linjc16/ctgov huggingface dataset:
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Study Overview
=================
Brief Summary
-----------------
This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.

Detailed Description
-----------------
The optimal approach to the treatment of PPHN remains controversial. In 1978, hyperventilation was advocated for the treatment of PPHN. Newer therapies such as alkali infusion have been introduced without the support of randomized trial. In addition, in 1993, large controlled trials of inhaled nitric oxide were in the planning stages. There is a lack of knowledge about how these diverse management styles impact patient outcome. Given the large number of treatments used in neonates with PPHN, we wished to document treatment of PPHN and outcomes of those treatments. Therefore, we performed a prospective, observational study to document prevalence of PPHN, the treatments and outcomes in a large population of infants treated at the 12 centers of the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Further, we sought to compare treatment with hyperventilation to treatment with alkali infusion.

Official Title
-----------------
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Conditions
-----------------
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Persistent Fetal Circulation Syndrome, Persistent Pulmonary Hypertension of Newborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 34 weeks gestational age On mechanical ventilation and/or fraction of inspired oxygen >0.50; and Had documented pulmonary artery hypertension as defined by either two-dimensional echocardiographic evidence of elevated pulmonary pressure (judged by right to left or bidirectional shunt), or a preductal to postductal oxygen gradient >20 mm Hg Exclusion Criteria: >7 days of age

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| Death |  | 120 days of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Persistent Pulmonary Hypertension of Newborn (PPHN)
Lokomat Treadmill Training Effects on MS Gait

Study Overview
=================
Brief Summary
-----------------
This study is being done to test the possible benefits of gait-specific training using body-weight supported, Lokomat assisted, treadmill training in people with Multiple Sclerosis.

Official Title
-----------------
Lokomat Treadmill Training Effects on MS Gait

Conditions
-----------------
Gait, Unsteady, Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Body-weight supported treadmill training +/- Lokomat assistance
* Other: Usual Care - no active intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Clinical diagnosis of MS EDSS level between 3.5-6.0 Problems with ambulation able to ambulate 25 feet without an assistive device Main Exclusion Criteria: Lower extremity injuries that limit range of motion or function Unable to demonstrate an understanding of the process of the study and or fully understand instructions in order to safely participate in the study and use study equipment Body weight over 150 kg complete inclusion/exclusion criteria listed in consent form

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 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 |
| --- | --- |
| Placebo Comparator: Control group<br>The placebo group did not receive treatment during the matched period yet did undergo all assessments. The MS Placebo group received equal treatment following the study intervention period. | Other: Usual Care - no active intervention<br>* No treatment used for comparison<br>* Other names: control group;|
| Experimental: Combination Treadmill training group<br>Subjects randomized to Combination therapy received 20 minutes of Lokomat assisted treadmill training followed by up to 20 minutes of BWS treadmill training (without robotic assistance) twice a week. | Other: Body-weight supported treadmill training +/- Lokomat assistance<br>* walking<br>* Other names: Lokomat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Parameters |  | Baseline, throughout study enrollment and 2 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, gait, falls, lokomat, body-weight support treadmill training
Evaluation of Effectiveness of Blue Code Team After In-hospital Cardiopulmonary Arrest

Study Overview
=================
Brief Summary
-----------------
This study aimed to retrospectively examine patients evaluated by the Code Blue team on a Code Blue call in our hospital between 2016-2017. Primary outcome: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2016-2017. Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.

Detailed Description
-----------------
This study aimed to retrospectively examine patients evaluated by the Code Blue team on a Code Blue call in our hospital between 20016 and 2017. Primary outcome: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2016-2017.Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients throughout the whole hospital for whom a Code Blue form was completed and who were evaluated by the Code Blue team on a Code Blue call.

Official Title
-----------------
Evaluation of Effectiveness of Blue Code Team After In-hospital Cardiopulmonary Arrest

Conditions
-----------------
In-hospital Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: -Patients intervened by code blue team Exclusion criteria: Cardiac arrest in the anesthesiology and reanimation intensive care unit Cardiac arrest in the newborn intensive care unit Out-of-hospital cardiac arrest

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 |
| --- | --- | --- |
| Blue code notification form | Survival rate of patients intervened by blue code team after in-hospital cardiac arrest | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In-hospital Cardiac Arrest, mortality
A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open-label, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction Between Glyburide and GK Activator(2) in Type 2 Diabetes Patients Inadequately Controlled With Glyburide as Standard Prescribed Therapy.

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

Intervention / Treatment
-----------------
* Drug: GK Activator (2)
* Drug: Glyburide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, aged 18-75 years; type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for >=3 months; untreated, or taken off anti-diabetic or statin therapy >=2 weeks before study start. Exclusion Criteria: type 1 diabetes mellitus, or latent autoimmune diabetes in adults; diabetic neuropathy, retinopathy or nephropathy; patients treated with insulin or PPAR gamma agonist with 6 weeks of screening.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GK Activator (2)<br>* 100mg po bid<br>Drug: Glyburide<br>* 10-20mg po daily<br>|
| Experimental: 2<br> | Drug: GK Activator (2)<br>* 100mg po bid<br>|
| Experimental: 3<br> | Drug: Glyburide<br>* 10-20mg po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-6h of plasma glucose |  | Days -1, 6 and 12 | 
| AUC0-12h of GK Activator (2) and metabolite. |  | Days 6 and 12 | 
| AUC0-tau of glyburide |  | Days -1 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters. |  | Throughout study |
A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.

Official Title
-----------------
An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431

Conditions
-----------------
Liver Insufficiency

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: If female, non pregnant, BMI less than 40 kg/m2 Patient has chronic, stable hepatic insufficiency Exclusion Criteria: Patient unwilling to refrain from alcohol and grapefruit juice prior to and shortly after study drug administration Patient has diabetes, had a heart attack or stroke, or uncontrolled congestive heart failure during the past 6 months Patient has a history of drug or alcohol abuse Patient smokes > 10 cigarettes per day Patient consumes more that 6 cups of caffeinated beverages per day Patient has had surgery, donated blood or participated in another clinical trial within the past 4 weeks

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sitagliptin phosphate|sitagliptin phosphate 100 mg MK0431 (2 x 50 mg tablets) taken orally after overnight fast; Duration of Treatment: 5 Weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the plasma and urine pharmacokinetic parameters of MK0431 |  | measured at predose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 18, 24, 32, 48, 72 and 96 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs |  | throughout study and at 12 weeks |
MODULA Modul 5 BEAT-HF

Study Overview
=================
Brief Summary
-----------------
Detektion and Registration of Atrial Tachyarrhythmias at Patients with Heart Failure; What proportion of patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia?

Detailed Description
-----------------
How many patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia in terms of rate, characteristics and severity of atrial rhythm disturbances at patients with CRT-therapy within 12 months after implantation of a CRT-device.

Official Title
-----------------
MODULA-Study: Modul 5 / BEAT HF: Detektion and Registration of Atrial Tachyarrhythmias at Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: ICD with CRT therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient under CRT-D or CRT-P therapy Exclusion Criteria: patients with permanent Atrial Fibrillation

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

| Intervention/Treatment |
| --- |
|Device: ICD with CRT therapy|permanently CRT pacing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of atrial tachycardia in CRT patients |  | 12 months |
External Device for Erectile Dysfunction (3D-Erect)

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).

Detailed Description
-----------------
A clinical trial to test the safety and feasibility of our newly developed non-invasive 3D-printed external penile device for the treatment and recovery of erectile dysfunction.

Official Title
-----------------
Non-invasive External Device for Erectile Dysfunction (3D-Erect): a Pilot Study

Conditions
-----------------
Erectile Dysfunction, Impotentia Erigendi

Intervention / Treatment
-----------------
* Device: 3D-Erect


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males >18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.) having a female partner willing to participate in the study. Exclusion Criteria: not willing to attempt sexual vaginal intercourse with their partner inability to wear/operate the external penile device for any reason

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-Erect arm<br>Participants will be asked to use the 3D-printed penile device during their intercourse with partners. | Device: 3D-Erect<br>* 3D-printed erectile device for intercourse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in modified International Index of Erectile Dysfunction score | score 0 to 30 with higher score meaning overall better erectile function | baseline and up to 1 month post-baseline |
TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Study Overview
=================
Brief Summary
-----------------
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.

Official Title
-----------------
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Drug: TMTP1
* Drug: ICG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspicious of cervical disease required a colposcopy-directed biopsy. Subjects must sign an informed consent indicating awareness of the investigational nature of this study. Exclusion Criteria: Breast-feeding or pregnant. Ongoing participation in another clinical trial with an investigational drug with 3 months. Own allergy towards ICG and/or alcohol. Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases. Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMTP1<br>The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. | Drug: TMTP1<br>* Fluorescent sites will be removed<br>|
| Active Comparator: ICG<br>The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. | Drug: ICG<br>* Fluorescent sites will be removed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG | 7 days | 
| Incidence of adverse events |  | 7 days |
Liraglutide and Cardio-Metabolic Risk Markers

Study Overview
=================
Brief Summary
-----------------
Incretin-based therapies have shown significant effects beyond those on glucose metabolism. We aim in the present study to evaluate the effects of liraglutide on several cardio-metabolic risk markers.

Detailed Description
-----------------
In details, we will evaluate the effects of liraglutide on carotid-intima media thickness, oxidative stress, ghrelin, heat shock proteins and lipoproteins.

Official Title
-----------------
Effects of Liraglutide on Cardio-Metabolic Risk Markers

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients with a diagnosis of type-2 diabetes Exclusion Criteria: - severe hepatic or renal diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Liraglutide<br>administration of liraglutide at 1.2 mg/daily | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intima-media thickness | carotid intima-media thickness will be assessed by doppler ultrasonography | every four months for a total period of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in oxidative stress markers | Serum LOOH levels were evaluated following the oxidation of Fe2+ to Fe3+ in the presence of xylenol orange at 560 nm. Levels of GSH were measured in serum using a spectrophotometric assay based on the reaction of thiol groups with 2,2-dithio-bis-nitrobenzoic acid, while the production of ROS was assessed using fluorescent probe dihydroethidium staining (Sigma). | after 2 months of therapy | 
| changes in plasma ghrelin concentrations and heat-shock proteins | plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA | after 2 months of therapy | 
| changes in atherogenic lipoproteins | the full LDL subclass profile (from larger and less atherogenic LDL-1 and LDL-2, to smaller denser LDL-3 to LDL-7) was assessed by gel electrophoresis (Lipoprint, Quantimetrix, USA) | after 2 and after 4 months of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, cardiovascular risk