linjc16/ctgov huggingface dataset:
Quetiapine in Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.

Detailed Description
-----------------
This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult outpatients 18-65 years of age primary diagnosis of social anxiety disorder, using DSM-IV criteria minimum CGI severity score of 4 at baseline minimum BSPS score of 20 at baseline written informed consent negative serum pregnancy test for women of childbearing potential Exclusion Criteria: current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition any current primary anxiety disorder other than SAD or current primary depression history of substance abuse or dependence with the last 6 months suicide risk or serious suicide attempt within the last year clinically significant medical condition or laboratory abnormality women of childbearing potential who are unwilling to practice an acceptable method of contraception concomitant medication use for psychotropic purposes history of hypersensitivity to quetiapine

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Social Phobia Scale (BSPS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions of Severity (CGI-S) |  |  | 
| Clinical Global Impressions of Improvement (CGI-I) |  |  | 
| Social Phobia Inventory (SPIN) |  |  | 
| Hospital Anxiety and Depression Scale (HADS) |  |  | 
| Connor Davidson Resilience Scale (CD-RISC) |  |  | 
| Sheehan Disability Inventory (SDI) |  |  | 
| Barnes Akathisis Scale (BAS) |  |  | 
| Simpson-Angus Scale (SAS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quetiapine, social anxiety disorder, antipsychotic, pilot study
Delirium in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.

Detailed Description
-----------------
This is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the ICU. Enrolled patients will receive a daily baseline delirium assessment using the CAM-ICU tool before the awakening from sedation and an assessment during the awakening from sedation. Each patient will thus serve as their own controls for these interventions.

Official Title
-----------------
An Assessment of Delirium in Mechanically Ventilated Patients Undergoing Daily Awakening From Sedation

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old intubated and mechanically ventilated receiving sedative and/or analgesic medication candidate for daily awakening from sedative and/or analgesic medication Exclusion Criteria: primary neurologic disease (stroke, seizure, elevated ICP) post cardiac arrest do not speak English (assessment only English language validated)

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 |
| --- | --- |
| Sedated mechanically ventilated patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium |  | Daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU admitting diagnosis |  | At enrollment | 
| Medications |  | Daily | 
| Ventilator free days (or first 28) |  | At 28 days post-intubation | 
| ICU complications |  | Daily | 
| Days to discharge |  | At discharge | 
| Survival |  | At discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypnotics and Sedatives, Respiration, Artificial, Ventilators, Mechanical, Critical care, Intensive care
Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

Study Overview
=================
Brief Summary
-----------------
This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.

Official Title
-----------------
Randomized Double Blind Comparison of Peri-Operative Standard Analgesia With Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: Ketamine
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female >/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study Exclusion Criteria: Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Ketamine infused at 0.25 mg/kg/hour. | Drug: Ketamine<br> <br> |
| Experimental: Lidocaine<br>Lidocaine infused at 0.5 mg/kg/hour. | Drug: Lidocaine<br> <br> |
| Experimental: Ketamine and Lidocaine<br>Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour | Drug: Lidocaine<br> <br> Drug: Ketamine<br> <br> |
| Placebo Comparator: Placebo<br>Placebo (saline) given to compare usual treatment against active agents in post operative pain management. | Other: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe). | postoperative day 1 - 3 |
Effect of Hyperuricaemia on Chronic Renal Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

Detailed Description
-----------------
This study aims to explore the best effective dose and adverse reaction of febuxostat in lowering serum uric acid to low level in patients with Chronic Renal Disease at different stages. To elucidate that low levels of serum uric acid can delay the progression of renal damage. Promote the application of anti uric acid drugs in the treatment of chronic renal failure and delay the progress of CKD in patients

Official Title
-----------------
Study on the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

Conditions
-----------------
Hyperuricemia, Chronic Renal Disease

Intervention / Treatment
-----------------
* Drug: 20mg Febuxostat
* Drug: 40mg Febuxostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-dialysis CKD patients with serum uric acid greater than 7mg/dl. eGFR≥15ml/min/1.73m². Low salt, low protein, low purine diet. Exclusion Criteria: Take drugs that raise blood uric acid at the same time. Patients with gout attacks. Patients with pregnant, lactating. Autosomal dominant polycystic kidney disease. Patients with poor general condition and multiple organ failure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Treatment group1<br>Febuxostat pill 20mg was used to treat CKD patients with hyperuricaemia. | Drug: 20mg Febuxostat<br>* Participants take 20mg febuxostat pill once a day for at least six months.<br>* Other names: 20mg Febuxostat pill group;|
| Active Comparator: Treatment group2<br>Febuxostat pill 40mg was used to treat CKD patients with hyperuricaemia. | Drug: 40mg Febuxostat<br>* Participants take 40mg febuxostat pill once a day for at least six months.<br>* Other names: 40mg Febuxostat pill group;|
| No Intervention: Control group<br>Treatment of CKD patients with hyperuricaemia with conventional methods. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum uric acid | intravenous blood sampling | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine | intravenous blood sampling | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uric Acid, Febuxostat, Chronic Renal Disease
Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

Study Overview
=================
Brief Summary
-----------------
The product is being tested to see if exposure to light causes toxic reactions on the skin.

Official Title
-----------------
Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Under 18 years of age

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Drug | Drug: Xenaderm<br>* 20mg under Finn chambers<br>|
| Placebo Comparator: B<br>Placebo comparator | Drug: Placebo<br>* 20mg under Finn chambers<br>|
| No Intervention: C<br>Subjects serve as own controls. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Reaction Score | Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound healing, phototoxicity, Healthy Subjects
Pain Processing in Anxiety and Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate pain, anxiety and depression in patients with panic anxiety disorders without pain or depression without pain compared with healthy volunteers

Official Title
-----------------
Pain, Anxiety and Depression in Patients With Panic Anxiety Disorders Without Pain or Depression Without Pain Compared With Healthy Volunteers

Conditions
-----------------
Pain, Anxiety, Depression

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with panic disorder or depression Exclusion Criteria: Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol, SSRI and benzodiazepines Serious or unstable medical disease Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation Patients who cannot cooperate and do not understand Danish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with panic anxiety disorder without pain | Other: Observation<br> <br> |
| 2<br>Patients with depression without pain | Other: Observation<br> <br> |
| 3<br>Healthy controls | Other: Observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative sensory testing |  | 3-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom checklist 92 |  | 3-4 hours | 
| Hamilton Depression and Anxiety Rating Scale |  | 3-4 hours | 
| Major Depression Inventory |  | 3-4 hours | 
| GAD-10 Anxiety Scale |  | 3-4 hours | 
| Health Survey SF-36 |  | 3-4 hours | 
| McGill Pain Questionnaire |  | 3-4 hours | 
| Sweat test |  | 3-4 hours | 
| Heart rate variability testing |  | 3-4 hours | 
| Coping Strategy Questionnaire |  | 3-4 hours | 
| Pain Catastrophizing Scale |  | 3-4 hours | 
| Pain rating (VAS) |  | 3-4 hours | 
| Interview |  | 3-4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Neuropathic pain, Chronic pain, Anxiety
Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD).

Detailed Description
-----------------
Kava kava (KAV) is a plant-derived treatment widely used in Europe to treat anxiety disorders. Several studies suggest that KAV may be effective in reducing anxiety symptoms; however, trial data are limited. This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of GAD. This study will last 10 weeks. Participants will be randomly assigned to receive KAV, VEN, or placebo for 8 weeks. Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation. Self-report scales and questionnaires will be used to assess the anxiety, depression, and functional impairment of participants. Side effects, vital signs, and laboratory measures will be monitored throughout the study.

Official Title
-----------------
KAVA KAVA in Generalized Anxiety: A Double-Blind Trial

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: Venlafaxine ER
* Drug: Sugar pill
* Drug: Kava


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of generalized anxiety disorder (GAD)
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active antidepressant drug comparator<br>Venlafaxine ER | Drug: Venlafaxine ER<br>* 75 to 225 mg daily<br>* Other names: Effexor XR;Drug: Sugar pill<br>* Upto 3 per day for venlafainxe and 4 per day for kava placebos.<br>* Other names: No brand name;|
| Placebo Comparator: Sugar pill<br>Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine | Drug: Sugar pill<br>* Upto 3 per day for venlafainxe and 4 per day for kava placebos.<br>* Other names: No brand name;|
| Experimental: Herbal treatment kava<br>Kava | Drug: Sugar pill<br>* Upto 3 per day for venlafainxe and 4 per day for kava placebos.<br>* Other names: No brand name;Drug: Kava<br>* 140 to 280 mg per day<br>* Other names: No brand name;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Scale |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kava, Complementary Therapies, Medicine, Herbal
Endometrial and Myometrial Changes, With and Without Fibroids

Study Overview
=================
Brief Summary
-----------------
fibroids are common among women in fertile age. the relation between fibroids and infertility is controversial. our goal is to claculate a ratio between uterine cavity - endometrium & myometrium in normal uterine s and study the interference of the cavity in uterine s with fibroids.

Detailed Description
-----------------
phase 1- retrospective measurments of uterine dimensions of 100 women with normal uterin measurment of the above during different sycle days in the same woman. 30 women. phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3- the same for 400 uterine malformations

Official Title
-----------------
Endometrial and Myometrial Changes, With and Without Fibroids

Conditions
-----------------
Fibroids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women at IVF unit Exclusion Criteria: inabilty to measure propperly the uterine dimensions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio between normal & abnormal(by fibroid) uterine cavity |  | year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio between endometriom & myometrium area, circumference &n volume |  | year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrium, myometrium, fibroids, uterine malformations
Genomic Evolution of Metastasis in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to track tumor evolution of regional and distant metastases in gastric cancer using the Next Generation Sequencing technologies.

Detailed Description
-----------------
Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Metastasis is the leading cause of death in gastric cancer patients, with median overall survival of less than 1 year. Currently, there is no effective treatment because the molecular mechanism of metastasis remains unclear. The aim of this study is to use advanced NGS technologies to dissect the genomic changes (genetic, epigenetic and transcriptional changes) of the primary tumor and associated metastatic sites of the same patients. With that, the investigators can reconstruct the clonal evolution from primary tumor to metastasis, identify key pathways governing metastasis development that can be targeted for future therapeutic development.

Official Title
-----------------
Genomic Evolution of Metastasis in Gastric Cancer

Conditions
-----------------
Gastric Cancer, Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients aged 18 years and older Histologically proven primary gastric adenocarcinoma and clinical evidence of metastasis (N1-3M1) Biopsies can be taken at multiple sites No known other concomitant cancer diagnosis Signed informed consent Exclusion Criteria: Gastric adnocarcinoma cannot be confirmed primary Unable to undergo biopsy or surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Genetic and epigenetic changes of the tumor | Ultra-deep NGS of the primary tumor and associated metastatic sites from the same patients to identify mechanism governing metastasis development | 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, Metastasis