louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06801158: Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase
Official title: Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Effects of Medical Drugs
Keywords: adverse effects
oncology
vigibase
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 8804863
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Antidepressants were employed as a proxy for identifying patients experiencing depression. These agents were identified according to the ATC classification for antidepressants (code N06A).

Brief summary: Importance:

Depression is prevalent among oncology patients and may influence the perception, reporting, and severity of adverse events (AEs) related to cancer therapies. Understanding this association is crucial for optimizing treatment outcomes and improving patient quality of life.

Objective:

To evaluate the association between depression and the reporting and severity of AEs among oncology patients using data from VigiBase®, the World Health Organization's global pharmacovigilance database.

Design:

This pharmacovigilance study employed a case/non-case disproportionality analysis using Individual Case Safety Reports (ICSRs) from 1968 to 2024. Multivariable analyses were conducted to adjust for potential confounders, such as age and sex.

Setting:

The study utilized data from VigiBase®, a global pharmacovigilance database containing reports from over 120 countries.

Participants:

ICSRs involving antineoplastic or immunomodulating agents were included. Depression was identified through antidepressant use, yielding 428,102 reports for patients on antidepressants and 8,376,761 for those not on antidepressants.

Exposure:

Oncology patients receiving antidepressant therapy were compared to those not receiving such treatment.

Main Outcome and Measures:

The primary outcome was the reporting of serious AEs (e.g., hospitalization, life-threatening events). Secondary outcomes included the 20 most frequently reported AEs among oncology patients, with comparisons made between those treated with and without antidepressants.


Eligibility criteria: Inclusion Criteria:

* ICSRs were limited to those involving liable antineoplastic or immunomodulating agents (per the Anatomical Therapeutic Chemical (ATC) Classification code L; hereafter referred to as antineoplastics)

Exclusion Criteria:

* Suspect of duplication

Primary outcomes:
measure: reporting of serious AEs
timeFrame: 1964 to 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT00198458: Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Official title: Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Hypersensitivity
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.


Eligibility criteria: Inclusion Criteria:

* Agreed to avoid disallowed meds

Exclusion Criteria:

* Known hypersensitivity to hyaluronidase and/or bee sting
* Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
* Atopic individuals assessed by medical history
* Topical/inhaled/systemic corticosteroids within 30 days
* Concurrent use of antihistamines or anti-inflammatory during study
* Active or chronic disease likely to affect immune function
* History of alcohol/drug abuse within 6 months

Primary outcomes:
measure: Hypersensitivity
timeFrame: 1-2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Lisa R Grillone, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06512558: Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
Official title: Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subclinical Breast Cancer Lesion
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Breast cancer is diagnosed by imaging at a non-palpable stage in more than half of all cases. Surgical removal requires preoperative guidance. Generally, preoperative guidance is performed using a metal guide under local anaesthetic and radiological control. This type of guidance has several limitations. For the patient, it can be painful and traumatic. The procedure involves two departments: radiology and the operating theatre, which poses logistical constraints. What's more, between 10% and 40% of patients require repeat surgery for unhealthy margins, raising the question of the effectiveness of the tracking procedure. The investigators propose to develop a non-invasive intraoperative guidance system: Augmented Reality, which will provide a 3D vision with virtual transparency of the breast during surgery, thanks to real-time fusion of preoperative imaging with video from a camera located in the operating room. The process is illustrated below.

Illustration of the general principle of the augmented reality system for locating non-palpable breast lesions. The images above represent a preliminary test carried out on the computer outside the operating room. This is an initial research prototype which has not yet been validated and is not suitable for routine use.


Eligibility criteria: Inclusion Criteria:

* Major women
* Requiring conservative surgical management of a subclinical cancerous breast lesion (not palpable), the histology of which has been previously proven by anatomopathology;
* Having a breast MRI indication at the time of the breast assessment performed at the Centre Jean Perrin
* Ability to give informed consent to participate in the study,
* Membership of a social security scheme

Exclusion Criteria:

* Patients with breast neoplasia during pregnancy;
* Persons deprived of their liberty or under guardianship or incapable of giving consent;
* Refusal to participate.

Primary outcomes:
measure: Feasibility of the study
timeFrame: 1 year
Secondary outcomes:
measure: Time measurement of the study procedure
timeFrame: 1 year
measure: Creating a phantom
timeFrame: 1 year
measure: Assessment of the feasibility of images fusion
timeFrame: 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
Study officials:
References:
Clinical trial NCT03634358: Bipolar Scissors for Circumcision
Official title: Bipolar Scissors Versus Classic Method for Circumcision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Circumcision
Keywords: bipolar
scalpel
foreskin
prepuce
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-08-16
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing Outcomes of two different surgical techniques between two groups
Primary purpose: TREATMENT

Brief summary: comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method

Detailed description: A prospective, randomized study, comparing two different techniques for pediatric male circumcision: the bipolar diathermy scissors technique with that of a classic scalpel technique. Study included male infants from 40 days old up to 18 month old. They were reviewed regarding Operative time, bleeding, complications, postoperative pain and morbidity. Differences in the outcome were compared.

Eligibility criteria: Inclusion Criteria:

* Male infant between 40 days and 18 month old
* parents' request and approval of circumcision

Exclusion Criteria:

* previous attempts of circumcision or revision cases
* bleeding tendency
* congenital anomalies involving genitalia
* age below 40 days (expected Vit. K deficiency) or above 18 month old.

Primary outcomes:
measure: Post-operative bleeding
timeFrame: A week
Secondary outcomes:
measure: Post-operative pain
timeFrame: A week
measure: wound complications
timeFrame: Two weeks
measure: Cosmetic outcome
timeFrame: Two month
measure: Operative time
timeFrame: Operative time
measure: Over or under correction
timeFrame: 2 month
Other outcomes:
Locations:
Study officials:
References:
citation: Mendez-Gallart R, Estevez E, Bautista A, Rodriguez P, Taboada P, Armas AL, Pradillos JM, Varela R. Bipolar scissors circumcision is a safe, fast, and bloodless procedure in children. J Pediatr Surg. 2009 Oct;44(10):2048-53. doi: 10.1016/j.jpedsurg.2009.06.008.
Clinical trial NCT00637858: Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects
Official title: Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: LycoRed Ltd.
name: The S. Daniel Abraham International Center for Health and Nutrition
First posted: 2008-03-18
Enrollment: 130
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of different doses of tomato extract (contain Lyc-o-Mato 6% Oleoresin which Contain: 5, 15 mg lycopene , in addition to Beta-carotene (0.15%), phytoene, and phytofluene (1%); and vitamin E (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never treated pre-hypertensive otherwise healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Aged 35-60,
* No antihypertensive treatment in the past or present,
* 135\< SBP\< 145 or 85\<DBP\<95,
* Informed consent signed,

Exclusion Criteria:

* Unwilling to participate in the study,
* Treated essential,
* secondary or complicated hypertension,
* SBP lower than 135 or higher than 145 mmHg,
* DBP lower than 85 or higher than 95 mmHg,
* Use of other medications (statins, NSAI ect..),
* Known allergy to tomato, carotenoids, or vitamin E,
* Diabetes Mellitus,
* Obesity BMI\>32,
* Significant dyslipidemia,
* Patients with ischemic pain, S/P MI, PTCA or CABG, LVH or CHF,
* Smoker,
* Valvular heart disease,
* PVD,
* Cerebrovascular disease, s/p CVA, TIA,
* Any kind of kidney disease (creatinine\>1.6),
* Chronic liver disease(elevated AST and ALT at least by 2 times of the normal range),
* Alcohol abuse,
* History of GI disease or surgery,
* History of malignancy in the past 5 years,
* History of autoimmune disease,
* Participation in other researches protocol

Primary outcomes:
measure: Blood Pressure
timeFrame: Every 2 weeks (Overall 12 weeks )
Secondary outcomes:
measure: Serum lycopene levels
timeFrame: Week 0,Week 12
measure: Serum Phytofluene levels
timeFrame: Week 0,Week 12
measure: Serum 8 isoprostane levels
timeFrame: Week 0,Week 12
measure: Serum nitrite-nitrate levels
timeFrame: Week 0,Week 12
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Hypertension Unit
Study officials:
affiliation: Hypertension clinic of the Soroka University Hospital
name: Ester Paran, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engelhard YN, Gazer B, Paran E. Natural antioxidants from tomato extract reduce blood pressure in patients with grade-1 hypertension: a double-blind, placebo-controlled pilot study. Am Heart J. 2006 Jan;151(1):100. doi: 10.1016/j.ahj.2005.05.008.
Clinical trial NCT02101658: Evaluating Expectancy Effects in Weight Loss Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy of Clinic-based Weight Measurements
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: undergraduate students

Brief summary: The purpose of this project is to examine potential bias or expectancies in individuals' measurement and recording of weight in a clinical-research setting.


Eligibility criteria: Inclusion Criteria:

* 19+ years-old
* available to attend clinic sessions on dates provided for data collection

Exclusion Criteria:

* younger than 19 years
* not available on specified dates of data collection

Primary outcomes:
measure: accuracy of clinic-based weight measurement
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT06472258: Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study
Official title: Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 104
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Therefore, this research intended to evaluate the efficacy of only IV artesunate versus IV artesunate plus IV quinine in the treatment of severe malaria in children. The findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.


Eligibility criteria: Inclusion Criteria:

Children admitted to the emergency department with the diagnosis of severe malaria.

Exclusion Criteria:

Children with chronic kidney disease, chronic liver disease, immunosuppressive disorders, hematological disorders, malignancies, and congenital heart disease.

Primary outcomes:
measure: Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride
timeFrame: Seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ghazi Khan
country: Pakistan
facility: Allama Iqbal Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT02691858: Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
Official title: Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intussusception
Keywords: Intussusception
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception.

Our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.

Detailed description: Experimental group will be given single dose IV Hydrocortisone 10 mg/kg with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Control group will be given Saline 100 ml IV single injection with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Eligibility criteria: Inclusion Criteria:

* Infantile Intussusception

Exclusion Criteria:

* Peritonitis Pneumoperitoneum Morbid patients

Primary outcomes:
measure: Success of Pneumatic Reduction
timeFrame: 1 Hour
Secondary outcomes:
measure: Reducing number of trials of Pneumatic Reduction
timeFrame: 2 Hours
measure: Reducing complications
timeFrame: 2 Hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Pediatric Hospital
Study officials:
affiliation: Cairo University
name: Gamal El Tagy, MD
role: STUDY_CHAIR
References:
citation: Gersema, Lisa, and Karen Baker.
citation: Kara, Cüneyt Orhan, and Inci Gökalan.
Clinical trial NCT05243758: Who is Rapid And Success? The Comparison Of Video Fiberscope And Video Laryngoscope
Official title: The Comparison Of Video Fiberscope And Video Laryngoscope,With Egri Score> 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Airway Responsiveness
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 60 patients aged between 18-65 years, who were operated in the operating room of our hospital, with an EGRI score of \>4 and an ASA (American Society of Anesthesiologists) score of \<4 were included.
Primary purpose: SCREENING

Brief summary: Endotracheal intubation plays an important role in general anesthesia. Complications can be prevented by using alternative airway devices in predetermined difficult intubation cases. In this study, the investigators aimed to compare the results of endotracheal intubation with video fiberscope and DCI video laryngoscope devices of two different experienced physicians (E and H).

Detailed description: In this randomized and prospective study, 60 patients with EGRI score\> 4 and ASA score \<4, operated between 1 October 2018 and 1 March 2019 in Ondokuz Mayıs University Medical Faculty Hospital were included. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.

Eligibility criteria: Inclusion Criteria:

* Operated in the operating room of our hospital,
* Aged 18-65,
* EGRI score\>4,
* ASA (American Society of Anesthesiologists) score\<4

Exclusion Criteria:

* Cerebrovascular disease (cerebral ischemia, hemorrhage or stroke), presence of carotid stenosis or history of coronary artery disease,

  * Neurological disorders (history of chronic headache, epilepsy or head trauma), alcohol or psychoactive drug addiction,
  * Serious heart and/or lung diseases, liver and/or kidney failure,
  * Uncontrolled diabetes and/or hypertension,
  * Dental abscess,
  * Mouth opening \<1.5 cm,
  * Known bleeding disorder,
  * Pregnancy,
  * Mental retardation,
  * Contraindications to drugs, allergy to drugs used,
  * Patient rejection

Primary outcomes:
measure: Intubation times,
timeFrame: during intubation
measure: Number of attempts
timeFrame: during intubation for patients,
measure: Time to find the glottis:
timeFrame: during intubation for patients
measure: Blood pressure
timeFrame: During intubation, at 1st, 2nd and 5th minutes after intubation
measure: Pulse oximeter
timeFrame: Before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Faculty of Medicine
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: ERSIN KOKSAL, PROFFOSOR
role: STUDY_DIRECTOR
References:
Clinical trial NCT01537458: Long-term Outcome After Isolated Tricuspid Valve Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
First posted: 2012-02-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing isolated tricuspid valve repair

Brief summary: Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly.

The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.


Eligibility criteria: Inclusion Criteria:

* tricuspid valve insufficiency

Exclusion Criteria:

* younger than 18 years
* associated valvular surgery

Primary outcomes:
measure: mortality
timeFrame: 10 year
measure: Redo surgery
timeFrame: 10 year
Secondary outcomes:
measure: functional capacity assessed by CPET
timeFrame: 10 year
measure: Atrial fibrillation
timeFrame: 10 year
measure: Hospitalisation
timeFrame: 10 year
measure: Functional capacity assessed by NYHA functional class
timeFrame: 10 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
References: