louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03906084: Evaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement
Official title: Evaluation of the Combined Effect of Corticotomy and Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement: Split Mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Malocclusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 16
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to compare, a standard efficient technique in accelerating OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT in an attempt for further acceleration of OTM.

Detailed description: The study design was a randomized split mouth design to compare, clinically and radiographically, between the two interventions (Corticotomy and Laser versus Corticotomy only) by assessing the rate of maxillary canine retraction achieved in 4 months. Secondary outcomes were to evaluate 1st maxillary molar anchorage loss, changes in tipping, torque and rotations values of maxillary canine and 1st molar. In addition, the impact of both interventions on root resorption was assessed. The present study was carried on 16 female patients. All patients required maxillary 1st premolar extraction and subsequent maxillary canine retraction.

Eligibility criteria: Inclusion Criteria:

1. Post pubertal patients with age more than 17 years.
2. Class I or Class II (Angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage.

Exclusion Criteria:

1. Patients having missing permanent canine teeth in maxillary arch.
2. History of trauma or root canal treatment in maxillary canines.
3. History of previous orthodontic treatment.
4. History of hormonal disorder or syndrome.

Primary outcomes:
measure: Rate of canine retraction
timeFrame: 4 months
Secondary outcomes:
measure: Root resorption
timeFrame: after 4 months from start of clinical trial
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02450084: Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
Official title: Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage the pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to single-port robotic gynecologic surgery which has incision site at umbilical area. Patients will randomly assigned to two groups, RSB group and Control group. Each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.

Detailed description: Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. The procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. After the procedure, a surgery scheduled will be proceeded. Patient of Control group will be proceeded the surgery after induction of anesthesia. All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively. If a patient complains pain more intense than VNRS 4 or demands an analgesic drug, a rescue analgesic would be allowed.

Eligibility criteria: Inclusion Criteria:

* Robotic single-port gynecologic surgery
* American society of Anesthesiologists (ASA) physical status classification I-II
* Age: 21-60

Exclusion Criteria:

* Gynecologic cancer operation
* History of previous abdominal surgery
* Allergy to local anesthetics(ropivacaine)
* Opioid tolerance
* Coagulopathy
* Infection at the needle insertion site
* Difficulty to cooperating

Primary outcomes:
measure: Verbal numerical rating scale
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: Total opioids use
timeFrame: 0, 1, 6, 12, 24, 48 hours postoperatively
measure: Time to first rescue analgesic request
timeFrame: 48 hours postoperatively
measure: Verbal numerical rating scale
timeFrame: 0, 1, 12, 24, 48 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Youn Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06217484: Investigation of Effects of Delayed Feedback on Non-motor Symptoms in Individuals With Parkinson's Disease
Official title: Investigation of Effects of Delayed Feedback on Non-motor Symptoms in Individuals With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson Disease
learning
feedback
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Parkinson Disease

Brief summary: Learning deficits are frequent in individuals with Parkinson's Disease. Clear feedback is integral because through feedback individuals know whether they should stick with an action that they have been doing (if the feedback is positive), or change their course of action (if the feedback is negative). Learning though immediate feedback has been shown to be depended on the brain chemical dopamine that is disrupted in individuals with Parkinson's Disease. During learning, feedback can also be presented after a delay. The investigators propose that learning through delayed feedback will lead to greater learning in individuals with Parkinson's Disease, since learning through delayed feedback does not rely on dopamine. During the proposed paradigm, participants with Parkinson's Disease complete a multiple-choice test. After making their selection on the multiple-choice test, they either see feedback immediately or are given feedback 25 minute later after reviewing their selection on the multiple-choice test. The investigators hypothesize that participants will learn better when they are provided with delayed feedback.


Eligibility criteria: Inclusion Criteria:

* Only participants with scores above 24/30 on the Montreal Cognitive Assessment will be recruited for participation to exclude dementia.

Exclusion Criteria:

* Individuals with neurological conditions other than PD such as epilepsy, multiple sclerosis, brain tumors, etc. will be excluded to control for the effects these conditions have on the brain and behavior.

Primary outcomes:
measure: Percent correct responses will be collected through the computer software
timeFrame: testing lasts 60 minutes and completed in 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Ekaterina Dobryakova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04166084: Trunk Stabilization Exercises at Lipoedema Patients
Official title: The Effect of Trunk Stabilization Exercises on Postural Stability at Lipoedema Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lipedema
Keywords: lipedema
postural stability
trunk stabilization exercises
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lipedema is a chronic, progressive adipose tissue disorder that is mostly seen as a symmetrical growth of the hips and legs, affecting women. The aim of this study is to investigate the effect of trunk stabilization exercises in addition to active range of motion exercises on body composition, pain, edema, trunk endurance, functional capacity and postural stability.

Detailed description: Thirty female patients with upper and lower leg lipedemia were included in the study.

Subjects were divided into two groups as experimental (n = 15) and control (n = 15).

The physiotherapy program of the control group will consist of active range of motion exercises and the physiotherapy program in the experimental group will include active range of motion exercises as well as trunk stabilization exercises. After recording demographic data of all subjects, limb volume (environmental measurement), body composition analysis, trunk endurance, pain (Visual Analogue Scale), postural stability (Biodex Balance System®) and functional capacities (6-Minute Walk Test) will be taken.

After the six-week treatment program, all evaluations will be repeated. SPSS (SPSS 21.0) program was used for statistical analysis of the data. Significance level in all analyzes will be accepted as p \<0.05.

Eligibility criteria: Inclusion Criteria:

* diagnosed with lower or upper type lipedema
* to be able to understand Turkish
* being older than 18 years

Exclusion Criteria:

* diagnosed with vestibular disorders
* having orthopedic or neurologic co morbidities

Primary outcomes:
measure: Extremity volume
timeFrame: Six weeks
measure: Body Composition
timeFrame: Six weeks
measure: Extremity pain
timeFrame: Six weeks
measure: Endurance
timeFrame: Six weeks
measure: Balance
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06902584: North American Comfilcon A Clinical Study
Official title: North American Comfilcon A Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Astigmatism
Presbyopia
Ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2025-03-30
Enrollment: 182
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female or male subjects aged 8 to 75 years who are established contact lens wearers. Screen and enrol approximately 182 participants wearing comfilcon A lenses with the aim of achieving at least 160 in the per protocol analysis cohort.

Brief summary: The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.

Detailed description: The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.

Eligibility criteria: Inclusion Criteria:

1. Age 8 to 75 years (inclusive).
2. Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
3. At least occasional overnight wear in the last 12 months.

Exclusion Criteria:

1. Current participation in a contact lens or contact lens care product clinical trial.

Primary outcomes:
measure: Visual Performance (Visual Acuity)
timeFrame: At the end of 2 hours of wear
measure: Incidence of contact lens-related adverse events
timeFrame: At the end of 2 hours of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of Berkeley
state: California
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
Study officials:
affiliation: University of Berkeley
name: Meng C Lin, OD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCare Vision Center
name: Katherine Bickle, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nittany Eye Associates
name: Abigail G Harsch, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464084: Interaction of Melatonin With MTNR1B Genotype on Glucose Control - Study 2
Official title: Interaction of Melatonin and Light With MTNR1B Genotype on Glucose Control - Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose
Circadian Rhythm
Melatonin
Genes
Light
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-03-13
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.

Detailed description: The investigators' recent GWAS discovery of MTNR1B as a novel type 2 diabetes gene has sparked great interest into the role of melatonin in glycemic control, for which the mechanism is largely unknown. This research will determine the effect of melatonin and MTNR1B on glycemic control under highly-controlled, in-laboratory protocols while manipulating circulating melatonin concentrations (both up and down) and assessing glycemic control by frequently-sampled intravenous glucose tolerance tests, as well as in ex vivo human pancreatic islets. This research will provide mechanistic insights into the metabolic effects of melatonin and the MTNR1B risk variant and may help in evidence-based approaches and personalized recommendations to improve glycemic control in night shift workers and late-night eaters.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index: 20 and 35 kg/m2
* Age: 21-55 years of age
* Caucasian
* Non-smoking
* With regular sleep-wake cycle
* Passed medical and psychological screening tests

Exclusion Criteria:

* Acute, chronic or debilitating medical conditions
* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Worked night or rotating shift work within past 1 year
* Drug or alcohol dependency

Primary outcomes:
measure: change in glucose tolerance
timeFrame: Day 1 of the three in-lab protocols
Secondary outcomes:
measure: change in first-phase insulin release
timeFrame: Day 1 of the three in-lab protocols
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank AJL Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426984: A Double Blind Crossover Study on the Effect of MPH on Decision-making Ability of Adults With BPD Compared to Adults With ADHD and Healthy Adults
Official title: A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With Borderline Personality Disorder (BPD) Compared to Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with BPD and compares it to its effect on healthy adults and adults with BPD (using data form study SHA 01-10), in a double-blind crossover design. The investigators hypothesize that Ritalin will result in better performance in all measures.

Detailed description: Participants will be required to arrive at the cognitive laboratory in "Shalvata" for two visits: the first visit will include obtaining informed consent, screening (as detailed below), and performing a battery of computerized tasks. The second visit will include performing of the same battery of tasks, and payment.

In one of the visits, participants will receive a capsule containing Methylphenidate or placebo (MPH; Ritalin) (dosage: 10 mg in case weight\<40 kg; 30 mg in case weight\>90 kg; otherwise 20 mg -( The pills will be 10mg each, and the number of pills will be administered according to the dosage stated; 1-3 pills, according to weight). Prior to performing the tasks, and in the other visit they will receive a capsule containing placebo.

Eligibility criteria: Inclusion Criteria:

* Adults in the age of 21-50 with diagnosed with Borderline Personality Disorder (BPD)

Exclusion Criteria:

* People diagnosed with a clinical disorder other than BPD or ADD/ADHD that may impair their performance in the tasks used in the study.
* People for whom there is a contra-indication for consuming Ritalin.
* Pregnant women and nursing women; Women participants will be required to report whether they are pregnant, and in case they are, they will not participate.

Primary outcomes:
measure: Test of Variables of Attention (TOVA) score
timeFrame: 20 minutes
measure: Iowa gambling task (IGT) score
timeFrame: 30 minutes
measure: Foregone Payoff Gambling Task (FPGT) score
timeFrame: 30 minutes
measure: Spatial Working Memory (SWM) score
timeFrame: 10 minutes
measure: digit span score
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon,
country: Israel
facility: Shalvata Mental Health center
Study officials:
affiliation: Shalvata MHC
name: Hilik Levkovitz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02196584: Clinical Evaluation of the RAVI-Guide
Official title: Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Diseases
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older who undergo intravitreal injection

Brief summary: Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid speculum during intravitreal injections

Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with those of the conventional lid speculum and caliper approach


Eligibility criteria: Inclusion Criteria:

* Patients age 18 years or older who undergo intravitreal injection for clinical indications.

Exclusion Criteria:

* Patients under the age of 18 years
* Patients unable to give informed consent
* Disorders that preclude the ability to judge pain or discomfort associated with intravitreal injection
* Disorders that preclude the ability to assess for complications of intravitreal injection
* Inability to assess the landmarks by which localization of intravitreal injection sites is determined, such as obscured corneal limbus
* Inability to communicate directly to the physician and immediately after the procedure the level of pain or discomfort

Primary outcomes:
measure: Pain severity associated with instrument type used for holding eyelids open during intravitreal injection
timeFrame: Within 15 minutes of injection procedure
Secondary outcomes:
measure: Procedural complications associated with instrument use during intravitreal injection procedure
timeFrame: Within 15 minutes of injection procedure
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert and Medical College of Wisconsin Eye Institute
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Dennis P Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02452684: Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
Official title: Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients (Study LUN01S)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 4876
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Insomnia participants who did not take eszopiclone before assessment

Brief summary: To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.


Eligibility criteria: Inclusion Criteria:

1. Insomnia participants who did not take eszopiclone before assessment
2. Participants who receive assessment by using sleep questionaries

Primary outcomes:
measure: Assessment of overall improvement
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
name: Akira Endo
role: STUDY_DIRECTOR
References:
citation: Japanese Journal of Sleep Medicine 10 : 425-441, 2016.