linjc16/ctgov huggingface dataset:
Study of Lithium Carbonate to Treat Niemann-Pick Type C1 Disease

Study Overview
=================
Brief Summary
-----------------
This study is planned to study whether lithium carbonate has protective effect on the brain of Niemann-Pick disease type C1.

Official Title
-----------------
a Single-center, Prospective, Open, and Non-randomized Case-control Study of Lithium Carbonate Effect on Niemann Disease C1 Type

Conditions
-----------------
Niemann-Pick Disease, Type C1

Intervention / Treatment
-----------------
* Drug: Lithium Carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged from 7 years to 40 years onset of neurological symptoms prior to 15 years of age confirmed diagnosis of NPC1 determined by either two NPC1 mutations or one NPC1 mutation with elevated plasma 7-ketocholesterol ability to walk either independently or with assistance Subject or parent/guardian able to communicate with investigator, understand and abide the rules of this clinical trial. parent/guardian able to accompany the subjects to participate in the clinical trial Subject or parent/guardian must provide written informed consent Exclusion Criteria: One NPC clinical severity scale score reached 5 Female in pregnancy or breastfeeding The predicted life span less than 1 year Severe liver insufficiency (defined as hepatic laboratory parameters, AST and/or ALT greater than three-times the upper limit of normal Renal insufficiency, with the serum creatine greater than 1.5 times the upper limit of normal Free with neurological symptoms Take antidiuretic hormone

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 40 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br> | Drug: Lithium Carbonate<br>* To observe whether lithium carbonate has protective role on the brain of Niemann-Pick disease C1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPC clinical severity score |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-ketocholesterol |  | 52 weeks |
Evaluation of the Coagulation Profile by Thromboelastography in Bariatric Patients

Study Overview
=================
Brief Summary
-----------------
thromboelastography can identify alteration in the coagulation profile in bariatric patients who undergo sleeve gastrectomy or gastric bypass

Conditions
-----------------
Bariatric Patients Undergoing Bariatric Surgery

Intervention / Treatment
-----------------
* Other: blood test by thromboelastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing bariatric surgery Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEG group<br> | Other: blood test by thromboelastography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation profile by thromboelastography |  | 1 year |
Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
A six week, fixed dose, double-blind, double-dummy, placebo, and active controlled, multicentre trial to evaluate the safety and efficacy of CP-316,311 in outpatients with major depressive disorder.

Detailed Description
-----------------
This study was terminated on March 17th, 2006. The results of the primary analysis at the interim showed that the CP-316,311 group was not significantly different than the placebo on the primary endpoint and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.

Official Title
-----------------
A Six-Week, Fixed Dose, Double-Blind, Double-Dummy, Placebo and Sertraline Controlled, Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Outpatients With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: CP-316,311
* Drug: Placebo
* Drug: Sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients with DSM-IV major depressive disorder Exclusion Criteria: Women of child bearing potential

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: CP-316,311|nan|
|Drug: Placebo|nan|
|Drug: Sertraline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HAM-D (17) at the week 6 visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, Recurrent
Better Hips- Better Function

Study Overview
=================
Brief Summary
-----------------
The focus of this project are elderly people who have experienced hip fracture and need at least two weeks rehabilitation after discharge from hospital. The aim is to increase the evidence-based knowledge base for planning and appropriate follow-up intervention for patients with hip fracture on short-term / rehabilitation stays. In this study the investigators want to explore whether training High Intensity Functional Exercises (HIFE) , of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a significant positive effect on physical function, pain and quality of life. The main aim is to explore whether a high intensive strength and balance training program has better effect than a low intensive strength and balance training program on functional status measured by Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to explore whether this high intensive strength and balance training program has better effect than a 'low intensive strength and balance training program' on pain, endurance and quality of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36. The study is a randomized controlled trial.

Official Title
-----------------
The Effect of Exercise in Elderly Hip Fracture Patients: a Clinical Randomised Trial

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Other: High intensity functional exercise
* Other: Low intensity functional exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fractura colli femoris, pertrochantar or subtrochantar) Discharged from hospital within 3 weeks since surgery. Need of minimum two weeks rehabilitation Life expectancy of more than one month Able to walk at least 3 m with walking aid Willingness to participate Able to follow instructions 65 years or older Exclusion Criteria: -Other reasons for gait impairment than hip fracture

Ages Eligible for Study
-----------------
Minimum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose exercise intervention<br> | Other: Low intensity functional exercise<br> <br> |
| Experimental: High dose exercise intervention<br> | Other: High intensity functional exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Short Physical Performance Battery |  | November 2015 -October 2018 (up to 3 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiotherapy, hip fracture, rehabilitation, high dose exercise, low dose exercise
Evaluation of Transperineal US in Labour

Study Overview
=================
Brief Summary
-----------------
Assessment of progress of labour is an important step in decision making of obstetricians

Detailed Description
-----------------
delayed progress of labour resemble an annoying problem to obstetrician so noninvasive diagnostic methods can play an important role in implementing a guidelines to follow patients in labour as transperineal US .

Official Title
-----------------
The Importance of Transperineal US in Labour

Conditions
-----------------
Labor Long

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women in labour Full term Exclusion Criteria: pregnant ladies not in labour Preterm labour

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ultrasound|Transperineal us are made to pregnant ladies in labour|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of participants who will deliver by normal delivery |  | within 24 hours |
Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

Detailed Description
-----------------
A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.

Official Title
-----------------
The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Conditions
-----------------
Diabetes Mellitus Type 2, Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Intravitreal Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Macular edema involving the center of the macula demonstrated on OCT Clear ocular media Untreated patients Older than 45 years BCVA of the fellow eye at least 20/100 Exclusion Criteria: Renal diabetic disease, uncontrolled hypertension or stroke history Other ocular disease Ocular surgery excepting uncomplicated phacoemulsification History of photocoagulation (panretinal or focal) History of another intravitreal treatment (like triamcinolone)

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

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

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 |
| --- |
|Drug: Intravitreal Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA |  |  | 
| Fluorescein Angiography |  |  | 
| Optical Coherence Tomography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diffuse Diabetic Macular Edema, Intravitreal Bevacizumab, Anti-VEGF drugs
Development of a Video-based Intervention for Suicide Prevention

Study Overview
=================
Brief Summary
-----------------
The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.

Official Title
-----------------
Development of an Adjunctive Video-Based Suicide Prevention Intervention Immediately Following Psychiatric Hospitalization: Open Trial

Conditions
-----------------
Suicide, Psychiatric Hospitalization

Intervention / Treatment
-----------------
* Behavioral: LifePlans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current psychiatric hospitalization for suicidal thoughts and behaviors 18 years or older ability to speak and read English plan to continue outpatient treatment access to means for viewing videos (computer, tablet, smartphone) Exclusion Criteria: current psychotic symptoms

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LifePlans<br>LifePlans is a video series using real patients telling their stories of overcoming suicidal thoughts and behaviors to help others who are struggling with these issues. | Behavioral: LifePlans<br>* LifePlans is a video-based intervention, in which patients watch episodes starting during a psychiatric hospitalization and continuing through 1 month post-discharge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire (CSQ) | The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Columbia Suicide Severity Rating Scale (C-SSRS) | The Columbia Suicide Severity Rating Scale is an interviewer-rated measure of suicidal thoughts and behaviors. The total score (sum of items) will be used and ranges from 2 to 25 with higher scores indicating higher suicidal thoughts and behaviors. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
video intervention, treatment development, open trial
Interstitial Lung Diseases Cohort Study in China

Study Overview
=================
Brief Summary
-----------------
In this project, the clinical diagnosis of interstitial lung diseases was carried out for the population with suspected interstitial lung diseases selected from the community cohort, and the confirmed patients were included into the existing clinical cohort of interstitial lung diseases, forming an interstitial lung diseases special disease cohort consisting of 3,000 patients and corresponding matched control groups. According to characteristics of interstitial lung disease and the needs of National Key R&D Program of China, this study will formulate unified clinical follow-up strategy to do long-term standardized clinical follow-up in patients with interstitial lung disease. The detailed information for clinical diagnosis and treatment as well as biological samples were collected to identify disease phenotype and build the database and biological sample library for interstitial lung disease cohort study. This study aims to provide evidence for molecular classification, screening and validation of biomarkers as well as precise diagnosis and prevention in patients with interstitial lung disease.

Official Title
-----------------
Interstitial Lung Diseases Cohort Study in China

Conditions
-----------------
Interstitial Lung Diseases

Intervention / Treatment
-----------------
* Other: disease history


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011 Agree to sign the informed consent Exclusion Criteria: Lung transplantation expected within the next 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: disease history|Clinical progression and prognosis of patients with interstitial lung diseases|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Database and biological sample library for Chinese patients with interstitial lung disease | Data analyses will be mainly descriptive. | up to 4 years |
A Pilot Study to Explore the Role of Gut Flora in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Multiple Sclerosis.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Multiple Sclerosis.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Multiple Sclerosis

Conditions
-----------------
MS, Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients of any age (interest is given to children to compare with mothers). Diagnosis of Multiple Sclerosis. Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with diagnosis of Multiple Sclerosis. | Other: No Intervention<br>* There is no intervention for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year |