louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06846944: Mixed-method Research Protocol: Evaluation of a Relaxation Technique for Anxiety Management in Pre-surgical Pediatric Patients
Official title: Mixed-method Research Protocol: Evaluation of a Relaxation Technique for Anxiety Management in Pre-surgical Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgeries Requiring a Minimum One Day Hospitalization
Anxiety
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children exhibit anxiety before surgery: in particular, the literature reports that younger children have a higher level of preoperative anxiety than older children. Preoperative anxiety has been associated with side effects such as postoperative pain and emergence delirium (ED), which are generally treated with the administration of analgesics but can cause nausea, vomiting, and drowsiness.

In addition to pharmacological strategies, there are behavioral and psychological techniques commonly referred to as nonpharmacological techniques to reduce preoperative anxiety. These are a broad set of strategies and methods, more or less complex, that can be applied to children and adolescents to help them cope with preoperative agitation and for pain control.

Nonpharmacological techniques include distraction techniques that have shown promise in reducing pediatric anxiety and include listening to music , the use of humor, and the use of games . Several researchers have found active distraction to be an effective preoperative anxiolytic in children. Of relevant importance for reducing preoperative anxiety are relaxation techniques as shown in the literature and in particular by a randomized trial that demonstrated the effectiveness of this type of proposed nonpharmacological technique for reducing anxiety and pain in pediatric patients in a preoperative setting.

This study plan to investigate the effectiveness of a breathing/relaxation intervention (Ladybug/Sunshine method) on pediatric patients' anxiety levels before surgery.


Eligibility criteria: Inclusion Criteria:

* Age between 5 years and 15 years;
* Admission for minor surgical conditions of low intensity, such as inguinal hernia, phimosis, sebaceous cysts, vascular malformations, skin lesions, ankyloglossus, afferent to the unified pediatric surgery day-surgery service of AOU Meyer;
* Knowledge of the Italian language and ability to express oneself;

Exclusion Criteria:

* Presence of cognitive impairment reported in history

Primary outcomes:
measure: Percentage reduction in anxiety score
timeFrame: From recruitment to end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital IRCCS, Firenze
state: Fi
Study officials:
References:
Clinical trial NCT01102244: A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharitis
Keywords: blepharitis
moderate to severe chronic blepharitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 122
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 this study is to evaluate the clinical efficacy and safety of Tobradex ST compared to AzaSite in the treatment of moderate to severe chronic blepharitis.


Eligibility criteria: Inclusion Criteria:

* Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye
* Have a minimum global score (the total signs and symptoms score) of 5 in the same eye qualifying.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to the test article (tobramycin, dexamethasone, azithromycin) or its components or any therapy associated with the trial
* Have a history of ocular surgical intervention within six (6) weeks prior to Visit 1 or during the study
* Have any ocular infections (bacterial, viral or fungal) - active ocular inflammation (i.e. follicular conjunctivitis, iritis) or preauricular lymphadenopathy, other than blepharitis
* Have worn contact lenses in the 72 hours prior to visit 1 and for the duration of the study
* Are currently taking any medication known to cause ocular drying that has not been on a stable dose for at least 30 days
* Have used any topical ocular or systemic antibiotics within 7 days of enrollment. Stable (greater than 1 month prior to enrollment) use of topical antibiotics on the face (except around the eyes) for dermatologic conditions is allowed. Dose must continue unchanged for duration of study
* Have used any topical ocular - aerosolized/nebulized - or systemic corticosteroid agents within 14 days of enrollment. Stable (greater than 1 month prior to enrollment) use of inhaled (using mouthpiece) and nasal corticosteroids and topical dermal steroids (except around the eyelids) are allowed. Dose must continue unchanged for the duration of the study.

Primary outcomes:
measure: Global sign and symptom score for blepharitis
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora
state: Massachusetts
Study officials:
References:
citation: Torkildsen GL, Cockrum P, Meier E, Hammonds WM, Silverstein B, Silverstein S. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis. Curr Med Res Opin. 2011 Jan;27(1):171-8. doi: 10.1185/03007995.2010.539603. Epub 2010 Dec 7.
Clinical trial NCT02081144: Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
Official title: Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Tobacco Abstinence
Keywords: Standard Care Condition
Texting + NRT Condition
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2014-03-07
Enrollment: 60
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: This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* have smoked \>= 100 cigarettes lifetime
* describe themselves as every or some day smokers
* are able to give written informed consent
* reside in Connecticut
* own a cell phone with texting capability.

Exclusion Criteria:

* inability to read or understand English
* currently receiving formal tobacco dependence treatment
* current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
* currently using Zyban (bupropion), Wellbutrin (bupropion) or Chantix (varenicline) for smoking cessation
* current suicide or homicide risk
* current psychotic disorder
* life-threatening or unstable medical or psychiatric condition
* does not have phone with CT area code and with texting capability
* lacks capacity to give informed consent
* leaving the ED against medical advice
* pregnant, nursing, or trying to conceive
* incarcerated
* resides in an extended care facility

Primary outcomes:
measure: Survey of satisfaction and usage of Smokefree TXT Program
timeFrame: 1 month post enrollment
Secondary outcomes:
measure: 7 day point prevalence abstinence
timeFrame: 1 month post enrollment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Steven L Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06133244: Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)
Official title: Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: Radboud University Medical Center
name: Leiden University Medical Center
name: Royal Free Hospital NHS Foundation Trust
First posted: 2023-11-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients (18 years and older) with:

1. SSc with hand contractures
2. SSc patients without contractures and disease duration of \< 4 years
3. VEDOSS patients

Brief summary: Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion

Primary outcomes:
measure: Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-up
timeFrame: 2 years
Secondary outcomes:
measure: Identify underlying mechanisms
timeFrame: 2 years
measure: - Validation of the Dutch PASTUL questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References:
Clinical trial NCT02443844: Comparison of Medical and Surgical Treatments of Benign Prostate Hyperplasia in Patients Who Have Low Grade Non Muscle Invasive Bladder Cancer for Tumour Recurrence and Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bladder Cancer
Keywords: BPH
bladder cancer
treatment
recurrence
progression
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare medical and surgical treatments of benign prostate hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and progression.


Eligibility criteria: Inclusion Criteria:

* Patients who have non muscle invasive bladder cancer male patients patients between 40-80 years old

Exclusion Criteria:

* Patients who have previous prostate surgery Patients who have muscle invasive bladder cancer

Primary outcomes:
measure: Recurrence
timeFrame: 3 years
Secondary outcomes:
measure: Progression
timeFrame: 3 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research Hospital
Study officials:
affiliation: Dıskapı TRH
name: Nihat Karakoyunlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li S, Zeng XT, Ruan XL, Wang XH, Guo Y, Yang ZH. Simultaneous transurethral resection of bladder cancer and prostate may reduce recurrence rates: A systematic review and meta-analysis. Exp Ther Med. 2012 Oct;4(4):685-692. doi: 10.3892/etm.2012.660. Epub 2012 Aug 9.
Clinical trial NCT06501040: Increasing Knowledge and Interest in Cancer Clinical Trials
Official title: Increasing Knowledge and Interest in Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-15
Enrollment: 384
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial investigates how well a video-based clinical trial education session works in increasing knowledge and interest in cancer clinical trials among individuals in the metropolitan Detroit region of the Karmanos Cancer Institute (KCI) catchment area. This educational activity may help researchers learn more about individuals' awareness of clinical trials, knowledge, and intention to participates in a clinical trial.

Detailed description: PRIMARY OBJECTIVE:

I. To increase cancer clinical trial knowledge and interest through video-based education among individuals aged 21 and older in the metropolitan Detroit region of the KCI catchment area.

OUTLINE:

Participants view educational video consisting of information on the purpose of clinical trials, myths associated with clinical trials, and how to find more information about clinical trials.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 21 and older
* Participants will be identified through Karmanos Cancer Institute's (KCI) clinical treatment center
* Participants will be identified through community-based KCI-sponsored events
* Participants will have voiced an interest to participate followed by an Informed consent

Exclusion Criteria

* none

Primary outcomes:
measure: Increase in Clinical Trial Awareness and Knowledge
timeFrame: Baseline and immediately post intervention up to 1 day
Secondary outcomes:
measure: Increase in intentions to participate in cancer clinical trials.
timeFrame: Baseline and immediately post intervention up to 1 day
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Hayley Thompson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02666040: Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia
Official title: A Multicenter Prospective Randomized Study Of Comparison Between Semi-Absorbable Prosthesis And Totally Nonabsorbable Prosthesis In Inguinal Hernia Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Zeta Research Ltd
First posted: 2016-01-28
Enrollment: 1200
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: With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material (conventional meshes in polypropylene "Prolene®"), and in terms of the costs for the hospital, the National Health System (NHS), and the society of associates for the use of the ULTRAPRO® in inguinal hernia surgeries.


Eligibility criteria: Inclusion Criteria:

* Elective surgery
* Males and females
* Adults over 18
* All primitive inguinal hernia

Exclusion Criteria:

* Emergency surgery
* Impossibility to complete the follow-up
* Patients with acquired immunodeficiency symptoms
* Patients with relapsed inguinal hernia

Primary outcomes:
measure: Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)
timeFrame: 6 months after the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Marco Montorsi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005440: Disability Among Adults With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To identify risk factors for work disability among adults with asthma treated by pulmonary and allergy specialists.

Detailed description: BACKGROUND:

Disability among those with asthma is common and costly. Little is known about the causes of disability in asthma; experience with other chronic diseases suggests that illness severity alone does not adequately predict disability. There is a theoretical and experimental basis upon which to postulate that other variables, including factors such as job flexibility, asthma self-efficacy, social supports, and cigarette smoking may be predictors of disability in asthma. The study helped to explain the inter-relationships among illness severity, other co-factors and disability in asthma, addressing a major research gap.

DESIGN NARRATIVE:

The study was a cross-sectional survey, including retrospective work history data. A random sample was conducted of 40 board certified pulmonologists in Northern California enrolling persons with asthma. Pulmonologists maintained a log of all persons meeting a clinical definition of asthma presenting to their offices for treatment over a one month period. A total of 601 subjects with any history of laborforce participation were interviewed by a trained survey worker in order to assess severity of disease using a severity scale based on symptoms, medications, and past-asthma history. The computer-assisted, telephone-administered interviews used established survey instruments to assess psychosocial variables, smoking exposure and work history.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Blanc PD, Cisternas M, Smith S, Yelin EH. Asthma, employment status, and disability among adults treated by pulmonary and allergy specialists. Chest. 1996 Mar;109(3):688-96. doi: 10.1378/chest.109.3.688.
citation: Katz PP, Yelin EH, Smith S, Blanc PD. Perceived control of asthma: development and validation of a questionnaire. Am J Respir Crit Care Med. 1997 Feb;155(2):577-82. doi: 10.1164/ajrccm.155.2.9032197.
Clinical trial NCT00784940: ATAC - Bone Density Sub-Protocol
Official title: A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, (in Comparison to a Control Group) When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Density
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 308
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.


Eligibility criteria: Inclusion Criteria:

* Eligible for entry into the main ATAC trial 1033IL/0029
* Women defined as post-menopausal
* Patients with histologically proven operable invasive breast cancer
* Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029)
* Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
* Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
* Patients who have had a bone fracture within the previous 6 months prior to randomisation

Primary outcomes:
measure: Time to withdrawal
measure: Time to recurrence
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03574740: Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)
Official title: Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Tobacco Use
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 1298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography. For these patients, the influence of tobacco smoking on the development of OSA will be studied.

Brief summary: The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).

Detailed description: The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).

Statistical analysis will be performed on this retrospective population to determine in tobacco smoking could influence the development of OSA.

Eligibility criteria: Inclusion Criteria:

* All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography

Exclusion Criteria:

* None

Primary outcomes:
measure: Obstructive Sleep Apnea (OSA)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Astes
name: Eric Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: