louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01518673: Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.
Official title: National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Patients Undergoing a Computed Tomography Examination
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Federal Agency for Nuclear Control, Belgium
First posted: 2012-01-26
Enrollment: 140
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing computed tomography are exposed to a relatively high dose of X-rays.

Brief summary: Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays. Pediatric patients are known to be very radiosensitive with respect to radiation induced cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can be detected. The technique will be applied in a multicenter setting for evaluation of X-effects induced by a computed tomography examination in a population of pediatric patients. To this end a blood sample will be taken from the patients before and after the examination.


Eligibility criteria: Inclusion Criteria:

* pediatric patients wearing a catheter

Exclusion Criteria:

Primary outcomes:
measure: X-ray induced genetic effects in pediatric patients directly after a computed tomography scan.
timeFrame: Within 30 min after the computed tomography examination.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Peter Smeets, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04777773: Dual-task Training in Children With Cerebral Palsy
Official title: The Effect of Dual-task Training on Activity and Participation in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Diplegia
Hemiplegic Cerebral Palsy
Physical Disability
Participation, Patient
Activity, Motor
Keywords: cerebral palsy
dual-task training
activity
participation
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There are studies investigating the dual-task effect in sitting, standing up without sitting and walking in children with spastic CP. Some of these studies investigated motor-motor, some of them motor-cognitive dual-task states, and children with CP were compared to typically developing children. In all these studies, it is clearly seen that children with CP have more dual-task complexities than their typically developing peers. Some of these studies draw attention to dual-task education in children with CP. However, other than a randomized controlled study and a case report in the literature, we did not find any studies investigating the effectiveness of dual-task training in children with CP. When the literature is examined in detail, there is no study that examines the effect of dual-task exercise programs on walking activities and children's participation in daily life in children with CP.

This study has been planned based on this deficiency in the literature. Based on ICF, This study has been planned dual-task training for children with CP.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with cerebral palsy,
* Having spastic type unilateral and bilateral involvement,
* Being between the ages of 7-18,
* Being GMFCSS Level I and Level II,
* Continuing normal education (not being a mainstreaming student),
* Not having any surgical operation involving the musculoskeletal system in the last 6 months,
* Not having Botulinum Toxin application in the last 6 months.

Exclusion Criteria:

* Failing to accomplish the cognitive task (starting from a number between 0-100 and not counting back 1 each)
* Being a behavioral problem that makes it difficult to participate in the study,
* Inability to walk without support

Primary outcomes:
measure: 10m walking test
timeFrame: 5 min
measure: 10m walking test with dual-task
timeFrame: 5 min
measure: 10m backward walking test
timeFrame: 5 min
measure: 10m backward walking test with dual-task
timeFrame: 5 min
measure: balance
timeFrame: 15 min
measure: participation of daily life
timeFrame: 15 min
measure: Visual Gait Assessment
timeFrame: 10 min
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu Uni
Study officials:
References:
Clinical trial NCT00876473: Evaluation of Different Continuous Positive Airway Pressure (CPAP) Systems in Patients With Acute Respiratory Failure
Official title: The CPAP in Patients Affected by Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Keywords: CPAP
Acute Respiratory Failure
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients affected by Acute Respiratory Failure

Brief summary: The aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.

Detailed description: Three CPAP systems are studied for each patient at the same level of PEEP: 1) continuous high-flow CPAP with fixed value PEEP valve; 2) continuous high-flow CPAP with Boussignac PEEP valve; 3) demand flow CPAP, supplied by a ventilator.

Eligibility criteria: Inclusion Criteria:

* Intubated-tracheostomized subjects receiving CPAP during the weaning from invasive mechanical ventilation

Exclusion Criteria:

* Hemodynamic instability
* Barotrauma
* Severe myopathy

Primary outcomes:
measure: Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange
timeFrame: 30 minutes
Secondary outcomes:
measure: Comfort of breathing
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06531473: Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures
Official title: Laser Outcomes Associated With HoLEP Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urologic Diseases
Prostate Obstruction
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2j 50hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as \> 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as \>10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

* Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates

Exclusion Criteria:

* Prostates measurements over 200g
* Patients who lack decisional capacity
* Patients who are non-english speakers

Primary outcomes:
measure: Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Krambeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01783873: Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
Official title: Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Occupational Asthma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new equipment will allow the realization of specific standardized bronchial challenges (BC) to occupational agents. Thus, we propose to study in more detail the cellular mechanisms involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled study.


Eligibility criteria: Inclusion Criteria:

For patients with occupational asthma to wheat flour:

* Clinical history,
* A positive skin test to wheat flour and / or specific IgE to wheat flour

For patients with occupational asthma to quaternary ammonium compounds:

-Clinical history,

For two types of asthma:

* Patients must have a worsening of bronchial hyperreactivity during work compared to a rest period assessed by a metacholine challenge
* FEV before challenge (nonspecific and specific) must be\> 70%.

Exclusion Criteria:

Asthmas:

* no occupational asthma:
* secondary to clinically relevant sensitization to an allergen domestic
* aggravated at work.

Primary outcomes:
measure: Assessment of cellular inflammation in peripheral blood and induced sputum
timeFrame: 33 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg,
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Frédéric De BLAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348673: A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
Official title: A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2006-07-06
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
* Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

Exclusion Criteria:

* Patients with a CD4 count less than 250 cells/mm3.
* Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
* Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).

Primary outcomes:
measure: Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8
timeFrame: Baseline, Day 8
Secondary outcomes:
measure: Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
timeFrame: Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])
Other outcomes:
measure: Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)
timeFrame: 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8
measure: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
timeFrame: 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8
measure: Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)
timeFrame: 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8
Locations:
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01665573: Cannabinoid Augmentation of Fear Response in Humans
Official title: Cannabinoid Augmentation of Fear Response in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fear Conditioning
Keywords: Fear Conditioning
Cannabinoids
Fear Response
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 31
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: OTHER

Brief summary: The purpose of this double blind, randomized, controlled, proof-of-concept study is to test the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On three days over not more than two weeks, subjects will be trained to associate cues with two different stimuli, then this association will be extinguished. Cannabinoid receptor stimulation will be accomplished indirectly by harnessing the brain's capacity to endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845. Some details of this study have not been disclosed to preserve the study design.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 65
* Male and female
* No major medical problems

Exclusion Criteria:

* Hearing problems
* Psychiatric or mental problems

Primary outcomes:
measure: Galvanic skin response
timeFrame: Test days #1, #2, and #3, on average a week
measure: Cortisol levels measured in blood
timeFrame: Test days #1, #2, and #3, on average a week
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Mohini Ranganathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915273: Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers
Official title: Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers: A 2-year Follow-up of a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapse
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 43
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the differences in relapse and failure rates in patients treated with fixed retainers (FRs) using Computer-Aided Design/Computer-Aided Manufacturing technology, lab-based technique, and chairside method.


Eligibility criteria: Inclusion Criteria:

* completion of comprehensive orthodontic treatment
* class I molar and canine relationships
* indication for a fixed retainer on the mandibular anterior teeth.
* no extractions done as part of their treatment.
* Treatment with preadjusted edgewise appliance.

Exclusion Criteria:

* refusal to participate
* refusal to have fixed retainers
* poor oral hygiene
* non-compliance

Primary outcomes:
measure: Change in intercanine width (ICW)
timeFrame: 2 years
measure: Change in Little's Irregularity Index (LII)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
name: Giau Tran
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
name: Ryan Rucker
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
name: Patrick Foley, PhD
role: STUDY_CHAIR
affiliation: Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
name: Brent Bankhead
role: STUDY_CHAIR
affiliation: Alexandria University
name: Samar M Adel, PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
name: Ki B Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT06262373: Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes
Official title: Are Early Pregnancies Implanted Close to the Tubal Ostia at Increased Risk of Miscarriage? A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Miscarriage in First Trimester
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 236
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are attending for a scan in the early pregnancy unit, aged over 16 years.

Brief summary: The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery.


Eligibility criteria: Inclusion Criteria:

* Have capacity to understand the study and to provide signed and dated informed consent.
* Willing to comply with all study procedures and be available for the duration of the study including consenting to follow up of the pregnancy outcome by letter, phone or email according to individual preference.
* Age 16 years or over
* Mean gestational sac diameter (GSD) on ultrasound of 2-15mm inclusive
* GS implantation site within the upper half of the uterine cavity on 2D USS

Exclusion Criteria:

* Women with pregnancies of unknown location, ectopic pregnancies or larger GSD than specified in the inclusion criteria.
* Implantation site within the lower half of the endometrial cavity on 2D USS screening.
* Intention to terminate the pregnancy
* Women with unicornuate uteri or unicornuate uteri with rudimentary horns
* Women with uterine fibroids which distort the uterine cavity

Primary outcomes:
measure: Primary
timeFrame: 2 years
Secondary outcomes:
measure: Secondary
timeFrame: 2 years
measure: Secondary
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
References:
Clinical trial NCT06084273: Investigation Of Two Different İnterventions İn Hemiplegic Patients
Official title: Effectıveness Of Relaxation And Respiratory Exercise On Sleep Quality, Depressıon And Spasticity In Hemiplegic Stroke Patients: Prelimınary Findings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Physiotherapy and Rehabilitation
Keywords: Depression
Exercise
Relaxation
Pain
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Our study aims to determine the effect of relaxation and breathing exercises in addition to the treatment procedure on depression level, sleep quality, and spasticity in hemiplegic patients.

Methods: Thirty patients aged 40-70 years diagnosed with hemiplegia were included in the study. All patients received the same Bobath exercise three days a week for six weeks. Patients in Group 2 additionally received breathing and relaxation exercises. Sleep quality assessment by Pittsburgh Sleep Quality Index (PUKI), depression by Hospital Anxiety and Depression Scale (HADS), and spasticity by Modified Ashworth scale (MAS) were used. All assessments were made at baseline and six weeks after exercise treatments.


Eligibility criteria: Inclusion Criteria:

* The study included patients who met the following inclusion criteria:
* having had a stroke at least six months ago,
* possessing adequate cognitive functions,
* having no pre-existing sleep problems before the disease,
* absence of emotional disturbance prior to the disease,
* voluntary participation in the study,
* no cardiovascular problems,
* having a score of 1, 1+, or two according to the modified Ashworth Scale

Exclusion Criteria:

* having a traumatic stroke caused by malignancy or other organic factors, alcohol or drug addiction,
* having a score of 3 or 4 according to the modified Ashworth Scale

Primary outcomes:
measure: Sleep quality assessment
timeFrame: 30 min
measure: Depression assessment
timeFrame: 30 min
measure: Spasticity assessment
timeFrame: 15 min
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydın University
Study officials:
References: