linjc16/ctgov huggingface dataset:
Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula

Study Overview
=================
Brief Summary
-----------------
This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.

Official Title
-----------------
Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula

Conditions
-----------------
High Complex Anal Fistula

Intervention / Treatment
-----------------
* Procedure: Decomprssion and drainage seton
* Procedure: Cutting seton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high trans-sphincteric cryptoglandular anal fistulas (involving >30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography) suprasphincteric fistulas were enrolled Exclusion Criteria: Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; - Patients with symptoms of fecal incontinence; A previous history of anal fistula surgical treatment; Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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: decomprssion and drainage seton<br> | Procedure: Decomprssion and drainage seton<br>* Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.<br>|
| Active Comparator: Cutting seton<br> | Procedure: Cutting seton<br>* Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of healing | complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination. | 6 months post-operation. | 
| Recurrence rate | recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton | within 12 months after the procedure | 
| The healing time of the anal wound (days) | the time needed to achieve complete healing of anal fistula. | 6 months post-operation. |
Cortical-Basal Ganglia Speech Networks

Study Overview
=================
Brief Summary
-----------------
In this research study the researchers want to learn more about brain activity related to speech perception and production.

Detailed Description
-----------------
Speech production is disrupted in a number of neurological diseases that involve the basal ganglia, including Parkinson's disease (PD) and dystonia. The investigators will use a novel experimental approach and combination of analytic techniques to elucidate the contribution of neural activity in cortical-basal ganglia circuits to the hierarchical control of speech production, in subjects undergoing deep brain stimulation surgery.

Official Title
-----------------
Cortical-Basal Ganglia Speech Networks

Conditions
-----------------
Parkinson Disease, Essential Tremor, Dystonia

Intervention / Treatment
-----------------
* Other: electrophysiological data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects scheduled for DBS implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of Parkinson's disease, essential tremor or dystonia. Subjects able to provide informed consent and comply with task instructions. Subjects 18-85 years old Exclusion Criteria: Subjects with reported hearing loss. Non-English-speaking subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain signal data collection<br>Brain signal data collection at the time of deep brain stimulation (DBS) surgery. | Other: electrophysiological data collection<br>* Electrophysiological data collection at the time of DBS surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects providing the interpretable speech related electrophysiological data collection. | The number of subjects providing the interpretable speech related electrophysiological data during DBS surgery. | Duration of single DBS surgery |
Prevention of Seasonal Affective Disorder

Study Overview
=================
Brief Summary
-----------------
A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder

Conditions
-----------------
Seasonal Affective Disorder (SAD)

Intervention / Treatment
-----------------
* Drug: Investigational Seasonal Affective Disorder (SAD) Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (Patient must meet these criteria in order to be eligible for this study.) Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern. Exclusion Criteria: (Patient cannot meet these criteria in order to be eligible for this study.) Patient has a current or past history of seizure disorder or brain injury. Patient has a history or current diagnosis of anorexia nervousa or bulimia. Patient has recurrent summer depression more frequently than winter depression. Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders. Patient has initiated psychotherapy within the last 3 months.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Investigational Seasonal Affective Disorder (SAD) Drug|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Skin Incision Adhesive in Pediatrics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).

Detailed Description
-----------------
Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.

Official Title
-----------------
Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Device: Surgiseal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 5 and 18 years of age, inclusive Candidate for use of a topical surgical skin adhesive Informed consent by a parental guardian Exclusion Criteria: A wound with evidence of active infection or gangrene or wounds of decubitus etiology Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to body fluids or dense natural hair Subjects with known hypersensitivity to cyanoacrylate or formaldehyde

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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: Surgical Glue<br>Surgiseal | Device: Surgiseal<br>* surgical glue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Closure | wound closure measured baseline to 14 days | baseline to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events Related to Wound Closure | Adverse events reported | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Wounds
Chronic Bronchiolitis or Resistant Asthma?

Study Overview
=================
Brief Summary
-----------------
Chronic Bronchiolitis or Resistant Asthma? Testing a way to diagnosis and treatment

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Erythromycin, Azithromycin , Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Difficult asthma Exclusion Criteria: Patients with potential allergic bronchopulmonary aspergillosis i.e. with peripheral blood eosinophilia, sputum eosinophilia, or any sputum production and bronchiectasis A history of smoking Significant occupational or environmental exposures Evidence on emphysema on chest high resolution computed tomography (HRCT) scan
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erythromycin, Azithromycin , Clarithromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the surgical risk factors and differences between different diseases in elderly patients submitted to elective surgery in our institution.

Official Title
-----------------
Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery: Comparative Study of Elective Vascular, Digestive and Biliary Surgery

Conditions
-----------------
PERIPHERAL VASCULAR DISEASES, Digestive Diseases, BILIARY TRACT DISEASES

Intervention / Treatment
-----------------
* Procedure: SURGERY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 65 years of age All necessary data to calculate p-possum and saps II Exclusion Criteria: Patients with incomplete data

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| I<br>VASCULAR SURGERY | Procedure: SURGERY<br>* ELECTIVE SURGICAL PROCEDURES<br>|
| II<br>DIGESTIVE SURGERY | Procedure: SURGERY<br>* ELECTIVE SURGICAL PROCEDURES<br>|
| III<br>BILIARY TRACT SURGERY | Procedure: SURGERY<br>* ELECTIVE SURGICAL PROCEDURES<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 1 MONTH | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SURGICAL RISK, ELDERLY, MAJOR SURGERY, P-POSSUM, SAPS II
Pilot Study of Diet and Behavior in Children With Autism

Study Overview
=================
Brief Summary
-----------------
We hypothesize that in children with autism dietary antigens can change the intestine, making it leaky and then affecting the brain changing their behavior.

Detailed Description
-----------------
Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).

Official Title
-----------------
PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Dietary Supplement: Gluten and dry milk
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the ages of 3 and 12 years, DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90), willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks. Exclusion Criteria: food allergies, celiac disease, inflammatory bowel disease, infectious gastrointestinal, seizure disorder, neurological problems with behavioral changes, unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gluten and Milk group<br>Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily | Dietary Supplement: Gluten and dry milk<br>* 0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk<br>* Other names: Gluten and dairy group;|
| Placebo Comparator: Rice flour<br>Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo) | Dietary Supplement: Placebo<br>* Rice flour 1.0 g/kg/day<br>* Other names: Control group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Permeability | Changes in intestinal permeability and behavior with changes in diet | baseline, 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric testing | Behavioral variables: hyperactivity, innatention, irritability | baseline, 2 weeks and 4 weeks | 
| Gastrointestinal symptoms | Changes in gastrointestinal symptoms with different diets | baseline, week 2, week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intestinal permeability, diet, gluten, dairy
Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

Study Overview
=================
Brief Summary
-----------------
The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.

Official Title
-----------------
Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Other: Notapplicable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive) Patients whose medical charts are available for data collection Exclusion Criteria: Patient participation in the OPUS registry Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Notapplicable<br>Not applicable as non-interventional study | Other: Notapplicable<br>* Not applicable as non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of incidence rates of adverse events | Incidence rates of liver test abnormalities, Occurrence of Hepatic Adverse Events (HAEs), Occurrence of any other Adverse Event (AE), Occurrence and reason for discontinuation of Opsumit treatment, hospitalization and death | Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of demographic characteristics of patients | To describe demographic characteristics of patients treated with Opsumit at beginning and during study time period | Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 | 
| Description of clinical characteristics of patients | To describe clinical characteristics of patients treated with Opsumit at beginning and during study time period | Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 |
Resilience for Young People With ADHD - a Randomized Controlled Trial of a Brief Intervention Program.

Study Overview
=================
Brief Summary
-----------------
In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for children, adolescents and adults (called myresilience.org). The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Detailed Description
-----------------
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Official Title
-----------------
Resilience for Young People With Attention Deficit Hyperactivity Disorder (ADHD) - a Randomized Controlled Trial of a Brief Intervention Program.

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Behavioral: The Resilience Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A random sample with 8.000 patients registered in the Danish National Patient Register: Age 18-27 ADHD diagnosis Exclusion Criteria: • Request for legal protection against contacts from researchers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 27 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Service as usual | |
| Experimental: Intervention group<br>Participants are offered access to the web based resilience program and are invited to join a short introduction course. | Behavioral: The Resilience Program<br>* See the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD Self-Report Scale (ASRS-v1.1) | The Symptom Checklist is an instrument consisting of the eighteen Diagnostic and Statistical Manual criteria (DSM-IV). Six of the eighteen questions were found to be the most predictive of symptoms consistent with ADHD. These six questions are the basis for the ASRS v1.1. The measure is a number score. The ASRS-v1.1 will be administered to all participants before and 1 year after the intervention. | Follow-up will be on the average 1 year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 12-item General Health Questionnaire (GHQ-12) | The GHQ-12 is a widely used standard Health Questionnaire. The GHQ-12 will be administered to all participants before and 1 year after the intervention. The measure is a number score. | Follow-up will be on the average 1 year after intervention |