louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04053985: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)
Official title: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma


Eligibility criteria: Inclusion Criteria:

older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent

Exclusion Criteria:

cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy

Primary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
measure: PFS
timeFrame: From date of randomization until the date of progress from any cause, assessed up to 60 months
Secondary outcomes:
measure: ORR
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
measure: DCR
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN YAT-SEN University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT02828085: Improvement of the Etiological Diagnosis of the Pericarditis
Official title: Improvement of the Etiological Diagnosis of the Pericarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infective Pericarditis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)


Eligibility criteria: Inclusion Criteria:

* Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome.
* Adult patient (= or \> 18 years old)
* Patient who freely signed the informed consent form.
* Patient affiliated to a health insurance regime

Exclusion Criteria:

* Minor patient ( age \<18 years)
* Pregnant, parturient or breastfeeding woman
* Adult patient incapable or unable to consent
* Patient deprived of liberty under judgment
* Person living in a health or social specialised structure
* Person in vital emergency situation

Primary outcomes:
measure: Percentage of pericarditis whose etiological diagnosis has been established.
timeFrame: 1 day
Secondary outcomes:
measure: Identification of the detected emerging pathogens among infectious causesof pericarditis
timeFrame: 1 day
measure: Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References:
Clinical trial NCT02200185: Titrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings
Official title: Efficacy and Safety of Nebulized Morphine Given at Two Different Doses Compared to Intravenous Morphine in Post-traumatic Acute Pain: a Randomized Controlled Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Headache
Acute Pain
Keywords: post traumatic pain
titrated morphine
nebulised morphine
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators test a different technique using morphine to improve pain relief in patient visiting the emergency department with acute trauma pain, for this we are comparing three different methods of morphine administration:

* intravenous titrated morphine
* low dose nebulized morphine and
* high dose nebulized morphine

Detailed description: Trauma patients are frequent in emergency department settings, and often require urgent care.

taking care of this patients consists on taking care of their pain and then the specific treatment of their traumatic lesions.

actually, the most used medicine and most efficient one in treating pain is morphine, it's mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit neurotransmitter release.

The most applied administration root of morphine is by intravenous (IV) titration or IV continuous perfusion, but until now, there is no clear recommendation concerning the superiority of this root over other administration techniques such as nebulization.

In this study we aimed to investigate the efficiency, the feasibility and the tolerance of three morphine administration roots in patients with acute traumatic pain and to clarify the most adequate one to apply in emergency department settings.

Eligibility criteria: Inclusion Criteria:

* patients older than 8 years and less than 50 years
* patients who consult emergency department for sever pain after an immediately trauma

Exclusion Criteria:

* Glasgow coma scale \<14
* inability to cooperate
* hypotension with systolic blood pressure\< 90mmhg
* bradypnea\<12cpm
* SAO2\<90%
* polytrauma
* nasal trauma
* rhinitis
* nasal obstruction
* allergy to opioids

Primary outcomes:
measure: Pain resolution
timeFrame: 30 minutes
Secondary outcomes:
measure: side effects
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency Department
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grissa MH, Boubaker H, Zorgati A, Beltaief K, Zhani W, Msolli MA, Bzeouich N, Bouida W, Boukef R, Nouira S. Efficacy and safety of nebulized morphine given at 2 different doses compared to IV titrated morphine in trauma pain. Am J Emerg Med. 2015 Nov;33(11):1557-61. doi: 10.1016/j.ajem.2015.06.014. Epub 2015 Jun 14.
Clinical trial NCT00939185: Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Official title: Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Keywords: Compliance and Safety Study in Children with Upper and Lower Respiratory Tract Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ZITHROMAX® administration will be considered in children / adolescents from the first year of life up to 14 years old with the following diagnoses: Acute otitis media, Sinusitis, Pharyngitis/tonsillitis, Pneumonia, Bronchitis.

Brief summary: The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract.

Detailed description: Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

Eligibility criteria: Inclusion Criteria:

* Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.

Exclusion Criteria:

* According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: 3 to 7 days after receiving treatment
Secondary outcomes:
measure: Number of Subjects Who Withdrew From the Study
timeFrame: 3 to 7 days after receiving treatment
measure: Compliance
timeFrame: 3 to 7 days after receiving treatment
measure: Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04198285: Post-Operative Voiding After Gynecological Surgery Trial
Official title: Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Retention
Postoperative Complications
Surgery
Keywords: laparoscopy, urinary retention
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. Primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Women
* Undergoing elective laparoscopy for a gynaecological indication
* Plan for same day discharge
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy
* Undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment
* Prior hysterectomy, or incontinence/pelvic organ prolapse procedures
* Pre-existing voiding dysfunction
* Known recurrent urinary tract infections
* Known genito-urinary malformations
* Known for neuromuscular disorders such as multiple sclerosis
* Use of anticholinergic medication
* Intraoperative bladder related complications
* Need for discharge with indwelling foley catheter
* Patients requiring overnight admission for any reason

Primary outcomes:
measure: Time to first void
timeFrame: 3 hours
Secondary outcomes:
measure: Time to discharge
timeFrame: 8 hours
measure: Post-operative complications
timeFrame: 1 week following surgery
measure: Patient satisfaction
timeFrame: 1 week
measure: Post-operative pain
timeFrame: Assessed at the 1 hour mark
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Ally Murji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moawad G, Tyan P, Marfori C, Abi Khalil E, Park D. Effect of postoperative partial bladder filling after minimally invasive hysterectomy on postanesthesia care unit discharge and cost: a single-blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Apr;220(4):367.e1-367.e7. doi: 10.1016/j.ajog.2018.12.034. Epub 2019 Jan 9.
citation: Zakhari A, Paek W, Chan W, Edwards D, Matelski J, Solnik MJ, Murji A. Retrograde Bladder Filling after Laparoscopic Gynecologic Surgery: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 May;28(5):1006-1012.e1. doi: 10.1016/j.jmig.2020.09.019. Epub 2020 Oct 3.
Clinical trial NCT03946085: Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)
Official title: Clinical Evaluation of a Micronized, Lipid-based Carotenoid Supplement in Eyes With Retinal Drusen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Drusen
Age-related Macular Degeneration
Macular Degeneration
Keywords: Lumega-Z
Carotenoid supplement
Lead sponsor: Guardion Health Sciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Western University of Health Sciences
name: Eye Clinic of Austin
First posted: 2019-05-10
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel treatment group participants will be randomly assigned either the experimental intervention, Lumega-Z, or the AREDS2 supplement. An observational, control group will be included for further comparison.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the clinical benefits in visual function from dietary supplementation of the Lumega-Z carotenoid liquid-supplement in participants with drusen and at risk of AMD. The effects of Lumega-Z supplementation will be compared to an active comparator, the AREDS2 multivitamin.


Eligibility criteria: Inclusion Criteria:

- patients with retinal drusen (as determined by clinical fundus photography examination) and dark adaptation recovery time of 6 to 10 minutes.

Exclusion Criteria:

* presence of congenital retinal pathologies that may impact data collection
* prior history of retinal-detachment or vitreo-retinal surgeries with any complications
* best-corrected visual acuity of 20/40 or worse

Primary outcomes:
measure: Mean Changes in Visual Acuity (VA)
timeFrame: Baseline, 3-months, and 6-months
measure: Mean Changes in Contrast Sensitivity (CS)
timeFrame: Baseline, 3-months, and 6-months
measure: Mean Changes in Dark Adaptation Recovery (DAR)
timeFrame: Baseline, 3-months, and 6-months
measure: Mean Changes in Macular Pigment Optical Density (MPOD)
timeFrame: Baseline, 3-months, and 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Eye Clinic of Austin
state: Texas
Study officials:
affiliation: Eye Clinic of Austin
name: T Henderson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davey PG, Henderson T, Lem DW, Weis R, Amonoo-Monney S, Evans DW. Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula. Nutrients. 2020 Oct 26;12(11):3271. doi: 10.3390/nu12113271.
Clinical trial NCT00567385: Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
Official title: An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 176
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* Growth failure due to growth hormone insufficiency (GHD)
* Turner syndrome: established diagnosis according to sex chromosome analysis, or
* Growth retardation in children with chronic renal disorders

Exclusion Criteria:

* Pregnancy
* Breast feeding women
* Suspected or know allergy to trial product
* Participating in any other trial involving other investigational products within the last 3 months
* Previous participation in the trial
* Other daily injection therapy (non-growth hormone, e.g insulin-therapy)

Primary outcomes:
measure: Assessment of acceptance
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Safety
measure: Adverse Events (AE)
measure: Compliance
Other outcomes:
Locations:
city: Altunizade-Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06952985: Role of Gum Chewing in Post-operative Gut Motility After Cesarean Section
Official title: Role of Gum Chewing in Post-operative Gut Motility After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Gum Chewing
Gut Motility
Lead sponsor: Combined Military Hospital Gujranwala
Sponsor class: OTHER
Collaborators: name: CMH Gujranwala
First posted: 2025-05-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many women deliver by caesarean section nowadays. The proportion of women who deliver by caesarean section ranges from 15% to over 50%, in some countries. After a caesarean section it is common for the bowel to stop working for several hours or days. Although this usually resolves by itself in a few days, it may be very uncomfortable. The retained gases and stools can cause the mother's belly to become swollen and painful with cramps and she may feel nauseated and vomit so she is not able to eat. She may need additional medications to ease these symptoms and her hospital discharge may be delayed. The use of medications that relieve pain during labour and painkillers following the surgery can also delay bowel function. Small intestine activity after abdominal operations returns to normal function within a few hours, gastric activity returns to normal within 24-48 hours, and colon activity returns to normal within 48-72 hours. Due to the delayed motility of the gastrointestinal system in the postoperative period, gas and secretions accumulate in the stomach and small and large intestines, which causes abdominal distension, nausea, vomiting, and pain, all of which negatively affect the comfort level of the patients. Chewing sugar-free gum after cesarean section can promote the early recovery of gastrointestinal function, but the side effects of chewing gum are still unclear, which needs more clinical, large sample and high-quality studies to further verify.


Eligibility criteria: Inclusion Criteria:

* Females of age 18-40 years
* Parity \<5
* Presenting at gestational age ≥ 37 weeks,
* Undergoing cesarean section (as per operational definition) under spinal anesthesia

Exclusion Criteria:

* Females with history of chronic constipation (medical record)
* Females with obstructed labour, hypothyroidism (TSH\>5IU)
* Females with intra operative complications such as bowel injury, history of gastrointestinal surgery, and water and electrolyte disturbances (on medical record), abnormal placenta (accrete, increta, previa, abruption)

Primary outcomes:
measure: Mean Time of Passage of First flatus
timeFrame: 06 Months
Secondary outcomes:
measure: Mean Duration of Hospital Stay
timeFrame: 06 Months
Other outcomes:
Locations:
city: Gujranwala
country: Pakistan
facility: CMH Gujranwala
state: Punjab
Study officials:
References:
Clinical trial NCT06512285: Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'
Official title: Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obstructive Sleep Apnea
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing adenotonsilectomy at Texas Children's Hospital Main campus that meet institutional requirements for post-operative admission for continuous pulse oximetry monitoring

Brief summary: Sleep apnea has become exceedingly recognized in children. The primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. The majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit.

Detailed description: Based on national and international consensus statements, institutional practice has developed at Texas Children's Hospital as to which patients require overnight observation following adenotonsillectomy for continuous pulse oximeter monitoring to assess for desaturation events. There is insufficient evidence to suggest which patients need to stay for pulse oximeter monitoring which has led to many patients being admitted unnecessarily. Therefore, the aim of this study is to capture data prospectively on pulse oximetry in children admitted overnight following adenotonsillectomy to identify risk factors for post operative oxygen desaturation.

Eligibility criteria: Inclusion Criteria:

* Adenotonsillectomy surgery
* Patient meeting institutional guidelines for postoperative admission (e.g, admitted following surgery from recovery room).

Exclusion Criteria:

* Parental refusal
* Airway Surgery in addition to adenotonsillectomy
* Patient psychological limitations, precluding wearing device (e.g. autism).
* Patient not meeting institutional guidelines for postoperative admission (e.g, discharged following surgery from recovery room).

Primary outcomes:
measure: Continuous pulse oximetry following adenotonsillectomy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: adam adler, MD
role: PRINCIPAL_INVESTIGATOR
References: