi-center, retrospective clinical study is designed to evaluate the application and effectiveness of an AI agent in the medical decision-making process. The AI agent integrates and analyzes multimodal data, including electronic health records (EHR) and various imaging data (e.g., X-rays, MRIs, CT scans, ultrasounds) to predict and diagnose a range of diseases. By leveraging the power of machine learning and data fusion techniques, the AI agent can identify patterns in large and complex datasets, offering insights that may not be immediately apparent through traditional diagnostic methods.The study will compare the AI agent's diagnostic accuracy and disease prediction capabilities with traditional diagnostic practices to assess its potential benefits in clinical settings. Key questions include whether the AI agent can assist in early diagnosis, predict disease progression, and support healthcare professionals in making personalized treatment decisions. Participants will not be required to undergo any additional interventions; they will only provide historical health data, including EHR and relevant imaging data, which will be analyzed by the AI agent. The AI system will then use this data to assist healthcare providers by offering predictions and diagnostic suggestions based on the analysis of the multimodal information. The ultimate goal is to determine whether this AI-driven approach can improve diagnostic accuracy, optimize treatment strategies, and enhance patient outcomes in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have comprehensive electronic health records (EHR) available, including demographic information, medical history, and laboratory results.
2. Participants must have available multimodal imaging data (e.g., X-rays, CT scans, MRIs, ultrasounds) relevant to their health condition.
3. Participants must have a confirmed diagnosis of one or more diseases or health conditions based on clinical records or imaging data.
4. Patients must provide consent for the use of their historical health data for research purposes.

Exclusion Criteria:

1. Participants with ambiguous or unverifiable diagnoses that cannot be accurately categorized.
2. Duplicate or redundant patient data (e.g., repeated records of the same patient without clear differentiation).
Omitting of Lymphadenectomy is Acceptable for Lung Cancer Smaller Than 6 mm in Solid Size

Many studies suggested that selective lymph node sampling was acceptable for specific non-small cell lung cancer (NSCLC). This study aimed to evaluate the acceptability of omitting of lymphadenectomy for selected NSCLC.

Patients with small-sized (≤2 cm) NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened.

Many studies suggested that selective lymph node sampling was acceptable for specific non-small cell lung cancer (NSCLC). This study aimed to evaluate the acceptability of omitting of lymphadenectomy for selected NSCLC.

Patients with small-sized (≤2 cm) NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened. The characteristics of patients with nodal metastasis were demonstrated. For selected patients, the perioperative and long-term outcomes of patients with and without lymphadenectomy were compared. Log-rank test and Cox regression analysis were adopted for prognostic evaluation.

A total of 2713 NSCLC patients were enrolled, and 75 of them (2.76%) had nodal involvement. None of patients with pure ground glass opacity (0/945) had nodal metastasis, while 14 patients with part-solid (14/1260, 1.11%) and 61 patients with solid nodules (61/508, 12.01%) had nodal involvement. Patients with nodal metastasis had a minimum solid size of 6 mm. NSCLC with solid components \< 6 mm (n=1588) had no nodal metastasis. Of them, 339 patients underwent sublobar resection without lymphadenectomy (SRN0), 1056 subjects received sublobar resection with lymphadenectomy (SRN1), and 190 patients received lobectomy plus lymphadenectomy (LRN1). Patients with SRN0 had a shorter operating time, less volume of drainage, a lower incidence of chylothorax (0 vs. 0.6% vs. 2.1%, P=0.012) and air leakage, as well as a shorter postoperative hospitalization (3 vs. 4 vs. 4 days, P\<0.001) than those with SRN1 or LRN1. During a median follow-up of 61 months, no patient with SRN0 was dead or tumor recurrent. The 5-year recurrence-free survival was 100%, 99.2% and 98.5% for patients with SRN0, SRN1 and LRN1, respectively (P=0.370).

Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed non-small cell lung cancer (NSCLC)
* the maximum tumor diameter ≤2 cm
* receiving surgical treatment between 2009-2022

Exclusion Criteria:

* non-primary NSCLC;
* with small cell lung cancer components;
* undergoing preoperative neoadjuvant therapies;
* with compromised resection;
* malignant tumor history over the past five years.
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.

Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Female sex
2. At least 18 years old at MBC diagnosis
3. Diagnosis of MBC at any point in patient history

   1. ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC
   2. Confirmation of metastatic disease
   3. At least 2 document clinical visits
   4. Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents
4. HR+/HER2-

   1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
   2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
5. Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.

Exclusion Criteria:

1. Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or Fulvestrant for MBC
2. First structured activity greater than 90 days after MBC diagnostic date
3. Treatment with a CDK4/6 inhibitor as part of a clinical trial
Evaluation of the French Version of Screening Questionnaires for Autism and Asperger Syndrome: AQ, EQ and SQ

Autism is considered as an invading disorder of the development. Asperger Syndrome (AS) is a particular form of autism and is difficult to diagnose. The Autism Spectrum Quotient (AQ) has been developed in order to measure the degree of autistic traits in autistic adolescent with normal intelligence (Baron-Cohen et al. 2001, 2006). AQ comprises 50 questions, with 5 groups of 10 questions assessing imagination, social skills, attention switching, attention to detail and communication skills. Each of these items scores 1 point if the respondent records abnormal or autistic like behaviour. The minimum score on the AQ is 0 and the maximum 50.

The principal objective of this study is to evaluate the accuracy of the French version of Autism Spectrum Quotient questionnaire.

Secondary objectives are to:

Evaluate if EQ and SQ can distinguish adolescents without psychiatric syndromes from those with classical autism or AS.

Evaluate if AQ, EQ and SQ can distinguish adolescents with psychiatric disorders from autistic adolescents.

Define the threshold of positivity for the 3 questionnaires.

4 groups of participants will be screened with the questionnaires: Group 1: 50 adolescents with AS or high functioning autism (HFS) diagnosed by psychiatrists using established criteria and with an IQ \>85.

Group 2: 50 adolescents with AS or classical autism diagnosed by psychiatrists using established criteria 70\<IQ\<84.

Group 3: 50 adolescents with psychiatric disorders. Group 4: Sample of 50 healthy adolescents selected randomly from 200. The questionnaires are given to the parents of adolescents during the first meeting. Parents are invited to send them back to the clinical investigation centre of Lyon (France).

Multicentre study: 8 clinical centres and 18 paediatricians

Eligibility Criteria:
Inclusion Criteria:

Group 1 (AS/HFA) and 2 (AS/classic autism) :

* Boys and girls aged 12 to 18
* Patients with autism or Asperger syndrome according to the diagnostic criteria (ICD 10)
* Patients receiving education in an ordinary school
* IQ\>70

Group 3 (adolescents with psychiatric disorders):

* Boys and girls aged 12 to 18
* Patients hospitalized on a psychiatric ward or at a psychiatrics patient visit or psychiatric consultation wit hout autistic syndrome
* Patients receiving education in an ordinary school when not in hospital

Group 4 (adolescent without psychiatric syndrome):

* Boys and girls aged 12 to 18
* Patients receiving education in an ordinary school

Exclusion Criteria:

For all groups :

* Problem with language or comprehension
* Participants who have not given their consent
A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19

This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with COVID-19 confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, or other bodily fluid) and evidenced by chest x-ray or CT scan
* Receiving systemic corticosteroids at baseline
* Oxygen saturation \< 93% on room air, or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) to maintain oxygen saturation \> 92% at screening and baseline

Exclusion Criteria:

* Gestational age \< 37 weeks
* Known severe allergic reactions to TCZ or other monoclonal antibodies
* Active tuberculosis infection
* Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19)
* Diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (MIS-C)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments
* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months prior to enrollment
* Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)
* Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)
A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care

The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1

Patients (N=3,000) will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.

Eligibility Criteria:
Inclusion Criteria:

* able to read English or Spanish at least at eighth-grade level
* have an email account or the ability to receive texts
* willingness to be re-contacted
* consent to MRR related to CRC screening
* not remember completing any CRC screening within recommended guidelines (i.e., \<10 years for colonoscopy, \<1 year for stool test).
* complete a FIT test:
* a) with a negative result only
* b) complete a FIT test with a positive result AND undergo a completion screening colonoscopy,
* Or c) complete a colonoscopy only.

Exclusion Criteria:

* unable to read English at least at eighth-grade level
* doesn't have an email account or the ability to receive texts
* unwilling to be re-contacted
* Unable to consent to MRR related to CRC screening
* have not had \<10 years for colonoscopy, or 1 year for stool test
Dietary Effects on Circulating Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity and Enzyme Activity in Peripheral Blood Mononuclear Cells (PBMCs) in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes

We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.

Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose \<126 mg/dL)
* or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL)

Exclusion Criteria:

* current and/or past history of cardiovascular disease including angina
* liver or kidney dysfunction
* thyroid or pituitary disease
* unstable weight loss/gain (≥2 kg) over the previous 12 months
* pregnancy or lactation
* taking medications or supplements