linjc16/ctgov huggingface dataset:
Optisure Lead Post Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.

Official Title
-----------------
Optisure Lead Post Approval Study

Conditions
-----------------
Heart Failure, Tachycardia, Ventricular

Intervention / Treatment
-----------------
* Device: St. Jude Medical Optisure Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients will meet all of the following: Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. Are 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: Patients will be excluded if they meet any of the following: Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study. Have a life expectancy of less than 5 years due to any condition.

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 |
| --- | --- |
| St. Jude Medical Optisure Lead<br>Patients implanted with St. Jude Medical Optisure Lead | Device: St. Jude Medical Optisure Lead<br>* Patients implanted with St. Jude Medical Optisure Lead<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from RV Lead Related Complications |  | Date at which all patients have completed their five year follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optisure Lead-Related Complication Rates |  | Date at which all patients have completed their five year follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HV Lead, ICD, CRT-D System, Treatment of Heart Failure, Treamtent of life-threatening ventricular tachyarrhythmia, Optisure
Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO)

Study Overview
=================
Brief Summary
-----------------
Bipolar disorder affects more than 1% of the population. This pathology is considered as one of the most serious psychiatric disorder because of it is high suicide rates. It impacts patients life quality on many aspects, and specially their sleeping and circadian Rhythms. This can lead to more severe symptoms up to for thymic relapses. It was shown that Luminotherapy and Psychoeducation Program have a positive impact on these type of symptoms.

Official Title
-----------------
Prise en Charge infirmière Des Anomalies du Sommeil et du Rythme Circadien Par luminothérapie et/ou un Programme Court de psychoéducation Chez Des Patients Souffrant de Troubles Bipolaires

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

Intervention / Treatment
-----------------
* Other: Luminotherapy and /or Psychoeducation Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: Bipolar disorder (type 1 and 2 according to DSM V) Mood Disorder Questionnaire MDQ ˂ 7 Sleeping and Circadian Rhythms Disorders Under treatment Main exclusion Criteria: No addiction except for tobacco Narcolepsy Sleep Apnea Psychiatric comorbidities Suicidal ideation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luminotherapy and Psychoeducation Program<br> | Other: Luminotherapy and /or Psychoeducation Program<br>* TO complete<br>|
| Active Comparator: Psychoeducation Program<br> | Other: Luminotherapy and /or Psychoeducation Program<br>* TO complete<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days in-hospital | Number of days patients spent in the hospital | Day 0 to Day 365 |
Sleep Apnea and Tromboembolic Disease

Study Overview
=================
Brief Summary
-----------------
There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (VTE). OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and BMI matched control group. Assessment of the association between SAHS and other risk factors for VTE. To compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with SAHS and VTE and those ones without SAHS.

Detailed Description
-----------------
DESIGN: Case-control study. METHODS: 133 SAHS patients and 133 controls will be studied. The study includes: a) medical history; b) anthropometric variables (weight, height, body mass index, Mallampati index); c) sleepiness tested by Epworth scale; d) London Chest Activity of Daily Living Scale; e) conventional polysomnography (PSG); f) testing: clotting-fibrinolisis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); g) d-dimer and thrombin-antithrombin III complex; h) basic biochemical profile and hemograma; i) Pulmonary artery obstruction index.

Official Title
-----------------
Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism

Conditions
-----------------
Sleep Apnea Syndromes, Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case group: Pulmonary embolism diagnosed by CT Pulmonary Angiography. Control group: randomly selected from among patients in two primary health care centers in Mallorca without tromboembolic disease Exclusion Criteria: Refusal to sign informed consent. Expected survival less than 12 months Long-term oxygen therapy Hospital admission in the previous two months. Familiar thrombophilia
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLEEP APNEA, venous thromboembolism, COAGULABILITY, COAGULATION FACTORS, HYPOXIA
People of Color and Dermatology: A Deeper Look at Patients' Perceptions of Care and the Need for Greater Diversity in Dermatology

Study Overview
=================
Brief Summary
-----------------
Surveys will be collected to evaluate views from people of color and their dermatology experience. The information collected will look at patients' perceptions of care and the need for greater diversity in dermatology.

Detailed Description
-----------------
This survey looks to gain a much-needed perspective from POC in order to better understand their views on 1. the field of dermatology 2. the diversity in dermatology and its acceptance of skin of color and hair 3. skin of color centers 4. Race concordant dermatology and 5. perceived views on dermatologic training. The sample size will be the number of participants that respond to the survey, with a target sample size of 1000 respondents. Eligible participants need to identify with at least one of the following groups Black or African American Latinx American Indian or Alaska Native Native Hawaiian or Pacific Islander Asian Participants will need to be over the age of 18 years old, English-speaking/English proficient and anticipated to be living within the United States. Recruitment and screening will be done through ResearchMatch.

Official Title
-----------------
People of Color and Dermatology: A Deeper Look at Patients' Perceptions of Care and the Need for Greater Diversity in Dermatology

Conditions
-----------------
Dermatology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants need to identify with at least one of the following groups Black or African American Latinx American Indian or Alaska Native Native Hawaiian or Pacific Islander Asian Over the age of 18 years old English-speaking/ English proficient Anticipated to be living within the United States Exclusion: Subjects who do not meet the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Frequency (percentage) of participants with knowledge of skin of color clinics/training | The frequency (percentage) of participants who responded as knowing about skin of color clinics and skin of color training for dermatology. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
People of color, dermatology training
Uptake of Comprehensive Eye Examination Trial

Study Overview
=================
Brief Summary
-----------------
To evaluate a educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong. To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong.

Detailed Description
-----------------
A comprehensive eye examination includes visual acuity, slitlamp exam, pupil exam, intraocular pressure, gonioscope lens and 90D lens with slitlamp exam fundus. A number of eye diseases are irreversible at on early stage. Both glaucoma and diabetic retinopathy(DR)are frequently asymptomatic until significant, often-irreversible, damage to the vision has already occurred. It has been estimated that only 10% of persons in India with glaucoma are diagnosed, and the Handan Eye Survey reports that only 10% of persons with diabetes in rural areas of China have received diabetic eye care. In order to deliver effective care for DR and glaucoma in areas with limited resources, education of patients and interventions to promote compliance among patients will both be needed.

Official Title
-----------------
The Impact of Multimedia Education on Uptake of Comprehensive Eye Examination in Rural Southern China:A Randomized, Controlled Trial

Conditions
-----------------
Glaucoma, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Behavioral: video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥40 years who have never had a comprehensive eye examination Exclusion Criteria: inability to join 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>view a 10-minute informational video about comprehensive eye examination | Behavioral: video<br>* view a 10-minute informational video about comprehensive eye examination<br>|
| No Intervention: control group<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acceptance rate of comprehensive eye examination in both groups | acceptance rate of comprehensive eye examination | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledges of eye disease and attitude of eye examination | knowledges of eye disease and attitude of eye examination | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
comprehensive eye examination, acceptance, glaucoma, diabetic retinopathy
Study of Cetuximab in Combination With Tarceva in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find a safe and effective dose of the combination of cetuximab (Erbitux) and Tarceva (erlotinib).

Official Title
-----------------
A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Cetuximab + Erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Measurable disease Life expectancy of at least 3 months Must have at least one prior chemotherapy containing a platinum Exclusion Criteria: Known or documented brain metastases Prior cetuximab therapy

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Cetuximab + Erlotinib<br>* IV solution + tablet, IV+ oral, ERB 100 mg/m2, 200 mg/m2, 250 mg/m2 IV + Erl 150 mg tablet, ERB weekly/ Erl once daily, Until disease progression.<br>* Other names: Erbitux;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of the combination of Tarceva and Erbitux |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Solid Tumors
Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.

Official Title
-----------------
Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients

Conditions
-----------------
Peritoneal Dialysis Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRD patients The first time of peritoneal dialysis Exclusion Criteria: Age <18 years at start of PD Transfer or follow-up loss Previous transplantation or HD history Incomplete clinical data

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 |
| --- | --- |
| A<br>defined as patients survived on PD for more than 10 years | |
| B<br>defined as patients survived on PD for 5-10 years | |
| C<br>defined as patients survived on PD within 5 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline clinical characteristics before PD | clinical characteristics about age,sex,comorbidities before PD,laboratory data would be aggregated from the existing record to find out the differences between the long-term PD patients and the others that may affect their clinical outcome. | within one month before the start of PD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the factors that may lead to the termination of PD | Some patients may end the PD early ,some late due to many reasons.To find out the factors that may influence survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment, the investigators collect and record the reasons for termination of PD to analyze. | up to 20 years |
The Effect of Pandemic on Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Cerebral Palsy (CP), is the most common cause of physical disability that begins in childhood and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17 million worldwide. Social isolation, economic conditions, interruption of treatments, etc. may cause physical, mental, behavioral and psychosocial changes in children with cerebral palsy. Discontinuing regular physiotherapy can worsen functional skills and cause complications in children with cerebral palsy. Our aim in this study is to investigate the sustainability of the treatments of children with cerebral palsy during the pandemic period, their physical and psychosocial effects, and the relationship between their parents' fear of covid-19.

Official Title
-----------------
Investigation of the Effect of Covid-19 Pandemic on Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021 Exclusion Criteria: Parents of Cerebral Palsy Patients over 18 years of age Parents who cannot be reached by phone Parents who do not agree to fill out the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Evaluation Survey | A questionnaire form consisting of 19 questions and 3 parts prepared by the authors in the light of the information obtained during the clinical observation process of children with cerebral palsy will be used. | First day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covid-19 Fear Scale | Parents' fear of COVID-19 will be evaluated with the COVID-19 fear scale consisting of 7 questions. The items of the scale were created on the basis of a comprehensive review of existing scales on fear, expert evaluations, and participant interviews. | First day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pandemics, Cerebral Palsy, Covid19
Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy

Study Overview
=================
Brief Summary
-----------------
This is a multi-center clinical study designed to assess the performance of the Triage NGAL test as an aid in the early risk assessment for contrast-induced nephropathy (CIN). Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving administration of iodinated contrast agent(s) will be enrolled.

Detailed Description
-----------------
EDTA anti-coagulated blood samples will be drawn at eight different time points from within 1 hour prior to first contrast administration through 48 hours. These blood samples will be processed to plasma at the clinical site, frozen and shipped to Biosite for storage and testing of Triage NGAL and serum creatinine. The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the subject. Any additional serum creatinine measurements obtained by the medical team as part of routine care as well as need for dialysis, hospitalization, major adverse cardiovascular events and mortality will be recorded through Day 30.

Official Title
-----------------
Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy

Conditions
-----------------
Cardiovascular Surgery With Coronary Angiography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 18 years of age or older; Undergoing angiographic procedure involving the intra-arterial administration of iodinated contrast agent(s); Chronic kidney disease indiacated by an eGFR < 75 ml/min/1.73 m2 based on screening labs performed ≤ 3 months prior to procedure. Able and willing to provide written informed consent for study participation and to comply with all study procedures. Exclusion Criteria: Renal transplant recipients Pre-existing evidence of acute renal failure at the time of enrollment. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at enrollment. Coronary artery bypass surgery or PCI within the previous 30 days. Participation in an interventional clinical study with an experimental therapy within the previous 30 days. Administration of intravasular contrast within the previous 30 days. Undergoing renal artery stenting.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast Induced Nephrophathy (CIN), Kidney, NGAL