louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01052246: Pulsed Dye Laser Treatment of Acne Vulgaris
Official title: The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne vulgaris
laser surgery
pulsed dye lasers
benzoyl peroxidase
clindamycin
randomized controlled trial
Lead sponsor: Laserklinik Karlsruhe
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said results in a similar, albeit not identical, study design. More recently published studies failed to resolve the controversy, varying in terms of treatment procedure(s) as well as results.

While published results are certainly promising enough to be followed up by independent research, they are insufficient to justify the abdication of methods with proven efficacy. Considering patient treatment ethics and the short 'window of opportunity' for scar prevention when active inflammatory lesions are present, the investigators planned the adjuvant application of the PDL in the present study, providing all patients with the well established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial inflammatory acne.


Eligibility criteria: Inclusion Criteria:

* Adolescents and adults with moderate inflammatory acne vulgaris (ISGA degrees 2-4)
* Fitzpatrick skin type I-III

Exclusion Criteria:

* Atopic dermatitis
* Oral antibiotics during the last 4 weeks prior to enrolment
* Oral isotretinoin during the last 52 weeks prior to enrolment
* Oral contraceptives during the last 26 weeks prior to enrolment
* Topical acne therapeutics during the last 4 weeks prior to enrolment
* Diagnosis or anamnestic indication of a regional enteritis, Morbus Crohn or antibiotics-associated colitis
* Laser surgery interventions within the treatment region during the last 12 weeks prior to enrolment
* Coagulation anomalies or anticoagulant treatment
* Photo-sensitizing medication (e. g., tetracycline, gold)
* Pregnancy

Primary outcomes:
measure: Investigator's Static Global Assessment
timeFrame: day 0, day 14, day 28
measure: Lesions count
timeFrame: day 0, day 28
Secondary outcomes:
measure: Dermatology Life Quality Index
timeFrame: day 0, day 28
measure: Documentation of side effects
timeFrame: day 28
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Laserklinik Karlsruhe
Study officials:
affiliation: Laserklinik Karlsruhe
name: Syrus Karsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03117946: Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
Official title: Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Head and Neck Cancer
Keywords: immunomonitoring
immune checkpoint
chemoradiation
T cells
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer) OR histologically confirmed Head and neck cancer
* Patient candidate to a first-line concomitant radiochemotherapy
* Written informed consent

Exclusion Criteria:

* Sequential radiochemotherapy, exclusive radiotherapy, or stereotactic radiotherapy
* History of adjuvant radiochemotherapy for cancer treatment
* Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.

Primary outcomes:
measure: tumor antigen specific T-cell responses
timeFrame: up to 12 months after the end of radiochemotherapy
Secondary outcomes:
measure: monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation
timeFrame: up to 12 months after the end of radiochemotherapy
measure: Progression free survival
timeFrame: date of first progression of the disease (within 2 year after the initiation of the treatment)]
measure: overall survival
timeFrame: date of death from any cause (within 2 years after the initiation of the treatment)
measure: Quality of life related to health measured by EORTC-QLQC30
timeFrame: from the inclusion to patient death, up to 1 year
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Dijon
country: France
facility: Centre Georges François LECLERC
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
city: Reims
country: France
facility: Institut Jean Godinot
Study officials:
References:
Clinical trial NCT06397846: Identification of Biomarkers Associated With the Presence of Malignant Pancreatic Lesions Compared to Benign Lesions.
Official title: Identification of Biomarkers Associated With the Presence of Malignant Pancreatic Lesions Compared to Benign Lesions.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Pancreatic Lesion
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The challenge for medical oncology is to develop plasma biomarkers that can detect the influence of the stroma on diagnosis, prognosis and response to chemotherapy.

Today, there is no validated blood test to help diagnose pancreatic cancer (PDAC). The search for blood biomarkers of the tumor stroma and immunological markers is therefore a major challenge in orienting the diagnosis towards PDAC and optimizing the therapeutic management of pancreatic cancers.

The aim of the study is to identify biomarkers associated with the presence of malignant pancreatic lesions (patients from the Pancreas-CGE cohort, a cohort already set up by our team) compared with benign lesions (patients followed up for benign pancreatic lesions). Candidate biomarkers from our preliminary work will be considered initially. Other biomarkers may be explored secondarily.

The ultimate goal is to develop a clinico-biological signature that is as efficient as possible in predicting the presence of malignant pancreatic lesions compared with benign ones.


Eligibility criteria: Inclusion Criteria:

* Men and women ≥18 years
* Patient followed for benign pancreatic lesions:

chronic pancreatitis acute pancreatitis at a distance from the acute episode (\> 4 weeks) with indication for echo-endoscopy for suspected precancerous pancreatic lesions (PanIN, TIPMP, mucinous cystadenomas) or other cystic lesions (serous cystadenomas)

Exclusion Criteria:

* Malignant pancreatic tumor
* Legal incapacity or limited legal capacity

Primary outcomes:
measure: the malignant versus benign nature of the pancreatic lesion, based on radiological, echo-endoscopic and/or anatomopathological characteristics.
timeFrame: one visit at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital of Besancon
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT02963246: Mindfulness Therapy in Inflammatory Bowel Disease
Official title: Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Disease
Keywords: mindfulness
quality of life
Bowel Disease
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual control group in patients with bowel disease. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Detailed description: Background: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms.

Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-as usual control group in patients with bowel disease.

Outcome measures: quality of life, inflammatory and stress markers. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Eligibility criteria: Inclusion Criteria:

* patients with bowel disease diagnostic
* patients with non active disease symptoms in the last 3 month
* patients with access to internet and basic informatic knowledge

Exclusion Criteria:

* active disease symptoms
* planned surgery
* cognitive impairment
* previous experience with mindfulness

Primary outcomes:
measure: Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)
timeFrame: Change from Baseline IBDQ-32 score at 12 months
Secondary outcomes:
measure: inflammation stress markers (reactive Protein C and faecal calprotectin)
timeFrame: Change from Baseline inflammation stress markers at 12 months
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad CEU Cardenal Herrera
Study officials:
affiliation: University CEU Cardenal Herrera. Plaza Reyes Católicos nº19 03204 Elche, Alicante, Spain
name: José M Soria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00599846: The Natural History of Geographic Atrophy Progression (GAP) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age-Related Macular Degeneration
Geographic Atrophy
Keywords: age-related macular degeneration
geographic atrophy
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients showing signs of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.

Brief summary: The objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.

Exclusion Criteria:

* Age related

Primary outcomes:
measure: GA progression rate using fundus autofluorescence
timeFrame: From baseline
Secondary outcomes:
measure: GA progression rate using fundus photography
timeFrame: From baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston
state: Texas
Study officials:
affiliation: Alcon Research
name: Patricia Zilliox
role: STUDY_DIRECTOR
References:
citation: Steinberg JS, Auge J, Jaffe GJ, Fleckenstein M, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Longitudinal analysis of reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2013 Jun 10;54(6):4054-60. doi: 10.1167/iovs.12-11538.
citation: Mauschitz MM, Fonseca S, Chang P, Gobel AP, Fleckenstein M, Jaffe GJ, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Topography of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2012 Jul 26;53(8):4932-9. doi: 10.1167/iovs.12-9711.
citation: Schmitz-Valckenberg S, Alten F, Steinberg JS, Jaffe GJ, Fleckenstein M, Mukesh BN, Hohman TC, Holz FG; Geographic Atrophy Progression (GAP) Study Group. Reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Aug 24;52(9):5009-15. doi: 10.1167/iovs.11-7235.
citation: Schmitz-Valckenberg S, Fleckenstein M, Gobel AP, Hohman TC, Holz FG. Optical coherence tomography and autofluorescence findings in areas with geographic atrophy due to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):1-6. doi: 10.1167/iovs.10-5619.
Clinical trial NCT02826746: Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasms
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy.

The secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* Thyroidectomy

Exclusion Criteria:

* Allergy to magnesium
* Chronic pain
* Chronic opioid use
* Chronic NSAID use
* Renal dysfunction
* Liver dysfunction
* Cardiac arrythmia
* Seizure

Primary outcomes:
measure: Throat pain
timeFrame: Up to 48 hours after surgery end
Secondary outcomes:
measure: Fentanyl dose in recovery room
timeFrame: Up to 30 minutes after surgery end
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoum
Study officials:
References:
Clinical trial NCT03188146: Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
Official title: Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Biliary Cholangitis (PBC)
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
First posted: 2017-06-15
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PBC who are referred to centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing from 2010 will be evaluated.

Brief summary: Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.


Eligibility criteria: Inclusion Criteria:

* With liver biopsy proved PBC

Exclusion Criteria:

* A positive serological test for hepatitis B or C virus,
* Comorbidity of primary sclerosing cholangitis,
* Alcoholic liver disease,
* Hemochromatosis,
* Wilson's disease,
* a1-antitrypsin deficiency
* Presence of complications of cirrhosis (Total bilirubin \>100 lmol/L, ascites, variceal haemorrhage and hepatic encephalopathy) on admission.

Primary outcomes:
measure: Liver related Death
timeFrame: During follow-up after a year of starting UDCA, an average of 1 year
Secondary outcomes:
measure: Complications of cirrhosis
timeFrame: During follow-up after a year of starting UDCA, an average of 1 year
measure: Liver transplant
timeFrame: During follow-up after a year of starting UDCA, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.
Study officials:
affiliation: Humanity and Health Medical Centre
name: George Lau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02961946: Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
Official title: Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal administration of Nitroglycerin. Aim of this prospective research study is to investigate equivalence on image quality after sublingual or transdermal Nitroglycerin administration (H0).

Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Scheduled cCTA with contrast.
2. Able to comprehend and sign the consent form.

Exclusion Criteria:

1. Known hypersensitivity to glyceryl trinitrate, and related organic nitrates.
2. Acute circulatory failure associated with marked hypotension (shock).
3. Conditions associated with elevated intracranial pressure, cerebral haemorrhage and head trauma.
4. Closed-angle glaucoma.
5. Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®), tadalafil (Cialis), or vardenafil (Levitra) within the last 24 hours
6. Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
7. Critical aortic stenosis
8. Systolic blood pressure \< 90 mmHg
9. Pregnant or lactating female; premenopausal women with a positive urine pregnancy test.
10. Age under 18
11. Unwilling or unable to inform consent.

Primary outcomes:
measure: Coronary Artery Diameter Change
timeFrame: obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04485546: Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis
Official title: An 8-week, Multicenter, Open Label, Prospective Study With 24 Weeks of Follow-up to Evaluate Safety and Efficacy of OXERVATE™ 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis (NK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neurotrophic Keratitis
Keywords: Stage 1 Neurotrophic Keratitis
Corneal Disease
Ocular Disease
Lead sponsor: Dompé Farmaceutici S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Dompé US
First posted: 2020-07-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).


Eligibility criteria: Inclusion Criteria:

1. Male or female aged ≥ 18 years.
2. Patients with Stage 1 NK defined by the Mackie criteria

Exclusion Criteria:

1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
2. Have current or history of conditions that may confound the study data including but not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD), neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome.
3. History of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease.
4. Patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind.
5. Ocular surgery or elective ocular surgery expected during participation in the trial.
6. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.

Primary outcomes:
measure: Corneal Epithelial Healing
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego
state: California
city: Edgewood
country: United States
facility: Edgewood
state: Kentucky
city: Boston
country: United States
facility: Boston
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis
state: Missouri
city: Philadelphia
country: United States
facility: Philadelphia
state: Pennsylvania
Study officials:
affiliation: Domp Farmaceutici SpA
name: Flavio Mantelli, MD, PhD
role: STUDY_CHAIR
References:
citation: Mastropasqua L, Massaro-Giordano G, Nubile M, Sacchetti M. Understanding the Pathogenesis of Neurotrophic Keratitis: The Role of Corneal Nerves. J Cell Physiol. 2017 Apr;232(4):717-724. doi: 10.1002/jcp.25623. Epub 2016 Oct 17.