louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03100513: PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
Official title: Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.

Detailed description: Polyethylene glycol electrolyte solution (PEG) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. It is used safely to clean the bowel before colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult Patients with Overt Hepatic Encephalopathy.

Exclusion Criteria:

1. Patients with active GIT bleeding.
2. Patients with history of bowel obstruction, perforation.
3. Patients with history of allergy to PEG.
4. Treatment with rifaximin or neomycin in the previous 7 days.
5. Patients with major psychiatric illness.
6. Patients receiving benzodiazepines and narcotics.
7. Patients with compromised renal.
8. Patients receiving medications highly bound to plasma proteins eg. Warfarin.
9. Pregnant or lactating women.
10. Fulminant hepatic failure.

Primary outcomes:
measure: 1 or more in HE grade improvement at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Time to HE resolution
timeFrame: 2 weeks
measure: Overall length of stay
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tropical medicine dept.-Tanta university hospital
Study officials:
affiliation: Tanta University Faculty of Medicine
name: Hanan Soliman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta university Faculty of Pharmacy
name: Amany Abd El-Rahim Abdin, MD
role: STUDY_DIRECTOR
affiliation: Tanta University Faculty of Medicine
name: Samah Mosaad Soliman, MD
role: STUDY_DIRECTOR
affiliation: Tanta University Faculty of Medicine
name: Hala Hany Shehata, Msc
role: STUDY_CHAIR
affiliation: Tanta University Faculty of Medicine
name: Sherief Abd-Elsalam, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02359136: Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty
Official title: Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Arthroplasty, Replacement, Hip
Anesthesia, Local
Ropivacaine
Randomized controlled trial
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified.

Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.


Eligibility criteria: Inclusion Criteria:

* all patients receiving total hip arthroplasty in the study period

Exclusion Criteria:

* contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen.
* Patients who received general anaesthetic
* patients who will get a different operation than standard direct lateral surgery
* Patients with osteosynthesis to be removed in the same operation

Primary outcomes:
measure: postoperative pain assessed by numeric rating scale
timeFrame: 1 day (first postoperative day)
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital, Department of Orthopedics
Study officials:
affiliation: St. Olavs Hospital
name: Tina Strømdal Wik, md phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofstad JK, Winther SB, Rian T, Foss OA, Husby OS, Wik TS. Perioperative local infiltration anesthesia with ropivacaine has no effect on postoperative pain after total hip arthroplasty. Acta Orthop. 2015;86(6):654-8. doi: 10.3109/17453674.2015.1053775. Epub 2015 May 22.
Clinical trial NCT02339636: A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis
Official title: A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vulgaris Psoriasis
Keywords: subclinical, enthesitis, synovitis
Lead sponsor: The 306 Hospital of People's Liberation Army
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both patients with psoriasis and patients with other skin diseases

Brief summary: A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis

Detailed description: A total of 100 patients with vulgaris psoriasis and 100 age-matched controls with other skin diseases, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded PDUS evaluation. Clinical assessment included demographics, severity of psoriasis, musculoskeletal clinical examination and sport activities. PDUS evaluation consisted of the detection of grey scale (GS) synovitis and synovial PD signal in joints of extremities, GS enthesopathy and entheseal PD signal in entheses of lower limbs.

Eligibility criteria: Inclusion Criteria:

* age≥18years
* patients with vulgaris psoriasis(dur
* patients with other skin diseases without musculoskeletal disorders
* no joint involvement and no clinical symptoms and signs of enthesitis and synovitis

Exclusion Criteria:

* BMI≥24
* have history of gout or arthritis or peripheral neurological disease of lower extremity or trauma
* have received any systemic therapy(i.e.NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
* pregnant or breast-feeding

Primary outcomes:
measure: Incidence of subclinical enthesitis and synovitis
timeFrame: one and a half year
Secondary outcomes:
measure: Number of participants with Risk factors of subclinical enthesitis and synovitis
timeFrame: one and a half year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 306 Hospital of PLA
Study officials:
affiliation: The 306 Hospital of People's Liberation Army
name: Jianjun Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06754436: Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)
Official title: Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Invasive Fungal Infections
Liposomal Amphotericin B
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics/pharmacodynamics of the drug with different dosing regimens.

Detailed description: The information of patient characteristics, physiological parameters, ECMO related parameters, administration and sampling information of L-AmB were collected.Patients were intravenously titrated after 3 doses of maintenance dose titration. The sampling window was from 0 to 24 h. The time points were 0.5 h before and 1, 2, 3, 6, 9, 12, 16, 20 and 24 h after administration. NONMEM software was applied to establish the PPK model of L-AmB.

Eligibility criteria: Inclusion Criteria:

* Diagnostic criteria for invasive fungal infections presenting to the intensive care unit (ICU) with probable or proved patients According to the 2021 EORTC/MSGERC guideline.
* Requiring ECOM assistance.
* Age 18 years.

Exclusion Criteria:

* Intolerance of L-AmB therapy.
* Pregnancy.
* Expected survival time \<24 hours.
* Lack of necessary data on patient demographics physiopathology, and clinical status.

Primary outcomes:
measure: Blood drug concentration of liposomal amphotericin B
timeFrame: The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04991636: Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.
Official title: Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Aortic Aneurysms
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aneurysm of the abdominal aorta is defined by a loss of parallelism of the arterial wall. The main risk of this pathology is the rupture of the aneurysm which is life threatening and this risk increases with the size of the aneurysm. Connected stents allow the management of complex thoracoabdominal aneurysms in patients at high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term CT follow-up remains essential to detect complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The prognostic factors of these complications remain poorly elucidated. The type of stent to be used could be an explanation, however, no stent has been proven to be superior in this application to date. Data from the literature suggest an influence of stents on the aortic geometry and the arterial axes of the digestive tract during respiratory movements. The work of the Stanford vascular surgery team shows that the deformations and modifications of the geometry of these stents induced by the respiratory cycle could have a negative impact by migration, stenosis and thrombosis.


Eligibility criteria: Inclusion Criteria:

* no contre indication for coroscanner

Exclusion Criteria:

* pregnant woman
* allergy to iodinated contrast media
* vulnerable people

Primary outcomes:
measure: Geometry of the visceral and renal branches
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Hopital Marie Lannelongue
Study officials:
References:
Clinical trial NCT01932736: Functional Manifestations of Pressure Changes in the Middle Ear System
Official title: Functional Manifestations of Pressure Changes in the Middle Ear System: An fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Middle-ear Function
Keywords: middle ear
Eustachian tube
fMRI
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and when the brain responds to pressure stimulations of the eardrum. The study requires 2 visits, 1 for screening to determine eligibility and 1 for the fMRI. This study will help to understand how the middle ear system is controlled, which may have an impact on how people with middle ear disease are treated.

Detailed description: Otitis media is a ubiquitous disease in young children which can persist through adolescence, and arise or recur in adults. A consequence of an infection and/or Eustachian tube dysfunction, it manifests as an effusion that disrupts the normal impedance matching function of tympanic membrane-ossicular chain system. Eustachian tube dysfunction prevents the equilibration of middle ear pressures and drainage of the accumulated effusion. It is thought that middle ear status modulates the function of the Eustachian tube via afferent signals processed centrally resulting in changes in its tonus or muscular function. This pilot study of right-handed 21-35 year olds of either sex will validate a published fMRI method for visualizing cortical brain activation in response to external ear canal pressure changes (N=5). The outcome measure is intensity changes of the cortex associated with applied stimuli.

Eligibility criteria: Inclusion Criteria:

* 21-35 years of age
* right-handed

Exclusion Criteria:

* left-handedness or ambidexterity
* fMRI safety reasons (ferromagnetic material in their bodies, epilepsy, claustrophobia
* history of middle ear/tympanic membrane surgery (tympanostomy tubes)
* abnormal otoscopic findings and/or tympanometry on physical exam
* pregnancy

Primary outcomes:
measure: changes in brain activation during pressure changes
timeFrame: 1 hour (Visit 2, during fMRI)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Douglas Swarts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04879836: Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething
Official title: Retrospective Analysis of the Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething in Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Eruption Disorder
Keywords: gums
redness
fever
paediatric
inappetence
sleep disturbance
Lead sponsor: University of Urbino "Carlo Bo"
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 51
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants, without ethnic limitations, of both sexes and between the ages of 2 and 12 months, affected by teething discomfort but considered otherwise healthy.

Brief summary: Teething discomfort is a widespread disorder affecting a very high percentage of infants. The use of hyaluronic acid gels has been shown in the last 20 years to be an effective tool, generally devoid of side effects, in reducing oral mucosal inflammation in adults. Its effectiveness in infants is affected by the strength of hyaluronic acid retention over the oral mucosa. This is in turn affected by formulation and may vary between different products due to the different ingredients used. In this study, the results collected by monitoring the paediatric experience regarding a newly developed HA-based medical device, intended to counteract teething discomfort in infants, will be reported.


Eligibility criteria: Inclusion Criteria:

* Teething discomfort
* Being healthy (except for teething discomfort)

Exclusion Criteria:

* Being placed on one of the following therapies in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotics, antifungal and hormone therapy

Primary outcomes:
measure: Unexplained cry
timeFrame: 1 month (1 check per week)
measure: Irritability
timeFrame: 1 month (1 check per week)
measure: Sleep disturbance
timeFrame: 1 month (1 check per week)
measure: Inappetence
timeFrame: 1 month (1 check per week)
measure: Salivation
timeFrame: 1 month (1 check per week)
measure: Gum redness
timeFrame: 1 month (1 check per week)
measure: Fever
timeFrame: 1 month (1 check per week)
measure: General well-being
timeFrame: 1 month (1 check per week)
Secondary outcomes:
Other outcomes:
Locations:
city: Urbino
country: Italy
facility: University of Urbino Carlo Bo
Study officials:
affiliation: University of Urbino "Carlo Bo"
name: Davide Sisti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05960136: Impact of COVID-19 on Sinus Augmentation Surgery
Official title: The Impact of COVID-19 on the Rate of Peri-operative Complications of Maxillary Sinus Floor Augmentation Procedure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 24
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: The risk of Schneiderian membrane perforation and the postoperative complications of the sinus floor elevation surgery were evaluated for patients with and without history of COVID-19 infection.

Detailed description: COVID-19 induced chronic sinusitis with subsequent increased Schneiderian membrane thickness could increase the risk of its perforation during the sinus floor elevation. The aim of the study is to compare the incidence of Schneiderian membrane perforation and the postoperive complications of the sinus floor elevation in patients with and without history of COVID-19.

Eligibility criteria: Inclusion Criteria:

* 4 mm or less residual alveolar bone height
* Age more than 18 years
* Highly motivated patients

Exclusion Criteria:

* Patients who suffer from any systemic disease
* sinus pathosis other than sinusitis induced covid 19
* Patients under any medication that may interfere with the normal bone healing

Primary outcomes:
measure: Sinus membrane perforation
timeFrame: Duration sinus lift
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Lecturer at Faculty of Dentistry, Cairo University
name: Nahla Awadallah
role: STUDY_CHAIR
References:
Clinical trial NCT06233136: Effect of Leg Pedalling Exercise From Inclined Position
Official title: Effect of Leg Pedalling Exercise From Inclined Position on Functional Ability and Trunk Control in Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Keywords: Leg Pedalling
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy

Detailed description: Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP) from both sexes will be recruited based on a pilot study according to the inclusion and exclusion criteria. They will be selected from the out-patient private clinics in Giza and Tenth of Ramadan City.

Study design:

Randomized controlled clinical trial. Children will receive intervention type randomly, 15 child received the designed physical therapy program and the pedaling exercise from inclined position and the other 15 child receieved the designed physical therapy program only. Children will be assessed by measuring functional ability with Gross Motor Functional measures and trunk control with trunk control measurement scale

Eligibility criteria: Inclusion Criteria:

.Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.

.Level II, III according to Gross MotorFunctional Classification System (GMFCS).

.Able to pedal independently on a static bicycle.

.Ability to follow command.

Exclusion Criteria:

.Significant visual or auditory impairments.

.Structural or fixed deformities of lower extremities.

.Perception disorders.

.Botox injection in the lower extremity in the past 6 months.

.Lower extremity surgery within the past 6 months.

Primary outcomes:
measure: The gross motor function scale
timeFrame: 2 months for each participant
measure: Assessment of trunk control
timeFrame: 2 months for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: DOkki
country: Egypt
facility: Faculty of physical therapy cairo University
state: Giza
Study officials:
affiliation: Professor
name: NANEES E Mohamed, Phd
role: STUDY_DIRECTOR
References: