louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02905058: Efficacy of Ketoprofen Before Intrauterine Device Insertion
Official title: Effect of Oral Ketoprofen on Intra Uterine Device Insertion Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Relief
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

Detailed description: To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.

Eligibility criteria: Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to insertion
* No contraindication to Non-steroidal drugs
* Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to device placement

Primary outcomes:
measure: Mean pain score during IUD insertion
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT06711458: Using Generative Artificial Intelligence (AI) to Create Patient-Friendly Discharge Summaries
Official title: Using Generative Artificial Intelligence to Transform Discharge Summaries Into Patient-Friendly Language and Format
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Discharge Summary Understanding
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 61
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 will be an open-label, parallel-group, randomized trial. Patients will be randomized to review the patient-friendly discharge instructions at the time of discharge (intervention group) vs the standard of care. The intervention differs from the standard of care in that patients will be given additional medical documentation in the intervention group.


Eligibility criteria: Inclusion Criteria:

* Admitted to Inpatient Medicine unit at NYULH
* Able to read and understand English
* Willing and able to consent to this research

Exclusion Criteria:

* Inpatient Hospice
* Discharged on home hospice

Primary outcomes:
measure: Number of Summaries with Positive Outcome on Composite Measure of Readability and Understandability
timeFrame: Day 1 (At Discharge)
Secondary outcomes:
measure: Changes made to AI-Generated Content
timeFrame: Day 1 (At Discharge)
measure: AI-Generated Content Perception Survey: Safety
timeFrame: Day 1 (At Discharge)
measure: AI-Generated Content Perception Survey: Understandability
timeFrame: Day 1 (At Discharge)
measure: AI-Generated Content Perception Survey: Empathy
timeFrame: Day 1 (At Discharge)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jonah Zaretsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05557058: GORE Glaucoma Drainage Implant Clinical Study Dominican Republic
Official title: A Prospective, Randomized, Single-Center, Early Feasibility Clinical Study Designed to Evaluate the Safety and Effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in Subjects With Primary Open-Angle Glaucoma Uncontrolled by Hypotensive Medications or for Which Conventional Incisional Glaucoma Surgery Would be More Likely to Fail Due to Scarring
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Open-angle Glaucoma
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (2 configurations) in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be more likely to fail due to scarring.


Eligibility criteria: Inclusion Criteria:

* Males and females, age 18 to 85 years, inclusive at screening visit
* A diagnosis of primary open-angle glaucoma (Shaffer angle ≥ 3 as seen on gonioscopy) at screening visit
* Medicated intraocular pressure at screening visit and the mean medicated diurnal IOP at baseline visit ≥ 18 mmHg and ≤ 40 mmHg by Goldmann Applanation Tonometry

Exclusion Criteria:

* Expected inability to implant the study device in the superotemporal quadrant (e.g., a lack of freely mobile conjunctiva to cover the entire implanted device in the superotemporal quadrant)
* Diagnosis of any active ocular disease or disorder (other than glaucoma) that requires treatment, where the disease or treatment could be reasonably expected to affect the vision or IOP during the duration of the study
* Prior corneal transplant surgery (full or partial thickness transplants) or clinically significant corneal dystrophy, e.g., Fuchs' dystrophy (\> 12 confluent guttae) in the study eye
* Concurrent cataract surgery or anticipated need for cataract surgery (i.e., clinically significant cataract) in the study eye during the 12 months following implantation
* BCDVA worse than 20/200 in the fellow (non-study) eye at the screening visit and BCDVA of the fellow eye cannot be worse than that of the study eye.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Laser Center
Study officials:
affiliation: Laser Center
name: Juan F Batlle Pichardo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00851058: Reducing Driving Offenses of Adolescent Drinkers
Official title: A Randomized Control Trial of the Effectiveness of of Group Motivational Counseling and an Emergency Department Experience in Reducing Risky Alcohol Use and Driving Behaviors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Alcohol Consumption
Keywords: Behavioral research
Motivational counseling
Group Counseling
Motivational Interviewing
Vicarious Learning
Risky alcohol use
Recidivism
Motor Vehicles
Crime
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 786
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the effectiveness of four group session of motivational counseling plus six hours of direct observations of the emergency department trauma services in comparison to four group session and six hours of community volunteering and also in comparison to four hours of education and 16 hours of community volunteering in reducing alcohol use and high risk driving behaviors and offenses among court referred 16-20 year old drivers.


Eligibility criteria: Age 16-20 years:

* Court referral for driving conviction and/or possession of alcohol
* Offense committed in Rhode Island
* Can speak English

Exclusion Criteria:

* Age over 20 years
* Not English speaking
* Not referred by courts

Primary outcomes:
measure: Recidivism for future criminal offenses
timeFrame: 12 months post intervention completion
Secondary outcomes:
measure: Alcohol use
timeFrame: 12 months post intervention completion
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Ted D Nirenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04803058: A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
Official title: A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-Myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in Living Donor Renal Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Kidney Transplantation
Lead sponsor: ITB-Med LLC
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients


Eligibility criteria: Key Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before any study assessment is performed
* Male or female patients ≥ 18 to 65 years of age
* Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor

Key Exclusion Criteria:

* Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
* A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Recipient with anti-HLA donor-specific antibody (DSA)

Primary outcomes:
measure: The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of biopsy proven acute rejection, death, and graft loss
timeFrame: 24 months
measure: The incidence of DSA
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Weill Cornell
state: New York
city: Seoul
country: Korea, Republic of
facility: Samsung Medical University
Study officials:
affiliation: ITB-MED
name: Nick Hryciw, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04839458: Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II
Official title: Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bite Force
Scan Delay
Keywords: Dental Prescale II,Scan Delay
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Dental Prescale II (GC Corp., Tokyo) is a pressure sensitive sheet for occlusal force measurement. According to the instruction, the patient need to bite the sheet for about 3 seconds and then the sheet will be scanned. But the delay response of coloring agent will influence the data collected and was noticed in vitro. To have a standard procedure, we need to know the time for scanning. This study will scan the sheet up to 2 hours and try to find the relation between the time the sheet scanned and the data collected.


Eligibility criteria: 1. Inclusive criteria:

   * full dentition except third molar
   * healthy periodontal condition
   * can sign consent
2. Exclusive criteria:

   * history of temporomandibular disorders

Primary outcomes:
measure: The relation between occlusal force and scanning time
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
Study officials:
affiliation: School of Dentistry, National Taiwan University College of Medicine.
name: TongMei Wang Wang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524758: Oculusgen (Ologen) Glaucoma MMC Control in Estonia
Official title: Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Angle Closure Glaucoma
Uveitis Glaucoma
Young Age Glaucoma
Neovascular Glaucoma
High Risk Patient
Keywords: ologen
oculusgen
collagen matrix
trabeculectomy
filtering surgery
mitomycin-C
MMC
Aeon Astron
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.

The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.

Detailed description: Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.

Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.

Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.

Eligibility criteria: Inclusion Criteria:

* Max anti glaucoma medication failed,

Exclusion Criteria:

* Age less than 18, woman in pregnant, hemodialysis patient

Primary outcomes:
measure: IOP <21mmHg without anti glaucoma medication
timeFrame: 180 days
Secondary outcomes:
measure: IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication
timeFrame: 180-day
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Clinics
Study officials:
affiliation: University of Tartu
name: Kuldar Kaljurand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066558: Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Official title: Basic Research on Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow in a Humane Experimental Headache Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Keywords: Carbon monoxide
Headache
Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators will research the hypothesis that the gas carbon monoxide induces headache and increases the blood flow velocity in the middle cerebral artery.

Detailed description: To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.

With transcranial Doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of the superficial temporal artery (STA), the radial artery and facial skin perfusion.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Smoking
* Primary relatives with current or previous migraine

Primary outcomes:
measure: Headache scores
timeFrame: 12 h
Secondary outcomes:
measure: Blood flow velocity
timeFrame: 0-180 min after inhalation
measure: Artery circumference
timeFrame: 0-180 min
measure: Facial blood flow
timeFrame: 0-180 min
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center, Glostrup Hospital
name: Nanna Arngrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04732858: Educational Interventions for Surgeons During COVID-19 Pandemic: Cross-sectional, E-survey
Official title: Educational Interventions to Integrate Surgical Staff Within Medical Units During the COVID-19 Pandemic: EDUCOVID Cross-sectional, E-survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: 2019-nCoV
COVID-19
Pandemic
Educational intervention
Medical education
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This survey was conceived as open to residents, fellows, consultants and physicians of any grade and affiliated to any surgical specialty.

Brief summary: The coronavirus disease 2019 (COVID-19) pandemic required a rapid surge of healthcare capacity to face a growing number of critically ill patients. For this reason, a support reserve of physicians, including surgeons, were required to be reassigned to offer support. Given the time shortage for trainers and trainees, time and cost-efficient programs to gain maximal benefit from short rotations for several physicians at one time are required 8. In case of pandemics, blending face-to-face education to e-learning seems sustainable, with online resources being scalable and more cost effective than other methods 9.

Detailed description: The aim of this study was to realize a survey on the educational programs (hospital based or web-based), during the COVID-19 pandemic, and their impact on behavior change, satisfaction and knowledge of the target population of surgeons.

Eligibility criteria: Inclusion Criteria:

* residents, fellows, consultants and physicians of any grade and affiliated to any surgical specialty

Exclusion Criteria:

* Mecical speciality

Primary outcomes:
measure: Kirkpatrick level 3 on a 5-modalities Likert scale
timeFrame: once at the time of survey
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - GHU AP-HP Hôpitaux Universitaires Henri-Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Raffaele BRUSTIA, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02062658: Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)
Official title: Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-02-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.


Eligibility criteria: Inclusion Criteria:

* Age 18-55
* Physically healthy and not currently pregnant
* Primary Diagnosis of OCD
* Sufficient severity of symptoms
* Currently off all psychotropic medication OR
* Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission
* Able to provide consent

Exclusion Criteria:

* Psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance dependence \[including nicotine\])
* Female patients who are either pregnant or nursing
* Planning to commence EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.

period of the study

* Allergy to ketamine
* Participants for whom being off of medication is not clinically recommended
* Medical conditions that make participation unsafe (e.g. high blood pressure, head injury)
* Currently on medications that make participation unsafe

Primary outcomes:
measure: Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Insitute
state: New York
Study officials:
affiliation: Columbia-NYSPI-RFMH
name: H Blair Simpson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez CI, Wheaton M, Zwerling J, Steinman SA, Sonnenfeld D, Galfalvy H, Simpson HB. Can exposure-based CBT extend the effects of intravenous ketamine in obsessive-compulsive disorder? an open-label trial. J Clin Psychiatry. 2016 Mar;77(3):408-9. doi: 10.4088/JCP.15l10138. No abstract available.