linjc16/ctgov huggingface dataset:
Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

Study Overview
=================
Brief Summary
-----------------
This is a prospective study designed to assess safety and potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.

Detailed Description
-----------------
MiroCam (IntroMedic, Ltd, Seoul, Korea) is a small bowel capsule endoscope using human body communication for data transmission. There is a concern of potential interactions between cardiac devices and capsule endoscope. This clinical study was designed to evaluate the potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.

Official Title
-----------------
Safety of Capsule Endoscopy Using Human Body Communication in Patients With Cardiac Pacemakers and Implantable Cardiac Defibrillators

Conditions
-----------------
Gastrointestinal Disease, Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20 years or older cardiac pacemaker or implantable cardiac defibrillator gastrointestinal disease Exclusion Criteria: previous GI perforation or obstruction history known or suspected GI stricture marked GI dysmotility uncompensated heart failure (EF ≤30% or Killip's classification class ≥ III) pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsule endoscopy, cardiac pacemaker, implantable cardiac defibrillator
Use of Methylphenidate in Children and Adolescents in France

Study Overview
=================
Brief Summary
-----------------
The use of methylphenidate in children and adolescents in France from 2010 to 2015

Detailed Description
-----------------
To describe the use of methylphenidate in children and adolescents in France from 2010 to 2015

Official Title
-----------------
Use of Methylphenidate in Children and Adolescents in France

Conditions
-----------------
Use of Methylphenidate in Children and Adolescents

Intervention / Treatment
-----------------
* Other: users of methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children and adolescents (0-17 years) registered in the French Health Insurance Database from 2012-2015

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| users of methylphenidate<br>Children and adolescents who are users of methylphenidate, 2010 to 2015 | Other: users of methylphenidate<br>* Children and adolescents who are users of methylphenidate, 2010 to 2015<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of methylphenidate over time | Describe of the use of methylphenidate over time to determine the impact of regulatory information of appropriate prescription conditions of use in September 2012 | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe methylphenidate patterns of use over time | Pharmaceutical specialties (immediate or extended release forms) prescribed by type of delivery: initial or renewals. Profile of prescribers: hospital or private practice (general practitioners, specialists) depending on type of prescription (initial or renewal); geographical distribution of the prescribers Profile of patients: sex, average age and age classes (0-23 months, 2-5 years, 6-11 years, 12-17 years), socioeconomic status, long-lasting diseases status for psychosis, severe personality disorder, mental retardation. Pattern of methylphenidate use: duration of treatment, prolonged use, interruption of treatment. | 6 years | 
| Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methylphenidate, drug utilisation study, pediatrics
Contingency Management for Stimulant Use Disorders

Study Overview
=================
Brief Summary
-----------------
The invetigators' objective is to implement Medication Assisted Treatment (MAT) and contingency management in patients affected by co-occurring opioid use disorder and stimulant use disorder. Participants will continue to receive standard of care for their opioid use disorder via MAT at our Outpatient Based Opioid Treatment (OBOT) Clinic. Participants' stimulant use disorder will be targeted through contingency management, with twice weekly urine drug screens and monetary prizes in exchange for negative urine drug screens. Through regular clinic visits and the use of incentives, the investigators hope to increase treatment adherence and increase the number of negative urine drug screens in subjects struggling with co-morbid opioid use disorder and stimulant use disorder. The investigators will determine whether or not this treatment is effective in this population, versus conventional treatment (baseline therapy patients were getting through OBOT). The investigators' primary outcome measure will be stimulant abstinence duration during the twelve week study.

Official Title
-----------------
Contingency Management for Stimulant Use Disorders

Conditions
-----------------
Stimulant Use, Contingency Management

Intervention / Treatment
-----------------
* Behavioral: Contingency Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Patients treated for opioid use disorder in the Outpatient Based Opioid Treatment (OBOT) Clinic and who also struggle with stimulant use disorder but failed conventional treatment (positive urine drug screen for substances other than THC and buprenorphine) Ideal candidates will test positive for 3 out of 4 weeks or more prior to starting contingency management Exclusion Criteria: Persons under the age of 18 Persons not able to attend follow-up clinic visits Persons not able to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency management<br>This arm will include data from participants who received CM | Behavioral: Contingency Management<br>* Contingency management involves receiving monetary prizes in exchange for negative urine drug screens.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stimulant abstinence | Duration of stimulant abstinence based on urine drug screens | 12 weeks |
Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

Study Overview
=================
Brief Summary
-----------------
Investigate safety/tolerability after a single dose intranasal administration of AZD8848 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season

Official Title
-----------------
A Double Blind, Placebo Controlled, Randomised, First Time In Man. Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD8848 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out Of Season

Conditions
-----------------
Healthy, Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: AZD8848
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years Body mass index (BMI) between 19 and 30 kg/ m2 and a weight between 50 and 100 kg No clinically relevant abnormal findings Exclusion Criteria: Acute illness which requires medical intervention Definite or suspected personal history of adverse drug reactions or drug hypersensitivity Clinical relevant disease or disorder (past or present) A history of asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD8848<br>* Concentrate for nasal spray,solution 60 mg/g<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical chemistry, haematology, urinalysis |  | During the study | 
| Nasal symptoms and peak nasal inspiratory flow |  | During the study | 
| Pharmacokinetics |  | During the study | 
| Biomarkers nasal lavage and blood |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy male, allergic rhinitis, tolerability, safety, intranasally, Healthy subjects
Discriminating Ability of the Cirrus High Definition (HD) Optical Coherence Tomography (OCT) for Glaucoma

Study Overview
=================
Brief Summary
-----------------
The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.

Detailed Description
-----------------
The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.

Official Title
-----------------
Discriminating Ability of the Cirrus HD OCT for Glaucoma

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cooperative patients Repeated OCT data Exclusion Criteria: Intraocular surgeries history DM High refractive error ( < -4.00 diopters, or > + 4.00 diopters) Media opacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C<br>Normal controls | |
| G<br>Glaucoma | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal nerve fiber layer thickness |  | when the OCT images are taking | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red-free fundus photo |  | when the OCT images are taking | 
| Visual field |  | when the OCT images are taking | 
| Intraocular pressure |  | when the OCT images are taking | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Retinal nerve fiber layer, Cirrus OCT
Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help doctors find out the extent of disease. PURPOSE: This research study is collecting bone marrow and blood samples from patients with metastatic choroid melanoma.

Detailed Description
-----------------
OBJECTIVES: Primary Develop and validate a method of detecting tumor cells in the bone marrow and blood in patients with metastatic choroid melanoma. OUTLINE: While patients are under general anesthesia for standard treatment of their disease, samples of bone marrow from the iliac crest and blood are collected. Samples are analyzed for the expression of tyrosinase and Melan-a via RT-PCR.

Official Title
-----------------
Evaluation of the Detection of Tumor Cells in Bone Marrow and Blood in Patients With Choroid Melanoma

Conditions
-----------------
Intraocular Melanoma

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Choroid melanoma Metastatic disease Planning to undergo general anesthesia PATIENT CHARACTERISTICS: Not pregnant or nursing No contraindications to the collection of a bone marrow sample No patient deprived of liberty or under trusteeship (including guardianship) No social or psychological situations that preclude the ability to give consent PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of micro-metastatic cells in 20 x 10^6 nucleated cells |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic intraocular melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size
Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients

Study Overview
=================
Brief Summary
-----------------
VLock suture studied in abdominal wound closure. Time and cosmesis was studied

Official Title
-----------------
Cost Effectiveness and Clinical Outcomes of Wound Closure Using V-Loc™ 90 Sutures.

Conditions
-----------------
Open Surgical Wounds

Intervention / Treatment
-----------------
* Device: conventional closure
* Device: V-Loc 90


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lipoabdominoplasty patients Exclusion Criteria: poor health, history of radiation, smoking

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm<br>Control arm- conventional method of wound closure | Device: conventional closure<br>* non barbed sutures used to close wounds Conventional three layer wound closure using non-locking sutures polyglactin 910 (Vicryl, Ethicon) and polyglecaprone 25 (Monocryl, Ethicon)<br>|
| Experimental: V-Loc group<br>V-Loc 90 barbed sutures | Device: V-Loc 90<br>* 2-layer wound closure using V-Loc 90 barbed suture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| closure time | operative closure time studied | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety- number of complications | Number of complications on control incisions vs number of complications on experimental incisions | 12 months | 
| Cosmesis | Scar thickness and appearance | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominoplasty
EMDR vs. PC For Motor Vehicle Accident Trauma

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. Participants will be assigned to the geographically nearest therapist, and then randomized to treatment condition.

Official Title
-----------------
EMDR vs. PC For Motor Vehicle Accident Trauma

Conditions
-----------------
Trauma, Psychological, Motor Vehicle Accident

Intervention / Treatment
-----------------
* Behavioral: EMDR
* Behavioral: PC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult reporting distress related to motor vehicle accident-related trauma English-speaking Exclusion Criteria: already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview) any indication of instability during interactions prior to the therapy session an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye movement desensitization and reprocessing (EMDR) arm<br> | Behavioral: EMDR<br>* Initial EMDR session of up to three hours; about one week later, follow-up session of up to one hour<br>|
| Experimental: Progressive counting (PC) arm<br> | Behavioral: PC<br>* Initial PC session of up to three hours; about one week later, follow-up session of up to one hour<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SUDS following treatment | Subjective Units of Distress Scale | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment | 
| Change in PRS following treatment | Problem Rating Scale | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment | 
| Change in PDS following treatment | PTSD Diagnostic Scale | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment |
OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

Detailed Description
-----------------
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population. Approximately 12 to 15 weight reduction surgeries are performed at William Beaumont Army Medical Center each month. It is the current practice that each patient receiving the laparoscopic gastric sleeve or laparoscopic Roux-en-Y gastric bypass receive an OnQ pain catheter during the surgery to reduce post-operative pain. There have been limited studies to quantify the efficacy of these devices. This study will seek to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

Official Title
-----------------
OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients

Conditions
-----------------
Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for Bariatric surgery Consents to be in protocol No local anesthetic allergy Will be having sleeve gastrectomy Doesn't have extensive scarring of abdominal wall that would prevent placement of OnQ catheter Exclusion Criteria: declines to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| receiving lidocaine<br>Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of 1% lidocaine. | |
| receiving injectable saline<br>Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of injectable saline. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic use | immediate post-operative narcotic use per patient | from admission to recovery room until discharge from the hospital (3-5 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain pump catheters, bariatric surgery, OnQ pump, sleeve gastrectomy, continuous infusion catheter