linjc16/ctgov huggingface dataset:
A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will be analyzed.

Official Title
-----------------
A 6 Month Observational Multicentric Prospective Study Observing the Use of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder, in the Course of a Major Depressive Episode

Conditions
-----------------
Bipolar Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients, diagnosed with Bipolar I or II Disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with a starting date of 6 months maximum before the inclusion. Current treatment with atypical antipsychotic(s) (AAP(s)) minimal 1 month and maximum 6 months prior to the first study visit Patient takes an AAP at an adequate therapeutic dose as indicated in the local Summary of Product Characteristics (SPC) and current medical practice Exclusion Criteria: Patients diagnosed with Bipolar I or II, experiencing a hypomanic, manic or mixed episode at time of inclusion Pregnant or breastfeeding women, or women of childbearing potential not using a medical reliable method of contraception as stated in the SPC of the AAPs

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Details of any AAP prescribed 1 to 6 months prior to the first study visit: |  | 4 visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression. |  | 4 visits | 
| Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania. |  | 4 visits | 
| Remission rate for the major depressive episode, in progress at inclusion |  | At completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antipsychotics, Bipolar Disorder, Depressive episodes, Bipolar I or II Disorders
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.

Official Title
-----------------
A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety

Conditions
-----------------
Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: Brexpiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 year of age Major Depressive Disorder (MDD) with symptoms of anxiety Stable treatment with less than 50% improvement Exclusion Criteria: Contraindicated to perform fMRI scan Previous exposure to brexpiprazole

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Brexpiprazole | Drug: Brexpiprazole<br>* Oral tablet; take once daily; target daily dose of 2 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fMRI resting-state salience network community structure from baseline to post-treatment |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment. | Utilizing Jaccardized Czekanowski index | Week 6 | 
| Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment. | Utilizing Jaccardized Czekanowski index | Week 6 | 
| Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment. | Utilizing Jaccardized Czekanowski index | Week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network, salience network, central executive network, functional brain connectivity
Carpal Tunnel Syndrome Release Using PSU Retractor

Study Overview
=================
Brief Summary
-----------------
The investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision. The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score and complications at 6 months.

Official Title
-----------------
Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: Limited incision using PSU retractor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months Exclusion Criteria: Underlying disease such as : DM, neuropathy Previous wrist or hand surgery in the same side Previous wrist and hand trauma Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control<br>carpal tunnel release using standard incision | Procedure: Limited incision using PSU retractor<br>* carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTS score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score |  | 1 year | 
| return to work time |  | 1 year | 
| satisfaction score |  | 1 year | 
| complication rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carpal tunnel syndrome, surgery, PSU retractor, carpal tunnel syndrome who failed to conservative treatment
Evaluation of Excessive UV Irradiation on Skin Aging by Multiphoton Laser Imaging and Biophysical Methods

Study Overview
=================
Brief Summary
-----------------
In this study, test persons with chronic excessive UV radiation and a control group are examined by multiphoton laser imaging and biophysical methods in order to evaluate the dermal fiber network. We expect to observe signs of advanced skin aging in the test group.

Conditions
-----------------
Skin Aging

Intervention / Treatment
-----------------
* Device: multiphoton laser imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non smokers contraception 12 subjects with chronic excessive UV irradiation 12 normal subjects Exclusion Criteria: dermatological and other severe disorders pregnancy and lactation dermatological topical therapy internal medication cosmetical intervention at test area

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: multiphoton laser imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Compare Epidural vs. Lumbar Plexus Analgesia After Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.

Detailed Description
-----------------
Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome: Time to first ambulation, assistance needed with ambulation, opiate and regional related side effects, time to discharge orders.

Official Title
-----------------
Compare Effectiveness of Epidural vs. Lumbar Plexus Blocks in Total Hip Arthroplasty (THA) Patients Using Multimodal Pain Control

Conditions
-----------------
Arthropathy of Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Diagnosis of: Primary THA, (identified by CPT code 27130) Either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449) Perioperative multimodal medication Hospitalized from July 1, 2012 to December 17, 2014. Exclusion Criteria: THA Revision ICU admission postoperatively History of dementia

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar plexus<br>Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management. | |
| Lumbar Epidural<br>Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate Consumption | Cumulative opiate consumption in intravenous (IV) morphine mg equivalents (MME) | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of First Ambulation | Time of first ambulation relative to anesthesia end time (hours) | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Postoperative, Nerve Block, Anesthesia, Epidural
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).

Official Title
-----------------
A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization

Conditions
-----------------
Vaccines, Pneumococcal Conjugate Vaccine

Intervention / Treatment
-----------------
* Biological: 13-valent Pneumococcal Conjugate Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults 65 years of age and older. Determined by medical history, physical examination, and clinical judgment to be eligible for the study. Expected to be available for the duration of the trial (up to approximately 13 months). Exclusion Criteria: Received previous immunization with 23vPS. Serious chronic disorders including metastatic malignancy Known or suspected hypersensitivity to any vaccine or vaccine components

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 13-valent Pneumococcal Conjugate Vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG). |  |  | 
| Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.

Official Title
-----------------
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study

Conditions
-----------------
Asherman Syndrome, Endometrial Polyp, Uterine Myoma

Intervention / Treatment
-----------------
* Drug: INTERCOAT administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 50 years Must be able to understand, read and sign consent form Exclusion Criteria: Signs of infection upon admission Ongoing pregnancy Carcinoma of the uterus or cervix Recurrent PID Women admitted for endometrial ablation Women that gave birth 6 weeks ago Women participating in another study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with INTERCOAT<br>injection of intercoat into the euterine cavity at the end of hysteroscopy | Drug: INTERCOAT administration<br>* Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery<br>* Other names: INTERCOAT;|
| No Intervention: without INTERCOAT<br>without INTERCOAT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy |  | one year |
36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.

Official Title
-----------------
36 Versus 42 Hour Time Interval From Ovulation Induction to Intrauterine Insemination in Stimulated Cycles With GnRH Antagonists

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Intrauterine Insemination 36 hours
* Procedure: Intrauterine Insemination 42 hours


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before. Patients who have no more than 4 follicles of 14 mm or more Patients who have no more than 6 follicles of 10 mm or more Exclusion Criteria: Patients who cannot give informed consent to language or comprehension barriers Patients who are deemed to be at high risk for high order multiple gestations Patients who cannot be monitored on the day of hCG administration or one day before

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 44 Years

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

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 |
| --- | --- |
| Active Comparator: 36 hours<br>Intrauterine insemination 36 hours after ovulation induction | Procedure: Intrauterine Insemination 36 hours<br>* Intrauterine insemination 36 hours after ovulation induction<br>|
| Active Comparator: 42 hours<br>Intrauterine insemination 42 hours after ovulation induction | Procedure: Intrauterine Insemination 42 hours<br>* Intrauterine insemination 42 hours after ovulation induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 4 weeks following insemination |
Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia

Study Overview
=================
Brief Summary
-----------------
Hair disorders, expecialy scarring alopecia were diagnosed by scalp biopsy specimens in horizontal and vertical sections.(1-4) Data on hair density in Thais are lacking, although in Asians have more fewer hairs than whites.(5-7)Howevery, previous study from East Asian just had only one study and the data was more differently from West Asian and whites. Then this study was performed to evaluate hair density in Thais, and compared to previous study.

Official Title
-----------------
Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia

Conditions
-----------------
Alopecia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thai Age >= 18 years Diagnosis alopecia and on list for hair transplantation in Siriraj hospital Exclusion Criteria: Alopecia areata or positive hair pulling test Underlying disease : DM, chronic renal failure, chronic liver disease

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 |
| --- | --- |
| Scalp biopsy<br>Subjects are on scadule list for hair transplantation in Siriraj hospital. Scalp biopsy with punch biopsy No.4 Scalp biopsy by punch biopsy No.4 at occipital area was done in subjects who have hair transplantaion. | |

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
-----------------
Scalp biopsy, Hair count, Vertical section, Horizontal section, Thais
A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the safety and efficacy of IC14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.

Official Title
-----------------
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis

Conditions
-----------------
Pneumonia, Sepsis

Intervention / Treatment
-----------------
* Drug: Recombinant Chimeric Monoclonal Antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current diagnosis of community-acquired pneumonia. Evidence of systemic inflammatory response to infection. Exclusion Criteria: Atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator. Presence of organ failure.

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: Recombinant Chimeric Monoclonal Antibody|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
-----------------
Safety and Efficacy, Community-Acquired Pneumonia, Sepsis