linjc16/ctgov huggingface dataset:
Sientra Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.

Official Title
-----------------
U.S. Postapproval Study of Sientra Silicone Gel Breast Implants

Conditions
-----------------
Breast Augmentation, Breast Reconstruction, Breast Revision

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic female with US residency Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation Agrees to Sientra study requirements Exclusion Criteria: Has an active infection anywhere in body Has active cancer without adequate treatment Currently pregnant or nursing Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements If control participant, has undergone breast implant surgery with silicone gel-filled breast implants

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gel Participants<br> | |
| Control Participants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of Sientra Silicone Gel Breast Implants in women |  | 10-years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants
Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets

Study Overview
=================
Brief Summary
-----------------
To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine. To study and analyze the main influencing factors of the acetylaconitine tablets.

Detailed Description
-----------------
The outpatients/inpatients meeting the criteria are included into this study after signing the Informed Consent Form. The patients received 5 visits in total, which take place after the patients are included into the real-world study, on the 3rd day after enrollment and at the 1st, 4th, 8th and 12th weeks thereafter, in the form of outpatient follow-up, telephone follow-up and APP follow-up.

Official Title
-----------------
Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally Exclusion Criteria: Patients who cannot communicate or receive follow-up Patients allergic to acetylaconitine Patients who have taken the acetylaconitine drugs orally
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 |
| --- | --- | --- |
| VAS (0-100mm), IDpain | Pain score | December 2022 to December 2023 |
Adductor Strength in Athletes Suffering a Groin Injury

Study Overview
=================
Brief Summary
-----------------
assess the difference in adductor peak strength evaluated with different instruments. Hand held dynamometer vs force frame

Detailed Description
-----------------
This study aims to compare the difference in adductor strength output performed by athletes suffering a groin injury between two different assessment methods. Previous studies have observed that add strength differs depending on the evaluation method. Isometric strength can be measured with hand held dynamometer or with force plates (forceframe). Wether one method is better in order to differenciate adductor strength between healthy and injured limb is not known to date.

Official Title
-----------------
Adductor Strength Assessment With Different Procedures for Athletes Suffering a Groin Injury

Conditions
-----------------
Groin Injury

Intervention / Treatment
-----------------
* Other: Adductor strength assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suffer a groin injury during the assessment period Accept participating in the study Exclusion Criteria: -

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 |
| --- | --- |
| Injured athletes<br>Athletes suffering a groin injury | Other: Adductor strength assessment<br>* Adductor strength will be evaluated with HHD (handheld dynamometer) and forceplates (Forceframe), both injured leg and healthy will be assess in order to compare both limbs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| handheld dynamometer strength | peak torque measured with the handheld dynamometer the athlete will lay supine with hips flexed at 0º and the examiner will put the forearm between the ankles, the participant has to exert the maximum possible strength with the adductor muscles by squeezing with both legs against the forearm | november 2022 to june 2023 | 
| forceframe strength | peak torque measured with the forceframe the athlete will lay supine with hips flexed at 0º and the ankles placed by the force plates, the participant has to exert the maximum possible strength with the adductor muscles by squeezing with both legs against the plates | november 2022 to june 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multidirectional sport, groin pain, adductor strength
A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.

Official Title
-----------------
A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as An Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Patients With Epilepsy Aged 12 Years or Older

Conditions
-----------------
Partial Onset Seizures, Epilepsy

Intervention / Treatment
-----------------
* Drug: Perampanel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians. Exclusion Criteria: Participation in another study involving administration of an investigational drug or device whilst participating in this observational study. Hypersensitivity [allergic] to perampanel.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Perampanel<br>Participants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first. | Drug: Perampanel<br>* Perampanel tablets.<br>* Other names: Fycompa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period |  | Up to 6 months | 
| Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period |  | Up to 6 months | 
| Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period |  | At 3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E2007, Fycompa, Perampanel, Prospective, Partial onset seizures, Epilepsy, Seizures
Lipid, Glycemic, and Insulin Responses to Meals Rich in Different Fatty Acids

Study Overview
=================
Brief Summary
-----------------
A meal rich in very-long chain omega-3 fatty acids or oleic acid may lower postprandial insulin levels in comparison to a meal rich in linoleic acid or palmitic acid. A meal rich in very long-chain omega-3 fatty acids may lower postprandial triglyceride levels compared to other fatty acids.

Detailed Description
-----------------
Research Design and Methods: Test meals rich in palmitic acid, linoleic acid, oleic acid, and eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and containing 1,000 kcal each were administered in a randomized cross-over design every 3 to 4 days to 11 patients with T2DM. Serum insulin, glucose, and triglycerides concentrations were measured for 360 minutes. All subjects received an isoenergic diet of constant composition throughout the study.

Official Title
-----------------
Lipid, Glycemic, and Insulin Responses to Meals Rich in Saturated, Cis-Monounsaturated, and Polyunsaturated Fatty (n-3 and n-6)Acids in Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Behavioral: Test meals rich in different fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus not on insulin therapy Exclusion Criteria: Thyroid, renal, or hepatic disease, uncontrolled hypertension, anemia, history of ketosis
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

| Intervention/Treatment |
| --- |
|Behavioral: Test meals rich in different fatty acids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin, and glucose |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus, Fatty acids, Postprandial response, Insulin, Glucose, Triglycerides
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.

Official Title
-----------------
Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment

Conditions
-----------------
Non Small Cell Lung Cancer (NSCLC)

Intervention / Treatment
-----------------
* Drug: ZD1839 (Iressa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment. No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician. Exclusion Criteria: Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded). In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease). Withdrawal, at any time, from the preceding gefitinib study. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ZD1839 (Iressa)|Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Retrospective Analysis on Small Bowel Perforations

Study Overview
=================
Brief Summary
-----------------
A retrospective, monocentric, code-related data analysis of patients with small bowel perforations was performed for the period 2010 to 2019.

Detailed Description
-----------------
Analyzed parameters were etiology and timing of perforation, associated morbidity and mortality, type of therapy and its success, and long-term consequences for patients, such as the development of short bowel syndrome.

Official Title
-----------------
Small Bowel Perforations: Etiology, Treatment and Outcome

Conditions
-----------------
Small Bowel Perforations

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: small bowel perforation in adults Exclusion Criteria: age < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Retrospective data analysis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with SBP<br> | Procedure: surgery<br>* interventional or surgical treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | death by SBP | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small bowel syndrome | malabsorption | 30 days |
A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Official Title
-----------------
A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 1)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib / Duration of Treatment 12 Weeks
* Drug: Placebo or Ibuprofen / Duration of Treatment 12 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA. Exclusion Criteria: No history of concurrent arthritic disease uncontrolled hypertension or an active cardiac condition No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, etoricoxib / Duration of Treatment 12 Weeks|nan|
|Drug: Placebo or Ibuprofen / Duration of Treatment 12 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Ocular Responses to Short and Long-term Lens Wear

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period.

Official Title
-----------------
Ocular Responses to Acute and Chronic Lens Wear

Conditions
-----------------
Ametropia

Intervention / Treatment
-----------------
* Device: Purevision Lenses with ReNu Multiplus
* Device: Purevision Lenses with Optifree RepleniSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 17 years old and has full legal capacity to volunteer; Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction; Is a current soft lens wearer and wears contact lenses six or more days/week; Has clear corneas and no active ocular disease. Exclusion Criteria: Has any clinically significant blepharitis or dry eye; Has undergone corneal refractive surgery; Is aphakic; Has any active ocular disease; Has any systemic disease affecting ocular health; Is using any systemic or topical medications that may affect ocular health;

Ages Eligible for Study
-----------------
Minimum Age: 17 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Purevision Lens with ReNu<br>Purevision Lenses with ReNu Multiplus Solution | Device: Purevision Lenses with ReNu Multiplus<br>* Purevision lenses using ReNu Multiplus lens solution for 28 days<br>* Other names: Balafilcon A;|
| Active Comparator: Purevision Lenses with RepleniSH<br>Purevision Lenses with Optifree RepleniSH Solution | Device: Purevision Lenses with Optifree RepleniSH<br>* Purevision lenses using Optifree RepleniSH lens solution for 28 days<br>* Other names: Balafilcon A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity. |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye Diseases