louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01976117: E-nose Utility in the Diagnosis of Bacterial Infection in COPD
Official title: E-nose Utility in the Diagnosis of Bacterial Infection in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-11-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from patients with COPD and bacterial infection

Detailed description: Thirty to 50% of COPD patients have airway colonization with potentially pathogenic bacteria. This is associated with worse prognosis. Currently, diagnosis of bacterial colonization relies mainly upon quantitative sputum culture. However, this method lacks good sensitivity. The electronic nose is a novel device made up of nanosensors capable of detecting specific volatile organic compounds (VOCs). OBJECTIVES: Main 1) To assess the usefulness of the electronic nose in the diagnosis of bacterial colonization in COPD. Secondary 1) To define the VOCs pattern associated with bacterial colonization. 2) To study the pattern of pulmonary and systemic inflammation associated with bacterial colonization as well its relationship with the aforementioned VOCs patterns.

Eligibility criteria: Inclusion Criteria:

* COPD patients

Exclusion Criteria:

* Exacerbation in the last 4 weeks

Primary outcomes:
measure: Breathprint in exhaled breath from patients with COPD
timeFrame: Day 1
Secondary outcomes:
measure: Breathprint in exhaled breath from COPD patients with bacterial colonization
timeFrame: Day 1
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: Sibila O, Garcia-Bellmunt L, Giner J, Rodrigo-Troyano A, Suarez-Cuartin G, Torrego A, Castillo D, Solanes I, Mateus EF, Vidal S, Sanchez-Reus F, Sala E, Cosio BG, Restrepo MI, Anzueto A, Chalmers JD, Plaza V. Airway Mucin 2 Is Decreased in Patients with Severe Chronic Obstructive Pulmonary Disease with Bacterial Colonization. Ann Am Thorac Soc. 2016 May;13(5):636-42. doi: 10.1513/AnnalsATS.201512-797OC.
Clinical trial NCT03007017: Novel Strategies for Innovating Deceased Donor Procurement
Official title: Novel Strategies for Innovating Deceased Donor Procurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Living Legacy Foundation
First posted: 2016-12-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. By innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. Further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. In this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.


Eligibility criteria: Inclusion Criteria:

1. Currently listed to receive a deceased donor kidney transplant
2. Able to fully understand the informed consent document
3. Recipient over the age of 18 years

Exclusion Criteria:

1. Recipients undergoing a bilateral native nephrectomy at time of transplant
2. Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant
3. Individuals who are unable to understand the informed consent document
4. Recipient under age 18 years
5. Recipients receiving desensitization protocols for high levels of donor specific antibodies

Primary outcomes:
measure: Sequence of organ procurement
timeFrame: 1 year
measure: Kidney quality
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
References:
Clinical trial NCT00642317: Asian Youth and Tobacco Control Survey
Official title: Asian Youth and Tobacco Control Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use
Smoking
Keywords: Healthy Control
Tobacco Use
Tobacco Initiation
Smoking
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-03-25
Enrollment: 617
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants self-identified as having Chinese or Vietnamese descent.

Brief summary: The overall goal of this study is to identify and understand the environmental characteristics associated with tobacco use and tobacco initiation among Asian American youth from primarily two communities: Chinese and Vietnamese. The specific aims of this study are twofold:

* To estimate the prevalence of smoking among Chinese and Vietnamese youth in the Houston area compared with non-Asian American communities.
* To study the relationship between environmental characteristics (both pro- and anti-tobacco) and tobacco initiation and use among Chinese and Vietnamese youth.
* To explore if degree of acculturation is related to tobacco initiation and use among Chinese and Vietnamese youth.

Detailed description: This is a survey about health-related behaviors, risks, attitudes and acculturation. It includes questions about use of alcohol, tobacco, and other drugs; safety and violence; diet and physical activity; and youth programs and resources in your community. Your answers are completely anonymous, and your name will not appear anywhere on this survey or as part of this survey. Your parents will not see your responses.

Eligibility criteria: Inclusion Criteria:

* Self-identified male or female of Chinese or Vietnamese descent
* Age 12-17 years
* Living in the Greater Houston area
* Intellectual age of 7 or higher

Exclusion Criteria: None

Primary outcomes:
measure: Prevalence Rates of smoking among Chinese and Vietnamese youth in the Houston area.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alex Prokhorov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01337817: A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
Official title: A Randomized, Double-Blinded, Active-Controlled, Crossover, Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorder
Smoking
Keywords: smoking
smokeless
aversion
nicotine
nicotine replacement
Lead sponsor: Star Scientific, Inc
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 37
Sex: ALL
Minimum age (years): 23
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.

Detailed description: Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® Wintergreen lozenge on a random basis.

Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.

After a washout period, each subject will repeat the steps with the second type of lozenge.

Eligibility criteria: Inclusion Criteria:

* healthy adult smoker
* smoking for at least 5 years
* smoking at least one (1) pack of cigarettes a day
* interest in quitting smoking

Exclusion Criteria:

* known allergy to silver or silver salts
* pregnant or breast-feeding
* current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study

Primary outcomes:
measure: Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Martinsburg
country: United States
facility: Comfort Inn
state: West Virginia
Study officials:
affiliation: Star Scientific, Inc
name: Maria Varga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454817: A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers
Official title: A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Implantable Cardiac Defibrillators
ICDs
Keywords: Quality of Life
Implantable Cardiac Defibrillators
ICDs
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-10-19
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (ICDs).


Eligibility criteria: Inclusion Criteria:

Patients:

* Patient has an ICD
* Age \> 18
* Fluent in English
* Consistent and reliable access to a phone.

Caregivers of Patients:

* Age \> 18
* Fluent in English
* Consistent and reliable access to a phone

Exclusion Criteria:

* Not having an ICD

Primary outcomes:
measure: Physical Symptoms
timeFrame: every 3 months plus after hospitalizations for an average of 1 year
measure: Psychological Symptoms
timeFrame: every 3 months plus after hospitalizations for an average of 1 year
Secondary outcomes:
measure: Quality of Life
timeFrame: every 3 months plus after hospitalizations for an average of 1 year
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado - Denver
state: Colorado
city: New Haven
country: United States
facility: Yale New-Haven Hospital
state: Connecticut
city: Rochester
country: United States
facility: Mayo Medical Center
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nathan Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03524417: Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
Official title: Effect of Equine Rabies Immunoglobulin Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rabies
Keywords: Rabies immunoglobulin
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1).

Detailed description: Rabies immunoglobulin (RIG) should be administered as soon as possible after the initiation of post-exposure prophylaxis. RIG should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. Nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7.

The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). The ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 60 years
* WHO category III rabies exposure
* Received rabies vaccination on day 0 and 3.

Exclusion Criteria:

* Received RIG
* Immunocompromised hosts or receiving immunosuppressive therapy
* Received blood or blood product within 3 months
* Received anti-malarial drugs

Primary outcomes:
measure: Rabies neutralizing antibody titers
timeFrame: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute, Thai Red Cross Society
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Suda Sibunruang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01439217: Endothelial Function, Arterial Stiffness and Components
Official title: Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia (ALL) Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute lymphoblastic leukemia
Survivor
Sibling control
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This descriptive, healthy sibling control study will utilize a convenience sample of 20 childhood ALL survivors, recruited from the Survivorship Program at Johns Hopkins (SPJH). The study will be introduced to survivors/parent/guardians during routine clinic visits. If they are interested in participation the consent form for both the survivor and sibling will be reviewed and taken home to discuss with the sibling and other family members. Follow-up phone call and questions will be encouraged. If all parties agree to participate an appointment will be set up to enroll the survivor/sibling and face to face informed consent will be obtained.

A second method for recruitment will include mailings (see attached) to ALL survivors seen/treated at Johns Hopkins. Letters will include phone and email contacts to acquire further information and a post card to decline further contact.

Brief summary: Specific Aim: Compare the endothelial function, arterial stiffness and components of metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls including measures of endothelial function and arterial stiffness obtained form a peripheral artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and insulin.


Eligibility criteria: Inclusion Criteria:

Survivor:

Inclusion

1. Ages 8-28 (8 is chosen as lower age limit because developmental understanding will allow survivor to follow instructions for procedures, 28 is chosen as upper limit to include age ranges seen for treatment in the pediatric program)
2. Off therapy for at least 6 months and not more than 10 years (6 months

Inclusion

1. Biological sibling
2. Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.))

Exclusion Criteria:

1. Uncontrolled medical conditions that could interfere with participation or interpretation of results
2. History of relapsed ALL or history of bone marrow transplantation

Primary outcomes:
measure: measure of endothelial
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
References:
Clinical trial NCT01795417: Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles
Official title: Safety and Efficacy of Non-invasive Dermatologic Procedure With XP200 Radiofrequency for the Primary Treatment of Wrinkles and Rhytids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Wrinkles
Keywords: wrinkles
rhytids
periorbital
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in 4 weekly applications to human periorbital skin area by grating pre- and 90-days post treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded evaluators.


Eligibility criteria: Inclusion Criteria:

* 35-60 years old
* periorbital wrinkles

Exclusion Criteria:

Primary outcomes:
measure: Improvement in wrinkles appearance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BTL Industries Ltd.
name: Georgi Petkov
role: STUDY_DIRECTOR
References:
Clinical trial NCT05431517: Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents
Official title: Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents: 25 Years of Experience in a Tertiary Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Stenting
Pancreatic Stent Displacement
Keywords: Endoscopic retrograde cholangiopancreatography
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 9073
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with placements of pancreatic stents under ERCP.

Brief summary: This study intends to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.

Detailed description: Endoscopic pancreatic stenting can be used to treat a variety of pancreatic disorders, including chronic pancreatitis-induced pancreatic duct stenosis, pancreatic schizophrenia, pancreatic leakage, pancreatic pseudocyst drainage, and prophylactic pancreatic duct stenting. Postoperative stent migration is one of the complications associated with pancreatic stent placement.

In this retrospective study, more than 9,000 Endoscopic retrograde cholangiopancreatography (ERCP) cases at our center over the past 25 years will be analyzed to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.

Eligibility criteria: Inclusion Criteria:

* Pancreatic stent placement under ERCP;
* Pancreatic stent migration found by ERCP;
* Displaced pancreatic stent removal by ERCP technique.

Exclusion Criteria:

* Incomplete ERCP records (e.g., missing stent size information);
* Immediate removal of pancreatic stent following implantation for a variety of reasons.

Primary outcomes:
measure: Incidence of proximally migrated pancreatic stents
timeFrame: Within 1 month after data analysis
measure: Success rate of endoscopic removal of migrated pancreatic stents
timeFrame: Within 1 month after data analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Liang-hao Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: