louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04609930: Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation
Official title: Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 143
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population corresponds to all patients within the University Hospitals of Montpellier system who received anti-PDF-1 and/or anti-PD-L1 immunotherapies.

Brief summary: The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.


Eligibility criteria: Inclusion Criteria:

* Electronic patient file "DxCare" at the University Hospitals of Montpellier
* Patient has received anti-PD-1 immunotherapy --AND/OR -- anti-PD-L1 immunotherapy according to central pharmacy records

Exclusion Criteria:

* No mention of % eosinophilia in the patient file

Primary outcomes:
measure: Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
timeFrame: Before treatment (before day 0) versus after (15 days)
measure: Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
timeFrame: Before treatment (before day 0) versus after (1 month)
measure: Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
timeFrame: Before treatment (before day 0) versus after (3 months)
measure: Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
timeFrame: Before treatment (before day 0) versus after (6 months)
measure: Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
timeFrame: Before treatment (before day 0) versus after (12 months)
Secondary outcomes:
measure: Indication leading to anti-PD-1 and/or anti-PD-L1 immunotherapies
timeFrame: Day 0
measure: Age (years)
timeFrame: Day 0
measure: Sex (male/female)
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Jeremy Charriot, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03161730: Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in Manikin by Novice
Official title: Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in a Normal and Cervical Immobilized Manikin by Novice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: videolaryngoscope, novice
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the intubation time and success rate between videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice airway managers.


Eligibility criteria: Inclusion Criteria:

* nurse without experience in tracheal intubation

Exclusion Criteria:

* refusal to consent

Primary outcomes:
measure: intubation time
timeFrame: within 2 min after insertion of laryngoscope into manikin's mouth
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Jong Yeop Kim
state: Gyeonggi-do
Study officials:
References:
citation: Yi IK, Kwak HJ, Lee KC, Lee JH, Min SK, Kim JY. Comparison of McGrath, Pentax, and Macintosh laryngoscope in normal and cervical immobilized manikin by novices: a randomized crossover trial. Eur J Med Res. 2020 Aug 20;25(1):35. doi: 10.1186/s40001-020-00435-0.
Clinical trial NCT01760330: IV Acetaminophen in Children Undergoing Palatoplasty
Official title: A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cleft Palate
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II
* Presenting for repair of palatoplasty with Drs. Kirschner or Pearson

Exclusion Criteria:

* ASA physical status \> II
* Underlying Syndrome
* Significant co-morbid diseases (cardiac, pulmonary, neurological disease)
* Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)

Primary outcomes:
measure: Pain
timeFrame: 24 hrs. post-op.
Secondary outcomes:
measure: Opioid consumption
timeFrame: 24 hrs. post-op
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00993330: Macular Pigment Optical Density in Healthy Subjects
Official title: Macular Pigment Optical Density in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age Related Macular Degeneration
Keywords: macular pigment
to measure macular pigment in the retina
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-10-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.

Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database.

Furthermore the nutritional habits and the influence on MP density will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects without any signs of AMD
* Age between 18 and 90 years, (20 subjects aged between 18 and 40, 20 subjects aged between 41 and 50, 20 subjects aged between 51 and 60, 20 subjects aged between 61 and 70, 20 subjects aged between 71 and 80, 20 subjects aged between 81 and 90)
* Clear non-lenticular ocular media
* Visual acuity \> 0.6

Exclusion Criteria:

* Any sign of AMD, or another retinal or optic nerve head disease
* Ocular surgery within the last 6 months
* Treatment with photosensitizing drugs

Primary outcomes:
measure: MPOD as measured with optical reflectometry
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Gerhard Garhofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04867330: Toripalimab Based Induction Chemotherapy Followed by De-escalation Protocols in HPV-related OPSCC
Official title: Induction Chemotherapy of Toripalimab With Docetaxel and Cisplatin Followed by De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oropharyngeal Carcinoma
Immune Checkpoint Inhibitor
De-escalation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma (NPC), oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers including EBV-related NPC. Oropharyngeal carcinoma was considered to be similar with NPC in terms of immune environment. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16
* positive or PCR HPV16 positive
* T1-2/N1-3M0（except T1N1M0 and single LN\<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
* Age ≥18
* No prior anti-tumor treatment
* Karnofsky Performance Score (KPS)≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* Cannot take contrast-MRI imaging
* Pregnant
* Combined with other malignant tumor (except basal cell carcinoma of skin)

Primary outcomes:
measure: PFS PFS
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Universtiy Shanghai Cancer Centre
Study officials:
References:
Clinical trial NCT05350930: Multidisciplinary Care Program to Secure MEdication Therapy for HematoLOgy Patients Receiving Injectable Anticancer Drugs
Official title: Multidisciplinary Care Program to Secure MEdication Therapy for HematoLOgy Patients Receiving Injectable Anticancer Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy Effect
G-CHOP Chemotherapy
R-CHOP Chemotherapy
Keywords: Haematology
Pharmaceutical Care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 38
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: 150 patients treated in the hematology department of a university hospital

Brief summary: Several experiences of multidisciplinary care pathways associating oncologists, pharmacists and nurses have been reported for cancer patients, with positive results on medication management safety, reduction of Drug-Related Problems (DRPs), and re-hospitalizations.

This study aims to evaluate the impact of a multidisciplinary city-hospital follow-up program on medication management safety in haematological oncology patients receiving intravenous chemotherapy in onco-haematology. Additional aspects will be evaluated, such as the impact of the follow-up on the city-hospital link, satisfaction of patients and professionals involved in the follow-up and the use of telecare


Eligibility criteria: Inclusion Criteria:

Adult patients aged 18 years or older With hematological malignancy at any stage Initiating R-CHOP or G-CHOP chemotherapy Who do not object to participation in the study and use of collected data

Exclusion Criteria:

* Patients already enrolled in a clinical trial evaluating any drug product
* Patients living in an institution
* Patients protected by law

  * Adults subject to a legal protection measure (curatorship, guardianship) (article L1121-8 of the CSP)
  * Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and persons admitted to a health or social establishment (article L1121-6 of the CSP)

Primary outcomes:
measure: Evaluation of the clinical impact of pharmacist interventions at first cycle of chemotherapy, according to the CLEO© scale.
timeFrame: 6 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud - Hospices Civils de lyon
Study officials:
References:
Clinical trial NCT02328430: Feasibility and Validity of Remote Lung Function Assessment
Official title: Comparison of Remote Camera Measures of Lung Function Compared to Standard Spirometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Lung Disease
Lead sponsor: North Bristol NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Bristol
First posted: 2014-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending UK secondary care outpatient department in respiratory medicine and how are scheduled to undergo spirometry

Brief summary: Comparison of standard spirometry to non invasive remote lung function measures of chest wall movement using depth camera technology.

Detailed description: This study plans to test a new non invasive way of measuring lung function and compare it to the current method of blowing into a spirometer.

Spirometry is an essential investigation for diagnosis and assessment of severity in people with Chronic Obstructive Pulmonary Disease (COPD) and other respiratory conditions, it is used in every respiratory unit and across primary care. It requires subjects to blow into a tube which measures volume and flow of expired air. It involves specialist equipment and training to perform and interpret. Not all patients are capable of performing spirometry, in particular children, frail, cognitively impaired and those experiencing a flare or exacerbation of symptoms. Remote lung function assessment technology has the potential to enable assessment of lung function in these groups of patients. In the future it is also hoped that it could be used to improve respiratory disease monitoring outside the healthcare environment such as in the patients home.

This new method uses the latest infra-red depth detection cameras to measure chest wall movement. (N.B this does not capture identifiable images). We would like to record participants chest wall movements while blowing into the spirometer.

Eligibility criteria: Inclusion Criteria:

1. Patients attending outpatient department in respiratory medicine.
2. Scheduled to undergo spirometry -

Exclusion Criteria:

1. Unable to give informed consent
2. Unable to perform spirometry -

Primary outcomes:
measure: Correlation between change in chest wall depth and Forced Expiratory Volume in 1 second (FEV1)
timeFrame: participants will be followed up for the duration of outpatient visit - on average 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
state: Avon
Study officials:
affiliation: Academic Clinical Lecturer
name: James W Dodd, MB CHB PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02393430: Clinical Effect of Rebamipide on Chronic Gastritis
Official title: Clinical Effect of Rebamipide on Chronic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastritis
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. The experimental group were treated with rebamipide 0.1g tid and optimization of life style, and the control group were only optimized their life style for 26 weeks. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before and after treatment.


Eligibility criteria: Inclusion Criteria:

* With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on
* diagnosed as chronic gastritis with endoscopic and pathological methods
* agree to join in this clinical trail

Exclusion Criteria:

-

Primary outcomes:
measure: modified Lanza score
timeFrame: 26 weeks
measure: visual Analog scale
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin meidcal university general hospital,China
name: Wang Bang-mao
role: STUDY_CHAIR
References:
Clinical trial NCT00962130: Glucose Monitoring in Tissue Transfers
Official title: Glucose Monitoring in Tissue Transfers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Reconstructive Tissue Surgery
Keywords: tissue perfusion
reconstructive surgery
continuous glucose monitoring
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 0
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: The purpose of this study is to determine if 1) a continuous glucose monitoring system can measure glucose levels in transferred tissue during reconstructive surgery, and 2) if glucose measurements from a continuous glucose monitoring system correlate with tissue blood perfusion.


Eligibility criteria: Inclusion Criteria:

* presence of a soft tissue deformity where reconstruction with a pedicled or free tissue transfer is indicated
* age 18 and over
* ability to follow-up post-operatively

Exclusion Criteria:

* age less than 18
* prisoner status
* inability to participate in a standard post-operative follow-up visit

Primary outcomes:
measure: Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue
timeFrame: Up to three days post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03585530: Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus
Official title: Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Phase-II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophagus Squamous Cell Carcinoma
Keywords: Esophageal neoplasma
adjuvant therapy
raltitrexed
radiotherapy
Lead sponsor: Huai'an First People's Hospital
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 32
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Concurrent chemoradiotherapy is one of the curative options for esophageal squamous cell carcinoma. We evaluated the efficacy and toxicity of raltitrexed with concurrent radiotherapy in elderly patients with esophageal cancer.


Eligibility criteria: Inclusion Criteria:

Histological or cytologic diagnosis of esophageal carcinoma. ECOG performance status 0-1. Age:70-85 years. Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy.

Stage IIa-Ⅳa(AJCC 2002). Target lesions can be measured according to RECIST criteria. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN.

Exclusion Criteria:

Multiple carcinomas of the esophagus. Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula.

Metastatic disease (M1b). A primary tumor that extended to within 2 cm of the gastroesophageal junction. Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor.

history of a second malignancy other than nonmelanoma skin cancer.

Primary outcomes:
measure: Overall survival(OS)
timeFrame: 3 years
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 3 years
measure: treatment-related toxicities
timeFrame: From the date of randomization until six months after treatment completion
measure: Quality of life(QOL)
timeFrame: 3 years
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Huai'an First Hospital
state: Jiangsu
Study officials:
References: