linjc16/ctgov huggingface dataset:
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Official Title
-----------------
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)

Conditions
-----------------
Actinic Keratoses

Intervention / Treatment
-----------------
* Drug: PEP005 (ingenol mebutate) Gel
* Drug: Vehicle gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be male or female and at least 18 years of age. Female patients must be of: Non-childbearing potential; Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception. 4 to 8 AK lesions on non-head locations. Exclusion Criteria: Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area. Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks. Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PEP005 (ingenol mebutate) Gel | Drug: PEP005 (ingenol mebutate) Gel<br>* two day treatment<br>|
| Placebo Comparator: 2<br>Vehicle gel | Drug: Vehicle gel<br>* two day treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Complete Clearance of Actinic Keratosis (AKs) | Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area. | 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Partial Clearance of Actinic Keratosis (AKs) | Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area. | baseline and 57 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peplin, Actinic keratosis, PEP005
Differences in Quality of Life After Thoracic Outlet Syndrome Surgery

Study Overview
=================
Brief Summary
-----------------
Quality of life evaluation after thoracic outlet surgery with Quick-DASH and SF-36 forms

Official Title
-----------------
Differences in Quality of Life After Thoracic Outlet Syndrome Surgery

Conditions
-----------------
Thoracic Outlet Syndrome

Intervention / Treatment
-----------------
* Other: QuickDASH form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: thoracic outel syndrome surgery scheduled in the vascular and thoracic surgery department of Angers ; age > 18 y ; french language understood Exclusion Criteria: denied of consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with a completed form<br> | Other: QuickDASH form<br>* Patients have to complete these two forms, Quick DASH and SF-36, before surgery then 6 weeks after<br>* Other names: SF-36 form;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from QuickDASH form results before surgery at 6 weeks after surgery |  | Results before surgery and at 6 weeks after surgery are compared | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from SF-36 form results before surgery at 6 weeks after surgery |  | Results before surgery and at 6 weeks after surgery are compared |
Nutritional Content of Breast Milk From Mothers of Premies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.

Official Title
-----------------
The Nutritional Content of Breast Milk From Mothers of Premature Neonates During the First 28 Days of Life

Conditions
-----------------
Prematurity, Nutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers of infants with a gestational age <=30 weeks in the NICU who are supplying their own breast milk for use by their baby Reasonable likelihood of survival of infant to 28 days Infant on/ready for oral feeding by DOL 7 days Willing to provide breast milk for their baby Able to produce at least 7mL breast milk per feeding Willing to abide by requirements of the study protocol Documentation of informed consent Exclusion Criteria: Unable to provide at least 7mL breast milk per feeding Medically unsuitable to provide breast milk to her baby Maternal age <18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 30 Weeks

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period. |  | 28 days of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prematurity, Nutrition, Breast Feeding
Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Study Overview
=================
Brief Summary
-----------------
Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity

Official Title
-----------------
Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Drug: intravitreal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retinopathy of prematurity stages III, IV and V in which we can not treat with laser o cryotherAPY Exclusion Criteria: PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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

| Intervention/Treatment |
| --- |
|Drug: intravitreal injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical appearance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinopathy of prematurity, antiangiogenic therapy
An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the effectiveness of BRAF inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600 mutation. Patients will be treated per the locally approved therapeutic options in clinical practice. The observation period for each patient will be up to 24 months.

Conditions
-----------------
Malignant Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age at diagnosis Histologically confirmed new diagnosis of unresectable or metastatic melanoma Patients with tumor samples available for assessment of BRAF V600 mutation Exclusion Criteria: Prior systemic therapy for metastatic disease Participation in interventional clinical trials

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2 years | 
| Best Overall Response Rate (BORR) |  | 2 years | 
| Time to response |  | 2 years | 
| Duration of response |  | 2 years | 
| ECOG performance status |  | 2 years | 
| Safety: Incidence of adverse events |  | 2 years |
Rhupus Syndrome and Efficacy of Etanercept Treatment

Study Overview
=================
Brief Summary
-----------------
between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

Detailed Description
-----------------
between March 2013 and March 2014, patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) >5.1 were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

Official Title
-----------------
the First People's Hospital of Chenzhou

Conditions
-----------------
Rhupus Syndrome, Etanercept

Intervention / Treatment
-----------------
* Drug: etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Rhupus patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) >5.1 Exclusion Criteria: - those who had participated in other studies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Rhupus syndrome, SLE without RA<br>Rhupus syndrome, SLE without RA | Drug: etanercept<br>* 25-mg etanercept injection subcutaneously twice a week<br>* Other names: TNFа blockade;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score in 28 Joints (DAS28) |  | 24 week |
Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications. The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.

Official Title
-----------------
Prophylactic Application of an Incisional Wound Vac to Prevent Wound

Conditions
-----------------
Spine Surgery, Wounds Vac

Intervention / Treatment
-----------------
* Device: Wound Vac
* Other: Standard Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be scheduled to have posterior spine surgery (inpatient procedures only). Have a BMI greater than or equal to 35. Exclusion Criteria: BMI less than 35 Previous spine infection Intraoperative dural tear

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wound Vac<br>Wound vac | Device: Wound Vac<br>* a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns.<br>* Other names: Negative pressure therapy;|
| Active Comparator: Standard Dressing<br>Standard Dressing | Other: Standard Dressing<br>* standard dressing with drain tube and bandage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative infection requiring return to operating room |  | 6 weeks post surgery |
Effect of Calcium and Vitamin D on Bone Loss From the Hip

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older.

Detailed Description
-----------------
In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared.

Official Title
-----------------
Effect of Calcium and Vitamin D on Bone Loss From the Hip

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Calcium 500 mg/day and vitamin D 700 IU/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >65 years calcium intake < 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment Exclusion Criteria: Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine > 300 mg/d women or >350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calcium 500 mg/day and vitamin D 700 IU/day|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Density of the hip |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual and Seasonal patterns of change in bone mineral density of the hip |  |  | 
| Associations between biochemical, physical and life-style factors |  |  | 
| Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calcium, vitamin D, bone loss
Dietary Intervention and Adults With Intellectual Disabilities

Study Overview
=================
Brief Summary
-----------------
Goal The overall aim of the study is to improve the health of persons with Intellectual disabilities

Detailed Description
-----------------
Purpose There are two main purposes of the study The first is to study the diet and heath of persons with intellectual disabilities. The second is to increase their knowledge on nutrition and health and that of service providers in municipalities housing facilities and to test, in an intervention, the effects of a method for weight reduction in adult persons with intellectual disabilities with overweight and obesity. Physical activity is also an important factor in weight reduction, but this study focuses only on nutrition, to obtain new information on this one factor in weight reduction. A combined study with many changes in a short period of time is very challenging for the group in question. The vision is that results from this study will lead to improved health promotive and preventive services in the municipality in the future, to adult persons with intellectual disabilities and that this study also can have effects on services also for other groups, such as those with the fields of psychiatry and drug problems.

Official Title
-----------------
Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method

Conditions
-----------------
Intellectual Disabilities Nutritional, Intellectual Disability

Intervention / Treatment
-----------------
* Behavioral: Nudging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Mild intellectual disability and overweight Moderate intellectual disability and overweight Exclusion Criteria: Metabolic diseases Hypertension Diabetes
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Improve dietary pattern<br>Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight | Behavioral: Nudging<br>* Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight by using a nudging approach in adults with intellectual disabilities | 2 kg weight decrease | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in consumption of fruits and vegetables as measured using dietary survey | Dietary change 1 | One year |
Prospera Test Evaluation in Cardiac Transplant (ProTECT)

Study Overview
=================
Brief Summary
-----------------
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.

Detailed Description
-----------------
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant.

Official Title
-----------------
Prospera Test Evaluation in Cardiac Transplant (ProTECT)

Conditions
-----------------
Heart Transplant Rejection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older at the time of enrollment. Exclusion Criteria: Pregnant at the time of signing informed consent.

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 |
| --- | --- | --- |
| Primary molecular endpoint: | Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test. | 3 years |