linjc16/ctgov huggingface dataset:
A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France

Study Overview
=================
Brief Summary
-----------------
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.

Official Title
-----------------
A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France

Conditions
-----------------
Haemophilia B

Intervention / Treatment
-----------------
* Drug: Alprolix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of haemophilia B and been treated previously with factor IX Product Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix, regardless of participation in the study Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations Exclusion Criteria: Participation in an investigational medicinal product trial at enrolment visit
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prophylactic patients<br>Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment | Drug: Alprolix<br>* Extended half-life factor IX product<br>* Other names: Eftrenonacog alfa, rFIXFc;|
| On demand patients<br>Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment | Drug: Alprolix<br>* Extended half-life factor IX product<br>* Other names: Eftrenonacog alfa, rFIXFc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualised bleeding rate (ABR) (prophylactic treatment) | Assessed by diary | 24 months | 
| Annualised injection frequency (prophylactic treatment) | Assessed by diary | 24 months | 
| Annualised factor consumption (International Unit [IU]) (prophylactic treatment) | Assessed by diary | 24 months | 
| Amount of factor Product used to treat a bleed (on-demand treatment) | Assessed by diary | 24 months | 
| Number of injections to treat a bleed (on-demand treatment) | Assessed by diary | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Coagulation Disorder, Hematologic Diseases, Coagulation Protein Disorder, Hemorrhagic Disorder, Genetic Diseases, Inborn
Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

Study Overview
=================
Brief Summary
-----------------
The investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.

Official Title
-----------------
Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

Conditions
-----------------
Alcohol Abuse, Drug Abuse

Intervention / Treatment
-----------------
* Behavioral: Brief Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-18 years old Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at least one year Previous participation in the screening validation study Evidence of problems related to substance use Exclusion Criteria: Medically or emotionally unstable or otherwise unable to provide assent/consent Unable to speak/read English Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual<br>Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure. | |
| Experimental: Brief Intervention<br>Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use. | Behavioral: Brief Intervention<br>* Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days abstinent | We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline | 30 days post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical complications | We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline | 30 days post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol abuse, Drug abuse, Diabetes Mellitus, Persistent Asthma, Juvenile Arthritis, Ulcerative Colitis
Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

Study Overview
=================
Brief Summary
-----------------
Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.

Detailed Description
-----------------
This is an prospective observational study of patients that have been treated with plugs (type Amplazer) at least one of the pelvic varicose veins. Patients are recruited when the plug is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24 months

Official Title
-----------------
Multicentric Spanish Record of Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer - Pelvic Congestion Syndrome: Study of Efficacy and Safety

Conditions
-----------------
Pelvic Congestion Syndrome, Pelvic Varicose Veins, Follow-up Study, Embolization, Therapeutic, Observational Study

Intervention / Treatment
-----------------
* Device: pelvic varicose veins plug embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female < 18 years Present symptomatology At least one image diagnosis Exclusion Criteria: Female > 18 Non present symptomatology Non diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with pelvic congestion syndrome<br>Women older than 18 years At least 1 birth Present symptoms | Device: pelvic varicose veins plug embolization<br>* pelvic varicose veins plug embolization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embolization of pelvic varicose veins using AVP | 39/5000 absence of symptoms and vaginal ultrasound | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic Congestion Syndrome, amplatzer vascular plug, Vascular plug, metallic embolization device, Chronic pelvic pain, embolization procedure
Effects of Constructive Debriefing on Procedural Skills and Satisfaction of Nursing Students in Low Fidelity Context. A Randomized Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
Purposes: This study was set out to measure the effectiveness of constructive debriefing on procedural skills and satisfaction of nursing students in the low-fidelity context in comparison to traditional debriefing. Method: The randomized controlled (Parallel double blinded) trial design was used. Participant: Out of 51 approached, 34 students were selected from the list of participants by a data collector using simple random sampling technique. Following, block randomization was applied using Microsoft Excel to create two equivalent (n=17) groups i.e. experimental and non-experimental. Setting: The study was conducted in private college of nursing Islamabad Pakistan Intervention: The experimental group received constructive debriefing and non-experimental group received the traditional debriefing. The data were collected using suctioning, sterile dressing skills checklist, and debriefing reflection subscale of Satisfaction with Simulation Experience Scale.

Official Title
-----------------
Constructive Debriefing

Conditions
-----------------
Procedural Skill. Learning

Intervention / Treatment
-----------------
* Other: constructive debriefing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Students who were enrolled in the Adult Health Nursing (AHN) course were included in the study Exclusion Criteria: Studentsnts who were repeating the course and were absent for two or more days during skills demonstration and signing off were excluded

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 27 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CONSTRUCTIVE DEBRIEFING<br>interventional group | Other: constructive debriefing<br>* Constructive debriefing was applied to an interventional group Traditional debriefing was applied on noninterventional group<br>* Other names: traditional debrieifng;|
| No Intervention: traditional debriefing<br>noninterventional group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| learning scores | learning scores of participant | 8months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction level | measure satisfaction level of participant | 8months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Debriefing, Procedural skills, Satisfaction, Reflection, Critical thinking
Dane County Safety Assessment (SAFE) Research Study

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial to assess the effectiveness of an at-home comprehensive approach to preventing falls among adults 65 years and older at high risk for falls.

Detailed Description
-----------------
A randomized controlled trial to assess the effectiveness of a comprehensive approach to preventing falls among adults 65 years and older at high risk for falls. This intervention includes a comprehensive health assessment in each participant's home combined with tailored risk reduction strategies such as individualized strength and balance exercises. The study is also conducting a community-based program to engage and educate physicians about fall prevention. The goal of the study is to demonstrate a 40% decrease in fall rates. Other expected outcomes include decreased hospital and nursing home stays, improved physical function, and a decreased fear of falling.

Official Title
-----------------
Dane County Safety Assessment for Elders (SAFE) Research Study

Conditions
-----------------
Falls

Intervention / Treatment
-----------------
* Behavioral: Exercise, fall risk reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 65+, at high risk for falls, - Exclusion Criteria: Adults <65 years -

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 |
| --- |
|Behavioral: Exercise, fall risk reduction|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased fall rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased hospital and nursing home stays |  |  | 
| improved physical function |  |  | 
| decreased fear of falling |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
falls, injury, elderly
Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is an important method to save the function of joint in the treatment of refractory RA. The clinical trial is to study the value of AS combine with DMARDs in the early stage of refractory RA.

Official Title
-----------------
Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis of Ankle

Intervention / Treatment
-----------------
* Procedure: arthroscopic synovectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010 ACR/EULAR（European League Against Rheumatism） RA classification criteria. The age is more than 18 years old and less than 60 years old. They received stable traditional DMARDs (including Chrysopidae, leflunomide, sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal antibodies) for at least 6 months. The disease is still in the active stage, which means the disease activity score (DAS28) is more than 3.2, and the elbow joint function is obviously limited. The patient agreed to undergo arthroscopic synovectomy. No contraindications were found. Exclusion Criteria: The disease is in remission. The patient has contraindications. Arthroscopic synovectomy was performed in different patients.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br>The refractory elbow RA who undergo arthroscopic synovectomy | Procedure: arthroscopic synovectomy<br>* arthroscopic synovectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR70 remission | the percent of patients who meet ACR70 remission | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4) | Remission: 2.6 Low activity: 2.6 to ,3.2 Moderate activity: 3.2 to 5.1 High activity: .5.1 | 1,3,6 and 12 months after surgery | 
| tender joint count | the number of tender joints | 1,3,6 and 12 months after surgery | 
| swollen joint count | the number of swollen joints | 1,3,6 and 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Arthroscopic Synovectomy
A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Open-label Crossover Study to Investigate the Potential Interaction Between GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged 18-75 years; type 2 diabetes mellitus; 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 within 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: 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<br>|
| Experimental: 2<br> | Drug: Simvastatin<br>* 80mg po<br>|
| Experimental: 3<br> | Drug: GK Activator (2)<br>* 100mg po<br>Drug: Simvastatin<br>* 80mg po<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-inf of GK Activator (2) and simvastatin acid. |  | Days 1, 8 and 15 | 
| AUC0-6h of plasma glucose from pre-dose to 6h post-dose. |  | Days 1, 8 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-6h of GK Activator (2) and simvastatin acid |  | Days 1, 8 and 15 | 
| AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. |  | Days 1, 8 and 15 | 
| Cmin, tmin, Cmax, tmax, plasma glucose. |  | Days 1, 8 and 15 | 
| AEs, laboratory parameters. |  | Throughout study |
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells

Study Overview
=================
Brief Summary
-----------------
Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the expression of SOCS3 in DCs.

Official Title
-----------------
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: IFNbeta-1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of MS Age 18-60 years, inclusive Expanded disability status of 0-6.5 Give written informed consent prior to any testing under this protocol

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

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

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

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 |
| --- | --- |
| Other: IFNbeta-1b<br>no drug was given under study. patients already taking IFNbeta-1b were enrolled for blood draw only. | Other: IFNbeta-1b<br>* no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the effect of IFN-1b-induced SOCS3 expression in DCs on Th1/Th2 cell differentiation and T-cell cytokine transcription. |  | 2 years |