linjc16/ctgov huggingface dataset:
Single Incision Pelvic Floor Mesh Implants

Study Overview
=================
Brief Summary
-----------------
Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse. Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure. Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.

Detailed Description
-----------------
Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates

Official Title
-----------------
Single Incision Pelvic Floor Mesh Implants

Conditions
-----------------
Intra-operative Complications, Post Operative Complications

Intervention / Treatment
-----------------
* Device: Single Incision Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Patients with Gr 2-3 Pelvic Organ Prolapse Exclusion Criteria: *Previous Pelvic irradiation

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

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

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

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 Incision Mesh<br>intervention: single incision mesh implantation | Device: Single Incision Mesh<br>* Single Incision Mesh is implanted for pelvic floor reconstruction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative mesh related complications |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single Incision, Mesh, Complications
Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.

Official Title
-----------------
A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Drug: KU-0059436 (AZD2281)(PARP inhibitor)
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of pancreas Locally advanced or metastatic unresectable disease Exclusion Criteria: No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Gemcitabine + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor)<br>* oral<br>* Other names: Olaparib;Drug: Gemcitabine<br>* intravenous injection<br>* Other names: Gemcitabine HCL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine |  | assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the dose-limiting toxicity of the combination therapy |  | assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced pancreatic cancer, Poly (ADP ribose) polymerases, Advanced Solid Tumours
Italian Validation of the Beaumont Behavioural Inventory (BBI)

Study Overview
=================
Brief Summary
-----------------
Up to 50% of patients affected with amyotrophic lateral sclerosis (ALS) can show behavioral dysfunctions within the spectrum of frontotemporal degenerations (FTD) - namely, apathy, disinhibition, loss of sympathy/empathy, perseverative and stereotyped behaviours, dietary changes [Strong et al., 2017]. The Beaumont Behavioural Inventory (BBI) [Elamin et al., 2017] is a questionnaire designed for detecting FTD-spectrum behavioural changes in ALS patients. The present study aims at both validating the BBI in an Italian ALS population and determining normative cut-off values of the instrument.

Official Title
-----------------
Validazione Italiana Dello Strumento BBI (Beaumont Behavioural Inventory) Per la Valutazione Delle Alterazioni Comportamentali Nel Paziente Affetto da Malattia Del Motoneurone

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Behavioral: BBI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: possible, probable or definite ALS according to El Escorial revised criteria Exclusion Criteria: Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>patients with amyotrophic lateral sclerosis | Behavioral: BBI<br>* administration of psychometric test<br>|
| Healthy control<br>healthy control participants | Behavioral: BBI<br>* administration of psychometric test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beaumont Behavioural Inventory | Psychometrics | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS; frontotemporal degeneration; behavioural changes.
Effects of Power-velocity Muscle Characteristics During Ageing

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to investigate the age-related differences in force-velocity muscle characteristics during isolated knee extensions variable in speed and load, during cyclic movements on a usual and recumbent bike variable in speed and velocity development and a functional test battery with healthy participants aged between 20-80 years.

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers age 20 to 80 years Exclusion Criteria: Knee or hip prothesis Systematic training Cardiovascular disease Acute lower back pain Acute knee pain Dementia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young<br> | |
| Middle-Aged<br> | |
| Old<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in power-velocity characteristics during ageing | peak power and rate of power development (slope) at different velocities during knee extension movement and cyclic multijoint leg press movement compared between young and old people | 1x at baseline (cross sectional study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of strength tests on regular and recumbent bike. | reliability of peak power and rate of power development outcomes measured twice within a period of 2 weeks | 1x at baseline (cross sectional study) | 
| Differences in muscle fascicle characteristics during ageing. | Differences between young and old people of fascicle shortening velocity during dynamic leg press movements measured via dynamic ultrasound | 1x at baseline (cross sectional study) | 
| Differences in muscle activation during ageing. | Differences in muscle activation pattern during dynamic leg press movements measured via muscle electromyography | 1x at baseline (cross sectional study) |
Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (HFREF) and heart failure patients with preserved ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted hazard ratio (HR) and the population attributable risk were used to compare the contributions of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. These findings were similar for HFrEF and HFpEF groups. Interaction analysis confirmed similar results.

Official Title
-----------------
Prevalence and Prognostic Impact of Noncardiac Comorbidities in Heart Failure Outpatients With Preserved and Reduced Ejection Fraction: A Community-Based Study

Conditions
-----------------
Heart Failure, Diastolic, Heart Failure, Systolic

Intervention / Treatment
-----------------
* Other: prognostic impact of non cardiac comorbidities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive heart failure patients with left ventricular ejction fraction available before or within 3 months from the index visit Exclusion Criteria: We excluded all patients who had severe primary left-sided valvular disease

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 |
| --- | --- |
| HFrEF<br>patients with heart failure and reduced ejection fraction | Other: prognostic impact of non cardiac comorbidities<br> <br> |
| HFpEF<br>patients with heart failure and preserved ejection fraction | Other: prognostic impact of non cardiac comorbidities<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall mortality |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First all-cause hospitalization |  | 2 years | 
| Heart Failure hospitalization |  | 2 years | 
| noncardiovascular hospitalization |  | 2 years |
Evaluation Coroacromial Ligament Thickness

Study Overview
=================
Brief Summary
-----------------
In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients.

Detailed Description
-----------------
The coracoacromial ligament, which is part of the coracoacromial arch, plays an important role in shoulder biomechanics, joint stability and proprioception. Age-related changes due to chronic stress and cellular impairment may contribute to thickening and stiffening of the coracoacromial ligament to rupture the rotator cuff and development of shoulder pathologies such as impingement syndrome. In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients. Secondary purpose is whether the thickness of the coracoacromial ligament is indicative of shoulder pathologies.

Official Title
-----------------
Should the Coroacromial Ligament be Evaluated in Shoulder Magnetic Resonance Imaging?

Conditions
-----------------
Shoulder Pain

Intervention / Treatment
-----------------
* Device: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 15 years diagnosed with shoulder pain Exclusion Criteria: Sensation and reflexes loss in the upper extremity Limitation in passive shoulder movements on physical examination Systemic rheumatic disease Diabetes mellitus Malignant disease Active infection Intraarticular injection Trauma History of surgery

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: magnetic resonance imaging|magnetic resonance imaging of shoulder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of coracoacromial ligament | magnetic resonance imaging of coracoacromial ligament | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder pain, coracoacromial ligament thickness
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

Study Overview
=================
Brief Summary
-----------------
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Detailed Description
-----------------
Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Official Title
-----------------
A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: Medisorb naltrexone 380 mg
* Drug: Medisorb naltrexone 190 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections Willing and able to return for scheduled clinic visits and study assessments Noncustodial, stable address and phone Written, informed consent Primary Exclusion Criteria: Pregnancy or lactation Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medisorb naltrexone 380 mg<br> | Drug: Medisorb naltrexone 380 mg<br>* Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.<br>* Other names: Naltrexone for extended-release injectable suspension;|
| Experimental: Medisorb naltrexone 190 mg<br> | Drug: Medisorb naltrexone 190 mg<br>* Administered via IM injection once every 4 weeks for up to 3.5 years.<br>* Other names: Naltrexone for extended-release injectable suspension;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period). | Up to 3.5 years of monthly treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol dependence
Stress Ventricular Function in Evaluating Patients With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
This study investigated clinical parameters, laboratory data, imaging studies to evaluate patients with suspected pulmonary hypertension.

Detailed Description
-----------------
Left and right ventricular ejection fraction (LV/RV EF) at rest and immediately after exercise treadmill test (ETT) were measured by nuclear medicine study in consecutively symptomatic patients with suspected pulmonary hypertension, along with other clinical variables were correlated with right heart catheterization parameters.

Official Title
-----------------
Using the Stress Ventricular Function Assessment to Evaluate the Long-term Prognosis and Treatment Outcome in Patients With Pulmonary Hypertension

Conditions
-----------------
Dyspnea

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suspicious for pulmonary hypertension. Exclusion Criteria: pregnant, lactating, CAD history

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 |
| --- | --- |
| pulmonary hypertension<br>The two groups were defined by catheterization result. (no intervention) | Other: no intervention<br>* no intervention<br>|
| non-pulmonary hypertension<br>The two groups were defined by catheterization result. (no intervention) | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | an average of 1 year |
Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups

Official Title
-----------------
Randomized Controlled Study Comparing Three Different Techniques for Open

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Hernia repair
* Procedure: Hernia repair
* Procedure: Hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years unilateral primary hernia open surgery Exclusion Criteria: Recurrent Hernia Bilateral Hernia laparoscopic surgery Female

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lichtenstein<br>Hernia repair with lichtenstein propylene mesh | Procedure: Hernia repair<br>* Hernia repair admodum Lichtenstein with polypropylene mesh<br>Procedure: Hernia repair<br>* Hernia repair with Ultra Pro Hernia System (UHS)<br>Procedure: Hernia repair<br>* Hernia repair with Prolene Hernia System(PHS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperatively pain | Visual analog scale (VAS) | Postoperative 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | SF36 | 36 month postoperative | 
| frequency of recurrencies | check patients journal | postopertive 36 month |