louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02040207: AM-101 in the Treatment of Post-Acute Tinnitus 2
Official title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinnitus
Lead sponsor: Auris Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety and local tolerance of repeated treatment with AM-101.

Detailed description: This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.

Eligibility criteria: Inclusion Criteria:

* Completion of TACTT3 study;
* Negative pregnancy test (woman of childbearing potential);
* Willing and able to attend the study visits.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Adverse event leading to treatment discontinuation in TACTT3;
* Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
* Ongoing drug-based therapy for otitis media or otitis externa;
* Drug-based therapy known as potentially tinnitus-inducing;
* Other treatment of tinnitus;
* Drug abuse or alcoholism;
* Subjects with psychiatric diseases requiring drug treatment;
* Use of antidepressant or anti-anxiety medication;
* Any clinically relevant disorder or abnormality in physical examination;
* Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
* Women of childbearing potential who are unwilling or unable to practice contraception.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Hearing threshold
timeFrame: Up to Day 203
Secondary outcomes:
measure: Hearing threshold
timeFrame: Up to Day 252
measure: Adverse events and serious adverse events
timeFrame: Up to Day 252
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Investigational site
Study officials:
References:
Clinical trial NCT01378507: Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
Official title: Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Digestive System Diseases
Keywords: endoscopic submucosal dissection
gastrointestinal neoplasm
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.

Detailed description: Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.

Eligibility criteria: Inclusion Criteria:

* Submucosal tumor
* Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion Criteria:

* Endoscopic ultrasound (EUS) or CT signs of metastasis
* Insufficient access to tumor

Primary outcomes:
measure: The lesion result before ESD
timeFrame: within 7 days before ESD
measure: Short-term result after ESD
timeFrame: whithin 7 days after ESD
Secondary outcomes:
measure: The safety of ESD procedure
timeFrame: 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Zhong-Sheng Lu, M.D.
role: STUDY_CHAIR
affiliation: Chinese PLA General Hospital
name: Yun-Sheng Yang, M.D.
role: STUDY_DIRECTOR
affiliation: Chinese PLA General Hospital
name: Jin Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
Clinical trial NCT04658407: Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Public Hospitals of Paris
Official title: Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Hospitals of the Assistance Publique - Hôpitaux de Paris (APHP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fulminating Hepatic Failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 18000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Severe liver failure or toxicants that may cause a liver failure

Brief summary: The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris.

Detailed description: Severe, fulminating acute liver failure is a rare but serious disease. The overall prognosis has improved in recent years thanks to advances in medical management and liver transplantation.

However, the epidemiology of this disease in France, the survival with or without liver transplantation of these patients and the factors that can influence this survival are not well known.

The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris (APHP).

The data will come from the APHP Health Data Warehouse

Eligibility criteria: Inclusion Criteria:

* Age \> 15
* Severe liver failure or toxicants that may cause a liver failure Or
* (PR\<50% or INR \>1.5) And ALT \>250

Exclusion Criteria:

* Patients with underlying chronic liver disease
* Patients with the conditions given by this following ICD (International Classification of Diseases) : B18 - E831 - K70 - K715 - K717 - K730- K731 - K732 - 738 - K74 - K753 - K758 - K760 - K761

Primary outcomes:
measure: The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe and fulminating acute hepatic failure within AP-HP hospitals
timeFrame: 1 month from the diagnosis of this episode
Secondary outcomes:
measure: Epidemiology of Severe and fulminating acute hepatic failure
timeFrame: Baseline
measure: Cause of death
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 9 years
measure: Analysis of Clinical Pathway
timeFrame: up to 1month after the diagnosis of this episode
measure: Reasons for new hospitalizations with an admission date within 6 months after the diagnosis this episode
timeFrame: within 6 months after the diagnosis this episode
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
References:
Clinical trial NCT01035307: Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421
Official title: Genomic and Proteomic Profiling of Childhood AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-12-18
Enrollment: 90
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously enrolled on POG 9421

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.

Detailed description: OBJECTIVES:

* To profile basal and potentiated phospho-protein networks (PPPNs) using tissue samples from pediatric patients with de novo acute myeloid leukemia (AML) previously enrolled on clinical trial POG-9421.
* To classify AML-based signal transduction mechanisms.
* To correlate profiles of basal and PPPNs with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and profiles of gene expression in tumor tissue samples.

OUTLINE: Banked tissue samples are collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria:

  * Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy)
  * Relapsed disease (early or late)
  * In continuous complete remission
* Previously enrolled on POG-9421
* Tissue samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples
measure: Classification of AML-based signal transduction mechanisms
measure: Correlation of basal and PPPN profiles with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and gene expression profiles.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Norman J. Lacayo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06989307: COVID-19 Serologies Among Healthcare Workers at CHSD (SERO2)
Official title: COVID-19 Serologies Among Healthcare Workers at CHSD (SERO2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
COVID-19 Serological Testing
COVID-19 Vaccines
Health Personnel
Antibodies, Viral
Seroepidemiologic Studies
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 447
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants will be selected from the staff of the CHSD hospital. The target population includes all hospital personnel, regardless of role or department, who volunteer to participate and provide informed consent for the serological survey.

Brief summary: This study looks at how many healthcare workers at CHSD hospital developed antibodies against COVID-19 after the second and third waves of the pandemic and after receiving a vaccine. It aims to better understand who might still be at risk of infection, how long immunity lasts after getting COVID or the vaccine, and how reliable previous antibody tests were. Blood samples will be collected from volunteer hospital staff during a one-month period to measure their antibody levels and compare them to earlier results.


Eligibility criteria: Inclusion Criteria:

- Volunteers from the hospital staff who have signed a new informed consent form

Exclusion Criteria:

* Refusal to participate (no signed consent form)
* Staff unavailable during the blood sampling period
* Participation only in the first seroprevalence survey without consent for the second

Primary outcomes:
measure: SARS-CoV-2 antibody prevalence (seroprevalence) among healthcare workers at CHSD
timeFrame: 1 month (during the serological testing period)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: France
Study officials:
References:
Clinical trial NCT03357107: Local Control After Robot-assisted Supraglottic Laryngectomy
Official title: Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supraglottic Squamous Cell Carcinoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with supraglottic squamous cell carcinoma who had undergone robot-assisted supraglottic laryngectomy and with at least 2 years follow-up

Brief summary: Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.


Eligibility criteria: Inclusion Criteria:

* Men or women over 18 years of age
* Patients with supra-glottic squamous cell carcinoma from T1 to T3, all stages N
* Patients with a robot assisted supra-glottic laryngectomy with at least 2 years follow-up

Exclusion Criteria:

* Patients for whom follow-up of at least 2 years has not been achieved;
* Major patients protected by the law (under guardianship or guardianship);
* Patients who expressed opposition to their participation in the study.

Primary outcomes:
measure: Local control
timeFrame: 2 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02236507: Normal Values for 3D High Resolution Anorectal Manometry in Children
Official title: Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Anorectal Disorder
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2014-09-10
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established.

The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.


Eligibility criteria: Inclusion Criteria:

* parental agreement
* age: 1 to 18 yr

Exclusion Criteria:

* parental disagreement
* children younger than 1 yr
* children after the surgery for anorectal malformations
* children with constipation during the last 10 months
* children with nonretentive fecal soiling
* children with inflammatory bowel diseases or any other type of large bowel inflammation
* children with anal fissure, anal varices, inflammation of the anorectal area or any other disease that may interfere with function of anorectum

Primary outcomes:
measure: Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal
timeFrame: up to 20 minutes
Secondary outcomes:
measure: Presence of Rectoanal Inhibitory Reflex
timeFrame: up to 5 minutes
measure: Presence of dyssynergic defecation
timeFrame: up to 1 minute
measure: Presence of Cough Reflex
timeFrame: 10 seconds
measure: Presence of Ano-anal Reflex
timeFrame: 10 seconds
measure: Presence of discomfort during the procedure
timeFrame: up to 20 minutes
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatric Gastroenterology and Nutrition
Study officials:
affiliation: Medical University of Warsaw
name: Marcin Banasiuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banasiuk M, Banaszkiewicz A, Dziekiewicz M, Zaleski A, Albrecht P. Values From Three-dimensional High-resolution Anorectal Manometry Analysis of Children Without Lower Gastrointestinal Symptoms. Clin Gastroenterol Hepatol. 2016 Jul;14(7):993-1000.e3. doi: 10.1016/j.cgh.2016.01.008. Epub 2016 Jan 25.
Clinical trial NCT00000307: Naltrexone as Adjunct in Alcoholic Cocaine Dependent Patients - 4
Official title: Naltrexone as an Adjunct in Alcoholic Cocaine Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol-Related Disorders
Cocaine-Related Disorders
Keywords: alcohol dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate naltrexone as an adjunct in alcoholic cocaine dependent patients; concurrent relapse prevention theory.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Verified abstinence from cocaine
timeFrame: over the 12 weeks of study
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: John Grabowski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00241007: A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension
Official title: A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: HYPERTENSION, VALSARTAN
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301


Eligibility criteria: Inclusion Criteria:

SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

-

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Adverse events and serious adverse events at each study visit for 54 weeks
Secondary outcomes:
measure: Change from baseline in diastolic blood pressure from baseline after 54 weeks
measure: Change from baseline in systolic blood pressure from baseline after 54 weeks
measure: Change from baseline in standing diastolic and systolic blood pressure after 54 weeks
measure: Hematology and blood chemistries up to 54 weeks
measure: Physical condition including pregnancy, pulse and weight at each study visit
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT03701607: Effect of Chemotherapy on PD-L1 in NSCLC
Official title: Effect of Platinum-based Chemotherapy on PD-L1 Expression in Patients With Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy
Immunotherapy
PD-L1
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced NSCLC without druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)

Brief summary: PD-L1 is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect PD-L1 in advanced NSCLC patients. The present study aims to evaluate whether PD-L1 will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
* Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

* Patient can not comply with research program requirements or follow-up;
* Patient will receive immunotherapy;

Primary outcomes:
measure: Number of participants with PD-L1 positive as assessed by immunohistochemical assay
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
References: