linjc16/ctgov huggingface dataset:
Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of aneurysms. Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by ruptured intracranial aneurysms.

Official Title
-----------------
Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial

Conditions
-----------------
Intracranial Aneurysms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subarachnoid haemorrhage caused by ruptured intracranial aneurysms endovascular embolization of the aneurysm Exclusion Criteria: none
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 |
| --- | --- | --- |
| early neurological clinical recovery | modified Rankin scale | 1 year after Subarachnoid Haemorrhage |
Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this prospective, randomized trial is successful intravenous (IV) cannulation on first attempt with the use of either the Vein Viewer (VV) or standard cannulation method. The secondary purpose is to find out if there is a difference in the total time to successful cannulation.

Detailed Description
-----------------
A single initial data page will be filled out by one of the study team members present with the IV Team at the time of the cannulation. The data from these forms will be entered by the investigator or research assistant into a database maintained only for this study. There will be two groups in this randomized study. One group will receive IV cannulation with the VV and the second group will receive standard cannulation without the VV. The chance of receiving either treatment is based on randomly generated computer codes, unknown by the IV team. We want to evaluate successful IV cannulation on first attempt as well as the time taken for cannulation. All documents will be de-identified of data that contains HIPAA protected health information (PHI) at the end of the study. We estimate approximate enrollment to be 790 children. The study is expected to last 12 months and will only be conducted at Children's Medical Center Dallas.

Official Title
-----------------
Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access.

Conditions
-----------------
IV Cannulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 0-18 requiring IV cannula (ASA 1-4) with a modified DIVA score ≥ 2 at the time of assessment Exclusion Criteria: Patients with visible veins will be excluded from the study as well as patients with known difficult IV access which are scheduled for PICC line placement.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Successful IV cannulation on the first attempt |  | Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time to successful IV cannulation |  | Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IV cannulation
Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to collect efficacy and safety data in real life condition within the first year of treatment in patients with progressive multiple receiving a daily dose of biotine of 300 mg.

Official Title
-----------------
Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis

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

Intervention / Treatment
-----------------
* Other: Non interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Progressive multiple sclerosis patients with an EDSS score ≤ 7 who have been prescribed high dose of biotin (temporary use administration) at Nantes university hospital (France) Exclusion Criteria: Patient with remittent recurrent multiple sclerosis Pregnant women or women contemplating pregnancy

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 |
| --- |
|Other: Non interventional Study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of post-treatment disability | Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-t scale | Change in Clinical global impression of improvement from both physician and patient assessments | after 6 months and 12 months | 
| Functional disability : Multiple sclerosis Functional composite | Composite score : Change in test measuring the patient's walking speed over a distance of 25 feet(TW25), Symbol Digit Modalities Test (SDMT), 9-Hole Peg Test Scores (9HPT) from baseline | 12 months | 
| Ambulation | Change in MSWS-12 score from baseline | 12 months | 
| Quality of life | Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline | 12 months | 
| adverse effect (adverse drug reaction) | number of AE | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disability, EDSS
Walking Impairment Questionnaire in PAD

Study Overview
=================
Brief Summary
-----------------
Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication

Detailed Description
-----------------
Questionnaires (WELCH and WIQ) submitted to patients referred for treadmill walking test Comparison of sore to MWD on treadmill. Comparison with WIQ will be performed

Official Title
-----------------
Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour un Test de Marche Sur Tapis Roulant

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent signed, french language fluent patients Exclusion Criteria: rejection of the questionnaire
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| claudicants<br>patients referred for a treadmill test | Other: questionnaire<br>* self completed questionnaire supervised by a technician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scoring of the WELCH questionnaire | predetermined score for the WELCH questionnaire answers (4 questions) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
questionnaire, peripheral artery disease, exercise
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer

Study Overview
=================
Brief Summary
-----------------
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.

Official Title
-----------------
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer

Conditions
-----------------
Active Cocaine Users

Intervention / Treatment
-----------------
* Drug: Cocaine
* Drug: Sustained Release d-Amphetamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent cocaine use, otherwise healthy Exclusion Criteria: Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br>Cocaine choice during d-amphetamine maintenance | Drug: Cocaine<br> <br> Drug: Sustained Release d-Amphetamine<br> <br> * Other names: Dexedrine Spansule SR;|
| Placebo Comparator: Placebo Treatment<br>Cocaine choice during placebo maintenance | Drug: Cocaine<br> <br> Drug: Sustained Release d-Amphetamine<br> <br> * Other names: Dexedrine Spansule SR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance. | 9 choice trials per cocaine dose level with each trial separated by 30 minutes |
Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type A for the treatment of focal upper limb poststroke spasticity

Conditions
-----------------
Stroke, Muscle Spasticity

Intervention / Treatment
-----------------
* Biological: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically stable poststroke patients with spastic muscles in the upper limb Exclusion Criteria: Stroke within 6 months of study enrollment Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998

Ages Eligible for Study
-----------------
Minimum Age: 21 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: 1<br>Botulinum Toxin Type A | Biological: Botulinum Toxin Type A<br>* Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg<br>* Other names: BOTOX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity as measured by the Ashworth scale |  | Week 54 |
Vitiligo Extent Score (VES) Score in Comparison to Vitiligo Area and Severity Index (VASI) Score

Study Overview
=================
Brief Summary
-----------------
All patients with vitiligo attending dermatology outpatient clinic at Kasr Alainy Teaching Hospital will be enrolled in this study to compare VES and VASI scores and evaluate them as assessment methods

Official Title
-----------------
In-depth Analysis of the Implementation of Vitiligo Extent Score (VES) Score in Comparison to Vitiligo Area and Severity Index (VASI) Score

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Other: VES and VASI scores as assessment methods for vitiligo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18. Non-segmental vitiligo patients Exclusion Criteria: Age < 18 Segmental vitiligo

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 |
| --- |
|Other: VES and VASI scores as assessment methods for vitiligo|compare VES and VASI scores as assessment methods for vitiligo|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of the use of vitiligo extent score (VES) as a scoring system for vitiligo |  | 6 months |
Post-market Clinical Follow-up of the SRS Implant

Study Overview
=================
Brief Summary
-----------------
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

Detailed Description
-----------------
National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.

Official Title
-----------------
National, Multicentre Observational Study on Surgical Reconstruction of the Anterior and Apical Compartment of the Pelvic Floor With a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system). This applies to primary as well as recurrent intervention. Age ≥ 21 years. Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study. Patient information has been provided and written consent exists. Exclusion Criteria: Contraindications according to the manufacturer's instructions for use. Patient with previous urogynaecological surgeries with alloplastic material. Patient with radiological treatment in the pelvic floor. Patient is institutionalised by court or official order (MPDG §27). Participation in another interventional study concerning pelvic floor reconstruction.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| SRS implant<br>Surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient´s Quality of Life | Evaluation of changes in quality of life twelve months after implantation of the SRS implant compared to baseline. Quality of Life was assessed by the P-QOL (Prolapse Quality of Life Questionnaire). The P-QOL yields a domain score in the range from zero to 100, wheras a score of zero is the best. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SRS Implant, Quality of Life, Pelvic Organ Prolapse, Surgical Reconstruction
Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
Decreased insulin sensitivity is and independent risk factor for stroke despite glycemic control. It is known that physical exercise increases insulin sensitivity in healthy subjects. Wether stroke patients can increase insulin sensitivity via physical exercise is not known. Chronic low-grade inflammation is associated with an increased risk of stroke. Physical exercise has shown to increase IL-6 directly after exercise in untrained subjects. When fitness is increased in each subject then the peak IL-6 concentration after exercise decreases and so does the basal level of IL-6. It is not known whether stroke patients can increase physical activity level to a degree where chronic inflammation are decreased. This study is designed to evaluate if physical exercise after stroke will increases insulin sensitivity and reduce low-grade chronic inflammation. Stroke patients have been randomized to intervention with physical exercise or control in the ExStroke pilot trial and followed for 2 years. Using the study population from the ExStroke pilot trail blood samples will be obtained at the last control. Insulin sensitivity can be measured from fasting glucose and insulin using the Homeostasis Model Assessment (HOMA). Interleukin-6, TNF-alfa and CRP is measured to estimate chronic inflammation.

Conditions
-----------------
Cerebral Infarction

Intervention / Treatment
-----------------
* Behavioral: Physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participated in the ExStroke Pilot trail Exclusion Criteria: Diabetes Mellitus Not able to give informed consent

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Physical exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between PASE and HOMA |  |  | 
| Association between PASE and IL-6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 concentration is lower in the intervention group than control group. |  |  | 
| TNF-alfa and IL-6 is positively associated. |  |  | 
| IL-18 is associated to HOMA |  |  | 
| Correlation between PASE and HOMA in the intervention group vs. controls |  |  | 
| HOMA mean value in the 2 groups |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HOMA, Cerebral infarct, physical exercise, insulin sensitivity, low grade chronic inflammation, intervention, PASE
Study for Validation of In-vitro Turbidometric Platelet Aggregation Assay Using Human Blood in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is designed for validation of in-vitro platelet aggregation assay using human blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for platelet aggregation assay, was collected from ten subjects, respectively. Preparation of Platelet Rich Plasma (PRP): Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate vacutainer vials. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP from multiple vacutainer tubes (if required) into a 15 mL conical tube. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15 minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL conical tube. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets in PRP using PPP. Aggregation Measurement: Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP is used as a reference to establish 100% optical transmission.

Conditions
-----------------
Validation of In-vitro Turbidometric Platelet Aggregation Assay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-50years old must be able to consent voluntarily consent to keep the study terms of obedience Exclusion Criteria: blood coagulation disorder or bleeding disorder blood donation within 60 days or blood transfusion within 30 days before screening smoker or who stopped smoking within 1month before screening administration of drugs such as anticoagulants or antiplatelets or alcohol within 14 days before screening eligibility failure under investigator's judgements

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal platelet aggregation(MPA) for the TRAP and 5-HT baseline aggregation response and the 5-HT amplification of TRAP-induced aggregation | Calculate each maximal platelet aggregation(MPA) for the TRAP and 5-HT baseline aggregation response and the 5-HT amplification of TRAP-induced aggregation, respectively. Compare the results with previous datas to evaluate the analysis machine and the assay methods. | Up to 6months |