linjc16/ctgov huggingface dataset:
Peer Education Program for HIV/AIDS Related Sexual Behaviors of Secondary School Students

Study Overview
=================
Brief Summary
-----------------
Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years. Studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. Peer-based interventions have become a common method to effect important health-related behavior changes and address the HIV/AIDS pandemic. This study therefore aimed to evaluate the effectiveness of peer education in improving HIV knowledge, attitude, and preventive practices among in-school adolescents

Official Title
-----------------
Impact of Peer Education Program on HIV/AIDS Related Sexual Behaviors of Secondary School Students in Rural Communities, India: a Quasi-experimental Study.

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: Peer Education Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 14 years of age; non-injecting use of heroin, cocaine or crack cocaine in the last six months; test HIV antibody negative; agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests; willing to return for visits at 1, 6, and 9 months post-enrollment; willing and able to provide informed consent. Exclusion Criteria: history of injection drug use in the previous 3 years; pregnant;

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Education Group<br>Group was self compared after the intervention | Behavioral: Peer Education Program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge score of HIV |  | From baseline to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| willingness to HIV testing |  | From Baseline to 6 Months | 
| willingness to participate in HIV counseling services |  | From Baseline to 6 Months | 
| frequency of use of Condoms |  | From baseline to 6 month |
Safety of Insulin Detemir in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.

Official Title
-----------------
Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for at least one year Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin HbA1C below 11.0% Willing to comply with Investigator's instructions Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia Exclusion Criteria: Impaired renal function Impaired hepatic function Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator) Proliferative retinopathy or maculopathy requiring acute treatment Uncontrolled treated/untreated hypertension Current treatment with total daily insulin dose of more than 2.00 IU/kg Current treatment or expected at the screening to start treatment with systemic corticosteroids

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

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin NPH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoglycaemic episodes |  | during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Laboratory assessments and other safety endpoints |  |  | 
| HbA1C, self monitored blood glucose and within-subject variability of glucose |  |  | 
| Height |  |  | 
| Insulin doses |  |  |
Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus

Official Title
-----------------
A Phase 1, Multiple Ascending Dose Glucose Clamp Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470 in Comparison to Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes Mellitus

Conditions
-----------------
Type1 Diabetes Mellitus, Type2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Biological: HM12470


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1DM or T2DM Female subjects must be non-pregnant and non-lactating Exclusion Criteria: Pregnant or lactating women Participation in an investigational study within 30 days prior to dosing

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>T1DM: Multiple dose subcutaneous administration | Biological: HM12470<br>* HM12470 is a long-acting insulin analogue<br>|
| Experimental: Cohort 2<br>T1DM: Multiple dose subcutaneous administration | Biological: HM12470<br>* HM12470 is a long-acting insulin analogue<br>|
| Experimental: Cohort 3<br>T2DM: Multiple dose subcutaneous administration | Biological: HM12470<br>* HM12470 is a long-acting insulin analogue<br>|
| Experimental: Cohort 4<br>T2DM: Multiple dose subcutaneous administration | Biological: HM12470<br>* HM12470 is a long-acting insulin analogue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of HM12470 | - Maximum concentration of HM12470 over the entire dosing period | 1 month | 
| AUC of HM12470 | - Area Under the Curve of HM12470 over the entire dosing period | 1 month |
Safety Study of Stemchymal® in Acute Liver Failure

Study Overview
=================
Brief Summary
-----------------
To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.

Official Title
-----------------
The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial

Conditions
-----------------
Stem Cells, Adult Stem Cells, Acute Liver Failure, Acute-On-Chronic Liver Failure, Steminent

Intervention / Treatment
-----------------
* Biological: Stemchymal®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALF or ACLF patients. Subjects are between 20 and 70 years of age. MELD scores meet 17 ≤ MELD ≤ 26. Subjects who had completed signing informed consent. Exclusion Criteria: Subjects who had been enrolled in any other cell therapy within six months. Females with a positive pregnancy test result. Subjects have contraindication for liver transplantation. Subjects with psychiatric illnesses. Subjects who are diagnosed as active tuberculosis (TB). Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit. Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stemchymal®<br>Biological: Stemchymal® ALF/ ACLF patients will receive low (0.5 x 10^6 cells/kg) or high (2 x 10^6 cells/kg) dose of Stemchymal® through intravenous infusion | Biological: Stemchymal®<br>* ALF/ ACLF patients will receive Stemchymal® through intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR) |  | 12 months |
Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Acute Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
In this study gas-exchange and respiratory mechanics variations to PEEP change will be correlated to CT lung morphological modifications assessed at different airway pressures (5, 15, 30 and 45 cmH2O).

Official Title
-----------------
Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
ARDS: Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Radiation: Chest computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome Mechanical ventilation Exclusion Criteria: Clinical diagnosis of chronic obstructive pulmonary disease Clinical diagnosis of pneumothorax Haemodynamic instability

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 |
| --- | --- |
| ARDS<br>Sedated and mechanically ventilated patients admitted to ICU | Radiation: Chest computed tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computer Tomography (CT) scan lung recruitment and CT lung weight | Aim of the study is to determine the relationship between the opening pressures (recruitment) and closing pressures (PEEP) in order to prevent the opening and closing of the lung parenchyma | Study day (day 1) |
Bioavailability Study of SPARC001 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
Bioavailability study

Detailed Description
-----------------
Bioavailability, safety and tolerability

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: SPARC001A
* Drug: SPARC001B
* Drug: Reference001 - Hydrocodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, male and female volunteers, 18 to 55 years of age Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening Female subjects must have a negative serum pregnancy test Medically healthy on the basis of medical history and physical examination Exclusion Criteria: Females who are pregnant, lactating, or likely to become pregnant during the study Life-time history and/or recent evidence of alcohol History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations Subjects with any condition in which an opioid is contraindicated

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: SPARC001A<br> <br> |
| Experimental: Treatment B<br> | Drug: SPARC001B<br> <br> |
| Experimental: Treatment C<br> | Drug: Reference001 - Hydrocodone<br>* Hydrocodone-acetaminophen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma hydrocodone and acetaminophen concentration (Cmax) |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC extrapolated to infinity (AUC0 ∞) |  | 17 days | 
| Time to Cmax (tmax) |  | 17 days | 
| Elimination half-life (t½) |  | 17 days | 
| Treatment emergent adverse event |  | 17 days |
A Comprehensive Look at Vascular Access

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.

Official Title
-----------------
A Comprehensive Look at Vascular Access: Utilizing a Near Infrared Vein Visualization Device For Vascular Access Planning, Attempts, and Post Access

Conditions
-----------------
Vascular Access

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requires peripheral venous access Intact skin on areas of assessment Patient and/or parent or legal guardian is able to understand consent Exclusion Criteria: No Intact skin Patient is under anesthesia during peripheral venous access Patient is not a suitable candidate, as determined by the discretion of the investigator
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard<br>Standard IV Access without device | |
| VeinViewer<br>IV access with VeinViewer device | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be total number of attempts for successful cannulation. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time for successful venous access |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vein identification, vascular access
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).

Official Title
-----------------
AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors

Conditions
-----------------
Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm, Brain Cancer, Glioblastoma Multiforme, Recurrent Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Device: AutoLITT system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy Clinical/radiographic suspicion of tumor recurrence/progression Exclusion Criteria: Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).

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: Single Active Arm<br>Only Arm. Patients treated using AutoLITT System. | Device: AutoLITT system<br>* laser treatment with the AutoLITT system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits |  | 14 days post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser interstitial thermal therapy, laser therapy, thermal therapy, brain tumors, recurrent brain tumor, progressive brain tumor, glioblastoma multiforme tumor
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.

Detailed Description
-----------------
In this prospective cohort study, the participants (children with predominantly spastic CP, GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators evaluated level of spasticity using the modified Ashworth scale (MAS) and other related measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural ability scale (PPAS) were performed.

Official Title
-----------------
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5

Conditions
-----------------
Spastic Cerebral Palsy

Intervention / Treatment
-----------------
* Device: TENS incorporated into the Mollii suit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - cerebral palsy with spastic disease, GMFCS 3-5. Exclusion Criteria: other disorders affecting the sensorimotor functions without spasticity, implanted electric medical devices, BMI>35 other severe concomitant diseases such as cancer, cardiovascular, inflammatory, psychiatric disease, medical dysregulated epilepsy or hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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
Interventional Model Description: prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>24 weeks of TENS | Device: TENS incorporated into the Mollii suit<br>* trans cutaneous electric stimulation,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified ashworth scale | spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal Attainment Scale | smart goals from -2 (worst) to +2 (best) | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mollii suit;, Goal Attainment Scale;, Reciprocal inhibition;, modified ashworth scale,, trans cutaneous electric stimulation, TENS, Spasticity reduction,
Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Study Overview
=================
Brief Summary
-----------------
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

Detailed Description
-----------------
After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide <0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.

Official Title
-----------------
Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant). Exclusion Criteria: Inability to provide written informed consent. Mentally unstable and/or unable to comply with the procedures of the study protocol. History of any solid organ transplant.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the rate of allosensitization in patients after failed islet transplantation |  | 10 years |