louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00051155: A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)
Official title: A 6-Week Safety and Efficacy Study of TRAVATAN Compared to XALCOM in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Keywords: Glaucoma
POAG
OAG
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-01-07
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: To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Europe
state: Texas
Study officials:
affiliation: Alcon Research
name: Alcon Investigators
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00272155: An Intervention to Reduce Inappropriate Prescriptions of Antibiotics for Respiratory Infections in General Practice
Official title: Can Antibiotic Prescriptions in Respiratory Tract Infections be Improved? A Cluster Randomized Educational Intervention in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Tract Infections
Anti-Bacterial Agents
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 118621
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to improve antibiotic prescriptions for respiratory infections.


Eligibility criteria: Inclusion Criteria:

* General practitioner
* Specialist in general practice

Primary outcomes:
measure: Change in antibiotic prescription patterns for respiratory infections
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Svein Gjelstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gjelstad S, Hoye S, Straand J, Brekke M, Dalen I, Lindbaek M. Improving antibiotic prescribing in acute respiratory tract infections: cluster randomised trial from Norwegian general practice (prescription peer academic detailing (Rx-PAD) study). BMJ. 2013 Jul 26;347:f4403. doi: 10.1136/bmj.f4403.
citation: Fossum GH, Lindbaek M, Gjelstad S, Dalen I, Kvaerner KJ. Are children carrying the burden of broad-spectrum antibiotics in general practice? Prescription pattern for paediatric outpatients with respiratory tract infections in Norway. BMJ Open. 2013 Jan 7;3(1):e002285. doi: 10.1136/bmjopen-2012-002285.
citation: Gjelstad S, Fetveit A, Straand J, Dalen I, Rognstad S, Lindbaek M. Can antibiotic prescriptions in respiratory tract infections be improved? A cluster-randomized educational intervention in general practice--the Prescription Peer Academic Detailing (Rx-PAD) Study [NCT00272155]. BMC Health Serv Res. 2006 Jun 15;6:75. doi: 10.1186/1472-6963-6-75.
Clinical trial NCT03294655: A Resilience Building Intervention to Promote Successful Aging
Official title: A Resilience Building Intervention to Promote Successful Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Dwelling Adults Aged 50 and Older
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 61
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre-post experimental design, 60 adults aged 50+ will be randomized to either a no-contact control or intervention condition
Primary purpose: TREATMENT

Brief summary: In this pilot study, a pre-post experimental design will be used, in which 60 community dwelling adults aged 50+ will recruited from a larger parent study, and will then be randomized to either a no-contact control or intervention condition. Those in the intervention condition will receive a psychoeducational intervention in which they will receive scientific literature-based information on resilience and strategies to bolster resilience, as well as developing an individualized plan on areas to engage in at home over the next four weeks. All participants will return for an immediate posttest using an abbreviated version of the baseline battery from the parent study.


Eligibility criteria: Inclusion Criteria/Exclusion Criteria:

* Must be enrolled in a larger parent study
* The criteria for the parent study are: no neurological or severe neuromedical disorders (e.g., stroke, schizophrenia), must be able to speak English, not be legally blind or deaf, not currently undergoing chemotherapy or radiation therapy, no brain trauma with loss of consciousness greater than 30 mins, and not homeless.

Primary outcomes:
measure: Resilience
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: the Holly Mears Building/Center for Research on Applied Gerontology
state: Alabama
Study officials:
References:
Clinical trial NCT01023555: Increasing the Yield of Blood Cultures in Neonates
Official title: Increasing the Yield of Blood Cultures in the Neonatal Intensive Care Unit- A Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteremia
Keywords: Bacteremia
Blood Cultures
Sepsis
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.


Eligibility criteria: Inclusion Criteria:

* All blood cultures taken in the NICU during the study period.

Exclusion Criteria:

* Bacteria that are normal flora of the skin such as Coagulase negative staphylococci or Streptococci Viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.

Primary outcomes:
measure: Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.
timeFrame: 6months
Secondary outcomes:
measure: utility of the routine use of anaerobic bottle for blood cultures in newborns
timeFrame: 6 months
measure: Comparison of time to positivity of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles (aerobic and anaerobic)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Yaacobi N, Bar-Meir M, Shchors I, Bromiker R. A prospective controlled trial of the optimal volume for neonatal blood cultures. Pediatr Infect Dis J. 2015 Apr;34(4):351-4. doi: 10.1097/INF.0000000000000594.
Clinical trial NCT05244655: Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study
Official title: Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Complications
Postoperative Pain
Acute Pain
Postoperative Complications
Surgery--Complications
Keywords: Early postoperative pain
Infectious complications
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent major abdominal surgery, mostly electively scheduled, between January 2014 and December 2020 were considered eligible for participation in our study.

Brief summary: In this retrospective cohort study, we assess the relationship between the intensity of early postoperative pain and the risk of infectious- and non-infectious complications within 30 days after major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Major abdominal surgery under general anesthesia

Exclusion Criteria:

* younger than 18 years of age
* procedures outside the operation room
* procedures solely under regional anesthesia, i.e. no general anesthesia

Primary outcomes:
measure: Acute postoperative pain
timeFrame: 1 day
Secondary outcomes:
measure: Infectious complications postoperative
timeFrame: 30 days
measure: Overall complications postoperative
timeFrame: 30 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
Study officials:
References:
Clinical trial NCT03449355: Sexuality After Different Mode of Deliveris
Official title: Effect of the Mode of Delivery on Sexual Functions and Quality of Life Among a Group of Egyptian Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction and the Mode of Deliveries
Keywords: sexuality
mode of delivery
quality of life
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primiparous women 6-12 months after deliveries either vaginal or cesarean section

Brief summary: Pregnancy and delivery usually affect the general women's quality of life. Some studies have reported that sexual health may be affected by the mode of delivery. More than 70% of pregnant women prefer C-section due to several reasons point out the fear of pain and complications of vaginal delivery as the most common reasons.

Aim of the work: To explore the relationship between quality of life and the possible sexual dysfunction after normal vaginal in comparison to cesarean section deliveries.


Eligibility criteria: Inclusion Criteria:

* Primiparas women who had been delivered by either vaginal or cesarean section about 6-12months.
* All included women should be officially married

Exclusion Criteria:

* Women with history of sexual dysfunction
* Women with history of any pelvic surgery apart from Cesarean.
* history of anti-depressive drug therapy.
* history of genital prolapse
* history of Diabetes mellitus
* loss of any family member or unfaveorouble neonatal outcome or childdeath
* Divorce experience
* family problems and cases who were not interested in participation

Primary outcomes:
measure: quality of life after delivery
timeFrame: one month
Secondary outcomes:
measure: the relationship between quality of life and sexual dysfunction after both modes delivery
timeFrame: one month
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT00926055: Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Official title: Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atherosclerosis
Keywords: high risk patients in atherosclerosis
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. Therefore, in this study the investigators intend to compare the effect of ezetimibe monotherapy or ezetimibe plus statin combination therapy on the atherosclerosis regression using FDG-PET.


Eligibility criteria: Inclusion Criteria:

* hsCRP \> 2 mg/L and LDL cholesterol \> 130 mm/dL

Exclusion Criteria:

* history of cardiovascular disease
* diabetes
* uncontrolled hypertension
* active infection
* previous anti-hyperlipidemic agents within 6 months
* previous steroid or anti-inflammatory agents within 6 months
* liver disease
* renal disease

Primary outcomes:
measure: The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups
timeFrame: 3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro
Study officials:
References:
Clinical trial NCT06492655: To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

Detailed description: Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19 to 54 years
* BMI measurement result is 18.0 kg/m2 to 30 kg/m2
* Written informed consent
* Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

* who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period

  1 administration)
* Other exclusive criteria, as defined in the protocol

Primary outcomes:
measure: AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
timeFrame: 0 hour ~ 48 hour after drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jaeyong chung, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05743855: The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.
Official title: The Effect of Co-therapy Chiropractic Plus Nutritional Supplement in Patients Experiencing Chronic Pain and Inflammation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Inflammatory Response
Lead sponsor: Standard Process Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluating the effect of a combined therapy of chiropractic sessions plus nutritional supplement containing hemp, omega-3 fatty acids, and broccoli extract oil in patients experiencing chronic pain and inflammation.


Eligibility criteria: Inclusion Criteria:

* Chronic pain (\>3years)

Exclusion Criteria:

* GABA/opioid medication

Primary outcomes:
measure: Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks.
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Pain intensity using the 11-Point Numeric Rating Scale (11-NRS) after 12 weeks.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Reactive oxygen species (ROS) status
timeFrame: At baseline and after 12 weeks
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Randolph Chiropractic Health Center
state: North Carolina
city: Kannapolis
country: United States
facility: Trull Chiropractic PA
state: North Carolina
city: Mooresville
country: United States
facility: Combined Chiropractic & Acupuncture PLLC
state: North Carolina
Study officials:
References:
Clinical trial NCT00718055: Magnetic Resonance Imaging (MRI) Using Liverspecific Oral Contrast Agent in Metastatic Colorectal Cancer Patients
Official title: MR Skanning Med Leverspecifikt Oralt Kontraststof Sammenlignet Med CT Skanning Hos Colorectalcancer Patienter Med Levermetastaser
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neoplasm Metastasis
Liver
Colorectal Neoplasms
Magnetic Resonance Imaging
Contrast Media
Keywords: MRI
liverspecific
contrast
colorectal
metastases
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 50
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: consekutive group of liver metastatic patients

Brief summary: The purpose of this study is to determine whether MRI with manganese containing contrast agent detects more livermetastasis compared to CT scan


Eligibility criteria: Inclusion Criteria:

* biopsy proved liver metastasis

Exclusion Criteria:

* pacemaker, metal in the body, claustrophobia, pregnancy, age below 18 years, psychiatry patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Copenhagen Uni. Hospital at Herlev dept. of Radiology
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Vibeke Løgager, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01286155: Epidemiology of Barrett's Esophagus: A Population Based Study
Official title: Epidemiology of Barrett's Esophagus: A Population Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Gastroesophageal Reflux Disease (GERD)
Olmsted County Resident
Keywords: Barrett's esophagus
gastroesophageal reflux disease
GERD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2011-01-31
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Olmsted county resident

Brief summary: To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community.

To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient


Eligibility criteria: Inclusion Criteria:

1. Case: Olmsted county residents \> 18 years old from the barrett's esophagus (BE) incidence cohort who are still alive at the time of study.
2. Control # 1 : Olmsted county residents \> 18 years old that responded to a recent community based survey and reported gastroesophageal reflux (GER) symptoms at least once a week and without a known diagnosis of BE.
3. Control # 2 : Olmsted county residents \> 18 years old that responded to a recent community based survey that did not report any GER symptoms and without a known diagnosis of BE.

Exclusion Criteria:

1. Cases: BE subjects who

   1. Have died prior to the start of this study;
   2. Refuse to participate;
2. Controls: respondents to the "constipation survey" who

   1. Are known to have BE;
   2. Have died prior to the start of this study;
   3. Refuse to participate; -

Primary outcomes:
measure: The primary outcome from the survey will be the proportion of patients willing to undergo an esophageal capsule study compared to those willing to undergo an endoscopic procedure (Esophagogastroduodenoscopy or transnasal endoscopy)
timeFrame: 18 months
Secondary outcomes:
measure: Study established (age, gender, ethnicity, reflux) and potential risk factors (sleep apnea, visceral adiposity, Helicobacter pylori infection, Metabolic Syndrome)to develop a clinical risk factor model for diagnosis of Barrett's esophagus(BE).
timeFrame: 18 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT02764255: Embryoscope and Reproductive Outcome
Official title: Does Embryoscope Improve Reproductive Outcome in ICSI Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invitro Fertilization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 770
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 770 women undergoing ICSI cycles

Brief summary: cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model

Detailed description: cases with embyos cultured in the standard incubator and evaluated only by morphology (control group) are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model(study group)

Eligibility criteria: Inclusion Criteria:

* Patient age:25-40 years old
* BMI:18-30
* patients with first or second ICSI trial

Exclusion criteria:

* AMH \<1
* severe male factor(total motile sperm \<1 million)
* frozen embryo transfer cycles
* patients with endocrinopathies or thrombophilia
* patients on medical treatment which may interfere with results
* hydrosalpinx

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 14 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: