cyrilzakka/clinical-trials huggingface dataset:
ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

The purpose of the study is to collect information on prostate tissue biopsies collected with the ClariCore System during a radical prostatectomy procedure. The ClariCore System is designed to improve how biopsies are taken from the prostate by using light sensors (fiber optics) that can see changes in the tissue. The information collected from the study will be used to develop a method to tell the difference between normal and suspicious tissue to help guide the physician during a biopsy procedure.

The overall objective of this study is to acquire and analyze spectral data and correlative tissue biopsy cores using the ClariCore System for the purpose of algorithm development.

The system algorithm will be trained to identify real-time in vivo 'Normal' versus 'Suspicious' prostate tissue. The 'Normal' or 'Suspicious' assignment will be based on the optical signal principle component parameters of the measured signal when compared to a threshold to be derived from pathologically known values of suspicious (or possibly cancerous) and normal (or non-cancerous) measurements in prostate tissue.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for radical retropubic prostatectomy
* Prostate volume \> 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or MRI
* Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

Exclusion Criteria:

* Patient opted for robotic (da Vinci robot) or laparoscopic surgery
* Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
* Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
* Bladder cancer (current or prior)
* Actively taking blood thinning agents (with the exception of low dose aspirin {81 mg}, Plavix, Coumadin etc.) or severe medical comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g. coagulopathy)
* Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years
* Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostate)
* Neo-adjuvant hormonal therapy
* Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
* Patient has compromised immune system or autoimmune disease (WBC \< 4000 or \> 20,000)
* Patient is not likely to comply with the follow-up evaluation schedule
* Patient is participating in a clinical trial of another investigational drug or device
* Patient is mentally incompetent or a prisoner
Acute Myocardial Infarction and Acute Cerebral Infarction (AMIAC) Registry and Follow-up

A registry of consecutive patients who were admitted and diagnosed with acute myocardial infarction or acute cerebral infarction were conducted at the Guangdong General Hospital or the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Yue Bei People's Hospital, China, between January 2000 and December 2016. The adverse clinical outcomes, including all-cause mortality, were followed from the date of admission for acute myocardial infarction or acute cerebral infarction until study end (December 31, 2016). All-cause mortality, including the date of death, was identified from the electronic hospitalization data, phone follow-up, and confirmed by the household registration (HUKOU) system, a record of registration required by law in China. Baseline characteristics, including major treatment of acute myocardial infarction or acute cerebral infarction, estimated glomerular filtration rate (eGFR) and proteinuria, were collected. Demographic data were determined from the electronic hospitalization data and electronic hospital discharge records. All comorbid conditions were identified using International Statistical Classification of Diseases, Tenth Revision (ICD-10), coding algorithms applied to electronic physician claims and electronic hospital discharge records. Life style (smoking), treatment regimen at discharge, including angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), were determined from the electronic hospitalization data.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients who were admitted and diagnosed with acute myocardial infarction or acute cerebral infarction

Exclusion Criteria:

* lacunar infarction
Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar.

The aim of this comparative study is to know the differences between the soft tissue volume changes around the autotransplanted tooth and the dental implant placed immediately after the extraction of a posterior tooth. Patient-centered results will also be obtained after having received one or the other treatment.

Dental autotransplantation has high levels of success in permanent teeth with open apex. The results of success in permanent teeth with closed apex are somewhat lower but sufficient to consider the treatment as a viable alternative and to extend the therapeutic range of the treatment to older ages.

The aim of this prospective observational investigation is to evaluate the dimensional and attachment changes that occur in the treated areas and in the autotransplanted teeth respectively of adult patients with permanent teeth with closed apex. All adult patients receiving a dental autotransplantation between the years 2022 and 2023 will be included.

Pre-treatment, volume and insertion parameters will be recorded before and one year after treatment. The comparison with the extraction and dental implant treatment will be made using the digital records that are usually obtained during the performance of this treatment. The comparison will be made with the same number of patients who have been recruited for the dental autotransplant treatment, and the volumetric changes that occur will also be analyzed.

The volume comparisons will be carried out using the Medit Link digital measurement software (Medit, Seoul, Republic of Korea) and data will be obtained and analyzed statistically in order to draw the appropriate conclusions.

Eligibility Criteria:
Inclusion Criteria:

* Patients in ASA-I health status
* Aged between 18 and 80 years,
* Present a tooth in need of extraction with a mature candidate donor tooth compatible with the recipient bed
* Acceptance of proposed treatment of dental autotransplantation

Exclusion Criteria:

* Unavailability of a candidate donor tooth
* Refusal of proposed treatment of dental autotransplantation
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with the following indications:

   i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
   * For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
   * For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
2. ECOG Performance Status of 0-2
3. Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
4. Willingness and ability to comply with all study procedures
5. Written informed consent obtained prior to any screening procedures
6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

Primary Objectives:

* To characterize the safety and tolerability of isatuximab in combination with REGN2810 in participants with metastatic, castration-resistant prostate cancer (mCRPC) who were naïve to anti-programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PD-L1)-containing therapy, or non-small cell lung cancer (NSCLC) who progressed on anti-PD-1/PD-L1-containing therapy, and to confirm the recommended Phase 2 dose (RP2D).
* To assess the response rate of isatuximab in combination with REGN2810 in participants with either mCRPC who were anti-PD-1/PD-L1 therapy naive, or NSCLC who progressed on anti-PD-1/PD-L1 therapy, or of isatuximab as single agent in participants with mCRPC.

Secondary Objectives:

* To evaluate the safety of the combination of isatuximab with REGN2810 or isatuximab monotherapy.
* To evaluate the immunogenicity of isatuximab and REGN2810.
* To characterize the pharmacokinetic (PK) profile of isatuximab single agent or in combination with REGN2810, and to characterize the PK of REGN2810 in combination with isatuximab.
* To assess overall efficacy of isatuximab in combination with REGN2810 or as a single agent.

The total study duration per participant was up to 28 months including an up to 28 days screening period, an up to 24 months treatment period, and a 3 months safety follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Participants must had a known diagnosis of either metastatic castration-resistant prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC) with evidence of measurable disease.
* Failure of, inability to, or refusal to receive standard of care.
* Greater than or equal to (\>=) 18 years of age.

Exclusion Criteria:

* Prior exposure to isatuximab or participation in clinical studies with isatuximab.
* For participants with mCRPC, prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
* Evidence of other immune related disease /conditions.
* History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
* Had received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus were permitted.
* Prior solid organ or hematologic transplant.
* Eastern Cooperative Oncology Group performance status (PS) \>=2.
* Poor bone marrow reserve.
* Poor organ function.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System

Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.

Exclusion Criteria:

* Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.
Swiss Childhood Health and Nutrition Survey 2023

This study will repeat previous studies done in 2002, 2007 2012 and 2017/18, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in Switzerland over the entire period. Furthermore, additional risk factors will be assessed for the later development of NCD using a questionnaire comparable to the one used in 2017/18.

A total of ca. 2500 children will be recruited throughout Switzerland and their height, weight, waist circumference as well as percentage body fat will be measured. In addition, children will be asked to complete a questionnaire on some aspects of their diet, physical activity, health and socioeconomic background. Data will be compared to previous surveys conducted since 2002 to monitor trends in overweight and obesity prevalence in Switzerland. The results from the questionnaire will be used to investigate risk factors for obesity and the later development of NCDs.

Eligibility Criteria:
Inclusion Criteria:

* age between 6 and 12 years

Exclusion Criteria:

* none
Virtual Classroom Training and SMS Supported Interventions Improving Foot Care and Self-Efficacy

The type of this research is a randomized controlled experimental study. The aim of the research is to determine the effectiveness of virtual classroom training and SMS support in improving foot care behaviour and foot care self-efficacy in diabetic patients.

The basic questions the research aims to answer are:

* Is virtual classroom training effective in improving foot care behaviour and foot care self-efficacy in diabetic patients?
* Are SMS-supported interventions effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? Within the scope of the research, participants are expected to attend virtual classroom training and read the SMS sentences sent.

In order to examine the effects of virtual classroom training and SMS-supported interventions, researchers created a control group, a virtual classroom, an SMS support group, and an SMS-supported virtual classroom group.


Eligibility Criteria:
Inclusion Criteria:

* Reporting that you have internet, computer/smartphone access
* Becoming literate
* Ability to use the internet and mobile devices effectively
* Declaring that you are competent to use technology-based training
* Being between the ages of 18-55
* Diagnosis period of 1 year or more

Exclusion Criteria:

* Having a psychiatric/neurological disability that may prevent participation in the research
* Having any diagnosis of learning disability
* Having an existing foot ulcer
* Having a history of foot ulcers and amputation in the past
* Having severe vision problems/retinopathy
* Having severe hearing impairment
Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion Criteria:

* More than 8 mood episodes in the past year from screen (visit 1);
* A current Axis I disorder other than bipolar disorder within 6 months of screening;
* patients with clinically significant abnormal laboratory findings in the investigator's judgment
Food Addiction and Follow-up in Subjects With Obesity

Obesity is a chronic disease. Its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. Indeed, it has been shown that a participation of abnormalities of food addiction type behaviour was frequently found in patients hospitalized for obesity (25% of patients). These disorders require specific management if you want to achieve a good weight result. The aim of the study is to compare the weight evolution of patients with addiction-type disorder (addict) versus those without addiction (non-addict) as well as the management modalities.


Eligibility Criteria:
Inclusion Criteria:

* Obese patients grade 2 and 3
* Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018
* Over 18 years of age
* Not objecting to its participation

Exclusion Criteria:

* No understanding of French
Retrospective Database Study: Influence of Post-endodontic Restoration Placement on Survival of Root Canal-treated Teeth

The aim of this study is to assess the influence (i.e. type and timing) of post-endodontic restorations on the survival of root canal-treated teeth and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity.

Patients who received a root-canal treatment between 1998 and 1999 with subsequent placement of an indirect restoration (e.g. crown, partial crown) will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records.

Survival and success of the root-canal treatments will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received a root-canal treatment followed by the placement of an indirect post-endodontic restoration (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1998 and 1999.

Exclusion Criteria:

* None.
Prison Connect-STI/HIV Prevention Intervention for Couples Affected by Incarceration

The purpose of this study is to adapt an existing couples-level HIV prevention intervention for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and their community-dwelling committed female partners.

This pilot study will recruit male inmates in the Connecticut Department of Correction and their community-dwelling female partner. Using an adapted version of an efficacious couples-level HIV prevention intervention for community populations (CONNECT; PI: El-Bassel), this study will pilot test a single in-prison intervention session using face-to-face or teleconferencing modalities and a brief community follow-up session. Feasibility and acceptability among the inmates and their partners will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* eight HIV-positive and HIV-negative/unknown status male inmates and their partners (N=16 couples, 32 participants).

Male Participants

* at least 18 years of age
* able to communicate in English, currently
* incarcerated in the Connecticut Department of Correction (CTDOC), due to be released within three months.
* have a committed female partner who is not currently incarcerated and willing to participate in the study, and is
* not concerned participation will cause violence in the relationship.

Female partners

* be able to communicate in English
* not currently incarcerated
* confirm the committed partnership with the male inmate and willingness to participate in the study
* not concerned participation in the study would cause violence in the relationship.

Exclusion Criteria:

* restricted to English-speaking participants due to language availability of staff and intervention materials.
Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery

* assess feasibility of detecting pulmonary complications postoperative using chest ultrasound compared to chest x-ray
* measure time lag between using ultrasound and using chest x-ray to detect pulmonary complications postoperative

It is well known that cardiothoracic surgery causes different types of pulmonary complications like residual pleural effusion and pneumothorax therefore it is common that surgeons make a thoracic drainage by introducing intercostal tubes for evacuation of air and fluid from the pleural space. Complications extend to involve the parenchymal pulmonary tissue causing consolidation or involve the interstitial tissue .all these complications affect the postoperative recovery.

As a classical technique a daily chest X-ray is performed from first day of surgical intervention to hospital discharge to assess the amount of residual pleural effusion so drainage removal can be done or not and also assess other pulmonary complications.

However, chest X-rays are costly, exposing patients and health care workers to ionizing radiation requiring patient movement with chest drains, difficult positioning of the patient to get good films, and time consuming.

On the other hand, using chest ultrasound is a good alternative for chest X-ray because it is a bedside, easier, more sensitive and accurate in detection of pulmonary complications.

Its main advantages represented in avoiding the danger of ionizing radiations, easier device portability, low cost and a rapid learning curve.

So it is easy and less time consuming to correlate between ultrasound findings and clinical data and assist in invasive procedures.

Hypothesis that detecting pulmonary complications postoperative using chest ultrasound is easier, more sensitive and accurate compared to chest X-ray.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiothoracic surgery at Assiut University Hospital include CABG, Valve replacement, minimal invasive cardiac surgeries, thoracic surgeries as open thoracotomy and VATS surgeries and others.
* Age \>18yrs: 80yrs.

Exclusion Criteria:

* Patients \<18yr and \>80yrs.
* patient refused to be enrolled in research
* patient with subcutaneous emphysema