linjc16/ctgov huggingface dataset:
Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation (LENEA)

Study Overview
=================
Brief Summary
-----------------
The LENEA study is an international, prospective, open label, non-randomized multicenter clinical research study designed to assess the safety and effectiveness of the NANO LV lead system.

Official Title
-----------------
Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation

Conditions
-----------------
LV Lead, LV Therapy, LV Treatment, LV Microcable

Intervention / Treatment
-----------------
* Device: implantation of the new LV lead: NANO system.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s) Receiving a new implant OR undergoing an upgrade from an existing ICD or pacemaker implant with no prior implanted LV lead OR undergoing a new LV implant attempt consecutive to a recent LV lead placement failure not related to coronary sinus cannulation failure Patient receiving the PARADYM RF CRT or PARADYM RF CRT SONR devices Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; Incessant Ventricular tachyarrhythmias; Unstable angina, or acute MI , CABG , or PTCA within the past 4 weeks; Correctable valvular disease that is the primary cause of heart failure; Post heart transplant (patients who are waiting for a heart transplant are allowed in the study); Patient who had previously a permanently implanted LV lead; Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or ICD devices should be removed prior to implant with the Paradym RF CRT-D or Paradym RF CRT SONR); Already included in another clinical study that could confound the results of this study; Life expectancy less than 1 year.

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
Interventional Model Description: NANO LV lead
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: implantation of the new LV lead: NANO system.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from left ventricular lead related complications through 1 month |  | 1 month |
Regulatory TYKERB® Tablets PMS

Study Overview
=================
Brief Summary
-----------------
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is a registered trademark of the GlaxoSmithKline group of companies.

Detailed Description
-----------------
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® tablets will be administered with capecitabine for HER2 overexpressing advanced or metastatic breast cancer treatment or with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 as described the prescribing information of TYKERB® tablets

Official Title
-----------------
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of TYKERB® Tablets Administered in Korean Patients According to the Prescribing Information

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: TYKERB® tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation: Subjects with indication in the locally approved prescribing information Subjects with no contraindication according to the prescribing information
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TYKERB® tablets<br>There is only one group. This group includes patients administrated TYKERB® tablets | Drug: TYKERB® tablets<br>* Patients administrated TYKERB® tablets according to the prescribing information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events after TYKERB® tablets administration |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PMS (post-marketing surveillance), TYKERB® tablets
Nutritional Screening in Older Individuals

Study Overview
=================
Brief Summary
-----------------
Hospital-based case management programs and home hospitalization services following the risk stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older individuals living in the community who are at high risk of hospitalization and adverse outcomes. The objective of these services is to avoid deterioration and hospital admissions or visits to the emergency services by regular follow-up, proactive home visits and support of self-care . The prevalence of malnutrition in patients selected using this model of care is unknown.

Detailed Description
-----------------
The aim of this study was to estimate the prevalence of malnutrition, using the MNA, in this high-risk community living population, and to explore risk factors that could identify subgroups of individuals at higher risk. This study was performed in individuals included in a Case Management (CM) Program lead by the Telemedicine Unit of a tertiary university hospital in Valencia. Patients admitted to the hospital with two or more hospital admissions for medical reasons in the previous year are detected by a computerized system and included in the program, an integrated care intervention developed for patients with complex multimorbidity using patient-centred education activities and integrated care interventions, with the support of a Hospital at Home Unit (HHU). Telephone follow-ups by case manager nurses are focused on identifying problems and detecting disease exacerbations. The main aim of this program is to avoid hospital admissions and reduce the number of visits to emergency services

Official Title
-----------------
Nutritional Screening in Community Living Older Individuals at High Risk of Hospital Admission.

Conditions
-----------------
Malnourished

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included at Case Management Program for complex chronic condition Must be able to answer questions on the telephone Exclusion Criteria: Subjects with no telephone, Subjects unable to determine their usual weight End-of-life clinical situation

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 105 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of malnutrition | prevalence of malnutrition by using MNA-SF | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sexBMI | male or female, average age, BMI | 2 months | 
| age | average age in years | 2 months | 
| BMI | body mass index in Kg / m^2 | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional screening MNA-SF malnutrition Case Management
Multicenter Trial for Adults With Partial Seizures

Study Overview
=================
Brief Summary
-----------------
To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.

Detailed Description
-----------------
A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.

Official Title
-----------------
Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Talampanel
* Drug: Placebo
* Drug: Talampanel
* Drug: Talampanel
* Drug: Placebo
* Drug: Talampanel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must weigh greater than or equal to 40kg Patients must have diagnosis of partial seizures At least 3 observable partial seizures a month Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs. Exclusion: Patients on Valproic acid, and Felbamate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Enzyme-inducing placebo TID | Drug: Placebo<br>* Enzyme-inducing placebo TID<br>|
| Experimental: 2<br>Enzyme-inducing Talampanel 35 mg TID | Drug: Talampanel<br>* Enzyme-inducing Talampanel 35 mg TID<br>|
| Experimental: 3<br>Enzyme-inducing TLP 50mg TID | Drug: Talampanel<br>* Enzyme-inducing TLP 50mg TID<br>|
| Placebo Comparator: 4<br>Non-enzyme-inducing placebo TID | Drug: Placebo<br>* Non-enzyme-inducing placebo TID<br>|
| Experimental: 5<br>Non-enzyme-inducing TLP 25mg TID | Drug: Talampanel<br>* Non-enzyme-inducing TLP 25mg TID<br>|
| Experimental: 6<br>Non-enzyme-inducing TLP 35mg TID | Drug: Talampanel<br>* Non-enzyme-inducing TLP 35mg TID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in frequency of partial seizures | Change in frequency of recognizable seizures as measured by entries in a seizure diary | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of seizure-free days and percent responders | A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline | 12 weeks |
Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL subjects that have never received rituximab as a treatment and are refractory or relapsed after previous chemotherapy.

Official Title
-----------------
A Phase 2 Randomized, Open-Label, Controlled Trial of the Addition of 8 Weeks SC Administration of Aldesleukin (Rh-Interleukin-2 [IL-2]) to 4 Weeks of IV Administration of Rituximab in the Treatment of Rituximab Naïve Subjects With Follicular Non-Hodgkin's Lymphoma, Refractory or Relapsed After Previous Chemotherapy

Conditions
-----------------
Non-Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: interleukin-2
* Drug: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD20+ follicular B-cell non-hodgkin's lymphoma with at least 1 site of measurable disease. Previous treatment with 1 to 4 prior chemotherapy regimens ECOG performance status of greater than or equal to 2 Life expectancy of greater than 18 weeks Meet safety lab requirements and organ function tests Exclusion Criteria: Prior treatment with rituximab or IL-2 Prior radioimmunotherapy including Zevalin or Bexxar 5 or more prior chemotherapy regimens Clinically significant cardiac disease, lung dysfunction, autoimmune disease, thyroid disease, active infection, unstable psychiatric condition, or HIV infection. History of allogenic bone marrow transplant Female subjects that are pregnant or breast feeding Immunosuppressive therapy including corticosteroids or investigational agents within 4 weeks prior to the planned start of study treatment

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: interleukin-2|nan|
|Drug: rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-hodgkins lymphoma, interleukin-2, rituximab, CD20+ follicular B-cell non-hodgkins lymphoma (grade I, II,III)
Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

Study Overview
=================
Brief Summary
-----------------
This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically stable poststroke with focal unilateral upper-limb spasticity Exclusion Criteria: Stroke within 6 months of the study enrollment visit Previous or current botulinum toxin therapy of any type in the study limb

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Botulinum Toxin Type A | Biological: Botulinum Toxin Type A<br>* 200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18<br>* Other names: BOTOX®;|
| Placebo Comparator: 2<br>Saline | Biological: Placebo<br>* Saline injection on Day 0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit) |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity of the upper-limb flexors as measured by the Ashworth Scale |  | Week 6 |
Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis.

Study Overview
=================
Brief Summary
-----------------
To investigate effects of repetitive peripheral magnetic stimulation (PMS) on pain reduction in knee osteoarthritis

Official Title
-----------------
Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis: A Randomized Controlled Trial.

Conditions
-----------------
Osteoarthritis of Knee

Intervention / Treatment
-----------------
* Device: Repetitive Peripheral Magnetic Stimulation
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary knee osteoarthritis patients who have had knee pain for at least 6 months and age more than 50 years, had morning stiffness not more than 30 minutes or crepitation. Kellgren and Lawrence classification 2-4 Visual analog scale of pain 4 or higher. Exclusion Criteria: Patients with other musculoskeletal problems associated with knee joint Patient with history of physical therapy in past 1 month Patient with pacemaker, cochlear implant or cerebral shunt Patient with history of knee surgery Patient with neurological or other severe disease Patient with previous seizure.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repetitive Peripheral Magnetic Stimulation<br>Repetitive Peripheral Magnetic Stimulation 1 session | Device: Repetitive Peripheral Magnetic Stimulation<br>* Repetitive Peripheral Magnetic Stimulation at knee joint 1 session<br>Behavioral: Education<br>* Conventional exercise and life style modification<br>|
| Sham Comparator: Sham Repetitive Peripheral Magnetic Stimulation<br>Sham Repetitive Peripheral Magnetic Stimulation 1 session | Behavioral: Education<br>* Conventional exercise and life style modification<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Visual analog scale | Pain measurement Score from 0-10, 0 means no pain and 10 means maximum pain. Higher scores mean worse outcome. | Change from baseline Visual analog scale at immediately after intervention and Change from Baseline visual analog scale at 1 week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Western Ontario and McMaster University Osteoarthritis Index | To assessing pain, stiffness, and function in patients with osteoarthritis. Score from 0-220. Higher scores mean worse outcome. | Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week. |
Multicomponent Cognitive Behavioral Therapy(CBT) for Posttraumatic Stress Disorder (PTSD) and Substance Abuse

Study Overview
=================
Brief Summary
-----------------
Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and substance abuse among persons with serious mental illness (SMI) treated in a community setting. Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center, served through the Orange Person Chatham (OPC) Area Program. Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the CBT intervention plus treatment as usual; or, 2) treatment as usual.

Official Title
-----------------
Multicomponent Cognitive Behavioral Therapy for Posttraumatic Stress Disorder and Substance Abuse: A Pilot Study

Conditions
-----------------
Posttraumatic Stress Disorder, Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: CBT and exposure therapy for PTSD
* Other: Treatment as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 18 years of age Currently receiving services at Freedom House Meet DSM-IV criteria for PTSD Meet criteria for Substance Use Disorder Able to understand and provide informed consent Exclusion Criteria: • Psychiatric hospitalization or suicide attempt in the past two months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT Intervention<br>The CBT intervention includes psychoeducation and coping and social skills delivered in a group format, and exposure therapy delivered in individual sessions | Behavioral: CBT and exposure therapy for PTSD<br>* The CBT intervention will be administered twice weekly in group therapy sessions for 7 weeks, and then twice weekly individual sessions for 4 weeks.<br>|
| Active Comparator: Treatment as Usual<br>The TAU Condition will receive usual services at the community clinic, which may include medications, individual or group therapy | Other: Treatment as Usual<br>* Participants in the treatment as usual condition will receive their usual services at the community clinic where they receive mental health and substance abuse services<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addiction Severity Index |  | 3 months |