louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00958425: Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
Official title: Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cicatrix
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of hyaluronic acid gel injections compared to saline injections in improving scar quality in patients undergoing breast reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the investigators therefore hypothesize that injections of hyaluronic acid gel into breast reduction incisions will improve their appearance compared to injections of saline.


Eligibility criteria: Inclusion Criteria:

* adequate organ function (BUN \< 4.0 mmol/L; serum creatinine \< 120 micromol/L; Hgb \> 100 g/L; WBC \> 4,000/mm3 and \< 12,000/mm3; platelets \> 100,000/mm3)
* age 18 years or older, with a minimum life expectancy of 2 years
* current non-smoker
* American Society of Anaesthesiology score of 1 or 2
* ability to provide informed consent

Exclusion Criteria:

* previous history of breast surgery; known allergy to polyglactin, poliglecaprone, or injectable hyaluronic acid gel (Restylane or Prevelle)
* history of current or recent (\<2 months) immunosuppression
* documented hypersensitivity to streptococcal products
* acute or chronic skin diseases such as folliculitis or psoriasis
* history of bleeding dyscrasia or active anticoagulation (INR\>2.0)
* pregnancy or active breast-feeding
* any additional surgical procedures performed in the same surgical session in the same anatomical region
* personal or family history of susceptibility to keloid or hypertrophic scar formation
* Fitzpatrick skin type 5 or 6.

Primary outcomes:
measure: Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
timeFrame: 12 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Capital District Health Authority; Dalhousie University
name: Michael Bezuhly, MD MSc SM FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06868225: Scientific Rationale and Design for a Prospective Study to Codify Coronary Lesions Based on Fluid Mechanics and Acoustic Mechanisms
Official title: Prospective Study to Codify Coronary Lesions Based on Fluid Mechanics and Acoustic Mechanisms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Unstable Angina (UA)
Lead sponsor: Tan Tao University, School of Medicine
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients without prior PCI nor CABG

Brief summary: From January 2020 to June 2025, patients coming to the cardiac catheterization laboratories (CCL) for out-patient coronary angiography with diagnosis of unstable angina were screened for inclusion. Patients were included in the study if they had previously undergone one or more coronary angiograms, allowing for a longitudinal comparison of dynamic flow and phenomena between the two or more angiograms.

Detailed description: Patients with history of prior percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG) were excluded. The aortic stenosis patients were also excluded if they had end-stage disease with survival time \<6 months or if they had other severe hemodynamic disturbances such as hypotension from non-cardiac problems (sepsis, bleeding, etc).

Eligibility criteria: Inclusion Criteria: Patients were included in the study if they had one or two lesions in coronary angiograms. -

Exclusion Criteria: Patients with history of prior percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG) were excluded.

-

Primary outcomes:
measure: New lesion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00945425: AZD7325 Japan Multiple Ascending Dose (MAD) Study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Volunteer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese subjects

Exclusion Criteria:

* Significant illness, as judged by the investigator, within 2 weeks of Day 1
* Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor

Primary outcomes:
measure: To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG.
timeFrame: Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).
Secondary outcomes:
measure: To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine.
timeFrame: Blood and urine samples will be taken before and after study drug administration (up to 48 hours post dose).
measure: To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition).
timeFrame: Observations/Assessments are made during the treatment visit.
Other outcomes:
Locations:
Study officials:
affiliation: Kitasato University East Hospital, Kanagawa, Japan
name: Yuji Kumagai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794325: Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors
Official title: Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure to Ionizing Radiation
Coronary Heart Disease
Vascular Access Complication
Keywords: Occupational radiation exposure
Transradial approach
Transfemoral approach
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital Ernesto Dornelles
First posted: 2013-02-18
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise.

The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.


Eligibility criteria: Inclusion Criteria:

* Indication for a elective coronary angiography
* Eligible for either transfemoral or transradial approach
* Accept to sign the written consent form (WCF)

Exclusion Criteria:

* Refusal to sign the WCF
* End stage renal failure
* Urgency/Emergency procedure
* Contraindication to perform both coronary and left ventricle angiogram
* Necessity of another vascular angiogram during coronary angiography

Primary outcomes:
measure: Patient radiation exposure (mGy)
timeFrame: during coronary angiography
Secondary outcomes:
measure: Physician radiation exposure (in uSv)
timeFrame: during coronary angiography
Other outcomes:
measure: Major adverse cardiac events
timeFrame: 30 days
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: RS
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Cristiano O Cardoso, MD, MSc
role: STUDY_CHAIR
affiliation: Hospital Ernesto Dornelles
name: Luis M Yordi, MD
role: STUDY_DIRECTOR
affiliation: Insituto de Cardiologia do Rio Grande do Sul
name: Claudio V Moraes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06749548: A Comparison of Multidetector CT and TE in the Diagnosis of Congenital Cyanotic Heart Diseases
Official title: A Comparison of Multidetector Computed Tomography and Transthoracic Echocardiography in the Diagnosis of Congenital Cyanotic Heart Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Congenital Heart Disease
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the Aim is to compare the Multidetector CT and TE in the Diagnosis of Congenital Cyanotic Heart Diseases

Brief summary: Multi-detector computed tomography angiography (MDCTA) provides high-resolution images of the heart and its vasculature, allowing for accurate anatomical assessment, detection of complex cardiac morphology,

Detailed description: evaluation of coronary artery anatomy, and identification of extracardiac anomalies including the coronaries, pulmonary arteries, aorta, and pulmonary or systemic veins, and it delineates vessel walls and also displays the airway, mediastinal abnormalities, and pulmonary parenchyma by using contrast media. This modality is particularly useful for evaluating complex cardiac anatomy and identifying potential surgical or interventional targets.

Eligibility criteria: Inclusion Criteria:

* age above 18 and less than 65.
* having Congenital Cyanotic Heart Diseases

Exclusion Criteria:

* heart surgery
* other heart issues
* not consented

Primary outcomes:
measure: Computed Tomgraphy Angiogrpahy
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Timergara Teaching Hospital, Timergara District Dir Lower
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT02437448: Breath Analysis in Lung Fibrosis
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Lung Fibrosis
Idiopathic Pulmonary Fibrosis
Keywords: Mass spectrometry
Exhaled breath analysis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: Swiss National Science Foundation
First posted: 2015-05-07
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Confirmed diagnosis of idiopathic pulmonary fibrosis based on clinical, radiologic and/or pathologic data without evidence or suspicion of an alternative diagnosis that may contribute to their interstitial lung disease. Patients must fulfill all of the following criteria:

Brief summary: The aim of the study is to answer the question whether a disease specific profile of breath in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility criteria: Inclusion Criteria:

1. Clinical symptoms consistent with IPF
2. Age 40 through 80 years
3. Diagnosis of UIP or IPF by HRCT and surgical lung biopsy as outlined in table 1. Only patients fulfilling the category "YES" will be included in the study.
4. Extent of fibrotic changes (honeycombing, reticular changes) greater than extent of emphysema on HRCT scan
5. No features supporting an alternative diagnosis

Exclusion Criteria:

1. Acute exacerbation within the last 6 weeks.
2. Any relevant lung disease other than pulmonary fibrosis.
3. Acute inflammatory disease (e.g. common cold) within the last 6 weeks.
4. Acute or chronic hepatic disease.
5. Renal failure or renal replacement therapy.

Primary outcomes:
measure: IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Pulmonary Division, University Hospital of Zurich
Study officials:
References:
citation: Gaugg MT, Engler A, Bregy L, Nussbaumer-Ochsner Y, Eiffert L, Bruderer T, Zenobi R, Sinues P, Kohler M. Molecular breath analysis supports altered amino acid metabolism in idiopathic pulmonary fibrosis. Respirology. 2019 May;24(5):437-444. doi: 10.1111/resp.13465. Epub 2019 Jan 25.
Clinical trial NCT01137448: The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
Official title: The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psoriasis
Obesity
Keywords: Psoriasis
Obesity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-06-04
Enrollment: 0
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: The purpose of this study is to evaluate the effect that weight loss has on the severity of psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program. The severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to determine what effect weight loss has had on their psoriasis. Serum TNF-alpha will be measured at month 0 and month 6. The hypothesis that will be tested is that weight loss will lead to a significant improvement in the severity of psoriasis and a reduction in TNF-alpha levels.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* A Body Mass Index (BMI) \>/= 30
* Subject has plaque psoriasis
* A Psoriasis Area Severity Index (PASI) score \>/= 10 or a total body surface area (BSA) affected by psoriasis \>/= 10%
* Capable of reading, understanding, and signing a consent form
* Females of childbearing potential must have negative urine pregnancy test on Day 0, and agree to a medically effective method of birth control (as determined by the investigator)

Exclusion Criteria:

* Already participating in a study for weight loss or a study of other psoriasis treatments
* If they are on systemic therapy for their psoriasis
* Female subjects who are pregnant or planning to become pregnant
* Patients with a history of anorexia nervosa, bulimia, or other diseases that would make a weight loss program a risk to their health
* Subjects unable to comply with study protocol

Primary outcomes:
measure: Severity of psoriasis
timeFrame: 6 months
Secondary outcomes:
measure: Serum TNF-alpha levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Dermatology Clinical Research
state: Texas
Study officials:
affiliation: University of Texas Medical School - Houston
name: Adelaide Hebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03659630: MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems
Official title: MyCompass in a Swedish Context - Lessons Learned From the Transfer of an Automated Self-help Intervention Targeting Mental Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Depression
Anxiety State
Sleep Disturbance
Stress, Psychological
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study present findings from the implementation of myCompass, a fully automated self-help intervention of Australian origin for mild to moderate anxiety and depression, in a Swedish context. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.


Eligibility criteria: Inclusion Criteria:

* Swedish resident
* Valid e-mail address
* 18 years old or older
* PHQ-9 score of 5-20
* GAD-7 score of 5-15

Exclusion Criteria:

* suicidal thoughts

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 2 weeks
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nilsson A, Sorman K, Klingvall J, Ovelius E, Lundberg J, Hellner C. MyCompass in a Swedish context - lessons learned from the transfer of a self-guided intervention targeting mental health problems. BMC Psychiatry. 2019 Jan 31;19(1):51. doi: 10.1186/s12888-019-2039-1.
Clinical trial NCT04340830: The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants
Official title: The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Free Gingival Graft
Dental Implant
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are studies investigating the dimensional changes following free gingival graft (FGG) around teeth with inadequate attached gingiva, however no study investigating the effect of smoking on dimensional changes following FGG around dental implants exists. In the present study, we hypothesized that smoking might increase the dimensional change of FGG around dental implants and affect the healing of donor site.


Eligibility criteria: Inclusion Criteria:

Implants with inadequate attached gingiva on the buccal site, which placed in posterior region at least 1 year ago, and loaded with a fixed prosthetic restoration at least 6 months ago.

Exclusion Criteria:

Implants with peri-implantitis, patients who had previously the soft or hard tissue graft surgery at the site in question, patients who had previously operated from the donor site, patients with systemic disease that may interfere with periodontal surgery, patients taking any medication that can prolong bleeding, patients with immune system disease, infectious diseases such as hepatitis or HIV, individuals under the age of 18, and women with pregnant or breastfeeding.

Primary outcomes:
measure: dimensional change of free gingival graft
timeFrame: 0,1, 3, 6 months
measure: change in total free gingival graft area
timeFrame: 0, 7th day, 1,3, 6 months
Secondary outcomes:
measure: Depth of vestibule sulcus
timeFrame: 0, 7th day, 1,3, 6 months
measure: tissue thickness of recipient and donor sites
timeFrame: 0, 7th day, 1,3, 6 months
measure: VAS
timeFrame: 0,1,2,3,4,5,6,7. days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06545630: Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases
Official title: Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for R0 Resection of Colorectal Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Carcinoma
Colorectal Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of R0 excision Colorectal Cancer Liver Metastases.


Eligibility criteria: Inclusion Criteria:

Pathologically confirmed diagnosis of colorectal cancer； Karnofsky performance status 0-1; Patients with tumors identified by pathologic immunohistochemistry as pMMR or by genetic testing as MSS/MSI-L; Imaging diagnosis of stage IV, resection of both primary and metastatic tumors and had NED status after surgery; With a high risk of recurrence, such as liver metastasis CRS score \>3 or successful conversion therapy; Multiple peritoneal metastases after CC0; Function of the main organs is normal; Edition Patient's written informed consent

Exclusion Criteria:

Tumor emergencies; Abnormal coagulation function; Contagious diseases, such as HIV, HBV, HCV infection; Mental disorders; Concomitant tumors; Immunological co-morbidities

Primary outcomes:
measure: Disease-free Survival
timeFrame: Up to 18 months
Secondary outcomes:
measure: Adverse Events Related to Treatment
timeFrame: Up to 12 months
measure: Overall Survival (OS)
timeFrame: Up to 36 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 month after the last administration of Tumor Antigen-sensitized DC Vaccine
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Colorectal Cancer Center, West China Hospital
state: Chengdu/Sichuan
Study officials:
References: