louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02220686: Vascular Physician Offer and Report (VAPOR) Trial
Official title: Vascular Physician Offer and Report (VAPOR) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease (PAD)
Keywords: VAPOR
smoking cessation
PAD
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Society for Vascular Surgery
First posted: 2014-08-20
Enrollment: 156
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 purpose of the study is to see if vascular physicians (your provider) using a combination of proven smoking cessation tools in an organized way can help vascular patients quit smoking better than usual.

The doctors where you are being treated have been chosen to either provide:

the combination therapy of giving you advice, considering prescribing medications to help you quit smoking, and referring you to a phone quitline, or to continue their usual smoking cessation practices (which may include all, some, or none of the treatments above).


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Current smoker
* Plan to have a Vascular Quality Initiative (VQI) procedure in \> 7 days

Exclusion Criteria:

* Pregnant Women, Fetuses and Neonates
* Children
* People with impaired decision-making capacity

Primary outcomes:
measure: Efficacy of the "Offer and Report" protocol for change in smoking status from Baseline Visit to 3 Month Visit
timeFrame: Change in smoking status from Baseline Visit to 3 Month Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial
state: Illinois
city: Shreveport
country: United States
facility: University Health
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Philip Goodney, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Alik Farber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spangler EL, Brooke BS, Beck AW, Hoel A, Farber A, Goodney PP; VAPOR Trial Investigators. Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial. J Vasc Surg. 2016 Apr;63(4):1121-5.e2. doi: 10.1016/j.jvs.2015.12.026.
Clinical trial NCT05037786: Effects of Pain Neuroscience Education Using an Infographic in Basketball Elite Athletes
Official title: Exploring the Effect of a Brief Pain Education Intervention on Elite Athletes: Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elite Basketball Athletes
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the control group, there will be a face-to-face intervention of 15 minutes of education on pain explained by Verbal form with supporting Powerpoint presentation. In the intervention group, the same pain education will be carried out, explained verbally but with the support of an infographic instead of a Powerpoint. The educational intervention will be carried out by one of the Unicaja Baloncesto Physiotherapists (research assistant), previously instructed by the research team.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to analyze the effectiveness of a brief educational intervention supported by an infographic versus that supported by PowerPoint on the understanding of pain in elite athletes.

Secondary objective: to analyze whether a greater understanding of pain has effects on the intensity, extent and characteristics of pain experienced in the year after the intervention.


Eligibility criteria: Inclusion Criteria:

* Elite athletes over 18 years of age from the ACB Unicaja Basketball team during years 2021-2022

Exclusion Criteria:

-

Primary outcomes:
measure: intensity, extent and characteristics of pain
timeFrame: 1 year follow up
Secondary outcomes:
measure: Understanding of pain
timeFrame: baseline and immediately after the intervention
Other outcomes:
measure: Sociodemographic variables (age, gender, country of origin, height, weight)
timeFrame: baseline
Locations:
city: Malaga
country: Spain
facility: Mar Flores Cortes
Study officials:
affiliation: University of Malaga
name: Alejandro Luque-Suarez
role: STUDY_DIRECTOR
References:
Clinical trial NCT06600386: Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications
Official title: The Influence of Individualized Intraoperative PEEP After Alveolar Recruitment Maneuvres on the Incidence of Postoperative Respiratory Complications Following Laparoscopic Abdominal Surgery. A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Respiratory Complications
Keywords: Alveolar Recruitment
Laparoscopy
Indvidualized PEEP
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ioanna Pikasi
First posted: 2024-09-19
Enrollment: 69
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: Patients ASA I-III, undergoing laparoscopic abdominal surgery will be randomly assigned, into one of two groups, namely group C-PEEP , that will be the control group ; and group I-PEEP, where alveolar recruitment maneuvres will take place in order to identify each patient\&#39;s individualized optimal PEEP. All patients will receive a standardized anesthesia regimen. The lung ultrasound score will be evaluated in all patients in the PACU and then respiratory complications will be recorded on the 24th hour, 48th hour, 7th day and 30the day, postoperatively.


Eligibility criteria: Inclusion Criteria:

ASA I-III Laparoscopic abdominal surgery

Exclusion Criteria:

Severe kidney dysfunction Severe hepatic dysfunction Severe respiratory disease Severe cardiac disease Severe neuromuscular disease BMI\&gt;30 Severe intraoperative hemorrage Severe intraoperative hemodynamic instability

Primary outcomes:
measure: Respiratory complications
timeFrame: 30 days
Secondary outcomes:
measure: Pplat
timeFrame: intraoperatively
measure: SpO2
timeFrame: intraoperatively
measure: PCO2
timeFrame: intraoperatively
measure: PaO2/FiO2
timeFrame: intraoperatively
measure: Cdyn
timeFrame: intraoperatively
measure: Ppeak
timeFrame: intraoperatively
measure: MAP
timeFrame: intraoperatively
measure: heart rate
timeFrame: intraoperatively
measure: LUS score
timeFrame: Preoperatively and 30 minutes postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
state: Attica
Study officials:
References:
Clinical trial NCT00509886: Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
Official title: Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Excess Sweating
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

Detailed description: The objective of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

Eligibility criteria: Inclusion Criteria:

* age 21-30 years
* males and females
* The subjects are in good health.
* The subjects have willingness and the ability to understand and provide informed consent for participation in the study.

Exclusion Criteria:

* Subjects with primary hyperhidrosis
* Subjects who are unable to withstand prolonged heat exposure or who have self-reported history of cardiovascular or respiratory disorders.
* Subjects who are unable to give informed consent.
* Subjects with mental illness.
* Subjects who are pregnant or nursing.
* Subjects with systemic or local skin disease and/or infection that may interfere with the conduct of the study.

Primary outcomes:
measure: Gravimetric analysis
timeFrame: 3 hours
Secondary outcomes:
measure: Subject sweat assessment
timeFrame: 3 hours
measure: HDSS
timeFrame: 3 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University dermatology
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University dermatology
name: Dennis West, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04097886: Timed Exercise Study
Official title: Investigating the Effects of Timed Exercise on Human Circadian Rhythms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Timing - Exercise
Keywords: circadian
phase shift
exercise
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to investigate the effect of timed exercise on human circadian rhythms. Subjects were randomized to 5 days of morning or evening treadmill exercise. A measure of internal circadian timing, or phase, was measured at baseline and following the exercise intervention. Change in circadian phase was compared between the morning and evening group.

Detailed description: This study investigated the effect of morning versus evening exercise on internal circadian timing, or phase. Young, sedentary subjects were recruited for this study. Baseline measures included anthropometric, body composition, cardiorespiratory fitness, chronotype, and circadian phase. Subjects were randomized to 5 consecutive days of morning or evening exercise. Thirty minutes of exercise was performed at the designated time and intensity was maintained at a heart rate corresponding with 70% peak VO2. The measure of circadian phase was salivary dim light melatonin onset, indicated by the time when saliva melatonin concentration exceeded 4pg/ml. Post-exercise circadian phase was measured the evening following the last day of exercise. Changes in circadian phase were compared between morning and evening groups.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-40.0
* sedentary; \<=2 hrs structured exercise weekly
* medication free (other than birth control)

Exclusion Criteria:

* diagnosed conditions that would contraindicate safe participation in physical activity
* diagnosed psychiatric conditions
* night or rotating shift work 1-year prior to study
* travel across time zones within previous 4 weeks
* having children \<2 years of age
* smoking

Primary outcomes:
measure: Change in onset (time) of melatonin secretion
timeFrame: baseline and following completion of exercise intervention (approximately 5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Julie Pendergast
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas JM, Kern PA, Bush HM, McQuerry KJ, Black WS, Clasey JL, Pendergast JS. Circadian rhythm phase shifts caused by timed exercise vary with chronotype. JCI Insight. 2020 Feb 13;5(3):e134270. doi: 10.1172/jci.insight.134270.
Clinical trial NCT00692263: The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
Official title: The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Healthy subjects
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2008-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours.

It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol


Eligibility criteria: Inclusion Criteria:

* Healthy
* Age: 18 - 45 years
* CYP2D6 phenotyped as extensive metabolizer
* CYP2C19 phenotyped as extensive metabolizer

Exclusion Criteria:

* Alcohol or drug abuse

Primary outcomes:
measure: AUC of (+)-M1 metabolite of tramadol
timeFrame: 24 hours
Secondary outcomes:
measure: Dynamic pupillometry
timeFrame: 24 hours
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Study officials:
affiliation: Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark
name: Kim Brosen, MD, D.Sc
role: STUDY_CHAIR
References:
Clinical trial NCT06183463: The Use of Reconstructive Surgery for Sexually Mutilated Women at the University Hospitals of Strasbourg
Official title: Use of Reconstructive Surgery for Women Consulting in Sexology at the University Hospitals of Strasbourg for Sexual Mutilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sexual Trauma
Keywords: Sexual mutilation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman (≥18 years old) having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.

Brief summary: Despite awareness since the 1980s and a legal framework to punish sexual mutilation, this tradition continues in many countries, particularly in Africa but not only in the Middle East, Malaysia and Indonesia. This custom, carried out among increasingly young little girls, exposes them to infectious, hemorrhagic and even death risks and sometimes significant obstetric complications.

Every year, 3 million girls and young women are sexually mutilated around the world, or one woman every 15 seconds.

In recent years, a surgical repair technique has been created by a French urologist, Professor Foldès. This technique allows clitoral reconstruction. Sensory reacquisition after this intervention may take a few months, but the functional results are quite good.

There is little or no data concerning the use of reconstructive surgery for these mutilated patients consulting in sexology and the future of patients post-operatively or who have not had recourse to reconstructive surgery. The investigators then questioned the decision of these patients and their future.


Eligibility criteria: Inclusion Criteria:

* Adult woman (≥18 years old)
* having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.
* having had clitoral repair surgery at the HUS between 01/01/2011 and 12/31/2021
* not objecting, after information, to the reuse of their data for the purposes of this research

Exclusion Criteria:

* Woman who expressed her opposition to participating in the study
* impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
* Woman under judicial protection or under guardianship or curatorship.

Primary outcomes:
measure: Evaluation of the future of patients who consulted sexology for sexual mutilation between 2011 and 2021 at the HUS, whether or not they opted for reconstructive surgery.
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Assistance Médicale à la Procréation - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00427063: Heredity of Retinal Vessel Tortuosity
Official title: Heredity of Retinal Vessel Tortuosity - A Twin Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: retinal vessels
tortuosity
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2007-01-26
Enrollment: 218
Sex: ALL
Minimum age (years): 20
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years. We expect to find a high heredity for the variation in tortuosity. This knowledge can contribute to the elucidation of the pathology in retinal diseases.

Detailed description: All persons underwent an ophthalmic examination including refraction, slit lamp biomicroscopy and digital fundus photography. Two independent graders (both with an MD degree) made a visual grading of the severity of tortuosity of the retinal arterioles in the fundus images.

Eligibility criteria: Inclusion Criteria:

* Samesex twin pairs of self-assessed good health

Exclusion Criteria:

* Diabetes mellitus
* Hypertension
* Thyroid disease
* Cataract or other opacities of the refractive media
* Missing fundus photographs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology Glostrup Hospital
state: Copenhagen County
Study officials:
affiliation: Department of Ophthalmology Glostrup Hospital University of Copenhagen
name: Michael Larsen, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04575363: RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer
Official title: RPSA as a Potential Prognostic Biomarker of PDAC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Keywords: Pancreatic ductal adenocarcinoma
Ribosomal protein SA (RPSA)
prognosis biomarker
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 90
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: PDAC (Pancreatic ductal adenocarcinoma) represents 90% of pancreatic tumors. The prognosis of PDAC remains poor at this time. Its management is based on surgery for early stages, associated with neoadjuvant and adjuvant chemotherapy. However, around 80% of patients will relapse after surgery. There is a lack of efficient biological biomarkers of PDAC, especially for prognosis. To date, CA19-9 is commonly used despite its lack of sensitivity and specificity.

Ribosomal protein SA (RPSA) is a transmembrane receptor localized at the cell surface but also in the cytosolic and nuclear regions. RPSA interacts with many proteins in the extracellular matrix (ECM), including laminin-1 and elastin. RPSA in involved in different cellular functions such as cell adhesion, migration, proliferation and differentiation. The expression of RPSA is increased in many cancers including breast, lung, prostate, pancreatic, etc. It could represent a molecular biomarker of tumor invasion and metastatic abilities. Moreover, the concentration of RPSA could be measured in the serum of patients with PDAC. Recent data suggest that a modification of the RPSA concentration could be a prognostic biomarker of PDAC.

Detailed description: The aim of this study is to explore the potential implication of RPSA as prognostic biomarker of PDAC.

Eligibility criteria: inclusion criteria :

* Patients treated at the Reims University Hospital for a resectable or potentially resectable pancreatic tumor, with or without neoadjuvant chemotherapy
* Adults (aged more than 18 years old)
* Patients who have signed the informed consent form

exclusion criteria :

* Patients with a prior history of cancer (excluding basal cell carcinoma or in situ cervical cancer that received conventional cancer treatment).
* Minors
* Patients for whom PDAC is not the retained diagnosis

Primary outcomes:
measure: RPSA serum concentration
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: