linjc16/ctgov huggingface dataset:
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.

Official Title
-----------------
A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ITCA 650
* Other: ITCA placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBA1c > 6.5% History of coronary, cerebrovascular or peripheral artery disease Exclusion Criteria: history of pancreatitis

Ages Eligible for Study
-----------------
Minimum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITCA 650 60 mcg/day<br>ITCA 650 is exenatide in DUROS | Drug: ITCA 650<br>* ITCA 650<br>|
| Other: ITCA placebo<br> | Other: ITCA placebo<br>* ITCA placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina), |  | 2 years |
Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to improve our knowledge on the stability and temporal dynamics of the Flemish female microbiome (vagina, skin and saliva) in relation to different lifestyle factors and environmental conditions and to establish certain individual and social risk factors that can influence the healthy microbiome. Therefore, microbial DNA from swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the microbial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics).

Official Title
-----------------
Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort

Conditions
-----------------
Vaginal Microbiome, Skin Microbiome, Saliva Microbiome

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Healthy individuals<br> | Other: no intervention<br>* self-sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSeq | After metagenomic shotgun and amplicon sequencing with the Illumina MiSeq, bio-informatic tools will be used to analyse taxonomic and functional data. The investigators will specifically screen for health-promoting and pathogenic taxa that can be associated with specific environmental conditions and lifestyle factors. Additionally, the investigators will pay attention to the dominant members of the vaginal bacterial community (i.e. beneficial microbes such as lactic acid bacteria). | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metagenomic sequencing, vaginal microbiome, skin microbiome, saliva microbiome, large-scale self-sampling cohort, Microbiota, Probiotics
A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity.

Official Title
-----------------
A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity

Conditions
-----------------
Retinopathy of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates being screened for retinopathy of prematurity Exclusion Criteria: medically unstable neonates
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 |
| --- | --- | --- |
| axial length | axial length as measured by a scan ulstrasonography | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior corneal curvature | anterior corneal curvature as measured by keratometer | one year | 
| wide angle fundus photography | wide angle fundus photography by RetCam camera | one year |
Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D (cholecalciferol)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Forced expiratory volume in one second (FEV1) < or = 50% of predicted Smoking history of at least 10 pack-years Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker) Exclusion Criteria: Currently taking > 500 I.U. per day of vitamin D supplements Primary diagnosis of asthma Uncompensated heart failure Heart attack in the previous 6 months Kidney disease (glomerular filtration rate < 45 mL/min/1.73m2)

Ages Eligible for Study
-----------------
Minimum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Cholecalciferol (2000 I.U. daily) | Dietary Supplement: Vitamin D (cholecalciferol)<br>* 2000 I.U. daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo capsule (sugar pill daily) | Dietary Supplement: Placebo<br>* Placebo (sugar pill) daily for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery (SPPB) Score | SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Level of Vitamin D (25-hydroxyvitamin D) |  | Baseline and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic obstructive pulmonary disease, Vitamin D, Cholecalciferol, Skeletal muscle
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

Study Overview
=================
Brief Summary
-----------------
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of D013, D326 and D337 Combination Therapy in Dyslipidemia Patients With Hypertension

Conditions
-----------------
Dyslipidemia Patients With Hypertension

Intervention / Treatment
-----------------
* Drug: D013, D326, D337
* Drug: placebo of D013, D326, D337
* Drug: D013, placebo of D326, placebo of D337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis. Subjects who agreed to participate in this clinical trial voluntarily. Exclusion Criteria: Subjects who were satisfied specific blood pressure levels that measured at screening period. Subjects who were satisfied specific lipid levels that measured at screening period. Subjects who cannot participate in a clinical trial based on the PI's judgment.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Experimental Group 1<br> | Drug: D013, D326, D337<br>* Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337<br>* Other names: Drugs are consist of antihypertensive agent and antihyperlipidemic agent;|
| Placebo Comparator: Comparator Group 1<br> | Drug: placebo of D013, D326, D337<br>* Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013<br>* Other names: Drugs are consist of antihypertensive agent and antihyperlipidemic agent;|
| Placebo Comparator: Comparator Group 2<br> | Drug: D013, placebo of D326, placebo of D337<br>* Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337<br>* Other names: Drugs are consist of antihypertensive agent and antihyperlipidemic agent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate from baseline in LDL-C | Compare experimental group 1 with comparator group 1 | 8 weeks after drug administrations | 
| Change from baseline in MSSBP | Compare experimental group 1 with comparator group 2 | 8 weeks after drug administrations |
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Study Overview
=================
Brief Summary
-----------------
This is a clinical study comparing the physiologic effects of two hypertonic solutions (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in patients with intracranial hypertension following serious traumatic brain injury (TBI).

Detailed Description
-----------------
This is a study comparing effects of two hypertonic solutions (mannitol, 6.4% hypertonic saline) on intracranial hypertension, cerebral blood flow, serum/urine osmolarity in patients with increased intracranial pressure caused by traumatic brain injury. The study is conducted during first 72 hours after the injury without any interference with standard medical treatment as performed at the institution. When the hypertonic solution is indicated by caregiver, the study team is informed and performs a set of physiologic bedside measurements including evaluation of cerebral blood flow and changes in plasma and urine osmolarity. The study is noninvasive and the study protocol does not hamper, in any way, standard care of treatment for these patients.

Official Title
-----------------
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Conditions
-----------------
Traumatic Brain Injury, Intracranial Hypertension

Intervention / Treatment
-----------------
* Drug: Mannitol
* Drug: Hypertonic Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe TBI (motor Glasgow Coma Scale [GCS] score < 5) Age > 18 years Health care provider indicated a treatment of intracranial hypertension using hyperosmotic agent Exclusion Criteria: Brain dead (GCS 3, fixed dilated pupils) Life-threatening systemic injuries (AIS > 4 in an organ system other than brain); AIS = Abbreviated Injury Score Hypotension not responsive to fluid resuscitation and low doses of dopamine Clinical or imaging sign/suspicion for internal carotid artery injury

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mannitol|nan|
|Drug: Hypertonic Saline|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
-----------------
Hypertonic Saline, Mannitol, Intracranial hypertension, Cerebral blood flow, Traumatic brain injury
Combined Buprenorphine and Behavioral Treatment With and Without Contingent Reinforcement on Opioid and Cocaine Abstinence. - 22

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test combined buprenorphine and behavioral treatment with and without contingent reinforcement on opioid and cocaine abstinence.

Official Title
-----------------
Combined Buprenorphine and Behavioral Treatment Without Contingent Reinforcement

Conditions
-----------------
Cocaine-Related Disorders, Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 47 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Weeks abstinent |  |  | 
| Weeks continuous abstinence |  |  | 
| Overall treatment outcome |  |  | 
| Opioid dependence and psychiatric status |  |  |
A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of gaboxadol in primary insomnia

Detailed Description
-----------------
To evaluate long-term safety of gaboxadol in healthy adults.

Official Title
-----------------
A Prospective Open-Label Extension Study (to Study 99784) of Gaboxadol in Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: Gaboxadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a diagnosis of primary insomnia

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gaboxadol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary insomnia
Feasibility of Ambulatory Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Hysterectomy is one of the most performed surgery in women. Public authorities wish that one-day surgery become a majority and hysterectomy could be part of it in the future. The aim of this study is to determine the feasibility of ambulatory hysterectomy. Patients and methods: Investigators will realize an observational descriptive survey based on questionnaires in two surgical gynecology units. Women under 70 years old, who undergo hysterectomy will be included.

Official Title
-----------------
Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH

Conditions
-----------------
Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus

Intervention / Treatment
-----------------
* Procedure: hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women, undergo surgery for hysterectomy by laparoscopy or vaginal procedure Exclusion Criteria: comorbidities included: heart disease, anti-coagulant treatment, anti-aggregant treatment; sleep apnea syndrome, laparotomy laparoconversion if hysterectomy associated with appendectomy and/or, omentectomy and/or, lymph nodes dissection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hysterectomy|laparoscopic hysterectomy and vaginal hysterectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PADSS score |  | Day 0 post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | questionnaire | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
one-day surgery, hysterectomy, ambulatory
The Relationship of Rehabilitation Therapy Time To The Prevention of Burn Scar Contracture

Study Overview
=================
Brief Summary
-----------------
This project will develop a descriptive database of patient information and patient outcomes. This database will be used to determine the association of time spent in rehabilitation and patient outcomes, to relate patient acuity to burn scar contracture development and to establish minimal time requirement guidelines for various rehabilitation patient outcomes.

Official Title
-----------------
Burn Patient Acuity Demographics, Scar Contractures and Rehabilitation Treatment Time Related to Patient Outcomes (ACT)

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: Routine post burn rehabilitation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 year of age or older Admission for primary diagnosis of cutaneous burn injury Anticipated length of stay equal to/greater than five days >2% deep partial thickness burn OR hand burn (which may be less than 2% deep partial thickness burn) Exclusion Criteria: Non-survivable burn as determined by the attending burn surgeon Electrical burn injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Post-Burn Rehabilitation<br>Patients with an acute burn injury who are admitted to the hospital with anticipated length of stay of 5 days or greater | Other: Routine post burn rehabilitation therapy<br>* No testing outside of routine clinical rehabilitation will be performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure patient outcome in terms of time devoted to rehabilitation | Standard information that is recorded as part of daily routine in the rehabilitation treatment of patients with burn injury will be used as data to analyze patient outcomes | At discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Rehabilitation