louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00542867: Pan-European Survey on the Under Treatment of Hypercholesterolemia
Official title: Pan-European Survey on the Under Treatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Third Joint European Task Force guidelines
Survey
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The survey try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines, overall and by country.·


Eligibility criteria: Inclusion Criteria:

* Patients had to be on a lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Primary outcomes:
measure: The number and percentage of patients achieving the LDL-C goals, according to the Third Joint European Task Force guidelines, overall and by country.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCL
name: M. Hermans
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hermans MP, Castro Cabezas M, Strandberg T, Ferrieres J, Feely J, Elisaf M, Michel G, Sansoy V. Centralized Pan-European survey on the under-treatment of hypercholesterolaemia (CEPHEUS): overall findings from eight countries. Curr Med Res Opin. 2010 Feb;26(2):445-54. doi: 10.1185/03007990903500565.
Clinical trial NCT00263367: Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
Official title: Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Oxidative Stress
Keywords: Autism
Oxidative Stress
Hyperbaric Oxygen
Reduced Glutathione
Lipid Peroxides
Lead sponsor: The International Child Development Resource Center
Sponsor class: OTHER
First posted: 2005-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure.

Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this study only for safety. It is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism.

This study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used "off-label" for this condition without safety studies.

Detailed description: Blood will be drawn immediately prior to a one hour session of hyperbarics (HBT. A catheter will be inserted in to a vein and converted to a heparin lock indwelling port for the next blood draw. The child (ages 5-12 years) will then undergo 1 hour of compression at 1.3 atmospheric pressure (4 psi above room air pressure). Supplemental oxygen will be provided to the child.

A second blood draw from the catheter site will be accomplished immediately after the child comes out of the HBT chamber.

These will be sent to the laboratories for evaluation of changes in reduced glutathione and lipid peroxides.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with autism ages 5-12 and undergoing hyperbarics

Exclusion Criteria:

* Seizures, acute URI, or inability to ventilate ears

Primary outcomes:
measure: glutathione
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: ICDRC
state: Florida
Study officials:
affiliation: ICDRC
name: James J Bradstreet, MD FAAFP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05676840: Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires
Official title: Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires. A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crowding of Anterior Mandibular Teeth
Keywords: Nickel Titanium
Archwires
Crowding
Alignment
Nitinol
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: three groups
Primary purpose: TREATMENT

Brief summary: To compare the alignment efficiency of conventional NiTi arch wire to Thermal and Super elastic NiTi arch wires.

Detailed description: Method: All the participants will be recruited from Ziauddin University dental OPD, each will be provided with full information about study. An informed consent form will be signed from every patient or their guardian/parents. Patients who agree to be part of this study will be included.

Subjects will be treated by Orthodontic resident under faculty supervision. Pre-treatment mandibular crowding will be assessed on dental casts. Randomization of the three groups will be done by "Opaque envelope technique" Bonding will be done using 3M uniteck brackets. After initial bonding good quality mandibular impressions will be taken and poured to obtain dental casts. Impressions and casts will be obtained at every 4 weeks interval until the initial alignment phase is complete. At the time of bonding all lower anterior teeth will be fully engaged in the archwire. The principal researcher will tag every model with an identification code before calculating measurements.

The contact point displacements will be measured with vernier caliper using the Little's index of irregularity. All measurements will be then summed and aggregated value will represent the degree of anterior irregularities.

Eligibility criteria: Inclusion Criteria:

* lower anterior crowding good oral hygeine all permanent lower incisors no previous orthodontic treatment

Exclusion Criteria:

* extracted or missing lower incisors poor oral hygeine relevant medical history previous orthodontic treatment

Primary outcomes:
measure: comparing the alignment efficiency of three types of NiTi archwires.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin University
state: Sindh
Study officials:
References:
Clinical trial NCT03047967: Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns
Official title: Effets du Tabagisme in Utero Sur la fonctionnalité de l'épithelium Respiratoire et Sur la Fonction Ventilatoire du Nouveau-né.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Tobacco Smoking
Lung Smokers
Newborn
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-02-09
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although environnemental tobacco smoke exposure effects are well known, consequences of prenatal tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial structure similar to those observed in KO α7-nAChR mouse pups. These findings support the hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco smoking on respiratory epithelium development. The purpose of the present clinical study is to compare PTSE neonates with controls according to lung function and respiratory epithelial functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained from gentle nasal brushing performed under antalgic premedication according to the method we previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be performed, by means of baby-body plethysmography.


Eligibility criteria: Inclusion Criteria:

* inborn full-term neonate
* social security affiliation
* informed consent form signed by parents

Exclusion Criteria:

* prematurity \< 35GW
* gemellary pregnancy
* Birth weight \< 2200 g
* neonatal respiratory distress syndrome (nasal oxygenotherapy \> 24 hours, invasive or noninvasive ventilation)
* neonatal malformation with conséquences on lung function
* neonatal liver or renal failure
* high risk of heritable lung disease
* contra-indication to saccharose or paracetamol antalgic use
* language barrier,
* mother refusal to declare or precise her tobacco consumption
* no social security cover
* informed consent form not signed

Primary outcomes:
measure: α7-nAChR functionnality
timeFrame: day 3
measure: CFTR functionality
timeFrame: day 3
Secondary outcomes:
measure: Lung function test
timeFrame: between ages 2 and 6 week
measure: ciliary frequency mesurement
timeFrame: day 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Inserm
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Pierre MAURAN, MD PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00446940: Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
Official title: Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Bader, Ted, M.D.
Sponsor class: INDIV
First posted: 2007-03-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change.


Eligibility criteria: Inclusion Criteria:

* Hepatitis C

Exclusion Criteria:

* HIV positivity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: OKlahoma City
country: United States
facility: VA Hospital
state: Oklahoma
Study officials:
affiliation: VA Medical Center, Oklahoma City, OK
name: Ted Bader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01737840: Comparison of Pantoprazole and Ranitidine in Dyspepsia
Official title: Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspepsia
Keywords: dyspepsia
pantoprazole
ranitidine
emergency department
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

Detailed description: Dyspepsia is one of the common complaints in emergency department. Proton pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.

Eligibility criteria: Inclusion Criteria:

* Epigastric pain
* Older than 18 years old

Exclusion Criteria:

* Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
* Pregnancy
* Patients with unstable vital signs
* Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
* Allergy to H2 receptor blockers and proton pomp inhibitors.
* Patients denied to give inform consent and who are illiterate

Primary outcomes:
measure: Visual Analogue Scale Score
timeFrame: 30th and 60th minutes
Secondary outcomes:
measure: Need for Additional Drug
timeFrame: 60 th minute
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Cenker Eken, Proffesor
role: STUDY_DIRECTOR
References:
citation: Welling LR, Watson WA. The emergency department treatment of dyspepsia with antacids and oral lidocaine. Ann Emerg Med. 1990 Jul;19(7):785-8. doi: 10.1016/s0196-0644(05)81704-4.
Clinical trial NCT05753540: The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain
Official title: Pilot Study on the Effects of MLS (Multiwave Locked System) LASER Therapy in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-specific Neck Pain
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-specific cronic low back pain is very common condition affecting 30-50% of adults. It is featured by neck muscles contractures which lead to pain and reduction of cervical spine mobility. High intensity laser therapy has been shown to be an effective treatment to improve symothoms in patient with non-specific neck pain.

The aim of this study is to assess the effects of a multi-wave locked system laser therapy in patient with non-specif neck pain.


Eligibility criteria: Inclusion Criteria:

* Chronic low back pain (\> 3 months)
* Body mass index \< 30
* Preserved cognitive ability to fully understand and observe indications received by medical personnel
* Ability to understand and give an informed consent

Exclusion Criteria:

* Spine surgery
* Spinal hernia
* spondylolisthesis
* Spinal infections
* Severe spine deformities
* Neural diseases
* Upper limbs radiculopathy
* Cervical rib
* Rotator cuff or other shoulder diseases
* Rheumatic diseases
* Diabetes
* Psychiatric diseases
* Vascular diseases
* Cancer
* Infectious diseases
* Skin abrasion
* Pregnancy or breastfeeding
* Recent injuries
* Known sensibility to Laser therapy
* Epilepsy
* Anticoagulant therapy
* Pacemaker
* hemorrhagic diathesis
* Photosensitizing drugs
* Known Photosensibility
* Neck Tattoos

Primary outcomes:
measure: Change in Neck pain
timeFrame: Change from baseline neck pain at 3 and 7 weeks
Secondary outcomes:
measure: Change in Disability
timeFrame: Change from baseline disability at 3 and 7 weeks
Other outcomes:
measure: Change in Neck mobility
timeFrame: Change from baseline neck mobility at 3 and 7 weeks
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT00437840: A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809
Official title: A Placebo-controlled, Single-blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses of GSK598809 in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Dependence
Keywords: healthy volunteers,
tolerability,
pharmacokinetics,
pharmacodynamics
safety,
smoking,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-21
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people who smoke and will also look at blood levels of GSK598809 and nicotine.


Eligibility criteria: Inclusion criteria:

* Healthy adult male smoker between the ages of 18 and 50 years
* Body weight greater than 50kg and BMI between 18.5-29.9 kg/m2.
* No abnormalities on the medical, psychiatric or laboratory evaluation
* Smoke on average more than 20 but less that 40 cigarettes per day for the past year and not tried to give up in the 3 months before the study.

Exclusion criteria:

* History of psychiatric disorder or sleep disorder.
* Receiving treatment for smoking cessation.
* Use tobacco products other than cigarettes.

Primary outcomes:
measure: Safety measures: ECG, Vital Signs, Adverse Events
timeFrame: for 48 hours after dosing.
measure: PK: Blood levels of GSK598809 and nicotine
timeFrame: for 96 hours after dosing
Secondary outcomes:
measure: Questionnaires on nicotine craving
timeFrame: for 24 hours after dosing
measure: Tests on cognition (thinking)
timeFrame: for 48 hours after dosing
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02396940: 3D HD Versus 2D HD in Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial
Official title: Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Inguinal Hernia Repair.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Hernia
Keywords: 3D
Three-dimensional
Laparoscopy
Inguinal hernia repair
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.

Detailed description: Experimental studies have shown that even experienced surgeons gain from stereoscopy when solving both easy and complex tasks. Inguinal hernia repair is a specialist operation and the large flow makes this type of operation suitable for exploring any advantage of three-dimensional laparoscopy for the experienced surgeon.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective inguinal hernia repair (out-patient treatment)

Exclusion Criteria:

* Previous lower abdominal surgery
* ASA-score 3 or above

Primary outcomes:
measure: Number of errors during the dissection of the hernia sac
timeFrame: Expected duration: 20 minutes
Secondary outcomes:
measure: Duration of the dissection of the hernia sac.
timeFrame: Expected duration: 20 minutes
measure: Duration of surgery
timeFrame: Expected duration: 1 hour
measure: The need for conversion to open surgery
timeFrame: intraoperative, expected duration of surgery: 1 hour
measure: Estimated blood loss in ml
timeFrame: intraoperative, expected duration of surgery: 1 hour
measure: Intraoperative complications
timeFrame: intraoperative, expected duration of surgery: 1 hour
measure: Assessment of fatigue and perceived exertion
timeFrame: an expected average of 15 minutes before and after the operation
measure: Evaluation of the optical modality and mental load assessment
timeFrame: an expected average of 15 minutes after the operation
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: Charlotte Fergo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01633840: New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
Official title: New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: double-blind placebo-controlled food challenges
food allergy
food hypersensitivity
triangle test
validated recipes
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: The Västerbotten county council
name: State Government founding for Health Care research
name: Oskarsfonden
name: Nutricia, Inc.
First posted: 2012-07-04
Enrollment: 275
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.


Eligibility criteria: Inclusion Criteria:

* Children belonging to one of two age groups: 7-8 years or 14-15 years
* No previous hypersensitivity reaction to the food to be tested
* Capacity to understand the test instructions and to participate in the test sessions

Exclusion Criteria:

* Children not belonging to one of the two age groups: 7-8 years or 14-15 years
* One or more previous hypersensitivity reaction to the food to be tested
* Unability to understand the test instructions and to participate in the test sessions

Primary outcomes:
measure: Number of participants detecting sensorial differences between the active materials (containing the allergens cow's milk, hen's egg, soy, wheat or cod) and the placebo materials
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Clinical Sciences, pediatrics
Study officials:
affiliation: Umeå University Sweden
name: Christina E West, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winberg A, Nordstrom L, Strinnholm A, Nylander A, Jonsall A, Ronmark E, West CE. New validated recipes for double-blind placebo-controlled low-dose food challenges. Pediatr Allergy Immunol. 2013 May;24(3):282-7. doi: 10.1111/pai.12061.