louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01505777: Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
Official title: Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome Without Diarrhea
Keywords: irritable bowel syndrome without predominant diarrhea
Probiotics(Medirac) 10/mosapride 10mg
Probiotics(Medirac) 15/mosapride 10mg
Probiotics(Medirac) 15/mosapride 15mg
Probiotics(Medirac) 30/mosapride 15mg
Probiotics(Medirac) placebo/mosapride placebo
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-01-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.


Eligibility criteria: Inclusion Criteria:

* Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
* Signed informed consent

Exclusion Criteria:

* IBS-D
* evidence of cathartic colon or history laxative abuse

Primary outcomes:
measure: Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
timeFrame: baseline and 4 week
Secondary outcomes:
measure: Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks)
timeFrame: baseline and 4 weeks, 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 16 institutions including Gangnam Severance hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Hyo Jin Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi CH, Kwon JG, Kim SK, Myung SJ, Park KS, Sohn CI, Rhee PL, Lee KJ, Lee OY, Jung HK, Jee SR, Jeen YT, Choi MG, Choi SC, Huh KC, Park H. Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double-blind, placebo-controlled, multicenter, phase II trial. Neurogastroenterol Motil. 2015 May;27(5):705-16. doi: 10.1111/nmo.12544. Epub 2015 Mar 25.
Clinical trial NCT05677477: The Effect of Hybrid Simulation on Evaluating Neonatal Jaundice
Official title: The Effect of Hybrid Simulation on Nursing Students' Ability to Evaluate Neonatal Physiological Jaundice: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nursing Education
Keywords: Nursing education
hyperbillirubinemia
simulation
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will be conducted as a single-blind randomized control group intervention trial to determine the effectiveness of the hybrid simulation method using standard patient and low-fidelity baby simulators in the intervention of nursing students for neonatal physiologic jaundice.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the course
* Had not taken this course before
* Accepted to participate in the research

Exclusion Criteria:

* Have any records of absence
* Taken this course before
* Graduate of health vocational high school

Primary outcomes:
measure: Student Information Form and First Knowledge Test
timeFrame: One week before Simulation (First week)
measure: Jaundice case checklist form
timeFrame: During simulation (Second week)
measure: Second Student Knowledge Test
timeFrame: Two weeks after simulation (Fourth week)
Secondary outcomes:
Other outcomes:
Locations:
city: Çankiri
country: Turkey
facility: Çankırı Karatekin Üniversitesi
Study officials:
affiliation: Çankırı Karatekin University
name: Müjgan Onarıcı
role: STUDY_CHAIR
affiliation: Çankırı Karatekin University
name: Tuğba Yıldırım
role: STUDY_CHAIR
References:
citation: Choi YJ. Exploring experiences of psychiatric nursing simulations using standardized patients for undergraduate students. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Sep;6(3):91-5. doi: 10.1016/j.anr.2012.07.001. Epub 2012 Jul 20.
Clinical trial NCT03419377: Lichen Sclerosus - the Influence on Quality of Life
Official title: Lichen Sclerosus - the Influence on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Sclerosus
Keywords: Treatment
Quality of Life
Sexology
Women
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2018-02-01
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.

Detailed description: The patients are randomized to an intervention Group and a control Group. The intervention gets 6-8 visits with clinical sexologist and the control Group is having the usual care.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Lichen Sclerosus
* Age over 18 years

Exclusion Criteria:

* Patients who does not understand or speak Danish
* Patients with a psychiatric diagnosis and can not follow the course

Primary outcomes:
measure: Quality of Life in women with Lichen Sclerosus
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: Vendsyssel Hospital
Study officials:
References:
citation: Vittrup G, Westmark S, Riis J, Morup L, Heilesen T, Jensen D, Melgaard D. The Impact of Psychosexual Counseling in Women With Lichen Sclerosus: A Randomized Controlled Trial. J Low Genit Tract Dis. 2022 Jul 1;26(3):258-264. doi: 10.1097/LGT.0000000000000669. Epub 2022 Mar 25.
Clinical trial NCT02774577: Oxygen Consumption After Acute Whole Body Vibration Session
Official title: Acute Effects on Oxygen Consumption and Blood Flow After a Single Session of Whole Body Vibration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Oxygen Consumption
Keywords: Oxygen Consumption
Aged
Whole Body Vibration
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: acute wbv session, measuring ergospirometric variables during protocol and blood pressure, borg exertion, borg dyspnoea, blood lactate, heart rate and SpO2 before and after protocol.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Noninvasive assessment of VO2 during a single session of whole body vibration and changes in blood flow caused by the acute activity.

Detailed description: A single whole body vibration session into two groups, a young adults groups and elderly group, booth healthy, will be held with concomitant collection of VO2 consumed during the session, by MetaMax cortex. Immediately after the session, it will be checked peripheral blood flow through US surface in color Doppler mode.

Eligibility criteria: Inclusion Criteria:

* healthy young adults (between 20 to 30 years) and healthy elderly (between 60 to 74 years), sedentary according International Physical Activity Questionnaire.

Exclusion Criteria:

* presence of thrombosis, labyrinthitis, osteoporosis and individuals who have difficulty adapting to the assessment or training protocol.

Primary outcomes:
measure: VO2 through the gas exchange measured by Cortex Metamax
timeFrame: up to 06 months
measure: peripheral blood Lactate
timeFrame: up to 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT00820677: Newborn Health Information Study
Official title: Innovative Delivery of Newborn Anticipatory Guidance: The Incorporation of Media-Based Learning Into the Primary Care Office.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: The Commonwealth Fund
name: Academic Pediatric Association
First posted: 2009-01-12
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized, controlled trial to test the use of an educational video during the newborn well-child visit. Parents who watch the video during their medical visit will be compared to those parents who receive traditional paper handouts. Measures obtained at baseline and 2-week follow-up include knowledge of infant development, self-efficacy with infant care, and problem-solving skills.


Eligibility criteria: Inclusion Criteria:

* Baby's first visit to the pediatric office

Exclusion Criteria:

* Baby \> 1 month old
* Parent/Caregiver \< 18yrs old
* Inability to understand English
* No access to a working telephone

Primary outcomes:
measure: Knowledge of Infant Development
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Heather A Paradis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Jill S Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paradis HA, Conn KM, Gewirtz JR, Halterman JS. Innovative delivery of newborn anticipatory guidance: a randomized, controlled trial incorporating media-based learning into primary care. Acad Pediatr. 2011 Jan-Feb;11(1):27-33. doi: 10.1016/j.acap.2010.12.005.
Clinical trial NCT00207077: Study of Cetuximab in Combination With Tarceva in Patients With Solid Tumors
Official title: A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Advanced Solid Tumors
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find a safe and effective dose of the combination of cetuximab (Erbitux) and Tarceva (erlotinib).


Eligibility criteria: Inclusion Criteria:

* Measurable disease
* Life expectancy of at least 3 months
* Must have at least one prior chemotherapy containing a platinum

Exclusion Criteria:

* Known or documented brain metastases
* Prior cetuximab therapy

Primary outcomes:
measure: Safety and efficacy of the combination of Tarceva and Erbitux
Secondary outcomes:
measure: Radiographic response
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03590977: Efficacy of Licorice on Reducing Salivary Streptococcus Mutans Versus Chlorohexidine in Caries Risk Patients
Official title: Evaluation the Efficacy of a Herbal Licorice on Reducing Salivary Streptococcus Mutans Levels (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries, Dental
Keywords: Streptococcus Mutans
licorice
chlorohexidine
caries index
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans.

Detailed description: A total number of fifty-two patients will be enrolled in the study. They will be divided into two groups: study group and control group. Study group will be subjected to licorice mouthwash and the control will be subjected to chlorohexidine mouth wash. Salivary bacterial count will be evaluated for both groups.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* co-operative patients
* not allergic to licorice
* not allergic to chlorohexidine

Exclusion Criteria:

* pregnancy
* allergic patients to licorice
* allergic patients to chlorohexidine
* lack of compliance
* evidence of parafunctional habits
* patients with periodontal disease
* xerostomia
* participants that receive any microbial agent two weeks prior to the study

Primary outcomes:
measure: salivary bacterial count
timeFrame: after one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dentistry, Cairo univerisity
name: nancy helmy, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almaz ME, Sonmez IS, Okte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30.
citation: Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964.
Clinical trial NCT00587977: Aortic Distensibility
Official title: ECG-Gated Multidetector CT of Aortic Distensibility FAMRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal aortic aneurysm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Flight Attendant Medical Research Institute
First posted: 2008-01-08
Enrollment: 67
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 undergoing imaging of their abdominal aortic aneurysm

Brief summary: Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.

Detailed description: Hypothesis: ECG-gated multidetector CT and ECG-gated Dual Source CT can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.

Eligibility criteria: Inclusion Criteria:

* AAA must be at least 3 cm to a maximum 4.9cm cross-sectional diameter.
* BMI 31 or less.
* Creatinine results \<2.0 and within six months prior to scan.
* US patients must have only normal creatinine (0.9 to 1.4) for one year before study visit.
* Patients who are originally scheduled for US, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial CTA.

Exclusion Criteria:

* Creatinine \> 2.0.
* Creatinine \<0.9 or \>1.4 for those who are scheduled for US.
* Atrial fibrillation or other arrythmia.
* Known AAA greater than 5 cm in size.
* Allergy to contrast dye.

Primary outcomes:
measure: In year one, this data will be used to develop pulsatility software and test robustness.
timeFrame: First Year
Secondary outcomes:
measure: In year two, the time-resolved CT angiographic datasets from each patient will be analyzed to determine peak AAA pulsatility and peak AAA relative pulsatility (to cross-sectional area within the aneurysm).
timeFrame: Year Two
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic - Rochester, Minnesota
name: Joel G. Fletcher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Fletcher JG, Vrtiska TJ, Manduca A, Thompson JL, Raghavan ML, Wentz RJ, McCollough CH. Large-vessel distensibility measurement with electrocardiographically gated multidetector CT: phantom study and initial experience. Radiology. 2007 Oct;245(1):258-66. doi: 10.1148/radiol.2451060530.
citation: Wentz RJ, Manduca A, Fletcher JG, Siddiki HA, Shields RC, Vrtiska TJ, Spencer GC, Primak AN, Zhang J, Nielson TA, McCollough CH, Yu L. SPIE Medical Imaging 2007.: Physiology, Function, and Structure from Medical Images, 2007; 6511:1-9
Clinical trial NCT01046877: Singapore Tympanostomy Tube Delivery System Study
Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For The Treatment of Patients Requiring Tympanostomy Tube Insertion For Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2010-01-12
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).


Eligibility criteria: Inclusion Criteria:

1. \>= 1 year of age
2. Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
3. Either male or female -

Exclusion Criteria:

1. History of sensitivity or reaction to anaesthesia
2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
3. Otitis externa
4. Active acute otitis media
5. Thickened Tympanic Membrane
6. Thick mucoid effusion (also known as "glue ear")
7. Otitis media pathology requiring T-tubes -

Primary outcomes:
measure: Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.
timeFrame: Procedural
Secondary outcomes:
measure: Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure
timeFrame: 12 months
measure: Percentage of Patent Tubes
timeFrame: 30 days
measure: Percentage of Patent Tubes
timeFrame: 3 months
measure: Percentage of Patent Tubes
timeFrame: 6 months
measure: Percentage of Patent Tubes
timeFrame: 9 Months
measure: Percentage of Ears With Adverse Events
timeFrame: 30 days
measure: Percentage of Ears With Adverse Events
timeFrame: 3 months
measure: Percentage of Ears With Adverse Events
timeFrame: 6 months
measure: Percentage of Ears With Adverse Events
timeFrame: 9 months
measure: Percentage of Ears With Adverse Events
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital Singapore
Study officials:
affiliation: KK Women's and Children's Hospital, Singapore
name: Henry Tan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02651077: Endometriosis and Brominated Flame Retardant (ENDOTOX Study)
Official title: Looking for a Link Between Endometriosis and Exposure to Lipophilic Environmental Chemicals Like Brominated Flame Retardant (ENDOTOX Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis, chemical contaminants, BFRs
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: ONIRIS
First posted: 2016-01-08
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 38 women with severe and deep endometriosis, aged 18 to 45 years old and hospitalized at Nantes University Hospital for surgical indication of endometriosis lesions ablation.

And 38 women aged 18 to 45 years old without suggestive signs of endometriosis

Brief summary: The investigators wish to highlight, in a Case-Control design, if there is an increased concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis with surgical indication ) versus bioaccumulation recorded in a control cohort ( women recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis ) . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes described by the HAS) and previous breastfeeding experience (yes / no , opposite the release expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .


Eligibility criteria: Inclusion criterion for de cases :

* Age : 18-45 years old
* Deep endometriosis with or without endometriomas that need surgery (clinical examination, MRI, surgery)
* Accessing to the omental and/or parietal adipose tissue
* Non opposition of the patients for the samples collection and consent for the present study.

Inclusion criterion for the controls :

* Patients without any history of endometriosis and without suggestive symptomatology. Often patients operated for cesarean section.
* Possible access to the adipose tissue of the omentum or abdominal wall

Exclusion criterion for the cases :

* Pregnancy
* Death

Exclusion criterion for controls :

* Pregnancy
* Death

Primary outcomes:
measure: Concentrations of brominated flame retardant (BFR) in adipose tissue and serum
timeFrame: baseline
Secondary outcomes:
measure: Concentrations of dioxins in adipose tissue and serum
timeFrame: baseline
measure: Concentrations of polychlorinated biphenyls (PCBs),
timeFrame: baseline
measure: Concentrations of organochlorine pesticides (OCPs) in adipose tissue and serum
timeFrame: baseline
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Stephane PLOTEAU, Dr
role: PRINCIPAL_INVESTIGATOR
References: