louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02070835: Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers
Official title: Autologous Skin Cell Versus Classic Skin Grafts in Treatment of Diabetic Foot Ulcers: a Comparative Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Autologous skin cell
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.

Detailed description: The primary objective of this study is to assess the effectiveness and safety of autologous skin cell with skin graft (experiment group) vs. skin graft (control group) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that the methods of experiment group is better than the control group.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years old
* with a diagnosis of type 1 or type 2 diabetes
* who had a diabetic low extremity ulcer last for over 4 weeks
* with a stage 2 by Wagner's scale
* size more than 3 cm2
* absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2)
* had indications of skin grafting were eligible for inclusion

Exclusion Criteria:

* patients with medical conditions that would impair wound healing (e.g. malignancy, autoimmune disease),
* using corticosteroids or immunosuppressor
* a high anesthesiology or surgical risk
* uncontrolled hyperglycemia (preoperative HbA1c greater than 12.0%)

Primary outcomes:
measure: healing rate
timeFrame: postsurgery week 4
Secondary outcomes:
measure: recurrent rate
timeFrame: postsurgery months 6
Other outcomes:
measure: complication rate
timeFrame: postsurgery week 4
Locations:
city: Guangzhou
country: China
facility: Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Burns, The First Affiliated Hospital, Sun Yat-sen University
name: Jiayuan Zhu, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03695835: A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.
Official title: A Retrospective and Prospective Study of a New Immunotherapy Regimen (MyVaccx) for Patients With Adenocarcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma
Keywords: prostate cancer
lung cancer
pancreatic cancer
colorectal cancer
bladder cancer
Lead sponsor: Gary Onik MD
Sponsor class: INDIV
First posted: 2018-10-04
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adenocarcinoma treated with the MyVaccx System through the Center for High Risk and Recurrent Prostate Cancer.

Brief summary: A retrospective and prospective data collection study on 27 consecutive subjects with adenocarcinoma who were treated using the MyVaccx system by Dr. Gary Onik. Retrospective data were collected on the treatment with the immunotherapy system and prospective data will be collected as they are prospectively monitored through their normal standard of care for their original cancer.


Eligibility criteria: Inclusion Criteria:

* Treatment with the MyVaccx System
* Greater than 18 years of age
* Signature of the informed consent

Exclusion Criteria:

* 2 subjects treated with the MyVaccx System with known visceral disease

Primary outcomes:
measure: MyVaccx immunotherapy treatment impact on late stage cancer disease
timeFrame: From date of treatment until the date of death from any cause up to 60 months
Secondary outcomes:
measure: MyVaccx immunotherapy treatment impact on late stage cancer disease
timeFrame: Time to progression after a complete or partial response up to 60 months
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: The Center for High Risk and Recurrent Prostate Cancer
state: Florida
Study officials:
References:
Clinical trial NCT04945135: Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of Transfusion, One-year Graft Survival and Mortality. Cohort Study,
Official title: Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing LT

Brief summary: RBC requirement ein DBD and DCD liver transplants

Detailed description: Background: Controlled donation after cardiac circulatory death (cDCD) is accepted to expand the donor pool for liver transplantation (LT). However, transfusion requirements and perioperative outcomes should be elucidated. The aims of this multicentre study are to assess the red blood cell (RBC) transfusions, one-year graft and patient survival after LT with cDCD compared to donors after brain dead (DBD).

Methods: 591 LT patients conducted in ten centers during 2019 were reviewed. Thromboelastometry was used to manage coagulation and blood product transfusion in all centres. Normothermic regional perfusion was the standard technique for organ recovery.

Eligibility criteria: Inclusion Criteria:

* patients undergoing LT

Exclusion Criteria:

* acute liver failure

Primary outcomes:
measure: RBC transfusion
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Bilbao
country: Spain
facility: Hospital de Cruces
Study officials:
References:
Clinical trial NCT00120835: Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
Official title: An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C
Keywords: Genotype-1
Treatment-Naive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-07-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.


Eligibility criteria: Inclusion Criteria:

* Documented clinical history compatible with genotype-1, chronic hepatitis C infection
* Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant
* Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
state: Florida
city: San Antonio
country: United States
state: Texas
city: Santurce
country: Puerto Rico
Study officials:
References:
Clinical trial NCT05908435: Impact of Sunscreen Dispensers in Parks Visited by Teenagers
Official title: Measuring the Impact of Free Sunscreen Dispensers in Community Settings Frequented by Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Neoplasm
Adolescent Behavior
Sunscreening Agents
Keywords: Skin Neoplasm
Adolescent Behavior
Sunscreening Agents
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2023-06-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the use of publicly available free sunscreen dispensers at Maine beaches and Boston and Cambridge parks.

Aim 1: Determine the impact of DFS+ (dispensers, flyers, enhanced signage, + a social media component delivered by teen ambassadors) sun protection education on the use of free sunscreen dispensers by adolescents ages 12-20 compared with DFS (dispensers, flyers, standard signage).

Aim 2: Outcomes evaluation to assess the effects of the sunscreen dispensers and the sun-safety educational intervention on sun protection knowledge, attitudes, beliefs, and behaviors within the community.

Aim 3: Cost Evaluation and Cost-Effectiveness Analysis

Detailed description: The investigators will build on the pioneering work of IMPACT Melanoma which has provided free sunscreen dispensers to a general population. This study will build on IMPACT Melanoma's ability to install, maintain, and now for the first time, target and publicize the use of dispensers for a teen population. The investigators will test scalable methods for improving the use of free sunscreen dispensers by testing DFS interventions compared with the addition of social media led by teen ambassadors. The investigators will evaluate the impact of the intervention in both parks and beaches in Boston, MA, Cambridge, MA and Maine.

Eligibility criteria: Inclusion Criteria:

* Being a Boston, MA, Cambridge, MA or Maine youth ages 12-20
* Able to complete a survey in English

Exclusion Criteria:

* Not a Boston, MA, Cambridge, MA or Maine youth ages 12-20
* Not able to complete a survey in English

Primary outcomes:
measure: Dispenser utilization/Measured reduction in sunscreen levels in dispensers
timeFrame: In real-time, up to 1 day
measure: Reported use of sunscreen from surveys completed by teens
timeFrame: In real-time, up to 1 day
Secondary outcomes:
measure: Sun prevention practices
timeFrame: In real-time, up to 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard TH Chan School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Alan Geller, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852135: Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres
Official title: Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Surgical Procedures
Keywords: Laryngeal Mask Airway
lateral position
laparoscopic surgery
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages over the classic LMA.Several publications have reported the successful, safe use of Laryngeal Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no studies that have examined the application of LMA in patients during lateral positioned laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general anesthesia.

Detailed description: We undertook a single-blind, parallel-group, randomized controlled trial.The patients were randomized to either LMA Proseal group or LMA Supreme group by computer generated allocation.

The patients were scheduled for elective lateral positioned laparoscopic surgery, such as laparoscopic radical nephrectomy, laparoscopic renal cyst decortication (LRCD) or laparoscopic adrenalectomy.Inclusion criteria for the patients were: Aged\>18 years, ASA physical status grade I - Ⅲ and body mass index ≤30 kg.m-2. Exclusion criteria were: anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Eligibility criteria: Inclusion Criteria:

* The patients belong to ASA physical status grade I and Ⅲ, aged above 18 years and body weight less than 30 kg/m2,who underwent elective laparoscopic urology surgery in the lateral position.

Exclusion Criteria:

* The patients with anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Primary outcomes:
measure: oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group
timeFrame: intraoperative
Secondary outcomes:
measure: Ventilatory efficiency scores for the LMAs
timeFrame: intraoperative
measure: Adverse effects in two groups
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433
name: Liu Yi, D.M
role: STUDY_DIRECTOR
References:
Clinical trial NCT05870735: Discovering Factors in Narcolepsy Patients' Clinical Research Experiences
Official title: The Patient Voice in Narcolepsy Clinical Trials: Reflections on Experiences and Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Narcolepsy
Keywords: Narcolepsy
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are actively considering involvement in an observational narcolepsy trial, but have not yet completed enrollment and registration.

Brief summary: An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs.

Overall, an observational clinical trial is an important tool for advancing the understanding of narcolepsy and improving outcomes for patients.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is able and willing to comply with the treatment/follow-up schedule and requirements
* Patient must provide written informed consent

Exclusion Criteria:

* Women who are pregnant, intend to become pregnant, or are lactating
* Inability to perform regular electronic reporting
* Participants who are vulnerable to any intervention

Primary outcomes:
measure: Rate of patients who decide to enroll in a narcolepsy clinical study.
timeFrame: 3 months
measure: Number of narcolepsy study participants who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.
citation: Bassetti CLA, Adamantidis A, Burdakov D, Han F, Gay S, Kallweit U, Khatami R, Koning F, Kornum BR, Lammers GJ, Liblau RS, Luppi PH, Mayer G, Pollmacher T, Sakurai T, Sallusto F, Scammell TE, Tafti M, Dauvilliers Y. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519-539. doi: 10.1038/s41582-019-0226-9. Epub 2019 Jul 19.
citation: Leschziner G. Narcolepsy: a clinical review. Pract Neurol. 2014 Oct;14(5):323-31. doi: 10.1136/practneurol-2014-000837. Epub 2014 May 15.
Clinical trial NCT02317835: Diabetic Foot Ulcer Prevention System
Official title: An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Foot
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: National Physical Laboratory
name: University of South Wales
name: Freeman Health System
name: Pennine Acute Hospitals NHS Trust
name: National Institute for Health Research, United Kingdom
name: Photometrix
First posted: 2014-12-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older
2. Has no history of diabetes
3. Has no previous history of foot ulceration
4. Has no previous history of foot surgery
5. Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
6. Has no history of peripheral neuropathy
7. Has no history of peripheral arterial disease
8. Must be able to provide meaningful written informed consent for the study

Exclusion Criteria:

1. Has active foot ulceration and infection
2. Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
3. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
4. Has an implantable electronic device
5. Is aged \<18

Primary outcomes:
measure: Detection of hot spots on a foot thermal map image
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
city: Manchester
country: United Kingdom
facility: The Pennine Acute Hospitals NHS Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals
Study officials:
References:
citation: Petrova NL, Whittam A, MacDonald A, Ainarkar S, Donaldson AN, Bevans J, Allen J, Plassmann P, Kluwe B, Ring F, Rogers L, Simpson R, Machin G, Edmonds ME. Reliability of a novel thermal imaging system for temperature assessment of healthy feet. J Foot Ankle Res. 2018 May 30;11:22. doi: 10.1186/s13047-018-0266-1. eCollection 2018.
Clinical trial NCT01808235: Oral Health Intervention Pilot Study for Individuals With Memory Problems
Official title: Developing a Caregiver-assisted Oral Health Intervention for Individuals With Memory Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to pilot test an intervention to improve oral health for individuals with memory problems. The results from this study will assist in developing prevention and intervention programs aimed at maintaining good oral health, or at least slowing its deterioration.

Detailed description: This project will involve two phases. The main purpose of Phase 1 is to conduct a focus group with 6 individuals with mild dementia (IMDs) and their live-in partners (usually spouse) and conduct in-depth interviews with staff at community organizations (e.g., dementia caregiver support group staff) to develop the protocol. Information from Phase 1 will provide input to refine the proposed pilot intervention that will be Phase 2 of this project. The pilot oral health intervention will last 6 months and will be conducted with up to ten IMDs and their live-in partners.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of mild dementia within the past year.
* Have at least four natural teeth.
* 60 years and older.
* Living with an informal caregiver who is willing to participate.
* Community-dwelling
* Physically able to brush own teeth.

Exclusion Criteria:

* Edentulism
* Unable to have an oral health evaluation done.
* Sensory or physical problems that prevent participation in the intervention.
* Terminal illness or hospitalization for a psychiatric disorder in the prior year.

Primary outcomes:
measure: Change in oral health
timeFrame: Day 1, 3 months, and 6 months
Secondary outcomes:
measure: Changes in subjects' self-efficacy
timeFrame: Day 1, 3 months, and 6 months
Other outcomes:
measure: Changes in oral hygiene recorded using a brief questionnaire
timeFrame: Every two weeks for six months
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Bei Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06445335: Prevalence of NAFLD in T2DM Patients
Official title: The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: NAFLD
T2D
Type 2 Diabetes
Fatty Liver, Nonalcoholic
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 385
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: To determine the prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Having type 2 diabetes mellitus (T2DM)
* Written informed consent obtained

Exclusion Criteria:

* Excessive alcohol use
* Exclusion of other causes of liver disease and secondary causes of steatosis

Primary outcomes:
measure: Prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Mathieu Struyve, MD
role: PRINCIPAL_INVESTIGATOR
References: