linjc16/ctgov huggingface dataset:
Female Cancer Patients' Preference For Sexual Health Interventions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to survey female cancer patients' awareness of and preference for methods to improve sexual health. This information will help to improve our understanding of the needs and preferences for sexual health strategies and interventions of our female patients. The findings of this survey will also be used to develop feasible sexual health resources for our patients and enhance the success of grant proposals to support future sexual health interventions at MSKCC.

Official Title
-----------------
A Pilot Study Surveying Female Cancer Patients' Preference For Sexual Health Interventions

Conditions
-----------------
Breast Cancer, Gynecologic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be able to communicate in English to complete the tests. Study group of breast and/or gynecological cancer survivors. History of Primary diagnosis of breast and/or gynecological cancer At least 21 years of age. In the judgement of the consenting professional able to provide informed consent In the judgement of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments. Exclusion Criteria: In the judgement of the consenting professional, the individual is able to provide informed consent. Patients with a psychiatric disorder precluding response to the surveys.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| survey<br>Participants will be asked to complete a survey as a one time assessment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant' awareness of sexual health issues & preference for sexual health intervention |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess & describe female cancer patients' attitudes towards & preference of methods to receive sexual health information (verbal or written) & psychosexual education patient information cards or intervention modality (telephone, in-person or online). |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survey, Sexual Health Issues, 10-034
Doppler Imaging and Morbidly Adherent Placenta

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta as well as predict the surgical outcome regarding the type of surgery and the intra operative morbidities.

Official Title
-----------------
The Role of Grey Scale Ultrasound, 2D, and 3D Power Doppler in Diagnosing and Predicting the Surgical Risks in Patients With Morbidly Adherent Placenta.

Conditions
-----------------
Antepartum Hemorrhage

Intervention / Treatment
-----------------
* Device: 3D Doppler Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 - 45. Pregnant 32 weeks or more. Placenta previa (Major and Minor). History of previous cesarean section. Exclusion Criteria: Medical disorders such as bleeding disorders. Lethal fetal anomalies. Delivery before 34 weeks.

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

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

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: Interventional group<br>Patients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion. | Device: 3D Doppler Ultrasound<br>* 3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 3D power Doppler in detecting morbidly adherent placenta. |  | 12 months |
A Possible Effect of Oxytocin During Interaction Between Humans and Animals

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals.

Detailed Description
-----------------
The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals and filling in instruments measuring anxiety and stress.

Official Title
-----------------
A Possible Effect of Oxytocin During Interaction Between Humans and Animals

Conditions
-----------------
Animal Assisted Therapy

Intervention / Treatment
-----------------
* Other: Measuring oxytocin level in blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman age 20-30 years old physical capable of being in a farm environment and have contact with cows Exclusion Criteria: pregnancy breastfeeding anxiety for blood sampling anxiety for animals allergies psychiatric diagnoses medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measuring oxytocin level in blood|Blood sampling and instruments measuring anxiety and stress|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the possible change in Oxytocin level in human blood during intervention with farm animals. | Blood sampling will be drawn at baseline, before intervention starts, and 5 minutes after start. 3rd sample will be drawn 15 minutes after start. Total time of intervention is 15 minutes. | Start medio October 2010, and end December 2011 (14 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self evaluation of anxiety and coping strategies. | Spielberger State Anxiety Inventory (SSAI) (Spielberger et al, 1979)and Coping Strategies Scale of the Pressure Management Indicator (Williams & Cooper, 1998. | Start medio October 2010, and end December 2011 (14 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin, Animal Assisted therapy, Farm animals, Healthy nursing students
Feasibility Study of the ReVENT Sleep Apnea System

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.

Official Title
-----------------
Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Obstructive Sleep Apnea (OSA)

Intervention / Treatment
-----------------
* Device: ReVENT Sleep Apnea System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of OSA with AHI 15-40 Body Mass Index (BMI) ≤ 32 Refused or failed Continuous Positive Airway Pressure (CPAP) Evidence of airway collapse at soft palate and/or base of tongue Exclusion Criteria: Prior OSA surgery Anatomy unable to accommodate implants Chronic immunosuppressive therapy or known problems with wound healing Type I or II diabetes Active systemic infection Pregnancy Other major medical conditions that could confound outcome measures or interfere with study completion

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReVENT Sleep Apnea System<br>All patients will be implanted with the ReVENT Sleep Apnea System | Device: ReVENT Sleep Apnea System<br>* The ReVENT Sleep Apnea System consists of minimally invasive biocompatible devices that are placed into the tongue base and palate of patients with obstructive sleep apnea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | Decrease in polysomnographically measured AHI post-intervention compared to baseline | 24 months post-procedure |
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a novel digital image enhancement (DIE) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail placement for treatment of hip fractures. Secondarily, to evaluate whether the image quality and reproducibility of desired images can be improved with use of the DIE technology. Finally, to evaluate whether DIE technology reduces total operative time.

Official Title
-----------------
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures

Conditions
-----------------
Radiation Exposure

Intervention / Treatment
-----------------
* Device: DIE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: closed hip fracture requiring intramedullary nailing Exclusion Criteria: age <18 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Image Enhancement (DIE) Group<br>A novel digital image enhancement technology will be used intraoperatively | Device: DIE<br>* digital image enhancement<br>|
| No Intervention: Control Group<br>Standard intraoperative imaging will be used intraoperatively | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge |  | intraoperatively | 
| Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge |  | intraoperatively | 
| Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge |  | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality and Reproducibility of Desired Images | Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality. | intraoperatively | 
| Operative Time |  | intraoperatively |
A Long Term Effect of Collaborative Care on Depression Treatment in a Community Dwelling Elderly

Study Overview
=================
Brief Summary
-----------------
Suicide is a significant cause of death in Korea. According to the report compiled by the Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when they committed suicide. Therefore, this study aimed the impact of a care management intervention on depression treatment and reducing suicidal ideation in elderly patients with depression.

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: care management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 and older current major or minor depression Exclusion Criteria: severe cognitive dysfunction severe auditory dysfunction history of psychosis

Ages Eligible for Study
-----------------
Minimum Age: 60 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: care management type 1<br>2-month care management | Other: care management<br>* 6-month care management<br>|
| Active Comparator: care management type 2<br>6-month care management | Other: care management<br>* 6-month care management<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAMD) |  | 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| suicide ideation | suicide ideation: suicide questionnaire | 6 months after baseline | 
| treatment compliance |  | at 6 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
care management, depression, elderly, Korea
Study of Sexuality in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the different aspects of sexual function among adults with Parkinson Disease to develop a treatment and address sexual problems as a routine part of diagnostic workup and therapeutic planning.

Detailed Description
-----------------
Because there is limited literature on sexual function in Parkinson disease, in this study, we examined sexual functioning in a large groups of patients with idiopathic Parkinson Disease compared with healthy subjects in the Italian community. To assess sexual function in PD we used the Brief Index of Sexual Functioning [(BISF-M for man; BISF-W for woman), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Participants were also assessed by the Beck Depression Inventory (BDI). This study aimed to provide a thorough epidemiological description of sexual dysfunction in Parkinson's disease. The knowledge of sexual function in PD might help to plan effective interventionist measures and ultimately to optimize patient's and the partner's quality of life. Parkinson patients (aged 40-80) and 123 healthy controls (aged 40-80) will be recruited from four Italian Movement Disorders Clinics.

Official Title
-----------------
Study of Sexuality in Parkinson Disease

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic PD marital status age 40-80 Exclusion Criteria: patients taking PDE

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson Disease<br>Patients with Parkinson Disease | |
| Healthy Subjects<br>Healthy Subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BISF | Brief Index of Sexual Functioning (BISF-M for man; BISF-W for woman)International Index of Erectile Function (IIEF) Female Sexual Function Index (FSFI) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI | Beck Depression Inventory (BDI) is a 21.-item self report inventory, for measuring the severity of depression in clinical and nonclinical populations. | Baseline | 
| PDQ8 | Parkinson' Disease Questionnaire-8 (PDQ- 8) is a self completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson's disease. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexuality, Parkinson Disease, BISF, IIEF, FSFI
A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.

Official Title
-----------------
A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Combination Product: VC-01™ Combination Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women (non-pregnant and non-childbearing potential) Diagnosis of type 1 diabetes mellitus for at least 3 years Stable diabetic treatment Willingness to use a continuous glucose meter Acceptable candidate for implantation Exclusion Criteria: Advanced complications associated with diabetes Immunosuppressive therapy

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>2 VC-01™ Combination Product implants | Combination Product: VC-01™ Combination Product<br>* Biologic and Device<br>|
| Experimental: Cohort 2<br>4 or 6 VC-01™ Combination Product implants | Combination Product: VC-01™ Combination Product<br>* Biologic and Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events Reported During the Study. |  | Thru the Month 24 Visit | 
| Change in C-peptide | The Full Analysis Set (FAS) is the intent-to-treat (ITT) set of subjects. This set is defined as all T1DM subjects who were enrolled into the study and received implantation of at least one VC-01-250 or sentinel unit on Study Day 1. The FAS (Cohort 2 T1DM subjects who meet the FAS criteria) will be used to analyze the primary efficacy endpoint. | Baseline to the Month 6 Visit |
Study of FFI-1010 in Pediatric Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.

Official Title
-----------------
Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).

Conditions
-----------------
Children Under 18 Years Old With Kidney Disease

Intervention / Treatment
-----------------
* Drug: FFI-1010


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney disease patients requiring exact evaluation of kidney function eGFR: >=30 and <=89 mL/min/1.73m^2 Exclusion Criteria: Edema on the day before start of study treatment Oliguria on the day before start of study treatment Dehydration on the day before start of study treatment Infection or inflammatory disease before administration History of epilepsy or organic brain disorder History of, clinically significant cardiac, hematologic, hepatic and pancreatic disease

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

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

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

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: FFI-1010<br> | Drug: FFI-1010<br>* Intravenous single dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Cin to Ccr measuring at the same time | Demonstrating usability of inulin clearance by comparison between inulin clearance and creatinine clearance at the same time after the start of FFI-1010 administration | 120 minutes |