louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02058537: Bethanechol for Eosinophilic Esophagitis
Official title: Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis (EoE)
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* Age 18-75
* Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain, food impaction
* Subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events
* Clinically or pathologically proven EoE

Exclusion Criteria:

* Known allergy to bethanechol
* Asthma
* Pregnant or breast-feeding women
* Severe neurological problems
* Severe diabetes
* Achalasia
* Known allergy to lidocaine or other local anesthetic
* Hypothyroidism
* Peptic ulcer
* Pronounced bradycardia or hypotension
* Vasomotor instability
* Coronary artery disease
* Epilepsy
* Parkinsonism
* Weakened gastrointestinal or bladder wall
* Mechanical obstruction of the gastrointestinal tract or bladder neck
* Urinary bladder surgery in the 6 months prior to the study
* Gastrointestinal resection and anastomosis
* Spastic gastrointestinal disturbances
* Acute inflammatory lesions of the gastrointestinal tract
* Peritonitis
* Marked vagotonia

Primary outcomes:
measure: Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
timeFrame: Day 1 and Day 7
Secondary outcomes:
measure: Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7
timeFrame: Day 1 and Day 7
Other outcomes:
measure: Change From Baseline Composite Vital Signs to Day 7
timeFrame: Day 1 and Day 7
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Yehudith Assouline-Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00209937: A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia
Official title: A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Active-Reference Study of Gaboxadol in Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Insomnia
Keywords: Primary insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

Detailed description: To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

Eligibility criteria: Inclusion Criteria:

* diagnosis of Primary insomnia

Primary outcomes:
measure: Efficacy
measure: Safety
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: H. Lundbeck A/S
name: Please contact: Annelies van der Hammen Legters
role: STUDY_DIRECTOR
References:
Clinical trial NCT06356337: A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1
Official title: Light Exposure Tracker in Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested.


Eligibility criteria: Inclusion Criteria:

* healthy adults over the age of 55
* score of 25 or greater on MoCA

Exclusion Criteria:

* Severe sleep apnea
* restless leg syndrome
* obstructing cataracts
* macular degeneration
* diabetic retinopathy
* glaucoma
* use of sleep medications
* brain disease

Primary outcomes:
measure: Saliva samples for melatonin levels
timeFrame: Baseline and 2-weeks post-intervention
Secondary outcomes:
measure: Light exposure using the Speck
timeFrame: worn all 12 study weeks
measure: Sleep time using actigraphy
timeFrame: worn all 12 study weeks
Other outcomes:
Locations:
city: Menands
country: United States
facility: Light and Health Research Center
state: New York
Study officials:
affiliation: Ichan School of Medicine
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02042937: Enhancing Gluteus Maximus Recruitment
Official title: Enhancing Gluteus Maximus Recruitment: a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Weakness
Keywords: Knee
Hip
Muscle Strength
Electromyography
Biomechanical Phenomena
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Can participants enhance gluteus maximus recruitment during a single-leg squat test following a neuromuscular training program?


Eligibility criteria: Inclusion criteria

* female
* healthy, active individuals
* age 18-36
* walk without assistive device
* able to run, jump, squat without difficulty
* show evidence of hip muscle dysfunction on screening exam

Exclusion criteria

* history of knee ligament injury, knee surgery, patella dislocation
* knee pain traversing stairs, squatting or after prolonged sitting within 6 months of test
* joint line tenderness suggestive of meniscus pathology
* positive knee ligament stress tests

Primary outcomes:
measure: Knee valgus angle
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John Hollman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollman JH, Hohl JM, Kraft JL, Strauss JD, Traver KJ. Modulation of frontal-plane knee kinematics by hip-extensor strength and gluteus maximus recruitment during a jump-landing task in healthy women. J Sport Rehabil. 2013 Aug;22(3):184-90. doi: 10.1123/jsr.22.3.184. Epub 2013 Apr 9.
citation: Hollman JH, Hohl JM, Kraft JL, Strauss JD, Traver KJ. Effects of hip extensor fatigue on lower extremity kinematics during a jump-landing task in women: a controlled laboratory study. Clin Biomech (Bristol). 2012 Nov;27(9):903-9. doi: 10.1016/j.clinbiomech.2012.07.004. Epub 2012 Jul 26.
citation: Hollman JH, Ginos BE, Kozuchowski J, Vaughn AS, Krause DA, Youdas JW. Relationships between knee valgus, hip-muscle strength, and hip-muscle recruitment during a single-limb step-down. J Sport Rehabil. 2009 Feb;18(1):104-17. doi: 10.1123/jsr.18.1.104.
Clinical trial NCT06947837: Study on the Influencing Mechanism and Promoting Strategies of Post-partum Nurses' Work Engagement
Official title: Study on the Influencing Mechanism and Promoting Strategies of Post-partum Nurses' Work Engagement
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nurses
Postpartum
Work Engagement
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses from Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology who returned to work within 1 month after delivery were selected.

Brief summary: The goal of this observational study is to through the combination of longitudinal qualitative research and longitudinal quantitative research, the work experience changes of nurses returning to work after delivery were analyzed, and the changing trajectory and influencing mechanism of work involvement of nurses returning to work after delivery were explored.On this basis, combined with the existing literature, the promotion strategy of post-natal nurses' work involvement was constructed in order to improve the level of post-natal nurses' work involvement, help them better adapt to clinical nursing work, and improve the quality of nursing service.


Eligibility criteria: Inclusion Criteria:

* Nurses returning to work after childbirth are engaged in clinical nursing work in the hospital;
* The time to return to work after childbirth is less than 1 month;
* Informed and voluntary participation in the study.

Exclusion Criteria:

* Training, rotation, practice nurses;
* Give birth to abnormal children.

Primary outcomes:
measure: Postpartum work engagement
timeFrame: Through study completion, an average of 1 year (the specific follow-up time was 1 month, 3 months and 6 months after delivery).
Secondary outcomes:
measure: Social Support situation
timeFrame: Through study completion, an average of 1 year (the specific follow-up time was 1 month, 3 months and 6 months after delivery).
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Yu Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03569137: Post-Ibrutinib Colitis and Intestinal Microbiota
Official title: Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Microbiome
Keywords: Gut Microbiome
hematologic malignancies B
biomarkers
targeted therapy
Gut microbiota
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Vendee Departmental hospital center
First posted: 2018-06-26
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: All patients hospitalized in the Hematology departments and receiving targeted therapy with Ibrutinib

Brief summary: Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology


Eligibility criteria: Inclusion Criteria:

* Age 18 years
* Outside the context of guardianship, -affiliated to the Social Security Regime and
* Having consented to participate in the COLMI study.
* Patient who benefit of treatment by targeted therapy to Ibrutinib

Exclusion Criteria:

* History of uncontrolled colitis before the start of treatment.
* Patient with inflammatory bowel disease.
* Patient not consenting to participate.

Primary outcomes:
measure: difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis
timeFrame: At the end of the study, after 2 years.
Secondary outcomes:
measure: Identify biomarkers of the gut microbiota associated with the occurrence of severe diarrhea (grade 3 and 4 CTCAE, version 4.0) in patients treated with Ibrutinib for malignant hemopathy B.
timeFrame: At the end of the study, after 2 years.
measure: Identify biomarkers of gut microbiota associated with the occurrence of diarrhea by subgroup: patients treated with Ibrutinib alone, patients treated with Ibrutinib in combination with another molecule
timeFrame: At the end of the study, after 2 years.
measure: Creation of a predictive score of the occurrence of diarrhea in patients treated with Ibrutinib for malignant hemopathy B, including the biomarkers of the intestinal microbiome and the clinical characteristics of the patient
timeFrame: At the end of the study, after 2 years.
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT02209337: Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Official title: Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Vaginal Wall Prolapse
Vaginal Apex/Uterine Prolapse
Lead sponsor: Lyra Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients


Eligibility criteria: Inclusion Criteria:

1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
2. Patient age is between 18 and 75 years old
3. POP-Q: Aa and/or Ba is at least -1

Exclusion Criteria:

1. Patient is pregnant or breastfeeding
2. Patient suffering from active infection (on antibiotic therapy)
3. Patient planning vaginal delivery
4. Patient had Previous vaginal mesh surgery
5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).
6. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
7. Malignancy .
8. Known hypersensitivity to PEEK and polypropylene materials.
9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
10. Tendency for hyper-scaring reaction
11. Diagnosed with mental or emotional disturbance.

Primary outcomes:
measure: No device related serious adverse events
timeFrame: up to 12 month
Secondary outcomes:
measure: Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)
timeFrame: up to 12 months
measure: Improvement in POP-Q: points Aa and Ba
timeFrame: up to 12 month
measure: Improvement in POP-Q point C
timeFrame: up to 12 months
measure: Achieving normal urinary function
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged
city: Bnei Brak
country: Israel
facility: Mayanei HaYeshua Medical Center
city: Zrifin
country: Israel
facility: Asaf HaRofeh Medical Center
Study officials:
affiliation: Mayanei HaYeshua Medical Center
name: Gil Levi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02516137: Hamstring Tightness
Official title: Clinical Effects of Dry Needling Among Asymptomatic Individuals With Hamstring Tightness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hamstring Tightness
Keywords: Dry needling
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out if individuals with tight hamstring muscles who receive dry needling in addition to a standard stretching exercise program, show an improvement in hamstring tightness and function compared to individuals with tight hamstrings who receive either sham dry needling or no needling (blunt needle) in addition to a standard stretching program.

Detailed description: Tightness of the hamstring muscles is a risk factor for injury. Currently, there is no data on the effect of dry needling on hamstring extensibility or functional performance measures among asymptomatic individuals with hamstring muscle tightness. The investigator wants to assess if individuals with tight hamstring muscles who receive dry needling in addition to a standard stretching exercise program, exhibit reduced hamstring tightness and improved functional performance compared to individuals with tight hamstrings who receive either sham dry needling or no needling (blunt needle) in addition to a standard stretching program.

Eligibility criteria: Inclusion Criteria:

* Hamstring 90/90 extensibility goniometric measurement of more than 20 degrees of knee flexion bilaterally
* Ability to perform a squat to 90 degrees of knee flexion without assistance of the upper extremities
* Asymptomatic during walking

Exclusion Criteria:

* History of systemic neurological or arthritic condition
* History of bony or peripheral nerve trauma or surgery lower extremities
* History of treatment with dry needling
* No contraindications to dry needling

Primary outcomes:
measure: Change in hamstring muscle extensibility
timeFrame: Baseline, at 5 weeks from baseline
measure: Change in unilateral hop for distance test scores
timeFrame: Baseline, at 5 weeks from baseline
measure: Change in crossover hop for distance tests scores
timeFrame: Baseline, at 5 weeks from baseline
Secondary outcomes:
measure: Change in dynamometry pressure readings
timeFrame: Baseline, at 5 weeks from baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Marie Johanson, PT, PhD, OCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736237: Identification and Verification of Candidate Genes Responsible for Optic Disc Drusen Development
Official title: Identification and Verification of Candidate Genes Responsible for Optic Disc Drusen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Disk Drusen
Keywords: Optic disc drusen
Genetics
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Families with ODD

Brief summary: The goal of this observational study is to learn about the genetic background for the development of optic disc drusen. The main question is:

• Can one or more candidate genes be found?

Participants will have a blood sample taken and answer a questionnaire.

Detailed description: The study is an international collaboration between University of Utah, University of Sydney, University of Valladolid, and University of Copenhagen. Patients with Optic disc drusen from 15 known optic disc drusen-families from different countries (USA, Australia, Spain and Denmark) are participating in this study.

Blood samples are drawn from each patient and their affected and unaffected family members, and DNA will be extracted. The investigators will do an Optical coherence tomography-scan (according to ODDS Consortium guidelines), and the participant will be asked to fill out the Visual Function Questionnaire (VFQ-25) including four additional questions about optic disc drusen.

The etiology of optic disc drusen will be analyzed with a Whole Exome Sequencing (WES), with the use of Next Generation Sequencing (NGS). Prior to WES, all participants will receive genetic counseling by a consultant to ensure awareness of possible secondary genetic findings.

Eligibility criteria: Inclusion Criteria:

* Adult patients over the age of 18, who are capable of giving consent
* Diagnosis of optic disc drusen and a minimum of 3 optic disc drusen-affected family members

Exclusion Criteria:

* Less than 3 affected family members
* Under the age of 18 or mentally disabled

Primary outcomes:
measure: Candidate gene
timeFrame: 2023-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology
Study officials:
References:
Clinical trial NCT01373437: Ultrasonography in Confirming Proper Position of Endotracheal Tube
Official title: Ultrasonography in Confirming Proper Position of Endotracheal Tube in Emergency Department at Siriraj Hospital: Applicability and Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Keywords: Ultrasonography
US
Confirming
Confirmation
Proper
Position
Endotracheal tube
ETT
Emergency department
ED
Applicability
Accuracy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who visited the emergency department, Siriraj hospital and needed ETT intubation as their adequate treatment. In the period from September 2010 to November 2010.

Brief summary: The purpose of this study is to assess the applicability of using ultrasonography in confirmation of the position of the endotracheal tube (ETT) after intubated to patients.

Detailed description: To assess the applicability of using ultrasonography as compared to routine portable CXR in confirmation of ETT position.

To determine the accuracy of ultrasonography in measuring the depth of ETT as compare to standard CXR method.

Eligibility criteria: Inclusion Criteria:

* age \>18 years old with either endotracheal or nasotracheal intubation
* having normal airway anatomy
* performed portable CXR after intubation

Exclusion Criteria:

* presence in history of neck radiation, cervical spine immobility/instability
* unstable vital signs
* unwilling to participate or denial of informed consent

Primary outcomes:
measure: The confirmation of ETT depth
timeFrame: 1 hour
Secondary outcomes:
measure: The confirming the presence of ETT in airway.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology Department
Study officials:
affiliation: Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
name: Phuriphong Songarj, MD
role: STUDY_DIRECTOR
References: