louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03049163: Comparison the Topical Anesthesia and Retrobulbar Anesthesia for 27-gauge Vitrectomy for Vitreous Floaters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perioperative Pain Experiences
Lead sponsor: The Eye Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 30
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: Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. However, both methods have potential complications that can vary from minor to severe.

Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries.

Hence, the investigators compared the effect of topical anesthesia (with eye drops) and retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.


Eligibility criteria: Inclusion Criteria:

1. patients who is going to undergo vitrectomy surgery for vitreous floaters
2. age\>18 years
3. patients who are willing to participate in this study

Exclusion Criteria:

1. patients who had vitrectomy surgery before
2. patients who had penetrating ocular trauma before

Primary outcomes:
measure: Visual Analogue Pain Scale
timeFrame: 2 hour post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ethics Committee of The Eye Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: Wu RH, Zhang R, Lin Z, Liang QH, Moonasar N. A comparison between topical and retrobulbar anesthesia in 27-gauge vitrectomy for vitreous floaters: a randomized controlled trial. BMC Ophthalmol. 2018 Jul 7;18(1):164. doi: 10.1186/s12886-018-0838-7.
citation: Lin Z, Zhang R, Liang QH, Lin K, Xiao YS, Moonasar N, Wu RH. Surgical Outcomes of 27-Gauge Pars PLana Vitrectomy for Symptomatic Vitreous Floaters. J Ophthalmol. 2017;2017:5496298. doi: 10.1155/2017/5496298. Epub 2017 Nov 29.
Clinical trial NCT01968863: Evaluation of a Microendoscopic Imaging System in Examination of Resected Tissues
Official title: Evaluation of a Microendoscopic Imaging System in Examination of Resected Tissues
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Known or Suspected Dysplasia or Cancer
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: University of Arkansas, Fayetteville
First posted: 2013-10-24
Enrollment: 13
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: Subjects with known or suspected dysplasia or cancer scheduled to undergo either endoscopic or surgical resection will be approached for participation.

Brief summary: The overall objective of this exploratory, laboratory study is to evaluate whether noninvasive fluorescence microendoscopic imaging of tissue can assist clinicians in detecting dysplastic (precancerous) areas during standard surveillance. This is a study designed to evaluate the feasibility of using prototype imaging technology to enhance the detection of precancerous changes in various tissues. The results of this laboratory study will be used to further develop the technology for clinical application.

The primary aim of this project will be to investigate what digital image analysis criteria can be used to best detect dysplasia in various types of resected tissue.


Eligibility criteria: Inclusion Criteria:

* Males and females over the age of 18 scheduled for standard of care resection of abnormal tissue

Exclusion Criteria:

* Previous chemotherapy or radiation treatment to the tissue to be resected
* Inability to provide consent

Primary outcomes:
measure: Statistical measurements of the spatial and intensity distributions of pixels within an image
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References:
Clinical trial NCT02375763: Dietary Analysis for Caries Prevention in Children Using a Computer Software
Official title: Dietary Analysis for Caries Prevention in Children Using a Computer Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Children will be recruited from the pediatric dentistry clinic of Marquette University at their first or recall appointment and will be asked to fill a questionnaire regarding their dietary habits. Afterwards a dietary analysis will be performed using a computer software, developed for this study and dietary instructions will be given to the children.


Eligibility criteria: Inclusion Criteria:

* Free medical history
* Informed Consent

Exclusion Criteria:

* General disease

Primary outcomes:
measure: Change from Baseline in dietary habits at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University Pediatric Dentistry Clinic
state: Wisconsin
Study officials:
References:
Clinical trial NCT02614963: Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
Official title: Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome: A Randomized, Double-blinded,Placebo- Controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Clostridium Butyricum
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Linyi People's Hospital
name: Taian City Central Hospital
name: Qingdao Eastsea Pharmaceutical Co., Ltd.
First posted: 2015-11-25
Enrollment: 300
Sex: ALL
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: Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome


Eligibility criteria: Inclusion Criteria:

* the presence of Rome III criteria for IBS ;
* Aged between 18 and 65 years old

Exclusion Criteria:

* Antibiotic, probiotic or laxative usage within 4 weeks.
* organic gastrointestinal diseases
* Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
* pregnancy or lactation.
* previous major or complicated abdominal surgery.
* severe endometriosis and dementia

Primary outcomes:
measure: the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores
timeFrame: 7 months
Secondary outcomes:
measure: IBS patients'quality of life
timeFrame: 7 months
measure: Composition of Microorganisms in stool
timeFrame: 7 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Li Yanqing, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01197963: A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
Official title: A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes.

The surgical procedures:

1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
2. ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.


Eligibility criteria: Inclusion Criteria:

* age- 21-55 years.
* Body Mass Index between 25-35 kf/m2.
* currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
* Documented HbA1c\>7.5% for at least 3 months.
* Stable weight for 3 months (+/-)
* Evidence of stable medical treatment for diabetes over the past 12 months.
* Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -

Exclusion Criteria:

* Type I diabetes/juvenile onset
* C-Peptid levels below 1.0 ng/ml
* Previous major upper abdominal surgery

  --Pregnant or plans to become pregnant with in the next 12 months
* Current Malignancy
* Severe pulmonary, cardia, or renal disease
* Eating disorders such as bulimia or binge-eating
* Severe mental health disorders such as schizophrenia and bipolar disorder
* Obesity due to other metabolic disorders
* taking appetite suppressants
* currently abusing illicit drugs,alcohol or using tobacco products
* Unable to provide informed consent
* Unwillingness or unable to comply with study procedures
* any condition that deems them unsuitable for the study in the opinion of the investigators

Primary outcomes:
measure: Serial Postoperative HgA1c levels
timeFrame: 1 month intervals for 3 months then every 3 months there after
Secondary outcomes:
measure: Serial Postoperative Lipid Profiles levels
timeFrame: 1 month for the first 3 months then every 3 months there after
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: The University of Texas
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Brad E Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03171363: Gaze Contingent Feedback for Anxiety Disorders in Children
Official title: Gaze-Contingent Music Reward Treatment for Anxiety Disorders in Children: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Attention bias modification treatment
Anxiety disorders
Attention training
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children.

Detailed description: Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for anxiety disorders in clinically anxious 6-10 year-olds children. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before and after eight training sessions. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with children and their parents. Attentional threat bias and Attentional control will also be measured to explore potential mediators of ABMT's effect on anxiety.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of GAD, SOP, or SAD.
* Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
* Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.

Exclusion Criteria: To be excluded youth must:

* meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
* show high likelihood of hurting themselves or others.
* have not been living with a primary caregiver who is legally able to give consent for the child's participation.
* be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
* be involved currently in another psycho-social treatment.
* have a serious vision problem that is not corrected with prescription lenses.
* have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.

Primary outcomes:
measure: Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)
timeFrame: Post treatment (1 week after treatment completion)
Secondary outcomes:
measure: Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)
timeFrame: Post treatment (1 week after treatment completion)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
References:
Clinical trial NCT00802763: Performance Proof of the New NORMA-SENSE
Official title: Performance Proof of the New NORMA-SENSE Panty Liner - in-Vivo STUD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Infection
Keywords: VAGINAL INFECTION
COLOR APPEARANCE
ELEVATED Ph
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women, age greater then 18 without symptoms of vaginal infection.

Brief summary: This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.


Eligibility criteria: Inclusion Criteria:

1. Women, age 18 years or greater without symptoms of vaginal infection.
2. Subject is ready to sign the informed consent form.

Exclusion Criteria:

1. Subject is unable or unwilling to cooperate with study procedures.
2. Subject is currently participating in another clinical study.
3. Subject suffers from vaginal bleeding or is menstruating.
4. Subject that have had sexual relations within the last 12 hours.
5. Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
6. Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Primary outcomes:
measure: We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Lin Medical center
Study officials:
References:
Clinical trial NCT05673863: Resilience in Girls Victims of Sexual Abuse
Official title: The Efficacy of the Psychological Resilience Program for the Adolescent Girls Who Are Victims of Sexual Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Sexual Abuse
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 38
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample consisted of girls who agreed to participate in the study and one of their family members (mother, father, aunt, etc.).
Primary purpose: PREVENTION

Brief summary: İn this study, it was aimed to examine the effectiveness of the psychological resilience program for adolescent girls after sexual abuse.This study is a randomized controlled trial.

Detailed description: Sexual abuse, which is a universal problem, affects the functioning of many institutions of society and can lead to lifelong physical, mental and social problems and health problems for children.The process of coping and adapting to stressful challenges such as sexual abuse is explained by psychological resilience.

Social support provided by parents, peers and professionals from the onset of sexual abuse contributes positively to children's lives and facilitates adaptation.Group therapies to be applied to abuse victims can increase perceived social support by reducing negative effects such as shame and stigmatization.

Eligibility criteria: Inclusion Criteria:

* Having applied to a child advocacy center due to sexual abuse
* Being a girl in the 11-18 age group
* The cognitive competence required to maintain the measurement tools and the training process to have
* Volunteering to participate in the research
* Being open to communication and cooperation
* No severe psychiatric disorder (such as psychosis, neurosis)
* The child can become literate (to be able to use assessment tools)

Exclusion Criteria:

* Not wanting to participate in the research
* To continue the group training or to fill in the measurement tools to be applied cognitive and physical dysfunction that would constitute an obstacle.

Primary outcomes:
measure: For children Resiliency Attitudes and Skills Profile (RASP)
timeFrame: 6 months
measure: For children Strengths and Difficulties Questionnaire (SDQ) Adolescent Form:
timeFrame: 6 months
measure: For children Resilience Scale(RS)
timeFrame: 6 months
Secondary outcomes:
measure: For parents(Strengths and Difficulties Questionnaire Parent Form (SDQ)
timeFrame: 6 months
Other outcomes:
measure: For parents Beck Depression Inventory (BDI):
timeFrame: 6 months
measure: For parents Beck Anxiety Scale (BAS)
timeFrame: 6 months
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
state: Serdivan
Study officials:
affiliation: Sakarya University
name: GÜLGÜN DURAT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02514863: Electrode Placement in Electrical Velocimetry
Official title: Influence of Electrode Placement on Electrical Velocimetry Cardiac Output Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing CMR

Brief summary: Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing diverging results. With electrode position being a suspected factor influencing measurement accuracy or reproducibility for impedance cardiography in general, no data is currently available on altering the gap of the two lower electrodes in EV. Reference values were determined using the non-invasive gold-standard cardiac magnetic resonance imaging (CMR).


Eligibility criteria: Inclusion Criteria:

* indication for CMR

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: difference between CMR and EV cardiac output measurements
timeFrame: 45 minutes
Secondary outcomes:
measure: difference between two consecutive EV cardiac output measurements
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Hospital Mannheim
Study officials:
References:
Clinical trial NCT02035163: Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi
Official title: Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complication of Coronary Artery Bypass Graft
Atrial Fibrillation
Keywords: Atrial fibrillation
coronary artery bypass graft
cryoablation
ganglionic plexi
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 0
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: Atrial fibrillation after coronary artery bypass graft is a common complication.

The investigators have thought that the mechanism of temporarily postoperative atrial fibrillation is closely related to the autonomic nervous system imbalance.

In a last several years, cryoablation was substituted for atrial incision in many reports to simplify the maze procedure.

However, there has been no comparative study to delineate the feasibility of the use of cryoablation.

Detailed description: Modified maze procedures that use energy sources for the ablation of atrial fibrillation concomitant with cardiac surgery have been shown to improve outcomes in patients with atrial fibrillation. Cryoablation of atrial fibrillation recently has been shown to lead to outcomes that were at least equivalent to those reported for other energy modalities over both short- and medium-term follow-up times.

Eligibility criteria: Inclusion Criteria:

* coronary artery graft bypass patient
* sinus rhythm

Exclusion Criteria:

* Patients using antiarrhythmic
* severe hypotension after surgery ( systolic blood pressure \<90mmHg)
* history of atrial fibrillation

Primary outcomes:
measure: freedom of atrial fibrillation or other atrial arrhythmia
timeFrame: 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St Mary's Hospital
state: Seo Cho Gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong Seog Oh, Ph.D
role: STUDY_CHAIR
References: