louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00386698: Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly Adults
Official title: Evaluate Reactogenicity & Immunogenicity of Adjuvanted Influenza Vaccine in Elderly Adults Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Administered in Young & Elderly Adults Will be Used as Reference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza,
improved vaccine,
influenza disease
elderly
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.


Eligibility criteria: Inclusion Criteria:

* The subjects must be healthy adults ages 18-40 years or \>/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.

Exclusion Criteria:

* Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination
* Have a history of influenza infection since previous vaccination
* Women who are pregnant
* Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

Primary outcomes:
measure: Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine
Secondary outcomes:
measure: Evaluation of the humoral immune response and cell-mediated immune response 21 days after revaccination with candidate vaccine
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04469998: Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
Official title: A Phase I/II, Randomized, Double-Masked, Vehicle-Controlled Study of the Safety, Tolerability, and Efficacy of AXR-270 Topical Eyelid Cream in Treating Posterior Blepharitis Associated With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posterior Blepharitis
Meibomian Gland Dysfunction
Keywords: Meibomian Gland Dysfunction
Posterior Blepharitis
Lead sponsor: AxeroVision, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)

Detailed description: AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270 cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis associated with meibomian gland dysfunction

Eligibility criteria: Inclusion Criteria:

Male or female, 18 years or older

Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate))

Have a score of ≥35 on Eye Discomfort using VAS

Have a tFCS score between 3 and 14 on the NEI scale

Have a Schirmer score of \>7 mm

Have a OSDI score \>30

If female, then subject should be non-pregnant and non-lactating

Exclusion Criteria:

Subjects with iritis, uveitis in either eye

Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD

Subjects with lid abnormalities

Subjects with ocular fungal, viral or bacterial infection

Subjects unable or unwilling to withhold the use of eyelid scrubs

Subjects with glaucoma and serious systemic disease

Primary outcomes:
measure: Adverse Events
timeFrame: 22 Days
Secondary outcomes:
measure: Total Meibomian Gland Dysfunction Score
timeFrame: 22 Days
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: AxeroVision, Inc.
state: California
Study officials:
affiliation: AxeroVision, Inc.
name: Houman D Hemmati, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05073198: The Effect of the Brochure on Testicular Self-Exam
Official title: The Effect of the Brochure Given to University Students on Testicular Cancer and Its Early Diagnosis on Health Beliefs and Testicular Self-Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Testicular Cancer
Keywords: testicular cancer
screening
university student
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to examine the effect of the educational brochure given to university students on testicular cancer and its early diagnosis on their health beliefs and self-examination; In non-randomized groups, pretest-posttest was conducted in a quasi-experimental design with control group. The research was carried out with students studying in the psychological counseling and guidance department of a state university in Turkey. The study group consisted of 92 students, 48 of which were experimental and 44 were control. Only the experimental group was given an educational brochure about testicular cancer and testicular self-examination. Data; Personal information form, testicular cancer and health beliefs scale about testicular self-examination were collected with the form for self-examination. In the evaluation of the data; Mann Whitney U, Wilcoxon and chi-square analyzes were performed.


Eligibility criteria: Inclusion Criteria:

* To study in the Department of Psychological Counseling and Guidance
* Studying in 3rd and 4th grade

Exclusion Criteria:

* Any previous diagnosis of cancer
* Having received previous training in Testicular Self Examination

Primary outcomes:
measure: rate of testicular self-exam
timeFrame: after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
References:
Clinical trial NCT01955798: Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery
Official title: Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery , a Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laparoscopic Gynecological Surgery
Keywords: Laparoscopy
Gyneacological
Entry techniques
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Veress needle is the laparoscopic entry technique most commonly used among gynecologists. Direct trocar entry is another method to gain entry to the abdomen that is uncommon to gynecologists.

This prospective and randomized study will compare the two entry techniques with regard to:

* Complications related to the entry technique and previous surgeries
* Time taken to enter the abdomen
* The number of attempts taken to enter the abdomen

Detailed description: Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for gynecological purposes will participate in the study. Patients with previous middle laparotomies or 3 or more abdominal suregeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the two arms of the trial. All patient information will be confidential and only be available to researches involved in the study.

Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.

300 women will be recruited over a two year period and the data will be analysed by a statistician.

Eligibility criteria: Inclusion Criteria:

* Any woman suitable for laparoscopic gyneacological surgery

Exclusion Criteria:

* Previus supra-infra umbilical laparotomy
* three or more previous abdominal surgeries

Primary outcomes:
measure: Complications during entry in laparoscopy
timeFrame: During surgery
Secondary outcomes:
measure: Time to enter in the abdominal cavity
timeFrame: During surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Quiron Dexeus
Study officials:
affiliation: Salut de la Mujer Dexeus
name: Alberto Vazquez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
citation: Tinelli A, Malvasi A, Guido M, Tsin DA, Hudelist G, Stark M, Mettler L. Laparoscopy entry in patients with previous abdominal and pelvic surgery. Surg Innov. 2011 Sep;18(3):201-5. doi: 10.1177/1553350610393989. Epub 2011 Jan 18.
Clinical trial NCT04502498: Preoperative Subclinical DVT Screening in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy.
Official title: Preoperative Detection of Subclinical Lower Limb Deep Venous Thrombosis in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer Patients Candidate for Radical Cystectomy
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced Bladder cancer patients candidate for radical cystectomy and with no symptoms of DVT

Brief summary: Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate for radical cystectomy.

Detailed description: 60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex within 1 week preoperative to radical cystectomy

Eligibility criteria: Inclusion Criteria:

* any age
* Any sex
* Muscle invasive bladder cancer local advanced patients candidate for radical cystectomy

Exclusion Criteria:

* Unfit patients
* any contraindication for surgery
* obese
* coagulopathy
* bedridden

Primary outcomes:
measure: Preoperative subclinical DVT
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05290298: Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19
Official title: Short-term Intervention With Nitrate-based Nutritional Formula on Oxygen Saturation and Patient-reported Outcomes in Covid-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 52
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: A preliminary open-label case report demonstrated the beneficial effects of an innovative nitrate-based nutritional formula on oxygen saturation in patients with COVID-19. Whether these initial findings are relevant in a more robust research design currently remains unknown. Therefore, the main objective of this randomized controlled trial was to analyze the acute effects of nitrate-based nutritional formula on peripheral SpO2, patient-reported outcomes, and safety indices in patients with acute COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

* age 3 18 years
* confirmed SARS-CoV-2 infection
* SpO2 \< 95%
* COVID-19 patients in stable condition (i.e., not requiring hospital admission)

Exclusion Criteria:

* regnant or lactating women
* concomitant pulmonary and cardiovascular conditions
* history of dietary supplement use during the past four weeks
* participation in another COVID-19-related study
* unwillingness to give informed consent

Primary outcomes:
measure: Change in oxygen saturation
timeFrame: Baseline vs. 72 hours post-intervention
Secondary outcomes:
measure: Change in fatigue
timeFrame: Baseline vs. 72 hours post-intervention
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
References:
citation: Ostojic SM, Milovancev A, Drid P, Nikolaidis A. Oxygen saturation improved with nitrate-based nutritional formula in patients with COVID-19. J Int Med Res. 2021 Apr;49(4):3000605211012380. doi: 10.1177/03000605211012380.
Clinical trial NCT01538498: Development for the Peritoneal Carcinomatosis Index (PCI) in Ovarian Cancer
Official title: A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: PCI
Ovarian cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2012-02-24
Enrollment: 134
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * primary ovarian cancer
* non-neoadjuvant
* Debulking operation

Brief summary: * Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively
* Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor location and tumor characteristics

Detailed description: Patients with primary ovarian cancer

* Informed consent
* Digital photography \& Checking PCI (tumor size, number, and Characteristics)
* Postoperative surveillance(tumor marker, image and physical examination)

  1. Developing the best fitting PCI model to reflect recurrence-free survival and overall survival

     * Selection of items
     * Weighting by items and tumor characteristics
  2. Analysis of prognostic impact of PCI compared to conventional staging system (FIGO stage) for ovarian cancer

Eligibility criteria: Inclusion Criteria:

1. Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage)
2. Available preoperative image study (CT and/or MRI and/or PET)
3. Patients who gave a written informed consent
4. Patients must be surgical candidate considering medical and psychological condition

Exclusion Criteria:

* Patients who refuse to participate or want to withdraw at anytime.

Primary outcomes:
measure: Devleopment for the peritoneal carcinomatosis index (PCI)
timeFrame: 55 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT05864898: Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula
Official title: Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula in Acute Respiratory Failure Patients : the Standardized PaO2 / FiO2 Ratio (P /F-st), ROX Index and HACOR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure Patients on NIV and HFNC
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in chest and Tuberculosis Departement, Assiut University

Brief summary: Comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula.

Detailed description: Delayed intubation after NIV / HFNC failure is associated with high mortality rate in acute respiratory failure patients.

There are Many factors to predict early failure but World still searching for new factors and comparing between each ;in order to eatablish best one that achieve the least mortality rate.

Little studies about effiecacy of HACOR Score as a predictor of failure in HFNC patients.

Little studies about effiecacy of ROX Index as a predictor of failure in NIV ventilating patients.

Eligibility criteria: Inclusion Criteria:

Acute respiratory failure patients who need ventilatory Support either NIV or HFNC due to :

1. RR \> 25 cycle / min
2. using accessory muscles and paradoxical breath.
3. PaO2 / FiO2 ratio \< 300

Exclusion Criteria:

1. Absolute indication for intubation like coma, haemodynamically unstable... etc
2. Contr-indication of NIV like untreated Pneumothorax.

Primary outcomes:
measure: Determine Golden time for intubation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02352298: Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude
Official title: Protocol for the Evaluation of Dario™ Blood Glucose Monitor (BGMS) Performance at Elevated Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: LabStyle Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings to readings obtained from the YSI 2300 STAT Plus glucose analyzer.

Detailed description: The study will be performed with 50 fresh capillary blood samples, collected by fingerstick using Dario single use lancet. Additional fingerstick with dedicated disposable lancets will be used to collect sufficient capillary fresh blood to be analyzed by the YSI 2300 STAT Plus analyzer. Additional fingersticks may be necessary if volume of blood from first fingerstick is insufficient.

Eligibility criteria: Inclusion Criteria:

* Age of subject is 18 years or older
* Able to speak and read English

Exclusion Criteria:

* Pregnant
* Has any condition that the principal investigator believes may interfere in the subject's participation in the trial.

Primary outcomes:
measure: Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)
timeFrame: 6 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
affiliation: Barbara Davis Center
name: Christie Beatson
role: STUDY_CHAIR
References:
Clinical trial NCT06712498: INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION
Official title: INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18-65
* and with ASA1-2 were included.

Exclusion Criteria:• Patients younger than 18 years of age and older than 65 years of age

* Patients allergic to local anesthetics
* Patients with opioid and alcohol addiction
* Patients with perioperative signs of acute cholecystitis
* Patients with contraindications for laparoscopic surgery
* Cases with ASA III-IV were not included in the study.

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
measure: Visual Analogue Scale
timeFrame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
Secondary outcomes:
measure: Riker Sedation Agitation Scale
timeFrame: Immediately after extubation
measure: Patient satisfaction score
timeFrame: at the 24th postoperative hour
measure: Postoperative vomiting and nausea
timeFrame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
measure: Opioid use
timeFrame: Postoperative 24 hours
measure: Mean Arter Pressure
timeFrame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
measure: Heart Rate
timeFrame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Health Sciences University Gazi Yaşargil Training and Research Hospital
state: Kayapınar
Study officials:
References: