louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02651246: Optional Sub-study to Intraoperative Imaging With ICG Registry
Official title: Optional Sub-study to Intraoperative Imaging With ICG Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung, Prostate, Breast, Colon, Pancreatic, Renal, Bladder,Thyroid, Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut) Cancer
Cancer of the Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut), Sarcoma Cancer
Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cancer patients who undergo surgery and intraoperative imaging

Brief summary: The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.

Detailed description: Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Eligibility criteria: Inclusion Criteria:

* Adult patients \>= 18 years of age
* Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence.
* Good operative candidate as determined by the treating physician and/or multidisciplinary team
* Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

* Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
* Vulnerable patient populations

Primary outcomes:
measure: Number of tumor recurrence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Sunil Singhal, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04579146: Coronary Artery Disease (CAD) in Patients HIV-infected
Official title: ROLE OF IMMUNE ACTIVATION PROFILES IN CORONARY ATHEROTHROMBOSIS IN PATIENTS HIV-1-INFECTED ON EFFECTIVE ANTIRETROVIRAL THERAPY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient VIH-1

Brief summary: HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation


Eligibility criteria: Inclusion Criteria:

HIV-infected patients \>= 45 years with 2 or more CV risk factors currently on ART HIV-RNA \< 50 copies \>= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months

Exclusion Criteria:

* Sign of coronary pathology (chest pain, syncope, dyspnea).
* ATCD of allergy to IV contrast agents
* Chronic inflammatory disease other than HIV
* Subject to a measure for the protection of justice

Primary outcomes:
measure: correlation between a particular profile of immune activation in patients HIV under treatment presenting cardiovascular risk factors and the presence of coronary atheromatous plaques
timeFrame: 24 months
Secondary outcomes:
measure: Identify the bacterial populations constituting the intestinal microbiota in patients infected with HIV and look for a microbiotic signature in patients with subclinical atherothrombosis.
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: BENNANI
Study officials:
References:
Clinical trial NCT02973646: Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection
Official title: Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis b
Keywords: chronic hepatitis b
peginterferon alfa-2b
interferon gene mutation
interferon receptor
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

Detailed description: Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex, symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also observed the laboratory test results including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).

Eligibility criteria: Inclusion Criteria:

1. Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy;
2. Hepatitis B e antigen positive.

Exclusion Criteria:

1. Patients received anti-HBV therapy in the past 6 months;
2. Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;
3. Patients with other factors causing active liver diseases;
4. Pregnancy or lactation women;
5. Patients with HIV infection or congenital immune deficiency diseases;
6. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
7. Patients with other reasons not suitable to receive interferon therapy.

Primary outcomes:
measure: good virologic response
timeFrame: 24th week
Secondary outcomes:
measure: common virologic response
timeFrame: 24th week
measure: bad virologic response
timeFrame: 24th week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05342246: Success Rates for Management of Separated Instruments
Official title: Success Rates for Management of Separated Instruments in Canals With Type II Vertucci's Classification: Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teeth, Endodontically-Treated
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 96
Sex: ALL
Minimum age (years): 33
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the prognosis of cases of Separated Instruments in Canals With Type II Vertucci's Classification treated with conservative approach

Detailed description: Teeth with Type II Vertucci root canal configuration are having more incidence of instruments separation due the presence of an S-type (Double curve). The aim of this study is to compare the outcome of minimally invasive approach (MIA), retaining the separated in one root canal, cleaning and shaping of portals of entry of the two canals and portal of exit of both canals through the other patent canal, in comparison to the outcome of retrieval of the broken instrument by ultrasonics retrieval techniques (URT)

Eligibility criteria: Inclusion Criteria:

* Presence of separated instrument in a root with a Vertucci's type II configuration (the level of the SI was evaluated using CBCT scans)
* Age range 35-55 years
* Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root

Exclusion Criteria:

* • Patients who refused to undergo radiographic follow-up.

  * Pregnant females.
  * Patients suffered from a systemic disease.
  * Teeth with lesions connected to adjacent teeth.
  * Teeth with root fractures or perforations.
  * Teeth with lesion communicating with the alveolar crest.
  * patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
  * teeth with damaged or resorbed peri- apex
  * teeth that were treated with a fiber post and teeth with canal curvature more than 25 degrees

Primary outcomes:
measure: monitoring of periapical index
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ainshams University
Study officials:
References:
citation: Hulsmann M. Methods for removing metal obstructions from the root canal. Endod Dent Traumatol. 1993 Dec;9(6):223-37. doi: 10.1111/j.1600-9657.1993.tb00278.x.
citation: Ward JR, Parashos P, Messer HH. Evaluation of an ultrasonic technique to remove fractured rotary nickel-titanium endodontic instruments from root canals: an experimental study. J Endod. 2003 Nov;29(11):756-63. doi: 10.1097/00004770-200311000-00017.
Clinical trial NCT03757546: Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections
Official title: Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Respiratory Virus Syncitial
Extra-respiratory
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults hospitalized with flu or RSV infections

Brief summary: The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.

Detailed description: Influenza virus and Respiratory Syncitial Virus (RSV) could be responsible for severe infections. Although flu was primarily considered as limited to the respiratory system, clinical reports suggest its association with organ involvement outside of the respiratory tract.

The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.

Eligibility criteria: Inclusion Criteria:

* Hospitalized adults ≥18 years old
* Flu or RSV infection confirmed by multiplex qPCR on nasal swab
* Oral non-opposition

Exclusion Criteria:

* No health insurance
* Co-infection with viruses other than influenza or RSV

Primary outcomes:
measure: Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data
timeFrame: at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
Clinical trial NCT05064046: Educating Providers About Lung Screening
Official title: Educating Providers About Health Disparities in Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer screening
provider education
health disparities
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-01
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Arm 1- LuCa + Health Disparity module: Providers enrolled in the LuCa+ arm will complete lesson 1 of the LuCa training and complete the Health Disparity module. Arm 2- LuCa module: Providers enrolled in the LuCa arm will complete session 1 of the LuCa training.
Primary purpose: SCREENING

Brief summary: We are conducting a randomized trial to compare the Health Disparities module to an existing provider module on lung cancer screening to evaluate the impact on primary care providers' knowledge, attitudes, and lung cancer screening referrals of African American and White patients.

Detailed description: We are conducting a randomized trial of two online, provider-facing education modules regarding lung cancer screening and smoking cessation. We will accrue 70 MedStar primary care providers (PCP). The baseline survey will incorporate items regarding lung cancer screening knowledge, providers' attitudes towards lung cancer screening, lung cancer screening ordering practices and provider characteristics. At the end of the baseline survey, PCPs will be randomly assigned to the LuCa + Health Disparities or LuCa only. PCPs will be asked to complete the intervention and the post-test within 1 week of randomization. The post test will cover knowledge of lung cancer screening, attitudes and opinions toward LCS. To assess PCP lung cancer screening ordering practices, we will review the MedConnect Electronic Health Record (EHR) to compare the two study groups post-randomization on the number of orders made for LCS.

Eligibility criteria: Inclusion Criteria:

* MedStar provider (attending or resident physician, physician's assistant, or nurse practitioner)
* English speaking
* ability to provide meaningful consent
* ability to provide last two digits of NPI.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of providers with improved mean lung cancer screening knowledge score
timeFrame: 1 week
measure: Number of providers with improved mean attitudes score
timeFrame: 1 week
Secondary outcomes:
measure: Rate of lung cancer screening referrals
timeFrame: 2 months post-randomization
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Health Georgetown University Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT03712046: Comparison of FDG PET and Bone Scintigraphy/Labelled Leukocyte/Gallium Scintigraphy in Diabetic Foot Osteomyelitis
Official title: Comparaison Entre la Performance du 18F-FDG PET/CT et de la Scintigraphie Osseuse/Gallium ou de la Scintigraphie Osseuse/Globules Blancs marqués /Souffre colloïdal Dans le Diagnostic d'Une ostéomyélite du Pied ou de la Cheville
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Infection
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Diabetic foot osteomyelitis is a common and serious complication of diabetes. While the diagnosis of soft tissue infection can be made with simple physical examination in most cases, bone involvement can be harder to diagnose, often requiring medical imaging. In addition to conventional radiological examinations (x-ray and MRI) nuclear medicine procedures can also provide important physiological information in these patients. These procedures include triple phase bone scan combined with Gallium scintigraphy or a combination of labelled leukocyte scintigraphy and bone marrow scintigraphy using sulfur colloid. These procedure, while they provide useful physiological information, are time consuming, generally requiring at least 2 separate image acquisition on separate days, and can be costly.

