louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01290445: Varenicline Pregnancy Cohort Study
Official title: Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malformations
Keywords: varenicline
smoking
smoking cessation
cohort study
drug safety
prospective study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: University of Aarhus
name: Karolinska Institutet
First posted: 2011-02-07
Enrollment: 885185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of all live born and stillborn infants in Denmark and Sweden.

Brief summary: A prospective population-based cohort study to examine whether varenicline use during pregnancy is associated with an increased risk of major congenital malformations in infants above that associated with smoking during pregnancy.

Detailed description: Sampling will not be employed. The data sources record nearly all (\>98.6%) births in Denmark and Sweden.

Eligibility criteria: Inclusion Criteria:

All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.

Exclusion Criteria:

Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.

Primary outcomes:
measure: Number of Infants With Major Congenital Malformations
timeFrame: For 12 months after birth
Secondary outcomes:
measure: Number of Infants With Stillbirths
timeFrame: At the time of birth
measure: Number of Infants Born Small for Gestational Age (SGA)
timeFrame: At the time of birth
measure: Number of Infants Born Preterm
timeFrame: At the time of birth
measure: Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes
timeFrame: At the time of birth
measure: Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)
timeFrame: For 12 months after birth
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00176345: Impact of Exercise Training on Endothelial Function in CAD
Official title: Impact of Exercise Training on Bradykinin-Mediated Endothelial Function in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: exercise training
endothelial function
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: Bradykinin has been identified to contribute to the release of nitric oxide (NO), prostacyclin, and EDHF through activation of specific bradykinin 2 (B2) receptors, which is finally promoting a vasodilatory respone. Regular physical exercise training results in an improvement of endothelial function in patients with CAD. These positive effects were partially attributed to an increased expression of endothelial NO synthase (eNOS) and cyclooxygenase (COX) as a result of the training intervention.

Aim of this trial is therefore to determine, whether the training-induced correction of endothelial dysfunction is also bradykinin-dependent.

Detailed description: A total of 20 patients with stable coronary artery disease are prospectively randomized to 4 weeks of exercise training or sedentary lifestyle.

Endothelial function of the radial artery is determined by a high-resolution A-mode ultrasound.

Eligibility criteria: Inclusion Criteria:

* stable CAD
* male gender

Exclusion Criteria:

* insulin-dependent diabetes mellitus
* significant valvular heart disease
* smoking
* exercise-induced myocardial ischemia
* conditions prohibiting exercise training

Primary outcomes:
measure: Endothelial function
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
state: Saxony
Study officials:
affiliation: University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
name: Rainer P Hambrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06382545: Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems
Official title: Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Treatment
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files.


Eligibility criteria: Inclusion Criteria:

* 20-50 years old
* No systemic diseases
* Mandibular first molar
* Asymptomatic tooth
* Normal periapical film
* Restorable teeth
* Periodontal scoring index \<2

Exclusion Criteria:

* Age \<20 and \>50
* Systemic disorders
* Articaine Allergy
* Inability to take paracetamol.
* Pregnancy or Nursing
* Symptomatic pulpitis.
* Pulp necrosis
* PDL is widening.
* Periapical radiolucency
* The sinus tract
* Periapical abscesses.
* Existence of resorption
* Tooth malposition.
* Fixed partial dentures.
* Analgesics intake in the last 12 hours.

Primary outcomes:
measure: comparing the intensity of post-instrumentation pain
timeFrame: The patients were referred for treatment over a period of 7 months from November 2021-May 2022.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Oral and Dental medicine, Ahram Canadian University
Study officials:
affiliation: Ahram Canadian University
name: Faten Ghonimy
role: STUDY_DIRECTOR
References:
Clinical trial NCT02648945: Effects of Low and High Intensity Exercise in Improving Working Memory Among Students With Anxiety Symptoms
Official title: A Comparative Study Between Effects of Low and High Intensity Exercise in Improving Working Memory Among Students With Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aerobic Exercise
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
Collaborators: name: Universiti Tunku Abdul Rahman
First posted: 2016-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anxiety levels among the younger generation especially students have been increasing drastically in recent years. This severely affects a student's academics as previous studies have shown a strong correlation between high anxiety levels and poor working memory. Working memory, also known as short term memory is an important component in studying as it aids in holding important information needed to understand following information for a short period of time. This concerning phenomenon has drawn the attention of researchers to find solutions to this issue where recent studies have found physical exercise to contribute in the improvement of cognition which also includes working memory. Hence, the aim of this study is to compare the effects of low and high intensity exercises on working memory among students with high anxiety levels. Thirty female undergraduate students from UTAR with relatively high levels of anxiety will be conveniently sampled using Beck Anxiety Inventory. Participants will then be randomly allocated into 2 groups to undergo low and high intensity exercise on a treadmill according to Balke's Protocol. 2 memory assessments involving Verbal Memory Task will be conducted for each participant before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Female students (Age group: 18-25 years)
* Participants with mild to severe anxiety levels (Score of \>8)

Exclusion Criteria:

* Participants with Cardiorespiratory problems (e.g. Asthma, Congestive heart disorders) or severe Musculoskeletal problems that prevent them from carrying out any physical exercise or advised by personal physician not to.
* Participants that have had a recent head injury (recent 5 years)

Primary outcomes:
measure: Change in Verbal Memory Task
timeFrame: baseline and 1 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Universiti Tunku Abdul Rahman
state: Selangor
Study officials:
References:
Clinical trial NCT02257645: Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks
Official title: A Multicenter, Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization Against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenza Type B in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenza Type B
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infant from 6 weeks of age.who is given this vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B

Brief summary: A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.

Detailed description: Euforvac-Hib vaccine manufactured by LG Life science in Korea, but it's not marketed in Korea. It is distributed to UN agencies in diverse countries. Thus, WHO recommended LG Life Science to conduct the safety study for assessing the vaccine safety if Euforvac-Hib is prequalified.

The objectives of this safety study are to identify any problems and questionable issues likely to emerge from the actual use of Euforvac-Hib vaccine after launching in the market.

Eligibility criteria: Inclusion Criteria:

1. Patients who had been signed informed consent by subjects legally acceptable Representative
2. Infant from 6 weeks of age.who is given this vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B

Exclusion Criteria:

1. Patients with hypersensitivity to any component for the vaccine
2. Patients who had a severe reaction to a previous dose of the combination vaccine or any of its constituents is absolute contraindication to subsequent doses of the combination vaccine.
3. Patients who had pertussis, encephalopathy or other serious neurological abnormality in the newborn period

Primary outcomes:
measure: Adverse event
timeFrame: up to 12 weeks after vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03344445: Difference of Information Gain Between Video-base and Doctor Interview After Preanesthetic Visit
Official title: Difference of Information Gain Between Video-base and Doctor Interview After Preanesthetic Visit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: simple compare of information gain between traditional visit and video-assisted visit
Primary purpose: OTHER

Brief summary: To investigate the differenec of patients' satisfaction and information gain betweem face-to-face interview and video introduction

Detailed description: We made up a video which showed the type, the method, the risk, and the benefit of all anesthesia with words, pictures, and image. A study nurse will ask the will of patients. The patients enrolled in the study will be randomly divided into traditional group(control group) and study group(study group). The study group will watch the video at first, then our anesthesiologist visit the patient. The control group will receive traditional anesthesiologist visit. After doctors' visit, the patients have to complete a test and a questionnaire. The patients who don't participate in the study will have traditional visit and no test.

Eligibility criteria: Inclusion Criteria:

* All adult patients were included who were scheduled to undergo elective surgery

Exclusion Criteria:

* Postoperative stay in the intensive care unit was expected or unexpected.,Repeated general anesthesia had been performed in the previous 6 months,ASA classification was more than or equal to III,There were pronounced cognitive and or speech barriers

Primary outcomes:
measure: inform gain analysis
timeFrame: after every 100 effective data or 1 year, analyzed the data
measure: satification anaylsis
timeFrame: after every 100 effective data or 1 year, analyzed the data
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Li Kuei Chen, M.D.
role: STUDY_CHAIR
References:
citation: Yang YL, Wang KJ, Chen WH, Chuang KC, Tseng CC, Liu CC. Improved satisfaction of preoperative patients after group video-teaching during interview at preanesthetic evaluation clinic: the experience of a medical center in Taiwan. Acta Anaesthesiol Taiwan. 2007 Sep;45(3):149-54.
citation: Snyder-Ramos SA, Seintsch H, Bottiger BW, Motsch J, Martin E, Bauer M. Patient satisfaction and information gain after the preanesthetic visit: a comparison of face-to-face interview, brochure, and video. Anesth Analg. 2005 Jun;100(6):1753-1758. doi: 10.1213/01.ANE.0000153010.49776.E5.
Clinical trial NCT00165945: 4-D Visualization Using Magnetic Resonance Imaging (MRI) in the Congenital Heart Disease Population
Official title: Using 4-D Visualization Software With Magnetic Resonance Images in the Congenital Heart Disease Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: pediatric, cardiology, diagnostic imaging using MRI
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2005-09-14
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatrics patients in all age groups evaluated with MRI for complex congenital cardiovascular lesions and associated hemodynamics. These are patients coming in for standard of care cardiac MRI's

Brief summary: In this study, the investigators wish to use images obtained from standard of care cardiac MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different computer in order to analyze them with a new computer. The investigators are hoping to better their understanding and management of complex congenital heart disease.

Detailed description: All patients enrolled in this study will be receiving standard of care cardiac MRI as prescribed by their physician. These MRI DICOM images will be transferred to a SGI Fuel workstation, where they will be manipulated using the newly developed 4-D Visualization software. No additional scanner time or new imaging sequences are required as presently prescribed sequences and produced data can be analyzed. The workstation is designed to include acceleration hardware for volume rendering, and was developed for advanced cardiac MRI viewing.

Eligibility criteria: Inclusion Criteria:

* Scheduled for a cardiac MRI at Children's Healthcare of Atlanta
* Informed consent
* meet MRI eligibility inclusion criteria

Exclusion Criteria:

* Not having a cardiac MRI
* No informed consent
* not meeting MRI eligibility exclusion criteria

Primary outcomes:
measure: To determine if the 4-D visualization software is beneficial in the investigators' understanding and management of complex congenital heart lesions and their associated hemodynamics/anatomy
timeFrame: throughout study
Secondary outcomes:
measure: To study the impact and role of 4-D Visualization on surgical planning and outcome
timeFrame: entire study
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University and Children's Healthcare of Atlanta
name: W.James Parks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01001845: Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
Official title: Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemodialysis
End Stage Renal Disease
Keywords: hemodialysis
oxidative stress
plasma malondialdehyde
Glutathion peroxidase
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most common cause of excess morbidity and mortality. Among the examined nontraditional risk factors, an increase in oxidative stress as well as inflammation are postulated to contribute to excessive cardiovascular risk in this population.

Flavonoids are naturally occurring substances that possess various pharmacological actions and therapeutic applications. Some due to their phenolic structures have antioxidant effect and inhibit free radical-mediated processes, as well as anti-inflammatory effects. Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating, and antifibrotic action.

In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and compared to vit E, a well known antioxidant.


Eligibility criteria: Inclusion Criteria:

* All hemodialysis patients age 18-60
* On hemodialysis for over 3 months, 3 times a week, and for 4 hours each time
* Signed informed consent

Exclusion Criteria:

* Heart Failure NYHA Class III or IV
* Recent MI (within 1 year)
* Use of anti-oxidant supplements: N-acetyl-cystein, Omega 3, Vit C, Vit E, green tea, soy extracts, pomegranate extract, grape extract..
* Hepatitis B or C
* Active Infection
* Psychiatric illness
* Active malignancy

Primary outcomes:
measure: RBC Glutathion Peroxidase level
timeFrame: 3 weeks
Secondary outcomes:
measure: Plasma malondialdehyde
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Nemazi Hospital
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences, Faculty of Pharmacy
name: Ghazal Vessal, PharmD, PhD
role: STUDY_DIRECTOR
affiliation: Shiraz University of Medical Sciences
name: Bahram Shahriari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology Urology Research Center, Shiraz University of Medical Sciences
name: Jamshid Roozbeh, MD
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: masoumeh Akmali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896245: Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
Official title: Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Specified Injuries of Vocal Cord, Sequela
Keywords: hoarseness
sore throat
intubating conditions
vocal cord injuries
sevoflurane
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.

Detailed description: We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. During tracheal intubation intubating conditions are noted. After surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.

Eligibility criteria: Inclusion Criteria:

* ear-nose-throat surgery
* orotracheal intubation for surgery of the ear
* ASA I-III

Exclusion Criteria:

* obesity
* allergy against the study drugs
* patients with a known or suspected difficult airway
* diseases of the larynx

Primary outcomes:
measure: incidence of vocal cord injuries
timeFrame: 24 hours after tracheal intubation
Secondary outcomes:
measure: incidence of hoarseness
timeFrame: 24, 48, and 72 hours after tracheal intubation
measure: incidence of soar throat
timeFrame: 24, 48, and 72 hours after tracheal intubation
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Department of Anesthesia and Intensive Care Medicine, University of Rostock
state: Mecklenburg/Vorpommern
Study officials:
affiliation: Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany
name: Thomas Mencke, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ovari A, Bicker I, Machmueller S, Schuldt T, Sauer M, Soltesz S, Noeldge-Schomburg G, Mlynski R, Mencke T. Sevoflurane at 1.0 MAC together with remifentanil and propofol produces clinically acceptable intubation conditions at the vocal cords: A prospective randomized study. J Int Med Res. 2017 Jun;45(3):1098-1108. doi: 10.1177/0300060517701355. Epub 2017 Apr 28.