louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01990937: Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)
Official title: Effectiveness of Oral Midazolam for Sedation in Patients Undergoing Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Conscious Sedation Failure During Procedure
Keywords: oral midazolam
sedation
premedication
upper gastrointestinal endoscopy
EGD
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?

Detailed description: Five mg of midazolam was intake orally about 30 minutes before undergoing perform upper gastrointestinal endoscopy. Declined of anxiety scores was primary end point.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo elective diagnostic EGD
* American Society of Anesthesia (ASA) criteria to be class 1 to 2

Exclusion Criteria:

* History of gastrectomy, esophagectomy, pancreaticoduodenectomy, or other operation on the upper-GI tract
* American Society of Anesthesia (ASA) criteria to be class 3 to 4
* Pregnancy
* Alcoholism
* Drug abuse
* Taking psychotic medications
* Allergy to midazolam.

Primary outcomes:
measure: Difference of Anxiety score
timeFrame: Asked the patient 5 minutes before EGD and then after fully recovery from sedation.
Secondary outcomes:
measure: Overall tolerance
timeFrame: Asked the patient after fully recovery from sedation.
Other outcomes:
measure: Amnesia score
timeFrame: Asked the patient after fully recovery from sedation.
measure: Overall satisfaction
timeFrame: Asked the patient after fully recovery from sedation.
measure: Willing to repeat EGD
timeFrame: Asked the patient after fully recovery from sedation.
measure: Vital signs
timeFrame: Vital signs were measured at 5 minutes before EGD then measured every 5 minutes during EGD until the patient was fully recovery after the EGD was finished.
Locations:
city: Bangkok
country: Thailand
facility: Division of Gastroenterology, Department of Medicine, Phramongkutklao hospital
Study officials:
affiliation: Division of gastroentrology, Department of Medicine, Phramongkutklao hospital
name: Chaipichit Puttapitakpong, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04501237: Sleep Hygiene Measures for Sleep Bruxism in Children
Official title: Efficacy of Sleep Hygiene Measures in the Occurrence of Sleep Bruxism in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Bruxism, Childhood
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy of sleep hygiene measures for the possible improvement of sleep bruxism in children through a randomized controlled clinical study of children under 8 years of age with probable sleep bruxism. In randomization both groups will receive information about bruxism, and the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio. The occurrence of sleep bruxism will be assessed through a diary to be completed by the child's responsible party. A randomized, stratified sample of approximately 16 children will be included in the study. One group will be composed of 8 children with probable sleep bruxism who will receive the sleep hygiene intervention, and another group of children who will only receive instructions on sleep bruxism, with causes and consequences. Participants will be followed-up for 30 days. Parents will respond to a questionnaire about socioeconomic, demographic (child's age and gender), as well as parafunctional habits such as nail biting, biting objects, pacifier sucking, finger / thumb sucking and bottle feeding, child's sleep characteristics, screen habits, parental smoking, problems breathing, parental profession and also on psychological issues. Sleep habits will also be answered in this questionnaire, and parents will also answer the Strengths and Difficulties Questionnaire. The children over 6 years old will respond a Child Stress Scale and the Child of stressing sources in child; children less than 6 years will have the questionnaire responded by parents. The children will undergo a clinical examination to assess dental wear, according to the BEWE (Basic Erosive Wear Examination Index). The study evaluations consist of baseline, 1, 7, 15 and 30 days.


Eligibility criteria: Inclusion Criteria:

* children with probable sleep bruxism

Exclusion Criteria:

* systemic diseases;
* Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child.

Primary outcomes:
measure: Questionnaire
timeFrame: Responded 1 month after intervention in both groups
Secondary outcomes:
measure: Clinical evaluation of child teeth
timeFrame: Analyzed 1 month after intervention in both groups
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: School of dentistry
state: RS
Study officials:
References:
Clinical trial NCT03903237: Herpes Zoster: Risk Factors, Complications and Special Situations
Official title: Herpes Zoster: Risk Factors, Complications and Special Situations- a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Zoster
Keywords: post-zoster neuralgia
Herpes Zoster-related complications
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with HZ who were seen at University Hospital Basel between 2004-2018

Brief summary: This retrospective analysis is to investigate patients' history and clinical presentation in Herpes Zoster (HZ), Zoster-related complications, post-Zoster neuralgia and Herpes Zoster management in order to improve the management of HZ patients, to refine HZ-vaccination strategies and elucidate cost factors of HZ in in the setting of a university hospital in Switzerland generally and in a dermatology department specifically.


Eligibility criteria: Inclusion Criteria:

* Reports of patients with HZ at University Hospital Basel between 2004-2018

Exclusion Criteria:

* rejection to use patient data

Primary outcomes:
measure: Evaluation of patients' history
timeFrame: single time point assessment at baseline
measure: Description of the clinical presentation of HZ
timeFrame: single time point assessment at baseline
measure: Evaluation of zoster-related complications
timeFrame: single time point assessment at baseline
measure: Evaluation of the herpes zoster management
timeFrame: single time point assessment at baseline
measure: Assessment of post-zoster neuralgia
timeFrame: single time point assessment at baseline
measure: Evaluation of zoster and pregnancy
timeFrame: single time point assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Simon Müller, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03015337: Relationship of Motor Skill Competency and Physical Fitness to Physical Activity in Elementary School Students
Official title: Relationship of Motor Skill Competency and Physical Fitness to Physical Activity in Elementary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 1844
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study examined how well elementary students demonstrated motor skill competency as a result of participating in the evidence-based quality physical education program and investigated relationships between levels of health-related physical fitness and physical activity in school-aged children.


Eligibility criteria: Inclusion Criteria:

* K-5 th grade students who are enrolled in 9 elementary schools in Southeast Michigan.

Exclusion Criteria:

-

Primary outcomes:
measure: Running skill assessment
timeFrame: 2 years
measure: Weight transferring skill assessment
timeFrame: 2 years
measure: hand dribbling skill assessment
timeFrame: 2 years
measure: underhand catching skill assessment
timeFrame: 2 years
measure: FitnessGram test
timeFrame: 1 year
measure: Daily physical activity participation in minutes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: School of Kinesiology, University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Weiyun Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen W, Hammond-Bennett A, Hypnar A, Mason S. Health-related physical fitness and physical activity in elementary school students. BMC Public Health. 2018 Jan 30;18(1):195. doi: 10.1186/s12889-018-5107-4.
citation: Chen W, Hammond-Bennett A, Hypnar A. Examination of motor skill competency in students: evidence-based physical education curriculum. BMC Public Health. 2017 Feb 23;17(1):222. doi: 10.1186/s12889-017-4105-2.
Clinical trial NCT06238037: Bone Mineral Density in Patients With Sarcoidosis
Official title: Bone Mineral Density in Patients With Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Osteoporosis Risk
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sarcoidosis seen in dep. of Respiratory Diseases and Allergology, Aarhus University Hospital

Brief summary: To assess the frequency and risk factors of decreased bone mineral density (BMD) and vertebral fractures in Danish patients with sarcoidosis.

Detailed description: An increased risk of bone fracture has been found in patients with sarcoidosis. Some data showed that the risk of fracture was limited to patients treated with glucocorticoid but data are conflicting and not all studies can prove an increased risk of fracture or bone mineral loss in sarcoidosis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent

Primary outcomes:
measure: Number of patients with osteoporosis
timeFrame: At baseline
measure: Number of patients with osteoporosis
timeFrame: 1 year from diagnosis
measure: Number of patients with osteoporosis
timeFrame: 2 years from diagnosis
measure: Number of patients with osteopenia
timeFrame: At baseline
measure: Number of patients with osteopenia
timeFrame: 1 year from diagnosis
measure: Number of patients with osteopenia
timeFrame: 2 years from diagnosis
Secondary outcomes:
measure: Number of participants with vertebral fracture
timeFrame: At baseline
measure: Number of participants with vertebral fracture
timeFrame: 1 year from diagnosis
measure: Number of participants with vertebral fracture
timeFrame: 2 years from diagnosis
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology
Study officials:
References:
Clinical trial NCT00485537: Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles
Official title: Pregnancy Outcomes With a Gonadotropin-Releasing Hormone (GnRH) Antagonist (Cetrorelix) Protocol Versus GnRH-Agonist Protocol in Ovarian Stimulation for ICSI Cycles-a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: GnRH antagonist
GnRH agonist
ICSI
miscarriage rate
pregnancy outcome
Lead sponsor: Clinic and Research Center in Human Reproduction Roger Abdelmassih
Sponsor class: OTHER
First posted: 2007-06-13
Enrollment: 2005
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized.

Detailed description: 160 women were equally divided between a GnRH antagonist protocol (Group 1) versus a GnRH agonist protocol (Group 2) in ICSI cycles. The trial was conducted between September 2005 and December 2006. The mean age in both groups was 32 (range 22-40). The main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates.

Eligibility criteria: Inclusion Criteria:

* Infertility couples, absence of endometriosis (confirmed by a previous surgical procedure to investigate infertility), polycystic ovarian syndrome, FSH levels \< 12 IU/l, basal levels of estradiol \< 20 in the group submitted to the agonist protocol and beginning of stimulation on day 2 in group submitted to antagonist protocol, in the absence of ovarian cysts on the endovaginal ultrasound

Exclusion Criteria:

* use of exogenous LH during stimulation

Primary outcomes:
measure: Comparative response to ICSI cycles with GnRH agosnist and cetrotide
timeFrame: 16 months
Secondary outcomes:
measure: Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups
timeFrame: 16 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinica e Centro de Reprodução Humana Roger Abdelmassih
state: SP
Study officials:
affiliation: Clinic and Research Center in Human Reproduction Roger Abdelmassih
name: Rosa M Neme, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00696137: Long-term Extension Study of BEMA™ Fentanyl
Official title: Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Depression
Keywords: Chronic Pain
Ventilatory Response to Hypercapnia (VRH)
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 5
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: This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.

Detailed description: This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.

Eligibility criteria: Inclusion Criteria:

1. previously qualified for and participated in study FEN-202 for at least 2 weeks,
2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
3. provide signed informed consent at screening prior to any study procedures.

Exclusion Criteria:

1. they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or
2. there is evidence of improper use of the study drug.

Primary outcomes:
measure: Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BioDelivery Sciences International
name: David Blum, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02195037: Changes in Cardiac Output During Delayed Umbilical Cord Clamping
Official title: Changes in Cardiac Output During Delayed Umbilical Cord Clamping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, Low
Keywords: Delayed Cord Clamping
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 20
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy full term infants delivered by vaginal birth with an estimated gestational age of 37+1 to 41+6 weeks corrected gestational age

Brief summary: Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition


Eligibility criteria: Inclusion Criteria:

* Healthy full term infants
* Delivered by vaginal birth
* Estimated gestational age of 37+0to 41+6 weeks corrected gestational age

Exclusion Criteria:

* Multiples
* Known fetal anomalies (including cardiac defects).
* Instrumentation during delivery (forceps or vacuum)
* Non-reducible nuchal cord during delivery.
* Any maternal or neonatal indication requiring immediate cord clamping.

Primary outcomes:
measure: Cardiac Output
timeFrame: 5 minutes of Life
Secondary outcomes:
measure: Stroke Volume
timeFrame: 5 Minutes of Life
measure: Bilirubin level
timeFrame: until discharge
measure: Hemoglobin level
timeFrame: until discharge
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.
Clinical trial NCT02295137: Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair
Official title: Image Fusion of Pre-procedural CTA With Real-time Fluoroscopy to Guide Proper Renal and Visceral Arteries Catheterization During Advanced Endovascular Aortic Aneurysms Repair: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Abdominal Aortic Aneurysm (AAA)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.


Eligibility criteria: Inclusion Criteria:

* male or female \>= 18 years;
* scheduled for advanced EVAR for abdominal aortic aneurysm.

Exclusion Criteria:

* Pregnancy;

Primary outcomes:
measure: Procedure success
timeFrame: within 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kong Teng Tan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02613637: Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project
Official title: Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: lung cancer
registry study
Biological Disease Profile
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with newly diagnosed or existent lung cancer of all LuCa BiO centers in Germany are intended to be registered with in the LuCa BiO Registry.

Brief summary: Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed or Existent Lung Cancer

The LuCa Biology and Outcome (BiO)-Project


Eligibility criteria: Inclusion Criteria:

* Patients with suspected diagnosis of lung cancer, or previously diagnosed lung cancer
* Age ≥ 18 years. There is no upper age limit.

Exclusion Criteria:

* Severe neurological or psychiatric disorder interfering with ability to give an informed consent
* No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
* No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

Primary outcomes:
measure: Overall Survival
timeFrame: maximally 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Stuttgart
country: Germany
facility: Pneumologie, Internistische Intensivmedizin, Beatmungsmedizin und Allgemeine Innere Medizin, Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: University Hospital of Ulm
name: Lars Bullinger, MD
role: PRINCIPAL_INVESTIGATOR
References: