cyrilzakka/clinical-trials huggingface dataset:
Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection

Fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) has been demonstrated to outperform other imaging modalities such as CT and magnetic resonance imaging (MRI) for the detection of metastatic cancers. Therefore, it is currently used for cancer staging, re-staging, and for monitoring response to therapy for many types of cancers. Major advances in PET imaging came to the field in 2016, 2020, 2021 and 2023 when the FDA approved additional PET imaging agents to expand the role of cancer detection to include prostate and neuroendocrine cancers. Despite its wide use and success, the diagnostic accuracy of PET/CT is suboptimal for lesions that are significantly smaller than 1 cm due primarily to limitations on image resolution and system sensitivity. The investigators have developed an Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) technology that can improve the image resolution and system sensitivity of current and future PET/CT scanners. This study will evaluate preliminarily whether the AWSM-PET/CT technology can provide additional high-resolution PET/CT images displayed concurrently with the standard of care PET/CT images to improve overall accuracy in depicting malignant lesions in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient 18 years of age or older
* Patient with suspected or pathologically confirmed diagnosis of carcinoma scheduled to undergo standard of care (SOC) PET/CT for initial diagnosis, initial staging, or suspected recurrence. Preference is to enroll those subjects who will undergo biopsy or surgical resection prior to other cancer treatment.
* Willing to undergo PET/CT imaging with AWSM-PET.
* Patients of child-bearing potential must have a negative urine pregnancy test on the day of the PET/CT scan. Postmenopausal women who self-report as amenorrheic for at least 12 consecutive months are to be considered not of child-bearing potential.
* Patients must be able to understand and sign an IRB-approved informed consent form that allows access to prior medical records, participation in the study and chart review follow up.
* Patients are able to tolerate up to approximately 30 min of PET imaging.

Exclusion Criteria:

* For FDG PET/CT only: Patients who have poorly controlled diabetes (fasting blood glucose \> 200 mg/dL obtained directly prior to FDG administration for PET/CT scan)
* Patients whose weight or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view
Improvement of Nutritional Status in Elderly Residents of Long-term Facilities

Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven.

The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.

Two interventions are evaluated during a 1 year study period, with a 4 arms factorial design.

The "Dentary" intervention implies a trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.

The "Nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) Incite patients to eat.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay

Exclusion Criteria:

* refusal to participate in the study
Persistant Organics Pollutants in Breast Cancer.

Persistant Organics Pollutants (POP) accumulate in the adipose tissue (AT) and could modulate tumor progression as part of the microenvironment. The investigators tested the hypothesis that POPs exposure may be associated with breast cancer metastasis analyzing the concentrations of 46 POPs in both adipose tissue and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis)

The investigators set up a longitudinal prospective monocentric cohort study in the gynecologic-oncologic surgery department of European Hospital Georges-Pompidou, with patients undergoing partial or total mastectomies, lymph node biopsies or axillary lymph node removal and sampling of the adipocytic tumour microenvironment to measure POPs using gas chromatography coupled to high-resolution mass spectrometry. The objective is to analyze the concentrations of 46 POPs including polychlorinated dibenzo(p)dioxins and furans (PCDD/Fs), polychlorinated biphenyls (PCBs), polybromodiphenyl ethers (PBDEs) and polybromobiphenyls (PBBs) in both adipose tissue (AT) and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis).

Eligibility Criteria:
Inclusion Criteria:

* Patient with breast tumor: benign or malignant
* Tumor size at least 1cm or palpable tumor
* Undergoing a breast surgery in European Georges Pompidou hospital
* Understanding the protocol and who signed a written consent

Exclusion Criteria: patients unable to give informed consent

* Dementia
* Guardianship
Observational Study of Meloxicam in Any Labeled Indication

Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Patients according to the physicians medical criteria on the labeled indications for Meloxicam

Exclusion Criteria:

* none
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia

A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH.

PROCEPT BioRobotics has developed the AquaBeam, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.

Eligibility Criteria:
Inclusion Criteria:

* Male age from 40 through 85 years with LUTS due to BPH

Exclusion Criteria:

* Any severe illness that would prevent complete study participation or confound study results
Multifactorial Fall Prevention Program

The main objective is evaluate the effectiveness of a Multifactorial Pilot Program on the Prevention of Falls in people aged 65 or over during 4 years at Gerencia de Atención Integrada de Talavera de la Reina.

Introduction: Falls are a major global public health problem. Falls are the second leading cause of death from unintentional injuries in the world. The highest mortality rates correspond to 60 years old people. 20-30% suffer from moderate-serious injuries (hip fractures, head injuries...), that reduce mobility and independence, increasing the risk of premature death. Moreover, there are more than 400 risk factors. Most can be modified to decrease the risk of falling.

Objective: To evaluate the effectiveness of a Multifactorial Pilot Program on the Prevention of Falls in people aged 65 or over during 4 years at Gerencia de Atención Integrada de Talavera de la Reina.

Material and methods: Randomized clinical trial with 264 patients is carried out. 65 years old or older patients are recruited from primary care (≥ 1 positive response in the Frailty Screening Test, or ≥ 3 in the Downton Test and \> 90 in the Barthel Index). Falls risk is assessed using validated scales. Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO). Control group receive recommendations (physical exercise, health education on risk factors, footwear, exercise, home adaptation, nutrition, ...). Variables are presented with their frequency distribution. Qualitative variables as median and range, and quantitatives with their mean and standard deviation. Association between qualitative variables are evaluated with Pearson's Chi-square test. Student's t test be used when the distribution of the variable adjusts to normality. The null hypothesis will be rejected with an error α less than 0.05.

Expected benefits: It is expected to reduce the risk of falls in 30-35% of 65 years old people or older in the urban area of Talavera de la Reina. It would mean great savings and improve the quality of life. It is expected to increase the years of healthy life. It is intended to provide health professionals with a tool to make clinical decisions based on evidence on the prevention of falls to be used as a unified work protocol at Gerencia de Atención Integrada de Talavera de la Reina.

Eligibility Criteria:
Inclusion Criteria:

* 65 years old or older patients
* Live in Talavera de la Reina
* Ability to walk at the Health Center
* ≥ 3 in the Downton Test
* \> 90 in the Barthel Index
* Sign the informed consent

Exclusion Criteria:

* Patients with an intense physical activity
* Use of a wheelchair
* Amputations or prosthetic limbs
* Deafness
* Blindness
* Moderate or severe cognitive impairment
* Vertebral, pelvic or lower limb fractures in the 12 months prior to entering the program
* Absolute contraindication to physical exercise
Lipoic Acid Supplement for Cystine Stone

This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily for three years, while the other half will receive a placebo. The funding source for this clinical trial is FDA OOPD.

Cystinuria is a rare inherited autosomal recessive disorder of the kidney that is the result of a defect in the dibasic amino acid transporter in the renal proximal tubule and small intestine. Supersaturation of cystine in the urine produces crystals that precipitate and form calculi, which can be a cause of obstruction, infection, and chronic kidney disease (Chillarón 2010).

One potential therapeutic is a thiol-containing compound alpha-lipoic acid (thioctic acid, 5-(1,2-dithiolan-3- yl) pentanoic acid, ALA). It is an over-the-counter supplement with antioxidant property. Once ALA is transported into the cell, it is reduced to dihydrolipoic acid (DHLA). Both ALA and DHLA have direct antioxidant activity (Scholich 1989), and they can regenerate endogenous antioxidants including ascorbic acid and vitamin E. It can also increase intracellular coenzyme Q10 and glutathione levels. ALA and DHLA also have additional biochemical effects as metal chelators, reactive oxygen species scavengers, and modulators of signaling transduction of several pathways (Gomes 2014).

While the potential therapeutic effects of ALA have been studied in a number of diseases including, for example, Alzheimer's disease, obesity, cardiovascular disease, hypertension, and several cancers (Gomes 2014), the efficacy of ALA has been best studied in type 2 diabetic peripheral neuropathy (Ziegler 2011). In our lab, results from a mouse model of cystinuria show that ALA markedly slows the initiation of cystine stone formation as well as the growth of existing stones.

Given this history in clinical medicine and, most importantly, based upon our positive findings of ALA effectiveness in a mouse model of cystinuria, we propose a pilot study on the use of this molecule in cystinuric patients.

Eligibility Criteria:
Inclusion Criteria:

* Documented cystinuria on prior 24-hour urine collection and/or stone analysis; history of previous cystine kidney stones.
* Being able and willing to provide consent.

Exclusion Criteria:

* Poorly controlled diabetes mellitus (hemoglobin A1C \> 8.0% for more than 1 year).
* Current alpha-lipoic acid administration at the time of screening or within the last year prior to screening.
* Vulnerable populations including incarceration status.
* Unable to give informed consent.
* Non-English primary language.
* Pregnancy, lactation, or child-bearing age without birth control devices.
* Anticipation of pregnancy during the study period.
* Serious illness likely to cause death within the next 5 years.
Single vs. Double Drain in Modified Radical Mastectomy

Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage is used routinely to reduce incidence of seroma. Usually two drains are used in patients who underwent MRM to reduce post operative seroma. It is often associated with significant patient discomfort and prolonged fluid drainage.

The aim of this study is to evaluate effect of number of drains on seroma formation rate, postoperative pain and hospital stay during the immediate postoperative period after mastectomy for breast cancer.

Modified Radical mastectomy is commonly performed procedure for carcinoma breast. After surgery two drains are placed, one in axilla and one beneath the flap. The use of two drains is associated with significant post operative discomfort and pain. On the other hand two drains have not been proven to decrease post operative seroma formation.

Eligibility Criteria:
Inclusion Criteria:

* All female patients underwent MRM for biopsy proven carcinoma breast

Exclusion Criteria:

* Immediate reconstruction
* Patient refusal to participate in study
Validity and Reliability in Measuring Iliotibial Tract by Using Ultrasound

The purpose of this study is to estimate the validity and reliability in measuring the iliotibial tract by using ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Patients with knee injuries who need magnetic resonance imaging (MRI) evaluation

Exclusion Criteria:

* Patients who have an iliotibial tract lesion
To Compare the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate to Severe Alopecia Areata

Alopecia areata (AA) is an autoimmune condition characterized by non-scarring hair loss, ranging from minor patches to complete baldness. Given the variable effectiveness of existing treatments, this study aimed to compare the efficacy of weekly Azathioprine pulse (WAP) therapy against Betamethasone oral mini-pulse (BOMP) therapy in managing moderate to severe AA.

Alopecia areata (AA) is an autoimmune disorder characterized by non-scarring, solitary, or multiple circular or oval patches of hair loss on scalp or other hear bearing areas. These patches often feature "exclamation mark hairs" near their leading edges. It effects all demographics irrespective of age, sex, and ethnicity. Clinically, Alopecia areata can be categorized in various forms depending on extent of involvement, such as patchy hair loss on the scalp, Alopecia Totalis (complete scalp hair loss), or Alopecia Universalis (complete scalp and body hair loss), or less commonly, as band-like hair loss on specific regions of the scalp.

Given the uncertain pathogenesis and course of the disease, the effectiveness of treatment modalities remains unpredictable. Effective treatment must address both the clinical efficacy and safety. Previous studies have reported variable safety profiles, remission, and relapse rates for weekly Azathioprine pulse therapy versus Betamethasone oral mini-pulse therapy, particularly when compared to placebo. However, direct comparisons, especially within our local demographic, are notably lacking. Therefore, this study aimed to bridge the existing gap in literature by offering a comparative evaluation of these therapies in the management of moderate to severe alopecia areata.

Eligibility Criteria:
Inclusion Criteria:

* aged 16-60 years
* scalp area involvement of ≥ 15% by Alopecia Areata

Exclusion Criteria:

* used topical and intralesional treatment within last 1 month,
* received systemic therapy or phototherapy within last three months,
* anemia, leukocytosis, leukopenia, thrombocytopenia, deranged renal and liver function test
* pregnant an lactating females
* patients with contraindications to corticosteroids or Azathioprine
Acute Effects of Beetroot Juice on Isometric Knee Extension Strength, Explosive Strength and Local Muscular Endurance

This is a double-blind placebo-controlled cross-over trial that aims to determine the acute effect of beetroot juice ingestion on isometric knee extension strength, explosive strength and local muscular endurance.

The study aims to determine whether concentrated beetroot juice has an acute effect on isometric strength of the knee muscles and the rate of force development in knee extension, as well as endurance of the same muscle. This will be a cross-over study. 20 subjects will be randomly selected to the experimental group or control group; after 1 week, participants will repeat the measurements in the other condition. Subjects will consume 140 ml of beetroot juice extract 2.5 hours before the measurement or placebo (140 ml of blackcurrant juice with added appropriate amount of sugar to equalize the carbohydrate value and lemon juice fort the taste). An isometric dynamometer will be used to measure the isometric strength of the knee extensors. Investigators will quantify peak force, rate of force development, endurance of knee extensors at 50 % of the maximal force, and the force recovery after a fatiguing protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30 years
* Physically active and healthy athletes (recreational or professional)

Exclusion Criteria:

* Cardiovascular, pulmonary, metabolic, neurological diseases and musculoskeletal injuries
* Smokers
* Consumption of drugs such as antacids and proton pump inhibitors in the previous 3 months
* Pregnant or breastfeeding women
* Beetroot allergic participants
The Cognitive-behavioral Approach, Standard Plan Security on Relapse Suicidal Adolescents

The recommendation for the treatment of suicidal adolescents, Cognitive Behavioral Therapy (CBT) targeted new generation offer effective approaches to suicidal crisis and relapse prevention

The recommendation for the treatment of suicidal adolescents, Cognitive Behavioral Therapy (CBT) targeted new generation offer effective approaches to suicidal crisis and relapse prevention.

Since 2009, our team is engaged in a partnership between France and Quebec Interuniversity agreement concluded by a University Picardie Jules Verne-University of Montreal. In this context, two teams G4 (Amiens and Rouen) have received training in suicidal crisis, including the security plan by a university instructor and TCC Québec, Dr. Labelle. Furthermore, we complete a descriptive and prospective study of risk and protective factors for adolescent suicide in which the Quebec team of Professor Labelle contributes as an expert (sponsor: Rouen). 200 subjects were recruited on 2 years by 3 (CHU Amiens, CH Compiègne, CHU Rouen) with an assessment of recurrence at 1 year (lost rates of view = 15%). The first results highlight the central role of personal coping strategies (coping) in suicidal recurrence. We want extend this study to validate the implementation of the security plan (safety level) with suicidal adolescents. The security plan is the initial step of the TCC approach short of suicidal crisis. It is established after working with adolescents and their families (chain analysis of the suicidal crisis, coping self-evaluation and identification of support resources). Developed by Stanley B from Columbia University and adapted for francophone adolescents R Labelle and JJ Breton wrote this list those resources and coping strategies to apply in case ideation and suicidal crisis. Signed by the young person and his family, he then uses to frame the monitoring and management plan of the youth and his family environment, friendly and professional in case of suicidal crisis.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 12 and 17, boys and girls, hospitalized for attempted suicide
* Adolescents whose parents gave informed consent and who themselves expressed their willingness to participate in research.
* Patients covered by the social insurance system

Exclusion Criteria:

* Clinical situations with self-injury without suicidal intent or suicide attempt
* mental disorders significantly impair the self-assessment questionnaire capacities: Intellectual disability, autism spectrum disorder, acute psychotic state and, psychopathy (including assessment questionnaire Frick) and the active use of alcohol and toxic (DEP teen\> 20)
* have benefited a security plan before the study
* adolescents deprived of liberty.
Prevalence of Colon Cancer in Pyogenic Liver Abscess

Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions, the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of cryptogenic pyogenic liver abscess by colonoscopic examination.


Eligibility Criteria:
Inclusion Criteria:

* Pyogenic liver abscess radiologically and bacteriologically diagnosed

Exclusion Criteria:

* Amebic liver abscess
* Other causes of pyogenic liver abscess such as cholangitis, liver cancer, complication of transarterial chemoembolization or radiofrequency ablation to hepatocellular carcinoma
* Refusal to colonoscopic examination
* Inadequate general patient status to perform the colonoscopic examination
* Patient who has had the screening colonoscopic examination within 1 year and showed normal finding or had 1 or 2 colon polyp in adequate exam