louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00807664: Biatain Ag vs Biatain in the Treament of Leg Ulcers
Official title: Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcers
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-12-12
Enrollment: 182
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 objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy


Eligibility criteria: Inclusion Criteria:

* • Patients over 18 who have given written informed consent

  * Patients with a venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8) that is between 2 cm and 13 cm in all directions
  * Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue
  * Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion
  * Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion
  * Patients who are available for monitoring for at least 10 weeks

Exclusion Criteria:

* • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment

  * Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion
  * Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion
  * Patients who have been taking systemic antibiotics in the two weeks prior to inclusion
  * Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion
  * Patients with unbalanced diabetes at the discretion of the investigator
  * Patients with a known allergy to one of the components in Biatain Argent® or Biatain
  * Patients who are already taking part in another clinical study
  * Patients who are pregnant or breastfeeding

Primary outcomes:
measure: Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline
timeFrame: Day 0 to Day 42
Secondary outcomes:
measure: Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline
timeFrame: Day 0 to Day 70
measure: Total Number of Adverse Events
timeFrame: Day 0 to Day 70
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02276664: Capitalizing on a Teachable Moment to Promote Smoking Cessation
Official title: Capitalizing on a Teachable Moment to Promote Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: lung cancer prevention
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
First posted: 2014-10-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.

Detailed description: Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.

Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.

Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.

Eligibility criteria: Inclusion Criteria:

Study 1

* Participants for Study I will be drawn from a list of patients who have received a CT scan at the Moffitt Cancer Center
* Smoked at least one cigarette per week prior to undergoing the CT scan
* Able to speak and read English

Study 2

* Smoked at least one cigarette over the past week
* Able to read English

Primary outcomes:
measure: Study 1 - Completion of Formative Evaluation
timeFrame: Up to 12 months
measure: Study 2 - Rate of Seven-Day Abstinence
timeFrame: Seven-day abstinence will be assessed at each follow-up, allowing for calculation of point-prevalence abstinence rates. For this pilot, we will not bioverify self-reported abstinence.
Secondary outcomes:
measure: Rate of Intervention Demand
timeFrame: Up to 9 months
measure: Degree of Practicality
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06340464: Preoperative Nutritional Status Scores to Predict PPC in Elderly With Cardiac Surgery
Official title: Investigation & Comparison of the Effects of Preoperative Nutritional Status Scores to Predict Post-op Pulmonary Complications Among Elderly Patients With Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery
Elderly Patient
Postoperative Pulmonary Complication
Nutrition Scoring System
Keywords: Cardiac surgery
Elderly, Aged
Postoperative pulmonary complication
Nutrition scoring system
GNRI
MNA
PNI
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 229
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients (aged ≥ 60 years old) who undergoing cardiac surgery in Songklanagarind hospital, Songkla, Thailand

Brief summary: This prospective study investigate prognostic values and compare the role of nutritional status by using GNRI, MNA, and PNI in predicting post-operative pulmonary complication among elderly patients with cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Elderly patient age ≥ 60 years
* Open heart surgical procedure on pump (CABG, valvular disease, combine CABG and valve surgery
* Elective surgery

Exclusion Criteria:

- Emergency surgery

Primary outcomes:
measure: Postoperative pulmonary complication
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
name: Panalee Kittisopaporn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556564: The Impact of Migraine on Canadians' Productivity: A Real-World Pharmacy-Based Study
Official title: The Impact of Migraine on Canadians' Productivity: A Real-World Pharmacy-Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: PeriPharm
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with migraine treated with triptans in Canada

Brief summary: This is a cross-sectional, real-world observational, community pharmacy-based study in which adults treated with a triptan for their migraine will self-report productivity and activity impairment using a web-based portal or paper-based questionnaire.

Detailed description: The primary objective of this study is to estimate the productivity and activity impairment associated with migraine in adults treated with a triptan.

Participant identification will be made using pharmacies member of the PROxy Network. Eligible participants will be identified using the prescription of any formulation of triptans either when filling or refilling a prescription of a triptan or in the pharmacy electronic database (patients with a renewal in the last 3 months).

The PROxy Network is a research network bringing together community pharmacies across Quebec to facilitate the generation of real-world evidence. This network is designed to better understand a disease or a treatment using patient-reported outcomes (PROs). The PROxy Network is an initiative of PeriPharm Inc., a company specializing in pharmacoeconomics and outcomes research.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* New or current prescription (renewal in the last 3 months) of any formulation of triptans medication (i.e., almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan and frovatriptan);
* Working full or part-time or going to school full or part-time;
* Ability to read and understand English or French;
* Signature of informed consent form (ICF).

Exclusion Criteria:

* Patients participating in a clinical trial.
* Patients filling a one-time vacation/emergency prescription (i.e. without a complete pharmacy file).

Primary outcomes:
measure: The Migraine Disability Assessment (MIDAS) questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: PROxy Network, an initiative of PeriPharm inc.
state: Quebec
Study officials:
affiliation: PeriParm inc.
name: Jean Lachaine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03154164: Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy
Official title: Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystolithiasis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 240
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing laparoscopic cholecystectomy

Brief summary: The present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. Patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All participating surgeons have experience of the traditional approach with electrocautery. The operation time as well as the surgeons own evaluation of difficulty and performance are noted. Selected films are analyzed by independent surgeons with experience of the fundus first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to record the intra and postoperative complication rate.

Detailed description: The present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. Patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All participating surgeons have experience of the traditional approach with electrocautery, but limited experience from gallstone surgery with ultrasonic tissue coagulation dissection.

The operation time as well as the surgeons own evaluation of difficulty and performance are noted. Selected video recordings are analyzed by independent surgeons with experience of the fundus first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to record the intra and postoperative complication rate. The study is intended to serve as a pilot study for a subsequent randomised controlled trial, comparing surgery with electrocautery and ultrasonic tissue coagulation dissection.

Eligibility criteria: Inclusion Criteria:

* Preoperatively discovered choledocholithiasis

Exclusion Criteria:

* Symptoms and signs of acute or chronic cholecystitis

Primary outcomes:
measure: Dissection time
timeFrame: 6 hours
Secondary outcomes:
measure: Level of technical complexity
timeFrame: 6 hours
measure: Level of technical performance
timeFrame: 6 hours
measure: Technical performance
timeFrame: 6 hours
measure: Complication rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT04161664: Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy
Official title: Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Squamous Cell Carcinoma of the Vulva
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a prospective, phase II trial to investigate the response rate of carboplatin and paclitaxel in patients with vulvar carcinoma
Primary purpose: TREATMENT

Brief summary: Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Detailed description: Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Eligibility criteria: Inclusion Criteria:

* Woman 18 years
* Signed and written informed consent.
* Histologically confirmed squamous cell vulvar carcinoma
* World Health Organization performance status of 0-2
* Adequate hematological function
* Adequate hepatic function
* Adequate renal function
* Negative pregnancy test for woman of childbearing potential
* Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma
* Measurable disease
* Lesion previously not irradiated
* TNM stage any T any N M1

Exclusion Criteria:

* Vulvar cancer other than squamous cell carcinoma at biopsy
* Previous radiotherapy of the vulva, groins or pelvis
* Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent
* Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study

Primary outcomes:
measure: tumour size reduction by neo adjuvant chemotherapy
timeFrame: 18 weeks
Secondary outcomes:
measure: chemotherapy related morbidity
timeFrame: 21 weeks
measure: overall survival
timeFrame: 5 years after treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
affiliation: NKI-AvL
name: Frederic Amant, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00465764: Tolerance and Development of Healthy, Term Infants
Official title: Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: healthy infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2007-04-25
Enrollment: 115
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.


Eligibility criteria: Inclusion Criteria:

* Healthy term infants;
* Age 0-8 days of age;
* Exclusively formula fed;
* No use of vitamin/mineral supplements.

Exclusion Criteria:

* Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Primary outcomes:
measure: Mean rank stool consistency at 14 days of age
timeFrame: 14 days of age
Secondary outcomes:
measure: Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding
timeFrame: 14 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Houston
country: United States
facility: Children's Nutrition Research Center, Baylor College of Medicine
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Marlene W Borschel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01809964: Clinical Trial to Evaluate ANT-1401 in Crow's Feet
Official title: Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crows Feet
Lead sponsor: Anterios Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 109
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.


Eligibility criteria: Inclusion Criteria:

* 30 - 60 years of age
* mild to moderate Crow's Feet wrinkles (IGA 1-2) at rest
* moderate to severe Crow's Feet (IGA 2-3) on contraction
* moderate to severe Crow's Feet (SSA 2-3) on contraction
* Have adequate vision to assess facial wrinkles in a mirror

Exclusion Criteria:

* botulinum toxin treatment in the prior 6 months
* history of periocular surgery, brow lift or related procedures
* soft tissue augmentation in the lateral canthal region in the prior 12 months
* dermabrasion or laser treatment in the periocular region in the last 6 months
* topical prescription-strength retinoids in the prior 3 months
* present or history of neuromuscular disease
* present or history of "dry eye"
* systemic aminoglycoside use in the week prior to treatment application

Primary outcomes:
measure: Investigator's Global Assessment Scale
timeFrame: Week 4
Secondary outcomes:
measure: Subject Self-Assessment
timeFrame: Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Miami
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Knoxville
country: United States
state: Tennessee
Study officials:
References:
Clinical trial NCT04937764: Interest of Medial Partial Arthrodesis in Degenerative and Inflammatory Damage of Lisfranc Tarsometatarsal Joint.
Official title: Interest of Medial Partial Arthrodesis in Degenerative and Inflammatory Damage of Lisfranc Tarsometatarsal Joint.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis Foot
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in the department of orthopeadic surgery of the CHU NANCY

Brief summary: Research Hypothesis: Lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate.

Objective of the study: To analyze the clinical and radiographic results in the medium term of arthrodesis of the Lisfranc tarsometatarsal joint in cases of primary osteoarthritis, post-traumatic osteoarthritis or in cases of inflammatory pathology.

Detailed description: Data collection by return to the patient record:

* Clinical score
* Analysis of imagery (X-rays, CT scan, )

The patients included were those who had undergone arthrodesis of the medial Lisfranc joint

Eligibility criteria: Inclusion Criteria:

* All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in
* Age \> 18 ans

Exclusion Criteria:

* Follow-up \< 6 months
* Lost to follow-up
* lack of data in the patient record.

Primary outcomes:
measure: Clinical improvement of the AOFAS score of the midfoot
timeFrame: 1 year post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU NANCY, Central Hospital
state: Meurthe Et Moselle
Study officials:
affiliation: CHU NANCY
name: Didier Mainard, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04127864: Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery
Official title: Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery Using a Functional Whole Blood Immune Stimulation Assay
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Surgery
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2019-10-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for minimally invasive colorectal cancer resection at Zealand University Hospital. They will undergo standard treatment characterized by strict adherence to the enhanced recovery after surgery guidelines

Brief summary: At Zealand University Hospital, Denmark, the investigators will examine the immune function of patients with colorectal cancer before and after tumor resection.

The immune function will be assessed with functional profiling of the immune function (TruCulture®)

The study aims to describe alterations in the perioperative immune response to surgery. The generatied knowledge will lead to better under standing of perioperative pathophysiology.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for laparoscopic resection of colorectal cancer with curative intent

Exclusion Criteria:

* Age under 18
* Neoadjuvant chemo or radiation therapy

Primary outcomes:
measure: Cytokines in LPS stimulated blood
timeFrame: Postoperative day 1
measure: Cytokines in CD3+CD28 stimulated blood
timeFrame: Postoperative day 1
measure: Cytokines in Poly I:P stimulated blood
timeFrame: Postoperative day 1
measure: Cytokines in R848 stimulated blood
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Cytokines in unstimulated blood
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Center for Surgical Science, Zealand University Hospital
state: Region Zealand
Study officials:
affiliation: Center for Surgical Science, Zealand University Hospital, Denmark
name: Ismail Gögenur, DMSc
role: STUDY_DIRECTOR
References: