louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01672333: Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
Official title: Phase 2 Study of Response Rate and Side Effects of Preoperative Chemotherapy With Docetaxel, Oxaliplatin and Capcitabine (TOX) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Milad Hospital
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Early stage diagnosis of gastric cancer has ensued different approaches in its resection strategies. In order to increase the proportion of cases that undergo radical resection and reduce the recurrence rate, different pre-operative treatments are introduced. Here, the investigators investigate an active preoperative chemotherapeutic regimen to in patients with locally advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Tissue diagnosis of gastric or gastroesophageaql junction Adenocarcinoma
* T3, T4 any N with non metastatic condition
* Age 18 - 70 years
* Performance status 0,1 according to ECOG criteria
* Adequate bone marrow , liver and renal function
* Hemoglobin ≥ 11 g/dl
* Platelets ≥ 100000 / mm3
* Absolute Neutrophil Count ≥ 1500/mm3
* Normal Bilirubin
* Normal Transaminases
* Normal creatinin
* Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM, cardiopulmonary disease)

Exclusion Criteria:

* Any metastatic disease, T1, T2, N0

Primary outcomes:
measure: Pathologic Response rate
timeFrame: Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.
Secondary outcomes:
measure: clinical Response rate
timeFrame: Participants are assessed after 2 courses of Chemotherapy 3 weeks apart, an expected period of 6 weeks from starting the study treatment protocol.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Fayyazbakhsh hospital
Study officials:
affiliation: Milad Hospital
name: Bahram Salmanian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05690633: Feasibility of Obtaining Pulse Oximetry Readings from the Oropharynx
Official title: Feasibility of Obtaining Pulse Oximetry Readings from the Oropharynx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Arterial Catheterization, Peripheral
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula

Exclusion Criteria:

* Patients in whom an arterial cannula is not indicated for the surgical procedure
* Patients in whom a peripheral pulse oximeter value cannot be obtained
* Patients in whom an invasive arterial cannula cannot be placed
* Patients with any type of intra-oral pathology or injury
* Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason

Primary outcomes:
measure: Accuracy of Pulse Oximetry
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06497933: Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter
Official title: Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Pulsed field ablation
registry
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 5223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent for the first time an atrial fibrillation ablation procedure, with pulmonary veins isolation performed with the pentaspline PFA catheter in France will be included in the registry

Brief summary: Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.

Detailed description: This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France.

All patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33.

A one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years
* Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.

Exclusion Criteria:

* Previous left atrial ablation.
* Patient's opposition to participating in this registry

Primary outcomes:
measure: long-term efficacy (AA)
timeFrame: within 1-year period post-procedure
measure: very long-term efficacy (AA)
timeFrame: Within 2 years period post-procedure
Secondary outcomes:
measure: long term efficacy (AF)
timeFrame: within 1-year period post-procedure
measure: very long-term efficacy (AF)
timeFrame: Within 2 years period post-procedure
measure: Safety outcomes
timeFrame: within 1-month post-procedure
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Frederic ANSELME, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00865033: A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions
Official title: A Relative Bioavailability Study of Metformin HCL 1000 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139633: Selective Dose Escalation for Esophageal Cancer
Official title: Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: esophageal cancer, chemotherapy, radiation
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: MedImmune LLC
First posted: 2005-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel. Patients with less than complete response (CR) or partial response (PR) received dose escalation of radiation to 59.4 Gy with the same chemotherapy.

Detailed description: we prospectively enrolled patients with T1-4, N0-1, M0-1a esophageal carcinoma to receive paclitaxel 45 mg/m2 IV over 1 hour and carboplatin AUC 2 IV over 30 minutes on days 1, 8, 15, 22, 29 and 36. 5-FU 225mg/m2 was delivered as a continuous infusion on days 1-38. RT was given 1.8Gy 5 days/wk for 5.5 wks (50.4Gy in 28 fx). After 6-8 weeks, patients underwent repeat staging with computed tomography (CT) scan, endoscopic ultrasound (EUS), and biopsy. Patients with a positive biopsy, or less than PR by CT and EUS, received a boost of 9 Gy with the same concurrent chemotherapy. Patients were followed every 4 months with CT/EUS first year, every 6 months thereafter.

Eligibility criteria: Inclusion Criteria:

* T1-4, N0-1, M0-1a esophageal carcinoma

Exclusion Criteria:

* distant metastases

Primary outcomes:
measure: survival at 4 years
measure: local control at 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
Study officials:
affiliation: The Oregon Clinic
name: Steven K Seung, MDPhD
role: STUDY_CHAIR
References:
Clinical trial NCT03164733: Age Dependency of Biological Reaction on Wear Particles
Official title: Age Dependency of Biological Reaction on Wear Particles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Hip Arthroplasty
Wear
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 80 patients having received a total hip arthroplasty 4 weeks before blood sample for this study

Brief summary: Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (\<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival.

The main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.


Eligibility criteria: Inclusion Criteria:

* having received a total hip arthroplasty 4 weeks before blood sample for this study

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: biological reaction
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05234333: COVID-19 Vaccines Associated Malaise
Official title: COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Adverse Reaction
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 1534706
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients

Brief summary: COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines.

To do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in VigiBase®, the WHO pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all COVID-19 vaccines on the market and malaise. Demographic data were also analyzed.


Eligibility criteria: Inclusion Criteria:

* all adverse events reported in the WHO pharmacovigilance database

Exclusion Criteria:

* none

Primary outcomes:
measure: disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines
timeFrame: from the 01/01/2021 to the 26/01/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital, Department of Pharmacology
state: Normandie
Study officials:
References:
Clinical trial NCT02362087: Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
Official title: A Multi-Centre Study to Investigate the Natural History of Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Keywords: pain
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 75
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: Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer

Brief summary: The purpose of this study is to document what course of action physicians choose for their patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the greatest risk of TAPS by examining specific human genome markers such as single nucleotide polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic (hereditary) component.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with either invasive breast or prostate cancer (stage I-IV)
* Age ≥18 years
* ECOG performance status ≤2
* Scheduled to receive intravenous taxane-based chemotherapy for either adjuvant or metastatic disease
* Participants need to have ability to complete questionnaires by themselves or with assistance and have the ability to provide informed written consent

Exclusion Criteria:

* Concurrent use of any agents to try to prevent or treat neuropathy or TAPS, including gabapentin, glutamine, vitamin B6, and vitamin E.
* Pre-existing history of peripheral neuropathy greater than grade 1 NCI CTCAE version 4.0 from any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.) other medical conditions that would make study participation unreasonably hazardous
* Uncontrolled diabetes
* Medical or psychiatric illness that would interfere with patients' ability to complete the diary

Primary outcomes:
measure: The incidence of TAPS
timeFrame: Every 21 days over 12 weeks
Secondary outcomes:
measure: The intervention used to reduced TAPS severity
timeFrame: Every 21 days over 12 weeks
measure: The TAPS associated treatment modification
timeFrame: Every 21 days over 12 weeks
measure: Collection of whole blood and archived tissue for future SNP analysis
timeFrame: At baseline and at one month from the end of Taxane chemotherapy
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ricardo Fernandes
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Ricardo Fernandes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06503887: COVID-19 and Intestinal Microbiota in Children
Official title: SARS-CoV-2, Intestinal Microbiota and Mucosal Response in Lebanese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
Collaborators: name: Université Paris Cité
First posted: 2024-07-16
Enrollment: 86
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged between 1 month and 12 years are enrolled in the study. Sample from the control group were collected before the pandemic (for a previous study).

For the infected and recovered children, a positive PCR test is is required for their enrollment in the study.

All the children are healthy and do not suffer from any disease or comorbidity

Brief summary: SARS-CoV-2 is the causative agent of the COVID-19 pandemic. It appears to cause only mild to moderate upper respiratory symptoms in children, in addition to gastrointestinal symptoms resulting from its penetration into intestinal cells. Viral respiratory infections are often accompanied by a change in the composition of the gut microbiota (GM). Additionally, intestinal metabolites and integrity appear to be altered. This work aims to study the composition of the GM of Lebanese children, currently (n=14) and previously (n=33) infected with SARS-CoV-2 and to compare it to pre-pandemic controls (n=39). Furthermore, the correlation between the composition of the GM and the intestinal homeostasis are evaluated. Clinical data and stool samples were collected from children aged 1 month to 12 years. The bacterial profile is determined by quantitative PCR and 16S rRNA sequencing. Levels of secretory immunoglobulin A (sIgA), fecal calprotectin, beta defensin type 2 (hBD-2), short-chain fatty acids (SCFAs), tryptophan derivatives, and bile acids are also evaluated. Given the well-established relationship between the GM and the immune system, the results of this study could serve as a potential basis for the implementation of personalized nutrition and biotic supplementations aimed at restoring the host-microbiota symbiosis, pointing to the prevention and treatment of COVID-19


Eligibility criteria: Inclusion Criteria:

* Within age limits
* positive PCR

Exclusion Criteria:

* metabolic disorders, hepatic disorders, immunodeficiency, allergy, autoimmune diseases, IBD, food intolerance, antibiotic administration within 3 months, pro and prebiotic administration within 3 months

Primary outcomes:
measure: Analysis of the gut microbiota in covid-19 children
timeFrame: june 2024
Secondary outcomes:
measure: Effect on covid infection on mucosal barrier
timeFrame: june 2024
measure: correlation between gut microbiota and mucosal response
timeFrame: september 2024
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph university
Study officials:
References:
Clinical trial NCT00714987: The EVLW for Set the Positive End Expiratory Pressure (PEEP) in the Acute Respiratory Distress Syndrome (ARDS)
Official title: Predictive Value of the Extra-Vascular Lung Water (EVLW) for the Alveolar Recruitment in the Acute Respiratory Distress Syndrome ( ARDS ).
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Mechanical ventilation
PEEP with low level
PEEP with high level
EVLW
Picco® system
PaO2/FiO2 ratio
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients mechanically ventilated, monitored with the Picco® system, hospitalized in a medical critical care unit of an university hospital

Brief summary: * ARDS is a severe pathology with high mortality and morbidity.Actual ventilatory management is clear for the set of the tidal volume and for the survey of the plateau pressure for the patients who require mechanical ventilation.
* The set of the PEEP (low or high levels) remains unclear : it seems that some patients need low levels of PEEP whereas anther need high levels; but there is no validated data that can discriminate them.
* We hypothesized that patients with low levels of EVLW ( measured with the Picco® system ) need low level of PEEP to ameliorate their oxygenation ( measured with the PaO2/FiO2 ratio ) whereas patients with high levels of EVLW) need high levels of PEEP.


Eligibility criteria: Inclusion Criteria:

* age\>18;
* ARDS criteria.

Exclusion Criteria:

* severe pulmonary hypertension;
* chronic right ventricular failure;
* pulmonary embolism;
* tricuspidian valvulopathy;
* history of spontaneous pneumothorax;
* severe emphysema;
* bronchomalacia;
* recent pulmonary surgery;
* BMI\>40;
* Interstitial pulmonary fibrosis;
* End of life;
* Chronic neuromyopathie;
* Recent neurosurgery or intracranian hypertension;
* Pregnancy.

Primary outcomes:
measure: Estimate the Lung Water Extra-Vascular as predictive marker of the answer (Variation of needs in oxygen) to the ventilatory strategy: the low level, and high level of pressure positive expiratory, in the SDRA
timeFrame: During all the period of stay of the patient Intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Fady KARA, MD
role: PRINCIPAL_INVESTIGATOR
References: