linjc16/ctgov huggingface dataset:
Symptom Management in African-American Men With Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life. PURPOSE: This clinical trial is studying symptom management in African-American men with localized prostate cancer.

Detailed Description
-----------------
OBJECTIVES: Develop a symptom management intervention for African-American men treated for localized prostate cancer, with a particular emphasis on low health literacy men. OUTLINE: Participants are interviewed by the principal investigator over the phone or meet the principal investigator at the Veterans Administration prostate cancer clinic. If the interview is conducted in the clinic, it is held in a private room in the clinic.

Official Title
-----------------
PROSTATE CANCER SYMPTOM MANAGEMENT FOR LOW LITERACY MEN

Conditions
-----------------
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
-----------------
* Other: questionnaire/survey administration


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Biopsy-proven localized prostate cancer Has received treatment for prostate cancer Patient self-identifies as being of African-American descent PATIENT CHARACTERISTICS: Able to speak and read in English Has an address in order to receive study materials by mail (a street address or post office box) Has either a telephone in order to be interviewed OR is able to meet the principal investigator at the Veterans Administration prostate clinic and be interviewed there PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire/survey administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom management taxonomy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychosocial effects of cancer and its treatment, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
HPV Infections in Older Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.

Detailed Description
-----------------
Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a longitudinal study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 300 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect four sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. We will identify behavioral and health predictors of type-specific HR HPV infections, predictors of repeatedly-detected HR HPV infections, and evaluate study participants' experiences with self-collecting vaginal specimens and attitudes towards HPV vaccination and cervical cancer screening. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.

Official Title
-----------------
HPV Infections in Older Women

Conditions
-----------------
Papillomavirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had sex with men Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website) Exclusion Criteria: Pregnant, breastfeeding, or planning a pregnancy in the next 6 months Hysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
| High-risk HPV DNA |  | Every 4 months for 1 year |
Safety and Patient Satisfaction With GLASH VISTA™ (Bimatoprost 0.03%) in the Treatment of Eyelash Hypotrichosis in Japan

Study Overview
=================
Brief Summary
-----------------
This is a post-marketing surveillance study in Japan that will evaluate the safety and patient satisfaction with GLASH VISTA™ (bimatoprost cutaneous solution 0.03%) in the treatment of hypotrichosis of the eyelashes.

Conditions
-----------------
Eyelash Hypotrichosis

Intervention / Treatment
-----------------
* Drug: Bimatoprost cutaneous solution 0.03%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients who have been prescribed GLASH VISTA™ in clinical settings and filled at least one prescription for GLASH VISTA™. Exclusion Criteria: -None.

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 |
| --- | --- |
| GLASH VISTA™<br>Patients with eyelash hypotrichosis prescribed bimatoprost cutaneous solution 0.03% (GLASH VISTA™) as per local standard of care in clinical practice. | Drug: Bimatoprost cutaneous solution 0.03%<br>* Bimatoprost cutaneous solution 0.03% (GLASH VISTA™) prescribed as per standard of care in clinical practice.<br>* Other names: Latisse®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | Up to 12 Months | 
| Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey |  | Baseline, Month 1 | 
| Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey |  | Baseline, Month 4 | 
| Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey |  | Baseline, Month 12 |
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.

Official Title
-----------------
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery

Conditions
-----------------
Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Ischemic Preconditioning

Intervention / Treatment
-----------------
* Procedure: Remote Ischemic Preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing heart surgery on cardiopulmonary bypass. Exclusion Criteria: Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection. End-stage renal disease. Inability to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preconditioning<br> | Procedure: Remote Ischemic Preconditioning<br>* Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.<br>|
| No Intervention: Control<br>Standard clinical management during cardiac surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl. |  | 48 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oliguria. |  | 12 hours after surgery. | 
| Incidence of acute kidney injury as defined by post-operative elevation in NGAL. |  | 3 hours after cardiopulmonary bypass. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Cardiac Surgical Procedures, Ischemic Preconditioning
Etiology of Anemia

Study Overview
=================
Brief Summary
-----------------
This study looks at the causes of anemia in adults of all ages who are referred by their primary care physician.

Detailed Description
-----------------
This study is being done to determine if the range of causes of anemia changes with advancing age. The goal of this study is to apply research methods to see if causes of anemia can be determined in patients where a clear cause is not found with routine clinical testing available to all patients in physician offices. Participants in this study will be evaluated at the NIA-ASTRA unit at Harbor Hospital in Baltimore. Testing will consist of both diagnostic and research blood and urine testing along with history and physical exam. An optional bone marrow aspirate or aspirate and biopsy may be performed if the patient permits and it is indicated for either research or clinical diagnostic purposes. All study information supporting a specific diagnosis will be provided to the patient and, at their request, to their primary care physician if specific treatment is indicated.

Official Title
-----------------
Studies in the Etiology of Anemia in an Unselected Sequential Referral Population

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Hemoglobin (Hgb) less than 13 in males and females Exclusion Criteria: Pregnant or nursing women Participation within the past six weeks in another research study which the Principal Investigator believes is incompatible with this study

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
-----------------
Aging
DNA Fragmentation - Effect on Pregnancy Rate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.

Official Title
-----------------
DNA Fragmentation - Effect on Pregnancy Rate

Conditions
-----------------
Infertility, Male

Intervention / Treatment
-----------------
* Dietary Supplement: Punalpin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male fertility patients with increased amount of DNA fragmentation in their spermatozoa 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Punalpin<br> | Dietary Supplement: Punalpin<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm DNA fragmentation | Reduction in DNA fragmentation | 4 months |
Endoscopic Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture

Study Overview
=================
Brief Summary
-----------------
The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL transfer may reduce the risk for soft tissue problems. Functional outcome parameters are investigated, wound/soft tissue complications registered.

Detailed Description
-----------------
The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot scores at 80-89. The extensive surgical field by either a two-incision approach or a single longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may reduce the risk for soft tissue problems while retaining a good functional outcome. Several functional outcome measures and scores are evaluated a year after surgery. Prospective study for evaluation of the surgical procedure.

Official Title
-----------------
Endoscopic Assisted Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture. A Prospective Multi Center Cohort Study

Conditions
-----------------
Achilles Tendon Rupture

Intervention / Treatment
-----------------
* Procedure: FHL transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Achilles Tendon Rupture Exclusion Criteria: Pregnancy BMI<18.5 or >39.9 Insufficient Norwegian Language proficiency lack of communication skills local skin conditions at site for planned surgery

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: FHL transfer|endoscopic transfer og flexor hallucis longus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score |  | one year after FHL transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for Pain (VAS pain) score | patient reported outcome | 3, 6 and 12 months after FHL transfer | 
| patient reported function score (PRFS) | patient reported Activity related disability | 6, 12 months | 
| Magnetic resonance imagine (MRI) | FHL hypertrophy | one year post surgery | 
| functional test battery | jump- and strength tests | 12 months | 
| local wound conditions | wound infection | within 12 weeks | 
| AOFAS hindfoot |  | 3,6,12 months | 
| VISA-A |  | 6 months after surgery |
Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety of DTI-0009 in patients with atrial fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial fibrillation with rapid ventricular response.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: DTI-0009


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Primary diagnosis of atrial fibrillation with rapid ventricular response of any duration as documented by an ECG Exclusion Criteria Presence of other significant cardiac disease or history of significant neurological, hepatic,cardiovascular, renal, gastrointestinal, thyroid, respiratory, rheumatologic, or hematologic disease or impairment that in the investigator's judgment is serious enough to preclude the patient from safely participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DTI-0009|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
By this study the investigators wish to (1) quantify hip strength and functional-performance deficits at discharge after fast-track total hip arthroplasty (THA), and (2) investigate if changes in thigh circumferences, or hip pain are correlated to changes in hip strength and functional-performance after fast-track THA.

Detailed Description
-----------------
The investigators intend to use the results to optimize the rehabilitation programs for THA patients shortly after surgery

Official Title
-----------------
Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty Monitored Pre-operatively, on the Day of Discharge, and One Week Post-surgery

Conditions
-----------------
Osteoarthrosis Patients With Total Hip Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total hip arthroplasty patients Exclusion Criteria: inability to speak and understand Danish inability to perform the functional measurements due to other conditions

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 |
| --- | --- |
| Hypothesis generating study<br>Consecutive total hip arthroplasty patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip muscles strength |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance | tested by: Timed Up & Go test, 10 meter fast speed walking | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
function, hip muscle strength, hip replacement, hip pain,
CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The number of patients with acute congestion on chronic heart failure is increasing. Ultrafiltration has recently been proposed as an alternative approach for the stabilization of volume balance, especially in patients with imminent diuretic resistance. There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser effects on blood pressure and activation of renin angiotensin system, respectively . However, recent studies revealed conflicting results: demonstration the superiority of ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess of adverse events with ultrafiltration. Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer than aquaphesis with a constant ultrafiltration with comparable effectiveness

Official Title
-----------------
CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure - A Pilot Study to Optimize Individualized Volume Depletion

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Ultrafiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic heart failure scheduled for LVAD Indication for CVVH/Aquapheresis Exclusion Criteria: Renal Disease (GFR <20 ml / min)

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

| Intervention/Treatment |
| --- |
|Procedure: Ultrafiltration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in central venous pressure |  | Changes from Baseline to 48 h after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of net fluid loss |  | 48 h | 
| Measure of dyspnea using a visual analog scale |  | Changes from Baseline to 48 h after intervention | 
| heart function | right/left heart function measured by Echocardiography and BNP (Brain Natriuretic Peptide) | 7 days | 
| Biomarker | GFR, Cystatin C, HCO3-, NT-proBNP, CK, Troponin, Hematocrit | Changes from Baseline to 48 h after intervention | 
| Time until impaired plasma refill rate |  | 48 h | 
| blood pressure |  | Changes from Baseline to 48 h after intervention | 
| heart rate |  | Changes from Baseline to 48 h after intervention | 
| Serum Creatinine level |  | 48 h |