louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07012512: Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children
Official title: Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pupillary Constriction
Accomodation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.

Detailed description: To compare the efficacy of pilocarpine 0.1%, phentolamine 0.75%, and combined therapy in reversing cyclopentolate-induced cycloplegia/mydriasis in pediatric patients using a within-subject paired-eye design (treated vs. untreated eye).

Interventions

Cycloplegia Induction:

Both eyes receive cyclopentolate 1% (2 drops, 5 minutes apart). Then cycloplegic effect confirmed at 30 minutes (accommodation ≤2 D, pupil ≥6 mm).

Reversal Agents (administered at 30 minutes post-cyclopentolate):

Pilocarpine group: Pilocarpine 0.1% (1 drop) in the study eye; placebo in the control eye.

Phentolamine group: Phentolamine 0.75% (1 drop) in the study eye; placebo in the control eye.

Combination: Pilocarpine 0.1% + phentolamine 0.75% (1 drop each) in the study eye; placebo in the control eye.

Eligibility criteria: Inclusion Criteria:

* Children between 5 and 12 years undergoing cycloplegia

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Reversal of pupillary dilatation
timeFrame: Hourly for four hours after administration of the drug
Secondary outcomes:
measure: Recovery of accommodation after instillation of the drop
timeFrame: Hourly for four hours after administration of the drug
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06148012: Investigation Of Marginal Bone Loss In Implants With Different Surface Properties And Geometric Designs: A Retrospective Clinical Study
Official title: Investigation Of Marginal Bone Loss In Implants With Different Surface Properties And Geometric Designs: A Retrospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Infection
Peri-Implantitis
Bone Loss
Keywords: dental implant
marginal bone loss
peri-implantitis
fractal analysis
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Purpose: The aim of this study was to investigate the influence of surface characteristics and geometric design on marginal bone loss and bone quality in dental implants.

Materials and Methods: A total of 378 implants from 114 patients were evaluated in this study using panoramic and periapical radiographs. Implants were categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design. Radiological evaluations were conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading. After obtaining measurements of marginal bone loss and fractal analysis data, the significance of differences between groups was statistically evaluated.


Eligibility criteria: Inclusion Criteria:

* Implants with a minimum length of 8 mm
* Implants with a minimum diameter of 3.5 mm
* Availability of panoramic and periapical radiographs at T0 (immediately after surgery) and T1 (3 months after prosthetic loading).

Exclusion Criteria:

* Presence of a systemic condition hindering dental implant treatment and routine check-ups
* History of regular alcohol/tobacco use
* Presence of severe parafunctional habits (bruxism, etc.)
* Prior grafting procedures before dental implant placement
* Implant failure

Primary outcomes:
measure: Marginal Bone Loss around different dental implants
timeFrame: 180 days
measure: Fractal values around dental implant radiographs
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Oral an Mazillofacial Surgery
state: Merkez
Study officials:
References:
Clinical trial NCT00560612: Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Official title: Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
Paroxetine
Subthreshold
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2007-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

1. Veterans 18-55 years of age
2. Diagnosis of subthreshold PTSD (at least one symptom in PTSD symptom clusters B, C, and D by structured interview; with or without functional impairment exposure to war zone stressors)
3. Written informed consent; and
4. A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

1. Lifetime history of DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
2. History of substance dependence within the last 3 months
3. Significant suicide risk or serious suicide attempt within the last year
4. Clinically significant medical condition or laboratory or EKG abnormality
5. Women of childbearing potential who are unwilling to practice an acceptable method of contraception
6. Subjects needing concurrent use of psychiatric medications
7. History of hypersensitivity to paroxetine
8. HADS depression subscale score \> 12
9. Failure to respond to an adequate trial of paroxetine (20 mg/day x 8 wks).

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS) Scores
timeFrame: Change in Scores (12 weeks-Baseline)
Secondary outcomes:
measure: Change in Short PTSD Rating Interview Scores
timeFrame: Change in Scores (12 weeks-Baseline)
measure: Change in Connor Davidson Resilience Scale Scores
timeFrame: Change in Scores (12 Weeks-Baseline)
measure: Change in Hospital Anxiety and Depression Scale Scores
timeFrame: Change in Scores (12 Weeks-Baseline)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
Study officials:
affiliation: Durham VAMC
name: Christine E Marx, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04042012: Percutaneous Needle Electrolysis (PNE) in Soleus Injury
Official title: Effect of the Application of Ultrasound-guided Percutaneous Needle Electrolysis on the Chronic Soleus Injury in Dancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soleus Injury
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates if the physiotherapy treatment based on eccentric exercise, ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue in dancers.


Eligibility criteria: Inclusion Criteria:

* Over 16 years.
* at least 5 years of formal dance training.
* at least 20 hours of training per week.
* Pain in the back of the leg
* diagnosis of chronic soleus injury

Exclusion Criteria:

* Unsurpassed fear of needles
* History of adverse reactions to needles
* Immune system disorder
* Difficulty expressing your feelings properly
* Epilepsy and / or allergies to metals.
* Other lower limbs pathology

Primary outcomes:
measure: change of pain level
timeFrame: Change from Baseline VAS at 3 months months
measure: Change of Lunge Test
timeFrame: Change from Baseline lunge test at 3 months months
measure: Change of the Releve test
timeFrame: Change from Baseline releve test at 3 months months
measure: Change of the Endurance test
timeFrame: Change from Baseline endurance test at 3 months months
measure: Change of the Balance test
timeFrame: Change from Baseline balance test at 3 months months
measure: Changes of the DFOS questionnaire
timeFrame: Change from Baseline DFOS questionnaire at 3 months months
measure: Change of the Minimal Detectable Change (MCD)
timeFrame: Change from after treatment at 3 months months
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
References:
citation: De-la-Cruz-Torres B, Barrera-Garcia-Martin I, Valera-Garrido F, Minaya-Munoz F, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Aug 27;2020:4156258. doi: 10.1155/2020/4156258. eCollection 2020.
Clinical trial NCT02159612: 1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy
Official title: Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: FSHD - Facioscapulohumeral Muscular Dystrophy
Keywords: FSHD
MRI
Disease progression
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons in Denmark diagnosed with Facioscapulohumeral muscular dystrophy is invited to the study.

Brief summary: An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.

Detailed description: A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan to describe the relation between backpain and disease affection in back muscles. After one year they are re-invited to perform another MRI scan to follow the disease progression.

The MRI scan is done to measure the quantity and quality of the muscles in the back, thigh and calf. Further, investigators investigate the muscle function by measuring of muscle strength in legs and in the back together with three functional tests. A walking test (6MWT), a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by a standardized questionnaire about backpain.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with FSHD type 1

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Patients with claustrophobia.
* Patients with implanted metallic parts in the body.

Primary outcomes:
measure: Fat infiltration
timeFrame: 1 year
Secondary outcomes:
measure: Muscle structure
timeFrame: 1 year
measure: Muscle strength
timeFrame: 1 year
measure: Back pain
timeFrame: 1 year
measure: Muscle function
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Study officials:
References:
citation: Dahlqvist JR, Poulsen NS, Ostergaard ST, Fornander F, de Stricker Borch J, Danielsen ER, Thomsen C, Vissing J. Evaluation of inflammatory lesions over 2 years in facioscapulohumeral muscular dystrophy. Neurology. 2020 Sep 1;95(9):e1211-e1221. doi: 10.1212/WNL.0000000000010155. Epub 2020 Jul 1.
Clinical trial NCT00768612: Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia
Official title: A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Acute, Schizophrenia, Phase2a, Vabicaserin
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects between \>=20 and =\<65 years of age
* Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
* Total PANSS score \>=70 and =\< 120

Exclusion Criteria:

* Subjects who are hospitalized against their will
* Current Axis I primary psychiatric diagnosis other than schizophrenia
* A score of 3 on CDSS question 8 which pertains to suicide

Primary outcomes:
measure: Positive and Negative Syndrome Scale PANSS
timeFrame: 6 week
Secondary outcomes:
measure: Calgary Depression Scale for Schizophrenia CDSS
timeFrame: 6 week
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05778812: Online Insomnia Treatment Program
Official title: A Study on Online Insomnia Treatment Programs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Sleep
Sleep Disturbance
Sleep Disorder
Sleep Hygiene
Sleep Initiation and Maintenance Disorders
Lead sponsor: Koko Home, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2023-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), the "gold standard" treatment for insomnia, with or without a bedside device to help track sleep.

Detailed description: Time needed from participant: 15 minutes per day to complete an app-based or online sleep diary and review information in an app-based or online CBT-I program.

To qualify, you must:

Be 18+ years old Have a diagnosis of insomnia or suspected insomnia Have access to the internet and an iphone, Android or other smart phone device

Coordinator Contact:

Cris Moreno (650) 721-7576 crismore@stanford.edu

Eligibility criteria: Inclusion Criteria:

* insomnia diagnosis or measure-confirmed moderate to severity insomnia (Insomnia Severity Index = 15-28)
* access to an iPhone with iOS 11+ or Samsung, Google, HTC, LG, OnePlus, or Motorola phone with Android 10+
* 18 years of age or older
* available 15 mins per day to participate

Exclusion Criteria:

* Restless Legs Syndrome
* narcolepsy
* sleep apnea
* sleep walking
* bipolar disorder
* seizures disorder
* substance abuse
* frailty/risk of falling
* severe memory problems
* shift work
* change in antidepressant medication within past 2 months
* serious mental/physical health problem
* other ongoing psychological treatment w
* sleeping with pets.

Participants should be aware that should they receive a device, its sound and light alerts could be disruptive to partners or others (e.g., children) that sleep in the same room.

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Completion of program (6-8 weeks)
Secondary outcomes:
measure: Sleep efficiency
timeFrame: Completion of program (6-8 weeks)
measure: Wakefulness after sleep onset
timeFrame: Completion of program (6-8 weeks)
measure: Number of awakenings
timeFrame: Completion of program (6-8 weeks)
measure: Sleep onset latency
timeFrame: Completion of program (6-8 weeks)
measure: Total sleep time
timeFrame: Completion of program (6-8 weeks)
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
Study officials:
References:
Clinical trial NCT00581412: Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
Official title: Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Composite biologic/synthetic graft
Abdominal sacrocolpopexy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent abdominal sacrocolpopexy

Brief summary: This study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.

Detailed description: This study will examine the erosion rate of a composite graft that is being used during abdominal sacrocolpopexy. The composite graft is composed of a dual layer of biological and syntheric material. Biological grafts have the advantage of significantly reducing erosion rates, but the longevity of biologic graft is uncertain. On the other hand, synthetic grafts have the advantage in that they are durable, but have higher erosion rates through the vagina and require re-operation in a small percentage of patients. This study will look at whether or not the use of a composite greaft carries the advantages of both types of materials and leads to decreased rates of erosion while maintaining longevity. The cost effectiveness of this new type of graft will also be reviewed since the disavantage of utilizing both the synthetic and biologic graft is that it will increase the cost.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent abdominal sacrocolpopexy with Drs. Noblett and Lane from 2001 to present

Exclusion Criteria:

* None

Primary outcomes:
measure: The erosion rates of composite biologic/syntheric grafts and synthetic-only grafts will be compared.
timeFrame: To the point of graft erosion after abdominal sacrocolpopexy
Secondary outcomes:
measure: Cost effectiveness will be examined by comparing the price of a composite graft to the cost of re-operation due to erosion of a synthetic-only graft.
timeFrame: To the point of graft erosion after abdominal sacrocolpopexy
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Karen L Noblett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254812: Does the Application of a Bilateral-dual Transverse Abdominal Plane (TAP)Block Have an Influence on Lung Function?
Official title: Changes on Pulmonary Function After Application of a Bilateral-dual TAP-block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Pain
Keywords: pulmonary function
BD-TAP-block
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young (18-45 yrs), healthy males with no history of lung diseases.

Brief summary: TAP-block (Transverse Abdominal Plane) block is a method of regional anesthesia used after abdominal surgery. The method is often applied ultra-sound guided.

In our department, the so-called bilateral dual TAP-block (BD-TAP-block) has been developed. This includes injection of local anesthetics at four sites on the abdominal wall, aiming at the best possible spread of the nerve block.

Clinical experience shows satisfying results on pain relieve using the nerve block, i.e the sensory nerves of the abdominal wall are successfully blocked. However, to our knowledge, clinical investigations regarding the effect on the muscles of the abdominal wall has never been executed.

Patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. Therefore it would be inappropriate if the motor nerves supplying these muscles were too, affected by the nerve block.

Our clinical experience has so far not given us suspicion or indication that the motor nerves become blocked, although these nerves are situated in the same muscle layer as the sensory branches.

Hence the investigators would like to examine on healthy, male subjects, whether application of a bilateral-dual TAP-block effects their ability to perform peak-flow and inspiratory and expiratory pressure. Our study hypothesis is:

There is no clinically relevant difference in the spread of results of pulmonary tests (peak flow et.c.) before and after application of bilateral dual TAP-block.


Eligibility criteria: Inclusion Criteria:

* No history of asthma
* Young male
* Has to be able to conduct lung function examination and the application of abdominal nerve block

Exclusion Criteria:

* History of asthma

Primary outcomes:
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: 1 hour after application of the BD-TAP-block
Secondary outcomes:
measure: Expiratory/Inspiratory pressure
timeFrame: 1 hour after application of the BD-TAP-block
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital, Dept. of Anesthesiology
Study officials:
affiliation: Bispebjerg Hospital
name: Christian P. Maschmann, MD
role: STUDY_DIRECTOR
affiliation: Bispebjerg Hospital
name: Maria Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References: