louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00813033: Use of a Patient Decision Aid for Gastrologic Endoscopy in a Pediatric Setting
Official title: Creation and Pilot Evaluation of a Patient Decision Aid as an Adjunct to the Consenting Process for Gastrointestinal Endoscopy in a Pediatric Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy
Keywords: create a patient decision aid for endoscopy
evaluate efficacy of a patient decision aid for endoscopy
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Parents need understandable information in order to make appropriate choices for their child's health care. This is especially true when making decisions about invasive medical procedures. Parents need to understand what will happen, the risks involved, how these risks will be managed and what other options they have before they can decide what is best for their child. The present proposal involves the creation of a novel patient decision aid about the gastro endoscopy procedure, called a "scope." The purpose of the aid is to provide parents with information so they are able to discuss the options with their child's health care providers.

Detailed description: True informed consent depends on effective, bi-directional communication between parents and their child's healthcare providers. Many things affect the quality of the consenting process including the parents' level of health literacy, English proficiency and cultural perspectives. Our long-term goal is to develop a standardized consenting process that ultimately addresses the needs of the patient and the patient's family so that a truly informed decision can occur. The specific hypothesis is that incorporating the use of a multimedia patient decision aid to assist in the education of patients and their families about an invasive medical procedure (i.e. gastro-endoscopy) will improve knowledge and positively impact the ability of the parent to act on this knowledge when making decisions regarding their child's health care.

Eligibility criteria: Inclusion Criteria:

* parents or LARs who are considering a gastro-endoscopy for their child

Exclusion Criteria:

* child has previously undergone an endoscopy
* parent of child has undergone an endoscopy
* non-English speaking

Primary outcomes:
measure: Validated survey tools will be used to assess change in the consenting parent's knowledge, expectations of outcomes, clarity of values, decision and decision conflict.
timeFrame: immeadiately after completing patient decision aid
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Nancy A Neilan, MT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05075733: Current Scope of Practice of Today's Hepatopancreatobiliary Surgeons: A Survey of AHPBA Members
Official title: The Current Scope of Practice of Today's Hepatopancreatobiliary Surgeons: A Survey of Americas Hepato-Pancreato-Biliary Association Members
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scope of Practice of Today's Hepatopancreatobiliary Surgeons
Keywords: survey
AHPBA
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Member of Americas Hepato-Pancreato-Biliary Association

Brief summary: The development of multiple training pathways to foster competent hepatopancreatobiliary (HPB) surgeons has led to a diverse group of surgical subspecialists. The objective of our study was to determine the current scope of practice of today's HPB surgeons. An online survey was sent to all the Americas Hepato-Pancreato-Biliary Association's members to assess the current scope of practice of today's HPB surgeons. We found very few surgeons run a solo HPB practice, so changes may be needed in HPB training to provide uniformity and enhance the scope of practice for future HPB surgeons.


Eligibility criteria: Inclusion Criteria:

* Member of Americas Hepato-Pancreato-Biliary Association

Exclusion Criteria:

* No or non-functioning email address

Primary outcomes:
measure: Survey outcome 1
timeFrame: December 2014 - February 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT02908633: Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract
Official title: Comparison of Safety and Efficacy of Three Variants of Canaloplasty: Ab-externo, Ab-interno and Minicanaloplasty Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma, Cataract
Keywords: open angle glaucoma
canaloplasty
migs
abic
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.


Eligibility criteria: Inclusion Criteria:

* co-existing glaucoma and cataract
* glaucoma types: primary open angle glaucoma,
* eye with characteristic glaucoma changes (biomicroscopic,visual field)
* IOP over 21 mmHg after washout
* patients not tolerating antiglaucoma medications,
* patients with poor compliance
* progression in visual field

Exclusion Criteria:

* previous surgical glaucoma procedure
* previous cataract surgery
* BCVA under 0,004
* closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary)
* poorly controlled diabetes mellitus
* advanced AMD
* active inflammatory disease
* pregnancy
* mental disease or emotional instability general steroid therapy

Primary outcomes:
measure: mean IOP
timeFrame: change form baseline at 24 months
measure: Number of antiglaucoma drugs
timeFrame: change from baseline at 24 months
measure: intraoperative complications
timeFrame: at the day of surgery
Secondary outcomes:
measure: Best-Corrected Visual Acuity
timeFrame: change from baseline at 24 months
measure: Visual Field changes
timeFrame: change from baseline at 24 months
measure: Early and Late postsurgical complications
timeFrame: within 24 months
measure: % IOP reduction
timeFrame: change at 24 months from baseline
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
Study officials:
References:
citation: Danielewska ME, Kicinska AK, Placek MM, Lewczuk K, Rekas M. Changes in spectral parameters of corneal pulse following canaloplasty. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2449-2459. doi: 10.1007/s00417-019-04433-9. Epub 2019 Aug 3.
Clinical trial NCT02883933: Clinical and Histological Features of Head and Neck Melanoma
Official title: Clinical and Histological Features of Head and Neck Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 1548
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with melanoma.

Brief summary: The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

Detailed description: Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.

Eligibility criteria: Inclusion Criteria:

* patients with melanoma
* melanoma diagnosed between January 2004 and December 2011
* patients living in Champagne-Ardenne

Primary outcomes:
measure: Location of melanoma
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
citation: Dabouz F, Barbe C, Lesage C, Le Clainche A, Arnoult G, Hibon E, Bernard P, Grange F. Clinical and histological features of head and neck melanoma: a population-based study in France. Br J Dermatol. 2015 Mar;172(3):707-15. doi: 10.1111/bjd.13489. Epub 2015 Feb 11.
Clinical trial NCT01632033: Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease
Official title: Estimation de la capacité Fonctionnelle a la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour Bilan artériel Des Membres inférieurs: Etude WELCH-bis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: Peripheral artery disease
claudication
walking
questionnaire
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2012-06-29
Enrollment: 150
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 referred for arterial leower limb investigations

Brief summary: The purpose of this study is to test the routine faisibility of a questionnaire to estimate walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.

Detailed description: The WELCH and WIQ questionnaires are self completed by the patients and scored by the physician after self-completion.

Eligibility criteria: Inclusion Criteria:

* Sigjned consent for the data treatment as a database

Exclusion Criteria:

* Non french native language age \< 18 years old

Primary outcomes:
measure: Scoring of the WELCH. Percent scored questionnaires
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Angers
name: Denise JOLIVOT, MD
role: STUDY_CHAIR
References:
citation: Ouedraogo N, Chanut M, Aubourg M, Le Hello C, Hidden V, Audat G, Harbonnier M, Abraham P. Development and evaluation of the Walking Estimated-Limitation Calculated by History questionnaire in patients with claudication. J Vasc Surg. 2013 Oct;58(4):981-8. doi: 10.1016/j.jvs.2013.03.039. Epub 2013 May 7.
Clinical trial NCT01010633: Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Pain
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 406
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: This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who are at least 18 years of age.
* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug or components.
* Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
* Subjects with elevated intraocular pressure (\>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
* Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.

Primary outcomes:
measure: Resolution of Anterior Chamber Cells (ACC).
timeFrame: Visit 5 (Postoperative day 8)
measure: Grade 0 Pain
timeFrame: Visit 5 (Postoperative Day 8)
Secondary outcomes:
measure: Resolution of Anterior Chamber Cells.
timeFrame: At visits 4-7- postoperative day 3, 8,15 & 18
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Inc.
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso
role: STUDY_DIRECTOR
References:
citation: Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.
Clinical trial NCT05335733: Menopause and Oral Microbiome
Official title: Evaluation of Dental Plaque and Saliva Microbiome and Their Association With Periodontal Parameters in Premenopausal and Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: The Forsyth Institute
First posted: 2022-04-19
Enrollment: 220
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Middle aged women.

Brief summary: The study examines the saliva and dental plaque microbiome of women aged 35-65 in two groups: postmenopausal (case) and premenopausal (control). For this purpose, Illumina Platform to sequence 16S rRNA gene regions will be used. The data will be analyzed using the QIIME2 bioinformatics tool. Serum estradiol levels will be determined by the ELISA method. The investigators will examine the relationship between microbiome data (alpha diversity, beta diversity, and relative abundance) and menopausal status, estradiol levels, and periodontal health status using linear statistical models. Clinical samples of the study will be collected at Ege University, and the laboratory studies and sequence analysis will be conducted at the Forsyth Institute in Boston.

To obtain longitudinal data besides the cross-sectional data, the investigators will contact the participants of a previous study from 2019, whose saliva, dental plaque, and serum samples are currently being stored at -80 °C, and ask them to participate for a second sampling.


Eligibility criteria: Inclusion Criteria Regularly mensturating women over 35 years of age Postmenopausal women under 65 years of age

-

Exclusion Criteria:

- Antibiotic useage in last 3 months Being in menopausal transition phase

Primary outcomes:
measure: Differences in the relative abundances of bacteria in groups, acquired by processing of Illumina sequencing data with QIIME2 bioinformatic tool.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References:
Clinical trial NCT05690087: Lidocaine Infusion on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomy in Trendelenburg Position
Official title: Effect of Systemic Lidocaine Infusion on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lidocaine
Optic Nerve Sheath Diameter
Laparoscopic Hysterectomy
Trendelenburg
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation.

Detailed description: Lidocaine use, both intravenous (IV) and laryngotracheal (LT), has been reported to blunt the ICP elevations during intubation. Also, Lidocaine injected IV has been shown in models to induce cerebral vasoconstriction leading to a decrease in cerebral blood volume and thus ICP. Furthermore, IV lidocaine leads to sodium channel inhibition and thus a reduction in cerebral activity and metabolic demands, as well as excitotoxicity, leading to a potential ICP reduction effect.

Eligibility criteria: Inclusion Criteria:

* Aged between 35 to 65 years
* American society of anesthesiology (ASA) physical status I - II
* Body mass index (BMI) between 18.5 to 28.0 kg/m2
* Scheduled for total laparoscopic hysterectomy taking approximately 2 h with a 30° Trendelenburg position for management of uterine fibroids or refractory dysfunctional uterine bleeding.

Exclusion Criteria:

1. Patients with eye diseases, central nervous system diseases, cardiovascular diseases, cerebrovascular diseases or diabetes.
2. If these events occurred intraoperative:

   * Ultrasound scans or measurements failed to clearly show the structure of Optic Nerve Sheath Diameter (ONSD).
   * Surgical time less than 1 h.
   * Interruption of carbon dioxide (CO2) pneumoperitoneum and Trendelenburg position.
   * Peak airway pressure exceeding 35 cm H2O
3. Patients with a history of allergy to lidocaine.

Primary outcomes:
measure: Optic Nerve Sheath Diameter (ONSD)
timeFrame: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
Secondary outcomes:
measure: Heart rate
timeFrame: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
measure: Mean arterial blood pressure
timeFrame: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
measure: The incidence of postoperative adverse reactions
timeFrame: Within 3 hours after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT01059487: Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine
Official title: Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine: A Pragmatic Clinical Trial Using Quality of Life Measures in a Community Health Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain Management
Traditional Chinese Medicine
Keywords: Traditional Chinese Medicine
Acupuncture
Lead sponsor: Chicago College of Oriental Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: QualityMetrics
name: Inspire Tech Group
First posted: 2010-02-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: At a time when there is so much focus in the United States on reducing the cost of health care delivery while maximizing the effectiveness of health care performance, Traditional Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision makers a tantalizing option. Traditional Chinese Medicine differs from its biomedical counterpart in that it is highly portable, inexpensive to administer, relies on a conversational diagnostic inquiry system to arrive at differential diagnosis for its patients, and has very few reported side effects associated with treatment. The World Health Organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders including stroke, pain management issues and rheumatoid arthritis; the WHO lists another over 65 diseases for which the therapeutic effect of acupuncture has been shown but for which further proof is needed including alcohol dependence, cancer pain and diabetes mellitus. With the completion of this pragmatic clinical trial and introduction of the Constant Care method of health care delivery to underserved communities on Chicago's south side, the investigators can both utilize an effective plan of health care delivery, advance the research needed to effectively utilize Traditional Chinese Medicine as a low cost therapeutic option in this country, and successfully treat disenfranchised populations that have been traditionally overlooked and that deserve a better health and wellness care future.


Eligibility criteria: Inclusion Criteria:

* Adults age 21 and over

Exclusion Criteria:

* Children
* Pregnant women

Primary outcomes:
measure: QualityMetric SF36v-2 Quality of Life
timeFrame: Every four weeks
Secondary outcomes:
measure: QualityMetric PIQ-6
timeFrame: Every four weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago College of Oriental Medicine, Inc. dba Chicago College of Asian Medicine
state: Illinois
Study officials:
References:
Clinical trial NCT05834387: The Impact of a Transitional Care Management Programme on the Migration Stress of Family Members of Patients
Official title: The Impact of a Transitional Care Management Programme on the Migration Stress of Family Members of Patients Transferred Out of the EICU Under the "Health Care-family-environment" Linkage Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 30
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 study investigated the impact of the establishment and application of the "health care-family-environment" linkage mechanism on the level of migration stress, coping styles and care satisfaction of families of patients transferred from the EICU, in order to provide a reference for improving the physical and psychological health of families and to promote the role of family members in the social support of patients transferred out of this category.


Eligibility criteria: Inclusion Criteria:

1. Family members of trauma patients scheduled to be transferred from the EICU to a general unit within 24h;
2. Family members of patients aged ≥ 18 years;
3. Family members who are responsible for the main care tasks and medical decisions of the patient during hospitalisation;
4. Family members of patients with clear language and good communication skills;
5. Families of patients who volunteered to participate in this study.

Exclusion Criteria:

1. Family members of patients temporarily transferred out of the EICU or temporarily discharged from trauma
2. Families of patients who voluntarily request termination of treatment;
3. Family members of patients with cognitive impairment, speech impairment or mental abnormalities.

Primary outcomes:
measure: Stress assessment
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Zunyi Medical College
state: Guizhou
Study officials:
affiliation: Zunyi Medical College
name: Xu Ren
role: STUDY_DIRECTOR
References: