louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00728416: Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
Official title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-05
Enrollment: 333
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* A subject must be 12 years of age or older, of either sex, and of any race.
* A subject must have at least a 2-year history of SAR which exacerbates during the study season.
* A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
* A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
* A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
* A subject who is participating in any other clinical study.
* A subject who is part of the staff personnel directly involved with this study.
* A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
* A female subject who is breast-feeding, pregnant, or intends to become pregnant.
* A subject previously randomized into this study.
* A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

Primary outcomes:
measure: Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
timeFrame: 15 days of treatment
Secondary outcomes:
measure: Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
timeFrame: 15 days of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.
Clinical trial NCT06179316: The Relationship Between Bone Pelvis Measurements and Erectile Function in Patients Who Had Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation
Official title: The Relationship Between Bone Pelvis Measurements and Erectile Function in Patients Who Had Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Erectile Dysfunction
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preoperative Prostate MRI imaging was performed, "Bilateral Nerve Saving Robot Assisted Radical Prostatectomy Operation" was performed, and a regular sexual life was performed; Male patients who have not received neoadjuvant therapy, have no history of radiotherapy to the pelvic region, and do not need postoperative hormono-radiotherapy

Brief summary: In order to evaluate the relationship between bone pelvis measurements and erectile function in patients who underwent nerve-sparing robot-assisted radical prostatectomy, bone pelvis measurements will be measured from MRI images of the patients before the operation and their erection quality will be evaluated with the IIEF-5 form. The erection quality of the same patients will be evaluated with the IIEF-5 form in the 3rd and 6th months after the operation. And it will be evaluated whether there is a relationship between the erection quality of the patients before and after the operation and their bone pelvis measurements.


Eligibility criteria: Inclusion Criteria:

* Having bilateral nerve-sparing robot-assisted radical prostatectomy operation
* Having a regular sexual life

Exclusion Criteria:

* Having received neoadjuvant therapy
* Having a history of radiotherapy to the pelvic area
* The need to receive postoperative hormono-radiotherapy

Primary outcomes:
measure: ııef-5 score
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06200116: Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation in Radiation Treatment Planning
Official title: Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation in Radiation Treatment Planning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Solid Neoplasm
Hematopoietic and Lymphatic System Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All employed medical dosimetrists or medical dosimetry assistants who routinely perform review of AI generated auto-segmentation of normal tissues.

Brief summary: This study measures the utility of a novel artificial intelligence (AI) algorithm for performing auto-segmentation of computed tomography (CT) scans for radiation therapy planning.

Detailed description: PRIMARY OBJECTIVE:

I. To measure the observed utility of an AI algorithm for normal segmentation by recording study subjects' observations of its function.

OUTLINE: This is an observational study.

Participants complete surveys about the performance/functionality of the auto-segmentation algorithm on study.

Eligibility criteria: Inclusion Criteria:

* Employment at Mayo Clinic Arizona, Florida, or Rochester (which includes Regional Practice sites located at Mayo Clinic Health System locations) as train clinical staff that participate in normal tissue segmentation

Exclusion Criteria:

* Inability to complete study surveys

Primary outcomes:
measure: Proportion of success
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Albert Lea
country: United States
facility: Mayo Clinic Health System in Albert Lea
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health Systems-Mankato
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Eau Claire
country: United States
facility: Mayo Clinic Health System-Eau Claire Clinic
state: Wisconsin
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic in Rochester
name: Doug J. Moseley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01085916: Prevalence of Asthma and Rhinitis Symptoms Among Secondary School Students in Saudi Arabia
Official title: Prevalence of Asthma and Rhinitis Symptoms Among Secondary School Students in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Rhinitis
Keywords: prevalence of asthma and Rhinitis symptoms among secondary school students in Saudi Arabia
Lead sponsor: King Abdulaziz Medical City
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-03-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 4000 students will be selected out of secondary schools for boys and girls , Their ages range from 16 to 18 years.

Brief summary: The purpose of this cross-sectional survey study is to describe the prevalence of asthma and Rhinitis symptoms among secondary school students in Saudi Arabia.

Detailed description: Cross sectional survey based on ISAAC protocol to characterize the symptoms of asthma and rhinitis and measure their frequency and its prevalence among secondary schools students (age 15 to 18 years, boys and girls) in Riyadh city, Saudi Arabia in period from 1st of April 2010 to 31st of May 2010.

The ISAAC protocol stated that the study population should consist of at least 3,000 students aged 15-18 years- in this case, enrolled in at least 40 randomly selected schools.

The 15-18 year age group was chosen because it is the age most adolescents go to school regularly, making data collection easier. Once requested by the research team, the education authority will provide a list of all secondary schools in Riyadh city and the number of students by school and their grades.

There are 400 secondary schools for boys and 400 school for girls (total number of boys and girls students 50,000).

A two stage stratified random sample of 4000 students will be selected out of secondary schools for boys and girls , Their ages range from 16 to 18 years.

Eligibility criteria: Inclusion Criteria:

* 15:18 year age group

Exclusion Criteria:

* Younger than 15 years or older than 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01915316: Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy
Official title: Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: ProSight
Sponsor class: INDUSTRY
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2013-08-02
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men. Primary biopsy and at least one secondary (repeat) biopsy diagnosed negative. Elevated PSA, \>10ng/mL. Subject directed at saturated trans-perineal biopsy

Brief summary: The purposes of this study are to: i) confirm and improve the accuracy of the correlation between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as determined through pathology; and ii) determine the levels of zinc in prostate tissue declared as non-cancerous by pathology and located in the vicinity of tissue declared as cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous tissue are lower (statistically significantly) than the levels for benign tissue not in the vicinity of cancerous tissue.


Eligibility criteria: Inclusion Criteria:

* Elevated PSA, \>10ng/mL
* Subject underwent primary and at least one secondary (repeat) prostate biopsy with negative diagnosis
* Subject directed at saturated trans-perineal biopsy

Exclusion Criteria:

* Subject was under Zn supplement nutrition treatment

Primary outcomes:
measure: Verify the existence of correlation between low levels of Zinc concentration in a biopsy specimen and the prostate cancer grade for that specimen determined by pathology.
timeFrame: Zinc measurements on biopsy specimens are performed during the biopsy session; pathology classification is typically performed within 2-4 weeks.
Secondary outcomes:
measure: Verify that the levels of zinc in non-cancerous specimens located in the vicinity of a specimen declared as cancerous by pathology are lower (statistically significantly) than the levels for benign specimens not in the vicinity of the cancerous specimen.
timeFrame: Time frame for pathology: within 2-4 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Haim Matzkin, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02320916: A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced During Arterial Puncture
Official title: A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced During Arterial Puncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Gas Analysis
Pain
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas exchange. However, arterial punctures are more painful than venous punctures and, in ICU patients, cause greater anxiety than tracheal aspiration. The only technique that has been shown to effectively reduce pain during arterial punctures is the subcutaneous injection of lidocaine. However, this technique is more time consuming and is poorly used.

Topical anesthesia is widely used during arterial punctures despite the lack of proof of efficacy.

While performing arterial punctures with small gauge needles is feasible, to the best of the investigators knowledge no studies have assessed the effect of needle gauge on arterial puncture related pain.

The aim of the present study was to compare the pain experienced during arterial punctures performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of the pain and the anxiety associated with the arterial punctures.


Eligibility criteria: Inclusion Criteria:

* patients who had a planned assessment of arterial blood gas in our Respiratory Department

Exclusion Criteria:

* under the age of 18
* inability to provide consent
* the presence of a contraindication to arterial punctures based on the American Association of Respiratory Care Guidelines

Primary outcomes:
measure: Pain experienced by the patient during arterial puncture
timeFrame: Less thant 60minutes after puncture
Secondary outcomes:
measure: Anxiety before and after puncture arterial puncture
timeFrame: Before puncture and less than 60minutes after puncture
measure: Most painful moment of the arterial puncture
timeFrame: Less than 60minutes after puncture
measure: Duration of arterial puncture
timeFrame: 10minutes
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Bouchra Lamia, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patout M, Lamia B, Lhuillier E, Molano LC, Viacroze C, Benhamou D, Muir JF, Cuvelier A. A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture. PLoS One. 2015 Sep 25;10(9):e0139432. doi: 10.1371/journal.pone.0139432. eCollection 2015.
Clinical trial NCT00321035: Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in Beijing Remin Hospital
Official title: Study of the Safety and Effectiveness of the OculusGen Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Pterygium
Keywords: Glaucoma
Pterygium
collagen matrix
oculusgen
ologen
trabeculectomy
anti scarring
prevent recurrence
tissue engineering
Aeon Astron
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.

Detailed description: ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Eligibility criteria: Inclusion Criteria:

* Age 18 years or over
* Patient able to cooperate with study procedures and able to perform tests reliably
* Patient willing to sign informed consent
* Patient able and willing to complete postoperative follow-up requirements
* Glaucoma：one/both eyes are affected by glaucoma
* Pterygium： patient with pterygium

Exclusion Criteria:

* Known allergic reactions to collagen

Primary outcomes:
measure: 1. the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
timeFrame: 180 day
Secondary outcomes:
measure: the safety via the incidence of complications and adverse events.
timeFrame: 180 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renmin Hospital of Beijing University
Study officials:
affiliation: Renmin Hospital of Beijing University
name: Xiao-Xin Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
Clinical trial NCT01995435: Refraction Determination Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia,
Hyperopia,
Astigmatism,
Presbyopia,
Eye Strain,
Lead sponsor: Lee, Steven, M.D.
Sponsor class: INDIV
First posted: 2013-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent.


Eligibility criteria: Inclusion Criteria:

* 18-40 years old
* healthy eyes

Exclusion Criteria:

* mid level ocular diseases (glaucoma, hypertension, retinal issues)
* psychiatric disorders
* brain tumor or history of
* under 18, or over 40 years old

Primary outcomes:
measure: refraction in diopters over telemedicine compared standard phoropter refraction
timeFrame: an average of 1 year
Secondary outcomes:
measure: telemedicine refraction results beyond dioptric readings
timeFrame: an average of 1 year
Other outcomes:
measure: patient satisfaction from telerefraction
timeFrame: an average of 1 year
Locations:
Study officials:
References:
Clinical trial NCT00588835: Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients
Official title: A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tumor
Keywords: pharmacokinetics
nausea and vomiting post chemotherapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.

Detailed description: Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug interaction with aprepitant.

CE can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.

Eligibility criteria: Inclusion Criteria:

* between 18 and 75 years of age
* able and willing to sign informed consent form
* indication for treatment with CE regimen
* subject is expected to receive at least 2 cycles of CE regimen
* able to swallow capsules

Exclusion Criteria:

* history of sensitivity/idiosyncrasy to aprepitant or excipients
* condition that might interfere with drug absorption, distribution metabolism or excretion.
* history or current abuse of drugs, alcohol or solvents
* inability to understand the nature and extent of the trial and procedures
* participation in a drug trial within 30 days prior to the first dose
* febrile illness within 3 days before the first dose
* concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
* abnormal liver or renal function

Primary outcomes:
measure: plasma concentrations of etoposide will be measured
timeFrame: just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3
Secondary outcomes:
measure: Nausea and emetic episodes are recorded
timeFrame: Day 1,3,5 and 8 of each cycle
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: David M. Burger, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References: