linjc16/ctgov huggingface dataset:
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
In this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to TAU.

Official Title
-----------------
A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression

Conditions
-----------------
Treatment Resistant Depression, Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Simvastatin 20 mg
* Other: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-5 current major depressive episode Must currently be on an antidepressant and must have had a non-response to >2 oral antidepressant treatments in the current episode (including the one they are currently taking). Capacity to give informed consent Willing to use adequate contraception Give written informed consent Exclusion Criteria: Primary psychotic or bipolar disorder History of intolerance to statins or presence of any contraindication to statins Presence of any serious medical condition or neurological problem Presence of autoimmune or inflammatory disorder Alcohol or drug dependence Active suicidal ideation Pregnant or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Interventional Model Description: 1-Simvastatin plus TAU, 2- Placebo plus TAU
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin with TAU<br>Participants will receive Simvastatin 20 mg added to TAU for 3 months | Drug: Simvastatin 20 mg<br>* Simvastatin 20 mg added to TAU for 3 months.<br>* Other names: Statins;|
| Placebo Comparator: Placebo Oral Tablet with TAU<br>Participants will receive placebo added to TAU for 3 months | Other: Placebo Oral Tablet<br>* Matched placebo added to TAU for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979) | The MADRS will be used as primary outcome measure in estimating depression severity | Week-2, Week-4, Week-8 and Week-12 |
Microcurrent Therapy and Low-Level Laser Therapy on Wound Healing

Study Overview
=================
Brief Summary
-----------------
The study aiming to compare between the Microcurrent and Low-Level Laser Therapy on wound healing

Detailed Description
-----------------
The study designed to compare between the Microcurrent and Low-Level Laser Therapy on wound healing

Official Title
-----------------
Microcurrent Therapy Versus Low-Level Laser Therapy on Post-surgical Wound Healing

Conditions
-----------------
Wound Healing Delayed

Intervention / Treatment
-----------------
* Device: Microcurrent therapy
* Device: Low Level Laser Therapy
* Other: Medical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient recently undergo appendectomy Exclusion Criteria: patient with neurological disorders patient with metabolic disorders

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 Years

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

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: medical therapy group<br>formed of 20 patients to whom ordinary medical therapy as the pervious groups and placebo shame laser had been applied. | Other: Medical therapy<br>* Medical therapy<br>|
| Experimental: medical therapy and Microcurrent group<br>formed of 20 patients to whom the microcurrent therapy had been applied with ordinary medical therapy. | Device: Microcurrent therapy<br>* Microcurrent therapy<br>Other: Medical therapy<br>* Medical therapy<br>|
| Experimental: medical therapy and Low-Level Laser Therapy group<br>formed of 20 patients to whom the Low Level Laser Therapy had been applied with ordinary medical therapy. | Device: Low Level Laser Therapy<br>* Laser therapy<br>Other: Medical therapy<br>* Medical therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of matrix metalloproteinases | analyze by Enzyme-linked immunosorbent assay | assessed at day 3 post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of matrix metalloproteinases | analyze by Enzyme-linked immunosorbent assay | assessed at day 30 post operative | 
| the tissue inhibitors of metalloproteinases | analyze by Enzyme-linked immunosorbent assay | assessed at day 3 post operative | 
| the tissue inhibitors of metalloproteinases | analyze by Enzyme-linked immunosorbent assay | assessed at day 30 post operative |
The Relation Between Pregnancy,Birth Outcome, Feeding , Oral Hygiene Habits and Early Childhood Caries Development.

Study Overview
=================
Brief Summary
-----------------
200 children between ages 36 to 48 months will be invited for a regular dental examination Parameters to be investigated Pregnancy history Birth outcome Child's general health Feeding habits Oral hygiene habits Dmft caries index Congenital enamel defects

Detailed Description
-----------------
Severe Early Childhood Caries is a condition whereby very young children suffer multiple caries. The value of a pre- perinatal preventive approach is currently being examined in the dental literature. At Hadassah, a Pilot Study is currently underway to test the feasibility of a comprehensive Baby Clinic designed to prevent Severe Early Childhood Caries. The pilot study in cooperation with the Woman's Health Center and with the midwives and the breastfeeding counselors of the maternity unit. Lectures are given by pediatric dentists to parents of firstborn children attending Hadassah's Birth Preparation Class, emphasis is given to the importance of breastfeeding and other feeding habits in the emotional, physical, nutritional and immunological development of the future baby. In addition the effect of these feeding habits on the dental/oral aspects, relevant for the developing dentition. After birth the parents are invited to come with their babies around 12 months for the first dental examination and follow up according to individual risk for caries development. The current proposed study will be a control group from offspring of women who have participated previous Sessions Hadassah's Birth Preparation Class (Historical Controls before the Baby Clinic project)

Official Title
-----------------
Assessment of Pregnancy History, Birth Outcome, Feeding and Oral Practices With Development of Early Childhood Caries in Offspring of Women Who Have Not Participated in Previous Birth Preparation Class

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Behavioral: feeding habits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children born in previous Sessions Hadassah's Birth Preparation Class  before the Baby Clinic project) Exclusion Criteria: children not born in previous Sessions Hadassah's Birth Preparation Class  before the Baby Clinic project)

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 48 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: feeding habits|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
-----------------
primary dental prevention, early childhood caries, prenatal oral care
Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.

Official Title
-----------------
Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Procedure: Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years, established diagnosis of ulcerative colitis for at least 3 months moderate to severe active ulcerative colitis with a Mayo endoscopic sub-score ≥ 1 before vedolizumab introduction patients receiving vedolizumab according to French drug labelling (previous exposure to anti-TNF, contraindicated or intolerant to anti-TNF), possibility of concomitant therapy including corticosteroids and immunosuppressors, patients naive to anti-integrin, no contraindication to proctosigmoidoscopy Exclusion Criteria: age under 18 years ulcerative colitis not proven, Crohn's disease, or inderterminate colitis personal history of high-grade dysplasia or colorectal cancer surgery with ileo-anal anastomosis patients' refusal to participate in the study

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopy|The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1 |  | 54 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 |  | 14 weeks | 
| Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 |  | 30 weeks | 
| Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 |  | 54 weeks | 
| Endoscopic pattern of mucosal healing |  | 54 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulcerative colitis, endoscopic activity, mucosal healing, vedolizumab
Patient-Centered Alternative to Psychiatric Hospitalization for Veterans

Study Overview
=================
Brief Summary
-----------------
A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although veterans have been among those served at START programs for many years, no previous study of START or any other model has focused specifically on veterans.

Detailed Description
-----------------
Background: A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although veterans have been among those served at START programs for many years, no previous study of START or any other model has focused specifically on veterans. Objectives: The study tested the hypotheses that veterans treated in a START program would demonstrate greater improvement in symptoms and quality of life, as well as greater satisfaction with treatment and lower costs of care than veterans treated at the VA inpatient unit. Methods: This study includes elements of both efficacy and effectiveness studies. VA psychiatric unit treatment and START are compared in a randomized trial, with follow up of subjects at 2, 6, and 12 months as they experience real-world treatment-as-usual. Symptoms, functioning, quality of life, and satisfaction with services are assessed on multiple standardized measures, as well as by qualitative assessments. Status: Final report is under preparation.

Official Title
-----------------
Patient-Centered Alternative to Psychiatric Hospitalization for Veterans

Conditions
-----------------
Veterans, Acute Hospitalization

Intervention / Treatment
-----------------
* Behavioral: Strong Patient Focus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have to a veteran and in need of acute hospitalization, but able to take care of themselves. (Max Age is 59) Exclusion Criteria:

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Behavioral: Strong Patient Focus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dysregulated Urea-synthesis at Terminal Uremia

Study Overview
=================
Brief Summary
-----------------
This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named Functional Hepatic Nitrogen Clearance

Official Title
-----------------
Dysregulated Urea-synthesis at Terminal Uremia

Conditions
-----------------
Urea Cycle Disorder, Uremia

Intervention / Treatment
-----------------
* Other: Aminoacid, alanine-infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or equal to 18 years Chronic hemodialysis during 3 months Patients with functioning arteriovenous-fistula assigned to Center-Hemodialysis at Nyresygdomme, AUH Skejby Exclusion Criteria: Active infection Conditions with vomiting or diarrhea Diabetes Active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. Disease under observation can be included. Liver disease Vessels on the upper extremities not suited for cannulation Prednisolone treatment during the last 8 weeks Pregnancy BMI > or equal to 30 or < or equal to 18 Physically or mentally condition that does not allow the project to be completed Language-difficulties that does not allow the project to be completed

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alanine-infusion<br>Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis | Other: Aminoacid, alanine-infusion<br>* During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urea synthesis rate during alanine infusion | Change in the synthesis of urea during a 3 hour period of alanine-infusion in pre and post hemodialysis patients. We will use a validated method named functional hepatic nitrogen clearance (FHNC) to evaluate the synthesis of urea. FHNC is calculated using the linear relation between urea nitrogen synthesis rate and blood-amino acid which is measured every hour. An estimated group of 10 dialysis patients will be included and compared to a clinical healthy group. The healthy group has also received alanine infusion and blood samples of urea and amino-acids has likewise been measured for every hour of infusion. | 4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion |
Predictors of Hypofibrinogenemia in Severe Trauma

Study Overview
=================
Brief Summary
-----------------
In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)

Official Title
-----------------
Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma

Conditions
-----------------
Severe Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 severe trauma Exclusion Criteria: age <18

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 |
| --- | --- | --- |
| rate of fibrinogen in blood sample at hospitalisation | This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation | day 0 (at hospitalisation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypofibrinogenemia, prediction score, severe trauma
Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients

Study Overview
=================
Brief Summary
-----------------
The administration of agar jelly may increase the number of defecation and the volume of feces, and then may improve fecal condition in chronic constipated patients.

Detailed Description
-----------------
Each subject eats one cap of agar jelly shortly before having dinner every day for 4 weeks. At 0, 7th, 14th, 21th, and 28th day , the frequency of defecation and defecation condition is assessed.

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Dietary Supplement: Agar jelly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects take laxatives. Exclusion Criteria: subjects underwent abdominal surgery.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Agar jelly, constipation<br>Subjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks. | Dietary Supplement: Agar jelly<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the condition of feces | Bristol scale is used. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number and amount of defecation |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, agar
Autostereoscopic Dynamic Near Vision Testing

Study Overview
=================
Brief Summary
-----------------
This is an analysis of tests of near vision. Visual perception testing using a novel program on an interactive three dimensional electronic device: Autostereoscopic dynamic near games for monocular visual acuity, stereopsis and color are compared with other conventional or similar tests.

Detailed Description
-----------------
Subjects with normal vision, exceptional vision, or visual deficits have near vision tested on the PDI Check game and compared to other clinical tests. Interclass Correlation and Bland Altman analysis utilized for continuous data. Sensitivity and Specificity calculated for defined clinical entities. Subjects are not assigned to either one screening test or another; instead different tests are compared.

Official Title
-----------------
Autostereoscopic Dynamic Near Vision Testing of Acuity, Stereo and Color on PDI Check

Conditions
-----------------
Visual Suppression, Amblyopia, Color Vision Defects

Intervention / Treatment
-----------------
* Diagnostic Test: Visual Acuity
* Diagnostic Test: stereopsis
* Diagnostic Test: Color vision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal subjects, patients with deficient binocular vision, patients with color vision disorders Exclusion Criteria: phthisis, enucleations

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 95 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 |
| --- | --- |
| PDI Check & Conventional<br>Autostereoscopic, dynamic forced choice game (ie on Nintendo 3DS) and Rosenbaum or HOTV near card, Ishihara color plates, Innova Rabin color test, Titmus Stereo test | Diagnostic Test: Visual Acuity<br>* autostereoscopic, monocular dynamic force choice test<br>Diagnostic Test: stereopsis<br>* autostereoscopic dynamic forced-choice depth perception test<br>Diagnostic Test: Color vision<br>* autostereoscopic forced choice monocular or binocular color vision tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Gold Standard clinical test of visual acuity | day 1 | 
| stereopsis | Gold standard clinical test of stereopsis (ie Titmus) | day 1 | 
| Color Vision | Gold Standard clinical test of color vision (Ishihara, Innova Rabin) | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stereopsis, visual acuity