linjc16/ctgov huggingface dataset:
The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Patients With Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the prevalence of white matter lesions in Chinese migraineurs with and without right-to-left shunt. The aim is to study the relationship among right-to-left shunt, migraine and white matter lesions.

Detailed Description
-----------------
This is a prospective multicenter study of Chinese population. Participants (normal individuals without migraine and migraineurs) are included after standardized diagnostic procedures (TCD and migraine diagnosis). For all the participants, brain MRI and c-TCD are required. Up to 10-15 study sites nationwide will be needed to recruit the planned participant population during a 1-year period. The information of each participants will be registered, including basic facts, the longitudinal headache history, frequency, location, quality, intensity, duration, accompanied symptoms, precipitating and exacerbating factors, with or without aura, and Headache Impact Test-6 (HIT-6) questionnaire.

Official Title
-----------------
The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Chinese Patients With Migraine:a Multicenter Study. CAMBRAIN Study.

Conditions
-----------------
White Matter Disease, Right-to-left Shunt, Migraine Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who fulfilled the criteria for migraine according to the International Classification of Headache Disorders III-beta were included. healthy volunteers without a history of migraine were included as controls. Exclusion Criteria: Subjects were excluded from the study if they had severe arterial stenosis, an insufficient temporal window, inadequate cubital venous access, and/or were unable to perform the Valsalva manoeuvre (VM) because of severe heart or lung disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Normal<br>Normal healthy individual without migraine. | |
| Magraine<br>Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast-enhanced transcranial Doppler (c-TCD) | Brain MRI | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Right-to-left Shunt, Brain White Matter Lesions, Migraine
Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is benefit from providing cognitive rehabilitation in the group setting. Several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up.

Detailed Description
-----------------
This research study will look at the outcome benefits of providing cognitive rehabilitation, utilizing the group process. Criteria for selecting the appropriate participants, group format and structure, as well as use of standardized assessments. The assessments used: Three Step Calendar Approach, (Sohlberg and Mateer) Satisfaction With Life scale (SWLS), Community Integration Questionnaire (CIQ), Independent Living Scale, and the Vocational Independence Scale. The group setting provides an atmosphere to work on building communication skills through peer feedback and to develop psychological coping strategies. Techniques such as the problem solving format and a calendar system. Analysis and outcomes of 17 past group participants were analyzed supporting cognitive rehabilitation in the group setting. Of the 20 participants, 3 chose not to be included.

Official Title
-----------------
Efficacy of Group Based Cognitive Rehabilitation Following Acquired Brain Injury

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Behavioral: Cognitive Group Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants involved in the Cognitive Rehabilitation Outpatient Group within the study time frame are eligible to be in the study.

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Group Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| provide evidence which supports cognitive therapy in a group setting |  |  | 
| less labor intensive |  |  | 
| cost effectiveness |  |  | 
| peer feedback is effective |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Rehabilitation
Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children

Study Overview
=================
Brief Summary
-----------------
Investigators have started an awake spinal anesthesia program in conjunction with pediatric surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a lack of significant hemodynamic changes in neonates and infants following spinal anesthesia; however, there are limited data regarding its impact on tissue oxygenation. The goal of the current study is to assess changes in tissue and cerebral oxygenation using non-invasive near infrared spectroscopy following spinal anesthesia.

Conditions
-----------------
Infants Undergoing Surgery

Intervention / Treatment
-----------------
* Device: NIRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that are candidates for and have agreed to spinal anesthesia. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRS<br>Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. | Device: NIRS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) | Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). | Intraoperative measure | 
| Tissue Non-invasive Near Infrared Spectroscopy (NIRS) | Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). | Intraoperative measure |
Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Tramadol hydrochloride/Acetaminophen Tab.
* Drug: Tramadol hydrochloride/Acetaminophen SR Tab.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males/Females aged over 20 years Patient with low back pain who needs analgesic administration Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification Pain VAS Value over 40 mm Subjects who voluntarily or legal guardian agreed with written consent Exclusion Criteria: Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease) Patients who had taken back surgery within 24 weeks from the screening point Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.<br> | Drug: Tramadol hydrochloride/Acetaminophen Tab.<br> <br> |
| Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.<br> | Drug: Tramadol hydrochloride/Acetaminophen SR Tab.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in '100 mm pain VAS' value from baseline |  | 0, 1, 7, 14, 28 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen
Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

Study Overview
=================
Brief Summary
-----------------
Peptic ulcer disease is the most common gastrointestinal disease. Antibiotic resistant Helicobacter pylori is a major problem worldwide. The gold standard for Helicobacter pylori eradication is composed of Proton-pump inhibitor/Ranitidine bismuth citrate + Amoxycillin + Metronidazole /Clarithromycin. In Thailand, clarithromycin resistant strains increased and led to treatment failure. Data on file at Rajavithi Hospital showed that metronidazole resistant H. pylori was about 50% and Clarithromycin resistant strains accounted for 8%. This molecular genetic study will be performed in patients presenting with dyspepsia, who had an indication for gastroscopic examination, to explore the incidence of antibiotic resistant Helicobacter pylori in Rajavithi Hospital, Thailand.

Detailed Description
-----------------
Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

Official Title
-----------------
Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Procedure: gastroscopic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female with dyspepsia age > 15 years fulfil indication for gastroscopic examination able to give informed consent Exclusion Criteria: contraindication for gastroscopic examination and biopsy

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 |
| --- | --- |
| 1<br>Gastroscope positive for H. pylori and resistant to clarithromycin | Procedure: gastroscopic examination<br>* gastroscopic examination for tissue biopsy and real time PCR for gene study<br>|
| 2<br>Gastroscope positive for H. pylori and not resistant to clarithromycin | Procedure: gastroscopic examination<br>* gastroscopic examination for tissue biopsy and real time PCR for gene study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of H. pylori Clarithromycin resistance gene |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristic of H. pylori clarithromycin resistant gene mutation |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H. Pylori, Clarithromycin resistant, gene
Gastric Ultrasound

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.

Official Title
-----------------
Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Point-of-Care Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia. Exclusion Criteria: History of upper gastro-intestinal surgery.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine<br>Patients who are scheduled for routine outpatient surgery. | Device: Point-of-Care Ultrasound<br>* Portable ultrasonography done at the bedside.<br>|
| Active Comparator: Urgent<br>Patients who are scheduled for urgent surgery. | Device: Point-of-Care Ultrasound<br>* Portable ultrasonography done at the bedside.<br>|
| Active Comparator: Emergent<br>Patients who are scheduled for emergency surgery. | Device: Point-of-Care Ultrasound<br>* Portable ultrasonography done at the bedside.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration Risk Grade | Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPO at the Time of Injury | Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups. | Baseline | 
| NPO at the Time of Surgery | Amount of time the patient was without food or water prior to their surgery. | Baseline | 
| Pre-operative Opioid Administration | Patients who received opioids for pain control prior to surgery. | Baseline |
Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
Memantine is a glutamate receptor antagonist that has been reported to reduce Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant individuals. The investigators hypothesized that memantine is an effective augmenting agent to standard intensive residential treatment of severe OCD. An intent-to-treat, single-blinded, naturalistic case-control design is employed. The sample includes subjects receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT) program, half of whom also receive memantine augmentation. Admission, monthly and discharge measures of OCD, depression and psychosocial functioning are collected by raters blinded to augmentation status. Matched controls are selected based upon gender, initial OCD severity, psychosocial functioning, and timing of admission. Descriptive and comparative analyses are conducted via SPSS, statistical significance is defined at p<0.05, clinically significant response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale captures global clinical change.

Official Title
-----------------
A Chart Review of Memantine Use in the Treatment of Obsessive-Compulsive Disorder at the OCD Institute

Conditions
-----------------
Obsessive-Compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients of IRT at the OCD Institute who agreed to augmentation with memantine. Consecutive patients of IRT at the OCD Institute who were not offered augmentation with memantine and who were matched according to OCD severity, gender, and psychosocial functioning. Exclusion Criteria: Subjects offered memantine augmentation who did not provide voluntary 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Group<br>Intensive Residential Treatment with memantine augmentation | |
| Control Group<br>Intensive Residential Treatment without memantine augmentation | |

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
-----------------
To evaluate the effectiveness of memantine as an augmenting agent for standard intensive residential treatment of severe obsessive-compulsive disorder (OCD)
Brief Integrative Therapy for Post-Traumatic Stress Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following childhood sexual abuse. This study will also promote the development of skills that are necessary for increasing quality of life and improving self-esteem.

Detailed Description
-----------------
BIT integrates interpersonal, problem solving, affect regulation, and psychoeducational components. In this study, BIT is used to encourage women to focus on current issues and problems. The BIT therapist will help patients identify the impact of PTSD on their functioning, help them identify effective coping strategies for dealing with trauma-related distress, and encourage them to establish and maintain a certain degree of independence from the therapist. Patients receive 15 weekly sessions of BIT. Assessments occur pre-treatment, post-treatment, and at a 3-month follow-up, and include self-report measures, clinician administered PTSD scale questions, interviews, and evaluations of lifetime stressors.

Official Title
-----------------
Development and Initial Evaluation of Brief Integrative Therapy for PTSD

Conditions
-----------------
Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Behavioral: Brief Integrative Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-Traumatic Stress Disorder (PTSD) diagnosis Childhood sexual abuse, defined as any sexual contact before the age of 16 with someone 5 or more years older At least 1 clear, detailed memory of sexual abuse Exclusion criteria: Substance abuse or dependence Psychotic disorder, bipolar disorder, or dissociative disorder 2 or more suicidal or parasuicidal acts in the past year Domestic violence involvement Pregnancy or attempting to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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

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 |
| --- |
|Behavioral: Brief Integrative Therapy|nan|

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
-----------------
Child Abuse, Sexual