louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06340386: Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC
Official title: Italian Validation for the Female Sexual Function Index for Breast Cancer Patients (FSFI-BC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at European Institute of Oncology for a operable breast cancer between 2012 and 2020

Brief summary: This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire.

The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies.

Detailed description: The original version of the questionnaire will be validated in two phases: a) translation, b) reliability.

1. Translation of the items and administration to a small sample of volunteers to assess usability.

   In the first phase, the questionnaire will be translated following the 5 steps:
   1. forward translation by two independent translators (from English to Italian);
   2. synthesis (discussion between translators to resolve any discrepancies);
   3. backward translation (from Italian to English) by two additional independent translators;
   4. expert committee (translators, psychologists, sexology consultants) comparing the two versions of the questionnaire; 5) testing the first version of the questionnaire with a sample (N=20) of native Italian speakers to evaluate the adequacy of content and clarity of terms used and proceeding to the final version.
2. Reliability of the questionnaire. To assess the reliability of the questionnaire, it will be administered again after a 2-week interval to a smaller sample compared to the recruited patient sample.

Eligibility criteria: Inclusion Criteria:

1. Women with operable breast cancer;
2. Operated on between 2012 and 2020;
3. Randomly selected from the institutional database; 18 years of age (Age stratification: equally represented women aged \<50 years and women aged ≥50 years);
4. Signing of the informed consent.

Exclusion Criteria:

1. Severe psychiatric or cognitive illness;
2. Ongoing psychological treatment.

Primary outcomes:
measure: Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Gabriella Pravettoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01995786: Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: Fluid Therapy
Cost-Benefit Analysis
Hemodynamics
Cost Control
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 200
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: The aim of the study is to evaluate clinical and economic impact of Goal Directed Fluid Therapy according to NICE haemodynamic protocol. Haemodynamic parameters were assessed using automated pulse contour analysis (Flotrac/Vigileo®). A specific dedicated software has been developed to perform clinical and expenditures data collection, both retrospective and prospective data are archived.


Eligibility criteria: Inclusion Criteria:

* Patients selected for major abdominal surgery

Exclusion Criteria:

•Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

Primary outcomes:
measure: rate of reduction of postoperative spending
timeFrame: 30 day postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena CI
Study officials:
affiliation: Regina Elena CI
name: Ester Forastiere
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05612386: Planning Message Recommending Same Time/Location as Last Vaccine
Official title: Planning Message Recommending Same Time/Location as Last Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
behavioral science interventions
vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 520000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the different arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. The focal comparison in this experiment is between a message suggesting the same day of the week, at the same time of day, and at the same pharmacy location as their last vaccination and a control message telling patients that an updated COVID booster vaccine is waiting for them. The intervention testing if text messages encouraging vaccination by suggesting patients receive a shot on the same day of the week, at the same time of day, and at the same pharmacy location as their last vaccination will produce more vaccinations than otherwise identical messages.


Eligibility criteria: Exclusion Criteria:

1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.

Primary outcomes:
measure: COVID bivalent booster receipt
timeFrame: During the 30 days after receiving the SMS/MMS intervention
Secondary outcomes:
measure: COVID bivalent booster receipt
timeFrame: 60 days after receiving the SMS/MMS intervention
measure: COVID bivalent booster receipt
timeFrame: 90 days after receiving the SMS/MMS intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01076686: Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects
Official title: An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Augmentation mammoplasty
Breast augmentation
Postoperative pain
Analgesia
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had been exposed to study drug and had undergone breast augmentation.

Brief summary: A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.

Detailed description: This was an observational, multicenter study conducted to investigate the long term follow-up of subjects who had been exposed to study drug (either SKY0402, bupivacaine HCl, or both) in prior SKY0402 breast augmentation studies. Specifically, the protocol was designed to elicit any changes in the response of the silicone shell of the implant after exposure to study drug.

Eligibility criteria: Inclusion Criteria:

* Participated in either Pacira SKY0402-C-210 or Pacira SIMPLE Breast Augmentation 315 and received a dose of SKY0402, bupivacaine HCl, or both
* Able and willing to comply with all study visits and procedures.
* Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments.
* Able and willing to provide written informed consent

Exclusion Criteria:

* Did not receive study drug in either Pacira SKY0402-C-210 or SIMPLE Breast Augmentation 315.
* Has a clinically significant systemic or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments.

Primary outcomes:
measure: Number of Subjects With Breast Implant Rupture
timeFrame: 12 to 24 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet Surg J. 2012 Feb;32(2):186-93. doi: 10.1177/1090820X11434524. Epub 2012 Jan 11.
Clinical trial NCT06560086: Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2
Official title: Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Testicular Macrophage Trem2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cryptorchidism
Keywords: cryptorchidism
testicular macrophages
Leydig cells
immune micro-environment
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 10
Sex: MALE
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Reduced hormone insulin-like 3, exclusively secreted by Leydig cells, has been identified as the recognized mechanism for cryptorchidism. Testicular macrophages residing in the testicular interstitium were thought to play a vital role in maintaining hormone secretion of Leydig cells. However, the contribution of macrophages to cryptorchidism remained poorly understood. Here, after 14 days of ketoconazole treatment, levels of both Trem2 and insulin-like 3 significantly decrease in human embryonic testes compared to the untreated control group. Conversely, 14 days of luteinizing hormone stimulation lead to elevated levels of Trem2 and insulin-like 3 in the testes compared to the untreated control group. Additionally, researchers find a positive correlation between Trem2 and insulin-like 3 expression in a human ex vivo tissue culture model. In summary, the study will propose Trem2 as a novel target for maintaining normal testicular descent by regulating the testicular immune microenvironment.


Eligibility criteria: Inclusion Criteria:

* 1. Termination of pregnancy is not related to the health of the fetus.
* 2. The fetus is intact in development and free of malformations and abnormalities.
* 3. Estimation of gestational age based on parietal-rump length must be between 8 and 13 weeks of gestation.

Exclusion Criteria:

* 1. The termination of pregnancy is related to the health of the fetus
* 2. The fetus is not intact in development.
* 3. The fetus has malformations, abnormalities
* 4. Estimation of gestational age based on parietal-rump length must not be within 8-13 weeks of gestation.

Primary outcomes:
measure: Relative expression of Trem2 and insulin-like 3 protein
timeFrame: The date of 14 days cultured
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated hospital of nantong university
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Wenliang Ge
role: STUDY_DIRECTOR
References:
Clinical trial NCT00769886: Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 144
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Primary outcomes:
measure: Ocular Itching
timeFrame: 3, 5, and 7 minutes post challenge at 14 days
measure: Conjunctival Hyperemia
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
Secondary outcomes:
measure: Ciliary Redness
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Episcleral Redness
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Chemosis
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Eyelid Swelling
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Percentage of Eyes With Tearing
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Percentage of Eyes With Ocular Mucus Drainage
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
Other outcomes:
Locations:
city: North Andover
country: United States
facility: Ophthalmic Research Consultants, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT05566886: Validation of a Vital Signs Monitoring Wristband
Official title: Multi Parameter Vital Signs Monitoring by the Corsano CardioWatch 287-2 Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Vital signs
Blood pressure
Oxygen saturation
Heart rate
Respiratory rate
Lead sponsor: Corsano Health B.V.
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to coronary angiography

Brief summary: Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. Wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs.

This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (RMSE); interbeat intervals at ≤ 50 ms RMSE; breathing rate at ≤ 2 brpm RMSE; and peripheral oxygen saturation at ≤ 3 percentage point RMSE. Also, this study aims to validate the Corsano CardioWatch 287-2 for the measurement of non-invasive blood pressure according to ISO 81060-2:2018.


Eligibility criteria: Inclusion Criteria:

* 18 years old;
* undergoing invasive monitoring, like coronary angiography;
* able to provide consent.

Exclusion Criteria:

Patients

* who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
* unable or not willing to sign informed consent;
* with significant mental or cognitive impairment;
* who do not have a suitable entry site for the invasive arterial line
* who do not comply to criteria established by ISO 81060-2:2018.

Primary outcomes:
measure: RMSE of Heart Rate
timeFrame: 30 minutes
measure: RMSE of Respiratory Rate
timeFrame: 30 minutes
measure: RMSE of Oxygen Saturation
timeFrame: 30 minutes
measure: RMSE of Blood Pressure
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
state: Zuid Holland
Study officials:
References:
Clinical trial NCT02407886: Retinal Ganglion Cell Layer in Patients With Intracerebral Processes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ganglion Cells
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with intracerebral lesions

Brief summary: Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans, retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in adults is considerable rare. It is, however, well established that retrograde transsynaptic degeneration affects other neural systems in humans even when the injury occurs during adulthood. Some histopathological evidence points to the possibility of transsynaptic degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults, but the clinical significance is unknown.'

Purpose:

To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to intracerebral processes. To correlate GCL with the localization and type of intracerebral lesion.

To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2 parameters is more sensitive to show retinal layer abnormalities.

To correlate GCL with visual field defects and electrophysiological parameters.


Eligibility criteria: Inclusion Criteria:

* adult patients with intracerebral lesions within the central visual tract
* associated visual field defects
* investigations (OCT, ERG) possible

Exclusion Criteria:

* lesions within the optic nerve without extension in the optic tract
* neurological disease
* optic disc anomalies: glaucoma, nystagmus, high myopia

Primary outcomes:
measure: Ganglion cell thickness
timeFrame: measurements will be taken at a minimum of 4 weeks after the inital diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Christina Gerth-Kahlert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03902886: Independent Walking Onset of Children With Cerebral Palsy
Official title: Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: toddlers, gait
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 27
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 toddlers with unilateral CP will be compared to 10 toddlers typically developed. The populations will have maximum 6 months of walking experience.

Brief summary: This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.


Eligibility criteria: Inclusion Criteria:

* Maximum age of 3 years old
* Independent walking experience of maximum 6 months
* Ability to walk 5 m without falling or needing a technical assistance
* A right or left hemiplegia in a predictive clinical context of a CP at the age of 2 years

Exclusion Criteria:

* History of lower limb musculoskeletal trauma in the last 6 months
* A known skin allergy to any adhesive product
* History of lower limb musculoskeletal surgery
* History of BTX injections into the lower limbs muscles in the last 3 months

Primary outcomes:
measure: The lower limbs Global Profile Score during gait
timeFrame: All the data collection and analysis wil be done within 2 months from the start point of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Bucharest
country: Romania
facility: Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"
Study officials:
References: