louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06586034: Mobile Smoking Treatment for Hispanic Individuals Who Smoke
Official title: Culturally-Adapted Smoking Cessation Mobile App for Hispanic Individuals Who Smoke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Mobile App
Smoking Cessation
Hispanic/Latino
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The specific aims of the project are to develop and test a mobile application for smoking cessation for Hispanic individuals who smoke called Impacto.

Detailed description: A total of 56 Hispanic individuals who smoke will be recruited for this project. Six (6) participants will complete usability/functionality testing of Impacto 2.0 in the English language for both iOS and Android. Following usability/functionality testing, a field test with 50 adult Hispanic individuals who smoke (50% English-speaking and 50% Spanish-speaking) will be recruited nationally and will receive Impacto 2.0 (50% Android and iOS platforms).

Eligibility criteria: Inclusion Criteria:

* 1) being Hispanic, 2) at least 18 years of age, 2) currently smoking (i.e., at least 5 cigarettes/day) biochemically verified by a CO \&gt; 7, 3), meeting criteria for high AS (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index), 4) motivation to quit \&gt; 5 on a 10 pt. scale, 5) able to provide informed consent, 6) has daily access to their own iPhone or Android smartphone, and 7) is a fluent English or Spanish speaker.

Exclusion Criteria:

* 1) current participation in substance abuse treatment, 2) in psychotherapy for anxiety or depression, 3) concurrent use of medication for anxiety or depression, 4) active suicidality (ideation, intent, and/or plan), or 5) current psychosis.

Primary outcomes:
measure: 7-Day Point Prevalence Smoking Abstinence
timeFrame: End of treatment (Week 8)
Secondary outcomes:
measure: Anxiety Sensitivity
timeFrame: Baseline, week 4, and end of treatment (Week 8)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04506034: Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy
Official title: Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Laparoscopic Gynecologic Surgery? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.

Detailed description: Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.

Eligibility criteria: Inclusion Criteria:

* female undergoing elective gynecologic surgery

Exclusion Criteria:

* known allergy to lidocaine,
* respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,
* inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* hepatic, renal
* chronic use of analgesics or corticosteroids

Primary outcomes:
measure: Pain VAS scores at rest and during coughing were recorded postoperatively
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT02609334: RSPR-007 Mannitol Challenge Trial
Official title: A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Trial, Investigating the Efficacy of CRD007 in Adult Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: RSPR Pharma AB
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment.

Detailed description: The present trial will include subjects with diagnosed asthma in a provocation model which mimics assessments of asthma control. Mannitol challenge is an indirect asthma provocation test, which requires the presence of inflammatory cells, particularly mast cells, in the airways.

The trial involved in total 5 subject visits and will last for a maximum of 30 days for each subject from Visit 2 (Randomisation) to Visit 5 (Follow up).

Visit 2,3, and 4 will be treatment visits where Investigational Medicinal Product (IMP) is administrated 3 hours before the Mannitol challenge.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age ≥18 and \<50 years
* Diagnosis of asthma

Exclusion Criteria:

* Clinical significant comorbidities
* Lower respiratory tract infection \<6 weeks prior to Visit 1
* Others, as specified in the protocol

Primary outcomes:
measure: PD15 for mannitol after treatment with CRD007 and placebo
timeFrame: Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: København NV
country: Denmark
facility: Bisbebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05292534: Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Official title: Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Tinnitus
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: State University of New York at Buffalo
First posted: 2022-03-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.

Detailed description: 2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.

Eligibility criteria: Inclusion Criteria:

* Hearing loss
* candidate for hearing aid amplification
* Bothersome chronic tinnitus (3 months+)

Exclusion Criteria:

* age less than 18 years
* normal hearing
* tinnitus presence for less than 3 months
* tinnitus not bothersome enough to warrant intervention
* non hearing aid candidates

Primary outcomes:
measure: Tinnitus Functional Index Evaluation (TFI)
timeFrame: TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: The State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Wei Sun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.
citation: Henry JA, Griest S, Thielman E, McMillan G, Kaelin C, Carlson KF. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application. Hear Res. 2016 Apr;334:58-64. doi: 10.1016/j.heares.2015.06.004. Epub 2015 Jun 12.
Clinical trial NCT02847234: Factors Associated With Complications of Cervical Necrotizing Fasciitis
Official title: Factors Associated With Complications of Cervical Necrotizing Fasciitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Necrotizing Fasciitis
Keywords: Cervical necrotizing fasciitis
mediastinitis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted in ICU for management of cervical necrotizing fasciitis

Brief summary: Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.

The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.

Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.


Eligibility criteria: Inclusion Criteria:

- Patient admitted in ICU for management of cervical necrotizing fasciitis between 2005 and 2016.

Exclusion Criteria:

* Patients admitted in ICU for management of cervical abscess without cervical necrotizing fasciitis
* Age \< 18 years

Primary outcomes:
measure: incidence of mediastinitis
timeFrame: At the entry in ICU (Day 1)
Secondary outcomes:
measure: factors associated with mediastinitis
timeFrame: At the entry in ICU (Day 1)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Intensive Care unit, Edouard Herriot Hospital
Study officials:
affiliation: Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE
name: Thomas Rimmelé, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07020234: National Survey to Understand Ethical, Legal and Social Issues in Communicating to the Public About Epigenetics
Official title: Investigating ELSI Issues That May Facilitate or Impede Clinical Translation of Epigenetic Research: National Survey
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Epigenomics
Epigenetics
Genetics, Behavioral
Bioethics
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2025-06-13
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Few people realize that environmental pollution and some behaviors like physical activity and tobacco smoking can affect their health by "turning on" or "turning off" certain genes through a process called "epigenetic modification." This study will develop and test strategies for communicating about epigenetics that are understandable and that increase acceptance of using epigenetics in clinical settings.


Eligibility criteria: Inclusion Criteria:

English language speaker,

Identify as one of five racial/ethnic groups:

1. Non-Hispanic White
2. Non-Hispanic Black,
3. Non-Hispanic Asian
4. Non-Hispanic Indigenous (i.e., Alaska Native/Native Hawaiians/American Indian/Other Pacific Islander)
5. Hispanic (all races)

Exclusion Criteria:

* Self-identify as a genetics expert

Primary outcomes:
measure: Knowledge & understanding of epigenetics Information
timeFrame: At enrollment
Secondary outcomes:
measure: Acceptability of epigenetics information
timeFrame: At enrollment
measure: Perceptions of epigenetic information
timeFrame: At enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00687934: Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors
Official title: A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: metastatic cancer
solid tumor
histologically or cytologically confirmed non-hematological
malignancy that is metastatic or unresectable for which no
standard therapy exists
STA-9090
ganetespib
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 53
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)


Eligibility criteria: Inclusion Criteria:

* Patients must be documented to be refractory or not candidates for current approved therapies.
* Must have an ECOG status 0-2.
* Peripheral neuropathy \< or = 2.
* Must have acceptable organ and marrow function per protocol parameters.
* No clinically significant ventricular arrythmias or ischemia.

Exclusion Criteria:

* Must not be pregnant or breastfeeding.
* Chemotherapy or radiation within 3 weeks.
* Previous radiation to \>25% of total bone marrow.
* Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.
* Primary brain tumors or active brain metastases.
* Use of any investigational agents within 4 weeks.
* Treatment with chronic immunosuppressants.
* Uncontrolled, intercurrent illness.

Primary outcomes:
measure: The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities
timeFrame: Cycle 1
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
city: Kettering
country: United States
facility: US Oncology Dayton Oncology and Hematology, P.A
state: Ohio
Study officials:
References:
citation: Goldman JW, Raju RN, Gordon GA, El-Hariry I, Teofilivici F, Vukovic VM, Bradley R, Karol MD, Chen Y, Guo W, Inoue T, Rosen LS. A first in human, safety, pharmacokinetics, and clinical activity phase I study of once weekly administration of the Hsp90 inhibitor ganetespib (STA-9090) in patients with solid malignancies. BMC Cancer. 2013 Mar 25;13:152. doi: 10.1186/1471-2407-13-152.
Clinical trial NCT02981134: The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease
Official title: The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease; A Single Center, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Disease
Keywords: bioabsorbable scaffold
computed tomography
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Bioresobable Vascular Scaffold for coronary disease

Brief summary: The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Patients treated withBioresobable Vascular Scaffold for coronary disease

Exclusion Criteria:

* History of allergy to contrast
* Serum Creatinine \> 2.0 mg/dl
* Severe arrhythmia
* Pregnancy or breast feeding

Primary outcomes:
measure: Computed tomographic scan parameters
timeFrame: 3 years
Secondary outcomes:
measure: Restenosis
timeFrame: 1 year
measure: Thrombosis
timeFrame: 1 year
measure: Lumen loss
timeFrame: 1 year
measure: Positive predictive value
timeFrame: 3 years
measure: Clinical outcomes
timeFrame: 3 years
measure: Proportion of analyzable lesion
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT04760834: Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players
Official title: Concussion in French Amateur Rugby: Descriptive Cross-sectional Survey About the Management and Knowledge of Players Over the 2019/2021 Seasons
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Concussion
Keywords: Cerebral Concussion
Systems thinking
Injury management
Sport-related injury
Rugby union
Mild Traumatic Brain Injury
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Amateur rugby players

Brief summary: Rugby is a popular contact sport in France the majority of whom are amateur players. Concussion is one of the main risks given its potential severity and frequency (between 2.78 and 10 per 1,000 player hours). Faced with a concussion, stop sport activity, medical evaluation and a progressive resumption of activity are simple things to do to avoid an over-risk of injury and better recovery of the player. For this purpose, the rugby federation implement the blue card and the concussion declaration by clubs. A recent study showed that the directives of the federation are not sufficiently respected. The non-declaration problem is added knowing that around 50% of concussions are not declared. In professional rugby, the presence of a medical staff makes possible to optimize care as much as possible. In the amateur world, there are not always medical or paramedical personnel trained for this problem at the edge of the field when all the participants (player, coach, coaching) lack of knowledge on the subject and that the general practicer remains the referent for the concussion management. We will reach a dozen amateur rugby club to complete a questionnaire about concussions and conduct un formation session about this issue.


Eligibility criteria: Inclusion Criteria:

* Male 18 years of age or older
* Amateur rugby players in a club of New Aquitaine region who agreed to participate
* Licensed with the federation for 2019/2020 or 2020/2021 season
* Between the federal 1 and the 4th series

Exclusion Criteria:

- Refusal to complete the questionnaire

Primary outcomes:
measure: Number of cessation of any sporting activity
timeFrame: Inclusion
Secondary outcomes:
measure: Number of post-concussion medical examination
timeFrame: Inclusion
measure: Number of resumption of sporting activity
timeFrame: Inclusion
measure: Number of "yes" to Players's knowledge on the definition of concussion
timeFrame: Inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Hélène Cassoudesalle, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03666234: Idiopathic Pulmonary Fibrosis Registry China Study
Official title: Idiopathic Pulmonary Fibrosis Registry China Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
Epidemiology
Nature History
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 800
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese newly diagnosed IPF patients

Brief summary: By mean of registry of newly diagnosed Chinese IPF patients from more than 15 sites, this study aims to build IPF prospective cohort, set up normative clinical database and a biological specimen bank, and examine the clinical characteristics of newly diagnosed Chinese IPF patients, as well as the nature history, prognosis, comorbidities and complications of IPF patients in China, the current treatment pattern, burden of illness, and quality of life of Chinese IPF patients.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
* Aged 40 years and above at recruitment
* Willing and able to sign an informed consent

Exclusion Criteria:

* Inclusion in any interventional clinical trials
* Lung transplantation expected within the next 6 months.

Primary outcomes:
measure: Demographic and clinical characteristic of newly diagnosed Chinese IPF patients
timeFrame: up to 5 years
Secondary outcomes:
measure: Mortality in Chinese patients with IPF
timeFrame: up to 5 years
measure: Cause of death in Chinese patients with IPF
timeFrame: up to 5 years
measure: Progression-free survival in Chinese patients with IPF
timeFrame: up to 5 years
measure: Description of the acute exacerbations in Chinese patients with IPF
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Huaping Dai
state: Beijing
Study officials:
References:
citation: Xie B, Ren Y, Geng J, He X, Ban C, Wang S, Jiang D, Luo S, Chen Q, Liu M, Feng R, Zhao L, Dai H, Wang C. Idiopathic Pulmonary Fibrosis Registry China study (PORTRAY): protocol for a prospective, multicentre registry study. BMJ Open. 2020 Nov 11;10(11):e036809. doi: 10.1136/bmjopen-2020-036809.