linjc16/ctgov huggingface dataset:
Anxiety and Depressive Symptoms in Placenta Previa / Accreta

Study Overview
=================
Brief Summary
-----------------
placenta previa is an obstetric complication which is associated with depression and anxiety. As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother

Detailed Description
-----------------
Placenta previa is an obstetric complication with a prevalence of 5.2 per 1000 pregnancies. placenta previa is associated with maternal morbidity and mortality. The delivery carries a risk of bleeding, emergency hysterectomy, organ damage and even death. During admission, counselling is done for the possible need for delivery at any time and the need for life saving hysterectomy. hysterectomy is a tough and difficult choice for patients, and the subsequent emotional process is often associated with depression, severe and prolonged feelings of sadness, diminished interest in activities and in sexual intercourse. Similarly, severe adverse psychological outcomes, including post-traumatic stress disorders, have been reported as a result of traumatic birth events. Antenatal depression and anxiety occur in approximately 13% and up to 21.7% of women, respectively. Rates of antenatal depression among women hospitalized for obstetrical risk can be as high as 19%. Research about the responses to a diagnosis of placenta previa is scarce. A study found increased anxiety score in women diagnosed with Placenta accreta spectrum. Other studies focussed on the post-trauma stress associated with hysterectomy versus uterine conservation. As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother.

Official Title
-----------------
Anxiety and Depressive Symptoms of Pregnant Women Diagnosed to Have Placenta Previa / Accreta

Conditions
-----------------
Anxiety Depression, Placenta Previa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient diagnosed to have placenta previa or accrete plan to deliver baby in Assiut women health hospital willing and able to participate Exclusion Criteria: pre-existing psychological disorders severe medical complications severe obstetric complications fetal abnormality
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 |
| --- | --- | --- |
| Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta | Depression Anxiety Stress Scale-21 | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of depressive and anxiety symptoms on women functioning and quality of life | SF-12 questionnaire | 10 minutes |
Cognitive Behavior Therapy for Adolescents With Bulimia

Study Overview
=================
Brief Summary
-----------------
We are interested in studying two different psychological treatments for eating disorders for adolescents (ages 12-18). The study is designed to help adolescents who are having problems with binge eating and/or purging. The treatment consists of 14 sessions of approximately one-hour each over about three months.

Detailed Description
-----------------
Interested adolescents will have a phone screen and then come in for an in-person psychiatric evaluation. If eligible and interested, they will be randomly assigned to 4 months of outpatient treatment (free of charge) that is either 1) cognitive-behavioral therapy or 2) supportive psychotherapy.

Official Title
-----------------
Cognitive Behavior Therapy for Adolescents With Bulimia Nervosa

Conditions
-----------------
Bulimia Nervosa

Intervention / Treatment
-----------------
* Behavioral: psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months) Major Depression Exclusion Criteria: Diagnosis of bipolar disorder, current psychosis, drug or alcohol abuse in past 3 months, acute suicidal risk, major depression producing significant functional impairment, significant medical illness, weight outside of normal weight range.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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: CBT, SP<br>cognitive behavioral therapy, supportive psychotherapy | Behavioral: psychotherapy<br>* 1) cognitive-behavioral therapy or 2) supportive psychotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge-eating a purging (EDE scores) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bulimia Nervosa, EDNOS, Adolescents
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

Study Overview
=================
Brief Summary
-----------------
To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population

Official Title
-----------------
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Device: RAM sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female subjects that are between 0 to 70 years old. Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin. Exclusion Criteria: Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications. Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI). Patients who the PI deems ineligible at the PI's discretion

Ages Eligible for Study
-----------------
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>The subjects will be enrolled into the test group and will receive RAM sensor. | Device: RAM sensor<br>* Rainbow Acoustic Monitoring sensor for measurement of respiratory rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects in which respiratory rate is collected | Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor | Duration of surgery |
Relative Bioavailability of a Fentanyl Patch

Study Overview
=================
Brief Summary
-----------------
Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.

Official Title
-----------------
A Study to Evaluate the Relative Bioavailability of a Fentanyl PAtch Transdermal Delivery System (25 ug/hr) (Sandoz) Compared to Duragesic (Fentanyl Transdermal SYstem 25 ug/hr Patches (Alza)

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Fentanyl patch 25 ug/nr Sandoz
* Drug: Duragesic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening. Exclusion Criteria: Negative test for HIV and hepatitis B and C No history of drug or alcohol treatment No allergies to opiates

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fentanyl patch 25 ug/hr Sandoz | Drug: Fentanyl patch 25 ug/nr Sandoz<br> <br> |
| Active Comparator: 2<br>Duragesic Patch 25 ug/hr | Drug: Duragesic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  | 3 weeks |
Ocular Imaging With Spectral Domain Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze macular retinal thickness and macular volume using the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with various ocular diseases.

Detailed Description
-----------------
Assessment of macular thickness is important for the treatment and follow-up of a variety of ocular diseases. The introduction of optical coherence tomography (OCT) has enabled clinicians to reliably detect small changes in macular thickness and to quantitatively evaluate the efficacy of different therapeutic modalities. In this study using the spectral domain-OCT, we examined the variations of macular retinal thickness and macular volume in normal eyes and in eyes with various ocular diseases.

Official Title
-----------------
Posterior and Anterior Ocular Imaging With Spectral Domain Optical Coherence Tomography

Conditions
-----------------
Healthy, Myopia, Hypermetropia

Intervention / Treatment
-----------------
* Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal eyes myopic eyes hypermetropic eyes Exclusion Criteria: systemic illness cataract previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spectral domain-OCT<br>Spectral domain-OCT scanning performed. | Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)<br>* macular cube scanning<br>* Other names: Cirrus™ HD-OCT, Carl Zeiss Meditec AG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular retinal thickness and volume |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spectral domain-OCT, macular thickness, myopia, hypermetropia, normal
Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells

Study Overview
=================
Brief Summary
-----------------
A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells

Official Title
-----------------
Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data

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

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with a checkpoint inhibitor (CPI) Age greater than or equal to 18 years on date of first claim for a CPI ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI Exclusion Criteria: Less than 18 years of age Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| Adults treated with a CPI therapy for cancer<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myocarditis |  | Approximately 7 years | 
| Incidence of myositis |  | Approximately 7 years | 
| Incidence of rhabdomyolysis |  | Approximately 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, myositis, myocarditis, rhabdomyolysis, checkpoint inhibitors
Phase I Pilot Study of Liver-Directed Gene Therapy for Partial Ornithine Transcarbamylase Deficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Evaluate the safety and feasibility of administering recombinant adenovirus containing the ornithine transcarbamylase gene to adults with partial ornithine transcarbamylase deficiency.

Detailed Description
-----------------
PROTOCOL OUTLINE: This a dose escalation study to estimate the maximum tolerated dose of recombinant adenovirus encoded with the ornithine transcarbamylase gene. Patients receive a single dose of virus infused into the liver under fluoroscopic guidance. Groups of 3 patients receive successively higher doses of virus; each cohort is observed for safety for 3 weeks before entry of the next group. Patients are followed weekly for 1 month, then every 3 months until stable.

Conditions
-----------------
Ornithine Transcarbamylase Deficiency Disease

Intervention / Treatment
-----------------
* Genetic: recombinant adenovirus containing the ornithine transcarbamylase gene


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Confirmed partial ornithine transcarbamylase deficiency Asymptomatic, i.e., at least 1 month since hyperammonemia --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- No pregnant or nursing women Negative pregnancy test required of fertile women

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

| Intervention/Treatment |
| --- |
|Genetic: recombinant adenovirus containing the ornithine transcarbamylase gene|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
-----------------
inborn errors of metabolism, rare disease, urea cycle disorder
Proton Radiation Therapy Registry

Study Overview
=================
Brief Summary
-----------------
The Johns Hopkins Proton Therapy center is establishing a registry to capture the full 3D radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.

Detailed Description
-----------------
Proton based radiation therapy has considerable dosimetric advantages over the standard photon based radiation therapy, with a significantly higher cost. The clinical advantages, however, may not be realized for all patient populations, even with the improved dose distributions. Establishing the clinical efficacy of proton therapy requires years of experience treating patients. The goal is to accelerate the knowledge gain through the use of the registry that allows for detailed information to be captured and is inclusive of every patient treated.

Official Title
-----------------
Proton Radiation Therapy Registry

Conditions
-----------------
Cancer, Therapy-Related

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated at the proton center. Exclusion Criteria: Any other than what is supplied in the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Cancer patients receiving proton radiation therapy<br>Registry of cancer patients who receive proton radiation therapy to track disease and toxicity outcomes. | Other: Registry<br>* Registry of cancer patients who receive proton radiation therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research registry of cancer patients receiving proton radiation therapy | This is a clinic based registry of cancer patients' data from participants to be collected over 15 years. The registry will be populated with 3D anatomy and radiation dosimetry from the RayStation treatment planning system used to plan all proton therapy patients. Clinical data will be extracted electronically from the MOSAIQ oncology information system used to manage the radiation therapy treatments. Structured clinical assessments will be routinely captured in the clinical workflow during patient encounters. Patient reported outcomes will be captured with iPad's using the OncoBrowser tools developed in radiotherapy that also interface with MOSAIQ. | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proton therapy
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether different types of online health tools can aid overweight individuals in reducing their weight and managing their cardiovascular risk factors in the context of an employee wellness program.

Official Title
-----------------
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Goal-Setting Tool
* Other: Health Web Sites


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vanderbilt University employee Completion of the 2009 Go For the Gold Health Risk Assessment (HRA) Obesity defined by BMI > 30 Identification of an additional risk factor on the HRA by either (a) a personal history of diabetes, high blood pressure, or high cholesterol or (b) a reported cholesterol >= 240 mg/dl, blood glucose >= 126 mg/dl, a systolic blood pressure >= 140 mm Hg, or a diastolic blood pressure >= 90 mm Hg Permission to be contacted regarding health on the HRA Exclusion Criteria: Pregnant females and those who become pregnant prior to completion of the study Age younger than 18 years or older than 65 years Non English speaking individuals

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal-Setting Tool<br> | Other: Goal-Setting Tool<br>* Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal<br>|
| Active Comparator: Health Web Sites<br> | Other: Health Web Sites<br>* Access to publicly available health-related web sites<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index |  | At enrollment and at 6 months | 
| Change in excess body weight |  | At enrollment and at 6 months | 

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