louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01862198: The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
Official title: Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bile Duct Obstruction
Disorder of Bile Duct Stent
Neoplasms
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Detailed description: Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years
* The presence of an unresectable malignant biliary obstruction
* Failed conventional ERCP stenting

Exclusion Criteria:

* Age \< 20 years
* An inability to sedate the patient due to advanced heart or pulmonary diseases
* A lack of informed consent

Primary outcomes:
measure: The stent patency rate
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Patients' survival rate
timeFrame: Up to 48 weeks
measure: Complication rate related to the hybrid stents
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Koyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea
name: Sang Soo Lee, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03255798: A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra
Official title: A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: G2 and G3
Primary purpose: TREATMENT

Brief summary: Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

Detailed description: Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Eligibility criteria: Inclusion Criteria:

* Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg

Exclusion Criteria:

* Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

Primary outcomes:
measure: 20% IOP reduction
timeFrame: Month 12
Secondary outcomes:
measure: IOP less than or equal to 18 mm Hg
timeFrame: Month 12
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Prof. Dr. med. Carl Erb
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens, OD
role: STUDY_CHAIR
References:
Clinical trial NCT06802198: A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes
Official title: Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibroid Uterus
Metrorrhagia
Adenomyosis
Benign Gynecologic Neoplasm
Endometriosis
Abnormal Uterine Bleeding
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. The secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence).

Participants will fill the following questionnaires pre-operatively and at the follow up:

* Short Form 36 (SF36),
* Euro Quality of life 5D-3L (EQ 5D-3L)
* Female Sexual Function Index (FSFI)
* Patient Global Impression of Improvement (PGI-I) only during the follow-up period.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Signed informed consent

Exclusion Criteria:

* Uterine or adnexal pathology suspect for malignancy
* Abnormal or unknown PAP test
* Patients with invasive neoplasia in the previous 5 years (excluding non-melanoma skin tumors, breast cancer T1 N0 M0 Grade 1 or 2 without signs of recurrence or activity).
* Previous radical pelvic surgery or radiotherapy;
* Age \> 80 years
* Pregnant patients
* Desire for further pregnancies
* Contraindications to general anaesthesia or to the Trendelenburg position
* Refusal to sign informed consent

Primary outcomes:
measure: Quality of life and patient's impression of improvement at 36 months after surgery
timeFrame: 5 years
Secondary outcomes:
measure: Postoperative pain
timeFrame: 5 years
measure: Intra-operative data
timeFrame: 5 years
measure: intraoperative complications
timeFrame: 5 years
measure: short and long-term postoperative complications
timeFrame: 5 years
measure: Urinary, bowel and pelvic floor symptoms
timeFrame: 5 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giovanni Panico, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03467698: Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population
Official title: Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Associative Memory in Healthy Subjects
Keywords: Aging
Memory
Associative learning
transcranial direct current stimulation
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups: (1) active tDCS (2) Sham tDCS.
Primary purpose: BASIC_SCIENCE

Brief summary: The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.

Detailed description: The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.

The aim of this study is to investigate the effects of transcranial Direct Current Stimulation (tDCS) stimulation during a verbal paired-associate learning task to determine if tDCS may be used as a way to enhance brain plasticity during an associative memory task, and to accelerate learning and to optimize associative memory performance. We hypothesize that participants who receive tDCS stimulation will improve their associative memory performance.

Eligibility criteria: Inclusion Criteria:

1. Age between 55 and 75
2. Currently not using any medication contradicting with tDCS
3. Native English speaker
4. Capable of understanding and signing an informed consent

Exclusion Criteria:

1. Acquainted with the Swahili language or culture
2. Severe disease
3. Mental illness
4. Cardiac history
5. History of severe head injuries
6. History of epileptic insults
7. Any implanted devices such as pace maker, neurostimulator
8. Pregnancy

Primary outcomes:
measure: A Computerized Verbal Paired-associate Memory Task Will be Used to Assess Memory Performance.
timeFrame: Memory performance changes will be assessed in two different visits. First assessment (baseline) on visit 1 (learning), then one-week after during visit 2 (memory)
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sven Vanneste, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luckey AM, McLeod SL, Robertson IH, To WT, Vanneste S. Greater Occipital Nerve Stimulation Boosts Associative Memory in Older Individuals: A Randomized Trial. Neurorehabil Neural Repair. 2020 Nov;34(11):1020-1029. doi: 10.1177/1545968320943573. Epub 2020 Sep 23.
Clinical trial NCT06171698: Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm
Official title: Prospective Measurement of Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo cardiac catheterization with cardiac output measurement and Fick
* Planned to undergo general anesthesia for cardiac catheterization standard of care
* Parent/Guardian able to provide informed consent

Exclusion Criteria:

* Not planned for standard of care general anesthesia for cardiac catheterization

Primary outcomes:
measure: Feasibility of a non-invasive monitoring device
timeFrame: From device placement to removal, up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Danielle Gottlieb Sen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00923598: Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks
Official title: Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Knee Pain
Keywords: TKA
Bilateral
Cleveland Clinic
UCSD
Catheter
Nerve block
Postoperative pain
Femoral Catheter
Bilateral Total Knee Arthroplasty
Bilateral Femoral Catheter
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2009-06-18
Enrollment: 48
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 is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.

Detailed description: The investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0.1% vs. 0.4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (TKA). These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks.

Eligibility criteria: Inclusion Criteria:

* Primary, bilateral TKA
* Age 18 years or older
* Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

Exclusion Criteria:

* Chronic, high-dose opioid use
* History of opioid abuse
* Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
* Pregnancy
* Incarceration

Primary outcomes:
measure: Quadriceps Femoris Muscle Strength Maximum Voluntary Isometric Contraction (MVIC)
timeFrame: morning of postoperative day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic, Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic, Chair, Department of Outcomes Research
name: Daniel I Sessler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03231098: Detection of GABHS in Throat Gargle
Official title: A Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Patient Throat Gargle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group A Streptococcus: B Hemolytic Pharyngitis
Lead sponsor: Gargle Tech
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 34
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: Adult patients age 18 years and older who present to the study site with complaints of sore throat and are suspected of suffering from GABHS pharyngitis.

Brief summary: The objective of this study is to investigate the use of patient throat gargle as an alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic Streptococcus (GABHS) infection, also known as strep throat.

Detailed description: The aim of this study is to procure a detailed quantitative and qualitative analysis of GABHS present in patient throat gargle and to compare various culturing techniques and immunoassay methods for efficient and effective GABHS detection from gargle fluid. During the course of this clinical trial, the following specimen samples will be collected from each participating patient: the patient will first be asked to gargle 10-15 mL of sterile saline to obtain a gargle sample, and then the patient will be subjected to two routine standard throat swabs. These specimen samples will be properly discarded after processing and analysis.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Suspected of suffering from GABHS pharyngitis.
* Able to communicate with study personnel (English or Hebrew).
* Able to understand oral and written information about the study.
* Willing to provide written informed consent to participate in the study.

Exclusion Criteria:

* Not capable of gargling 10-15 mL fluid.
* Diagnosed or self-reported pregnancy.
* History of dementia, cognitive impairment, or psychiatric or mental disorders.

Primary outcomes:
measure: Comparative: Method sensitivity to investigate method effectiveness.
timeFrame: Through study completion, about 9 months
measure: Comparative: Method specificity to investigate method effectiveness.
timeFrame: Through study completion, about 9 months
Secondary outcomes:
measure: Quantitative: Average GABHS in gargle.
timeFrame: Through study completion, about 9 months
measure: Quantitative: Minimum GABHS in gargle.
timeFrame: Through study completion, about 9 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: TEREM Ha'Gdud Ha'Ivri Family Clinic
Study officials:
affiliation: Shaare Zedek Medical Center
name: Avraham Alpert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karabay O, Ekerbicer H, Yilmaz F. Efficacy of throat gargling for detection of group a beta-hemolytic streptococcus. Jpn J Infect Dis. 2005 Feb;58(1):39-40.
Clinical trial NCT02014298: Non Ablative Fractional Laser Treatment of Burn Scars
Official title: LONG-TERM AND CONTINUED IMPROVEMENT OF MATURE BURN SCARS IN RESPONSE TO NONABLATIVE FRACTIONAL LASER - A RANDOMIZED CONTROLLED TRIAL WITH HISTOLOGICAL EVALUATION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Scars
Keywords: Burns
Non-ablative fractional laser
scar texture
histology
laser treatment
erbium:glass laser
meshed skin-grafts
photothermolysis
skin
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars.

OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn scars after NAFL-treatment.

HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and functional appearance.

METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment Scale; 1 = normal skin, 10 = worst imaginable scar).


Eligibility criteria: Inclusion Criteria:

* legally competent adults aged 18-60 years
* Fitzpatrick skin type I-III
* burn scar 1 year or older
* total scar area allowing selection of two similar side-by-side test areas of minimum 1.5 × 3 cm for study purpose

Exclusion Criteria:

* pregnancy or lactation
* suntan
* wounds or infections in study area
* tendency to form hypertrophic scars or keloids
* oral retinoids, anti-inflammatory or immunosuppressive drugs within the last six months
* current anticoagulants
* previous treatments in test area with laser, Intense Pulsed Light, dermabrasion, chemical peel or filler.

Primary outcomes:
measure: Change in overall Scar-appearance
timeFrame: 1,3 and 6 months follow-up
Secondary outcomes:
measure: specific clinical and histological scar appearance
timeFrame: 1, 3, and 6 months follow-up
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital, University of Copenhagen
state: Copenhagen
Study officials:
affiliation: Bispebjerg Hospital, University of Copenhagen
name: Merete Hædersdal, MD,PhD,DmSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06521398: Postpartum Care in the NICU (PeliCaN) Transitions
Official title: Postpartum Care in the NICU (PeliCaN) Transitions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Premature Birth
Postpartum Depression
Postpartum Anxiety
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.


Eligibility criteria: Inclusion Criteria:

* HUP postpartum patients who are at least 16 years old at the time their newborns' birth
* Infant born at HUP
* Preterm birth \<34 weeks
* English language speaking

Exclusion Criteria:

* Unable to read or sign informed consent
* Parents of infants transferred into HUP NICU
* If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks
* HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth

Primary outcomes:
measure: Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum
timeFrame: 6 months
measure: Number of participants who have attendance with a primary care provider by 6 months postpartum
timeFrame: 6 months
Secondary outcomes:
measure: Difference in Depression scores at 6 months postpartum
timeFrame: 6 months
measure: Receipt of ACOG-recommended postpartum care by patient's designated provider
timeFrame: 12 weeks postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Heather Burris, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: