linjc16/ctgov huggingface dataset:
Transvenous Lead Removal Post-Market Clinical Study

Study Overview
=================
Brief Summary
-----------------
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations

Official Title
-----------------
RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.

Conditions
-----------------
Cardiac Electrophysiology

Intervention / Treatment
-----------------
* Device: Cook lead extraction devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years of age or older Lead indwell time greater than 1 year Exclusion Criteria: Patient is unable or unwilling to provide informed consent (per the IRB/EC requirements) to participate in the clinical study Patient presents with an extracardiac lead

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cook lead extraction devices<br>The Cook lead extraction devices are indicated for use in patients requiring percutaneous removal of CIED leads, indwelling catheters and foreign objects. | Device: Cook lead extraction devices<br>* The Cook lead extraction devices are mechanical devices that encompass a full variety of devices required for percutaneous removal of CIED leads, indwelling catheters and foreign objects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete procedural success | Complete procedural success is the removal of the targeted lead and all lead material from the vascular space, with the absence of permanently disabling complications or procedure-related death. | Immediately following lead extraction | 
| Rate of clinical procedural success | Clinical procedural success is the removal of all targeted leads and all lead material from the vascular space, or retention of a small portion of the lead (fragment that is 4 cm or smaller) that does not negatively impact the outcome goals of the procedure. | Immediately following lead extraction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac pacing, artificial, Cardiac Resynchronizaton Therapy Devices, Defibrillators, Implantable
Obstetric Outcomes in Women With PCOS

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate body composition in newborn children of women with PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.

Detailed Description
-----------------
A prospective cohort study investigating 208 women with PCOS giving birth after singleton pregnancies at Odense Univesity Hospital during 2003-2011 and a date-of-childbirth matched control group of 1040 women. Anthropometric data from children is recorded as well as data on maternal parity, age, pre-gestational BMI, and adverse obstetric outcomes.

Official Title
-----------------
Size at Birth in Newborn Children and Obstetric Outcomes in Women With PCOS

Conditions
-----------------
Polycystic Ovary Syndrome, PCOS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with PCOS and giving birth during 2003-2011 Exclusion Criteria: Multiple pregnancy
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 PCOS<br>208 women diagnosed with PCOS and giving birth after singleton pregnancies at Odense University Hospital during 2003-2011. | |
| Controls<br>1040 women giving birth after singleton pregnancies at Odense University Hospital during 2003-2011, matched 1:5 to women with PCOS according to date-of-childbirth. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measures | Abdominal circumference, birth weight, birth length, and head circumference. | Date of birth (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse obstetric outcomes | Presence of gestational diabetes mellitus, pregnancy induced hypertension, or pre-eclampsia during pregnancy. Registration of gestational age at childbirth, medical induction of birth, caesarean section,instrumental delivery, anal sphincter rupture, and shoulder dystocia. | From beginning of pregnancy until the date of delivery (approximately 9 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Pregnancy, Obstetric
Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
We are trying to develop better ways to detect when cancer therapies are working.

Official Title
-----------------
A Pilot Study to Determine the Feasibility of Quantifying Apoptosis and Bcl-2 Expression in Circulating Tumor Cells (CTCs) in Women Undergoing Treatment for Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Females at least 18 years of age 2 Diagnosis of metastatic breast cancer 3.ECOG Score of 0-2 4.Treating oncologist has decided to initiate any new systemic therapy with emphasis on recruiting patients commencing a taxane-based regimen. Taxine-based therapy may be docetaxel or paclitaxel, and it can be given on any schedule,including weekly or every 3 weeks. Other treatment can include non-taxane chemotherapy or trastuzumab-with or without other therapy. 5.Patient is willing to return for one or more additional  18 mL blood draw (s) at 24-48-, and /or 72 hours and  3-4 weeks after the initiation of therapy.At a minimum, patients must donate blood at baseline, one intermediate interval (24, 48, 72 hr) and at  3-4 weeks 6.Signed Informed Consent Form - Exclusion Criteria: Patient is unable and unwilling to provide a blood specimen at a minimum of one of the intermediate blood draw time points at 24, 48, or 72 hours -

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

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

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 |
| --- | --- | --- |
| To determine the feasibility of detecting Bcl2 expression and apoptosis in CTCs |  | Prospective |
Reward and Punishment Sensitivity in Bipolar Disorders

Study Overview
=================
Brief Summary
-----------------
Bipolar disorder (BD) represents a chronic mood disorder and one of the leading causes of disability worldwide. Complexity of its clinical presentations leads to delayed diagnosis and difficult management in routine clinical settings. Whereas distinguishing BD-I and BD-II main subtypes has a significant relevance for treatment strategy and for outcome, there are currently no clinical determinants of the BD subtype which could be used as early diagnostic predictors. While neurobiological specificity of each BD subtype is still controversial, available evidence suggest different dopaminergic abnormalities in each subtype. Dopaminergic function is involved in decision making and reward processing which may represent useful BD subtype markers. This study aims at assessing decision making during appetitive and punitive reinforcement learning in patients with BD I and BD II subtypes compared to healthy controls

Official Title
-----------------
Reward and Punishment Sensitivity in Bipolar Disorders

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: behavioral assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bipolar disorder (BD) type I or II, according to DSM (Diagnostic and Statistical Manual)-5 criteria Montgomery and Asberg Depression Rating Scale (MADRS) score < 15 Young Mania Rating Scale (YMRS) score < 12 Exclusion Criteria: other main diagnosis than bipolar disorder other medical condition leading to cognitive deterioration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Bipolar disorder type I<br> | Behavioral: behavioral assessment<br>* Probabilistic learning task<br>|
| Bipolar disorder type II<br> | Behavioral: behavioral assessment<br>* Probabilistic learning task<br>|
| healthy controls<br> | Behavioral: behavioral assessment<br>* Probabilistic learning task<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response performance in reward and loss trials | percentage of correct responses in the probabilistic learning task | one day visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reinforcement learning
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson's disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

Official Title
-----------------
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease; Udall Project 2 Aims 1 & 2

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of idiopathic PD have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN) Existing 7T brain imagery Exclusion Criteria: history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs other significant neurological disorder history of dementia or cognitive impairment as found with UBACC (or MacCAT-CR) post-operative complications or adverse effects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: Parkinson's disease with DBS<br>Participants will have a diagnosis of idiopathic PD and have undergone/will undergo neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN) | Device: Deep Brain Stimulation<br>* Pallidal Deep Brain Stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque | Average movement rate and amplitude for each tone rate-movement amplitude interval. The amount of variability in angular displacement and velocity will be calculated using the root mean square of the zero mean signal. The structure of the variability will be calculated using the sample entropy function. In addition, we will quantify the number and duration of movement festination or freezing episodes. | 3 weeks |
Study of Eyes and Attention Deficit (SEAD)

Study Overview
=================
Brief Summary
-----------------
Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent chronic health conditions in children. It affects between 4% and 12% of young children. A relationship between convergence insufficiency (eye teaming) and ADHD has been shown. However, the effect of ADHD medications on focusing and eye teaming has not been previously investigated. Therefore, the purpose of this study is to determine the effect of ADHD medication on focusing and eye teaming skills.

Conditions
-----------------
ADHD, Convergence Insufficiency, Accommodative Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity of 20/25 in both eyes at distance and near; Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary; 500 random dot stereopsis Exclusion Criteria: Amblyopia (lazy eye); Eye disease

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 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 |
| --- | --- | --- |
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of dinitrochlorobenzene (DNCB) in patients with early HIV infection by monitoring immunologic parameters and serum HIV RNA. To facilitate the understanding of possible alterations in the immunological status of the HIV+ patient cohort.

Official Title
-----------------
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Dinitrochlorobenzene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: EITHER HIV negative or documented HIV+ by both the ELISA and Western blot tests. For HIV+ patients: Patients must fail to meet the AIDS-defining criteria. CD4 lymphocyte count between 200 - 500 cells/mm3. Exclusion Criteria Co-existing Condition: Excluded: Patients with obvious ultra violet(UV)-irradiated skin damage in the treatment sites. Concurrent Medication: Excluded: Patients who are likely to commence antiretrovirals within the 6-month study period. Patients using other immunomodulator therapies or other alternative therapies. Patients likely to require chemotherapy during the course of the study. Concurrent Treatment: Excluded: Patients who are likely to require significant UV light exposure during the study period. Patients who are likely to require radiation therapy during the course of the study. Prior Medication: Excluded: Prior exposure to DNCB. Patients who have used antiretroviral medications within the previous 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dinitrochlorobenzene|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
-----------------
Dinitrobenzenes, Cohort Studies, RNA, Viral, Administration, Cutaneous, Anti-HIV Agents
Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

Study Overview
=================
Brief Summary
-----------------
Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR). The purpouse of this study is to evaluate the indication to a second TAVR, the selection criteria of the second transcatheter aortic valve, procedural and clinical outcomes. The primary endpoint of the study is overall mortality and Cardiovascular mortality at 1 year

Official Title
-----------------
Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve. An International Registry

Conditions
-----------------
Failed Transcather Aortic Valve

Intervention / Treatment
-----------------
* Device: TAVR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR). 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 |
| --- | --- |
| failed transcather aortic valve (Stenotic)<br> | Device: TAVR<br>* Trancatheter aortic valve replacement<br>|
| failed transcather aortic valve (Regurgitation)<br> | Device: TAVR<br>* Trancatheter aortic valve replacement<br>|
| failed transcather aortic valve (Regurgitation and stenotic))<br> | Device: TAVR<br>* Trancatheter aortic valve replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Overall mortality and Cardiovascular mortality at 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VARC-3 Events | Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2). | 1 year |
Superficial and Cutaneous Fungal Infections Among Drug-users in Northeast Region of Iran

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran

Detailed Description
-----------------
There were two groups with overall members of 1436. Statistically, the investigators have used Likelihood ratio  and  Exact's Fisher tests.

Official Title
-----------------
The Comparison of Dermatophytosis and Other Fungal Infections Between Drug Users and Non Drug Users

Conditions
-----------------
Skin and Subcutaneous Tissue Fungal Infections

Intervention / Treatment
-----------------
* Other: Direct Examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected fungal lesions Exclusion Criteria: non use of local or edible anti-fungal drugs and not taking bath within the last 48 hours of testing
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 |
| --- | --- |
| Drug Users<br>Case group that consisted of drug users with fungal infections | Other: Direct Examination<br>* It was an observational study and subjects received their routine treatment.<br>|
| Non-drug Users<br>Control group that consisted of non drug users with fungal infections | Other: Direct Examination<br>* It was an observational study and subjects received their routine treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users |  | up to two months |
Study to Evaluate the Effects of Kuvan on Individuals With Phenylketonuria (PKU) With Maladaptive Behaviors

Study Overview
=================
Brief Summary
-----------------
To validate the outcome measures and the tolerability of Kuvan treatment in the improvement of behavioral symptoms in 10 selected adults with Phenylketonuria (PKU) with or without mental retardation.

Official Title
-----------------
Pilot Study to Evaluate the Effects of Kuvan on Adult Individuals With Phenylketonuria With Measurable Maladaptive Behaviors

Conditions
-----------------
Phenylketonuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biochemical confirmation of PKU, Measurable maladaptive behavior at baseline, Signed informed consent, Not pregnant or lactating, Females on birth control if applicable, Willing to comply. Exclusion Criteria: Subjects or care provider unreliable, use of investigational products within 30 days prior to enrollment, Pregnant or lactating, Concurrent disease or condition that would interfere with study participation or safety, ie multiple psychotropic meds, any condition the PI renders the subject at high risk, on drugs that inhibit folate synthesis, Concurrent use of levodopa.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Pattern of change from baseline to 6 and 12 months in Vineland scale standard scores, evaluated with a repeated measure ANOVA approach. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation and regression methods (non-linear if appropriate) to examine the relationship between changes in behavior and in amino acid profiles. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PKU,, Phe,, PAH,, Kuvan,, Trp,, Tyr