18F-FDG is a glucose analog that can be used for PET imaging. In addition to its application in oncology, the literature has shown that FDG can be used to investigate a wide variety of inflammatory and infectious conditions, including diabetic foot infections.

The aim of this study is to compare the usefulness of FDG PET imaging versus "conventional" nuclear medicine (either bone scan and Gallium scintigraphy or labelled leukocytes and sulfur colloid scintigraphy) in patient with suspected diabetic foot osteomyelitis.


Eligibility criteria: Inclusion Criteria:

* Diabetic patient with suspected diabetic foot osteomyelitis referred for nuclear medicine examination (bone scan and Gallium or labelled leukocytes).
* Being treated or followed by a physician at CHUM

Exclusion Criteria:

* Pregnant woman
* Breastfeeding patient
* Claustrophobia/patient unable to complete imaging procedure

Primary outcomes:
measure: Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
References:
Clinical trial NCT05611346: HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers
Official title: HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers : Study Protocol of a Pilot Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dermatitis
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Atopic dermatitis (AD) is a chronic inflammatory dermatosis, common in children. It causes pruritus and skin lesions that can have a significant impact on patients' quality of life. AD can be difficult to treat because of its chronicity, demanding local care, corticophobia and the financial cost of non-reimbursed products. Patients are often looking for therapeutic alternatives. Medical hypnosis is a therapeutic alternative via hypnoanalgesia induced by direct suggestions of comfort and skin soothing and via anxiolysis, by working on stress management and self-esteem reinforcement. Four studies are interested in its action in AD and seem to show a reduction in pruritus, skin pain, an improvement in the intensity of atopic dermatitis, sleep, mood and for some a cure of AD. These results are encouraging but limited by the absence of a control group or by the small population included. Therefore, we propose in a first step to evaluate the feasibility of an hypnosis program through a pilot study, designed in the miniature format of a future, larger scale, randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Children aged 8 to 17 years
* Understanding french
* With moderate to severe AD clinically diagnosed by a physician (SCORing Atopic Dermatitis (SCORAD) ≥ 25)
* Referred by their referring physician in the Reunionese therapeutic education program for AD provided within the atopy school of the Reunion University Hospital. - Oral consent of the child and of one of the legal representatives collected.

Exclusion Criteria:

* Children refusing to participate in the hypnosis session
* Not having the possibility to listen to an audio file,
* Already practicing self-hypnosis for their AD before inclusion,
* Having a contraindication to hypnosis (psychiatric disorders, psychosis)
* Treated by a systemic treatment for their AD.

Primary outcomes:
measure: Patient Recruitment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
Study officials:
affiliation: CHU de la Réunion
name: Juliette MIQUEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754346: Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
Official title: Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema, Breast Cancer
Lymphedema of Upper Limb
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
name: Istanbul Kent University
First posted: 2023-03-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Complete decongestive therapy is proven to be effective in reducing lymphedema related symptoms such as swelling and pain. Breathing exercises, on the other hand, may also help managing lymphedema symptoms. Deep breathing creates a pressure change in the abdomen, which creates a vacuum effect in the thoracic cavity and helps to empty the lymphatic vessels. Thus, we aimed to investigate whether addition of diaphragmatic breathing exercises to physical exercise component of complete decongestive therapy provides further benefits on lymphedema volume, pain and quality of life in patients with breast cancer related lymphedema.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of arm lymphedema after being treated for unilateral breast cancer with axillary node dissection
* Completion of the treatments for the disease including chemotherapy and radiotherapy after breast surgery

Exclusion Criteria:

* Having recurrent cancer
* Having cognitive disability
* Having any concurrent diseases that may interfere with the measurement of lymphedema

Primary outcomes:
measure: Change from baseline lymphedema volume at 6th week
timeFrame: 6 weeks
Secondary outcomes:
measure: Change from baseline upper extremity pain at 6th week
timeFrame: 6 weeks
measure: Change from baseline quality of life at 6th week
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Alis Kostanoglu, assoc.prof.
role: STUDY_DIRECTOR
References: