linjc16/ctgov huggingface dataset:
PET-guided External Beam Radiotherapy in Differentiated Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
Description of the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.

Detailed Description
-----------------
The role of post-operative external beam radiotherapy (EBRT) in differentiated thyroid cancer is still discussed considering the low clinical aggressiveness and the availability of ablative 131Iodine therapy. However, there is a subgroup of tumors which lose the ability to capture Iodine over time. This study wants to describe the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.

Official Title
-----------------
18F-FDG PET-guided External Beam Radiotherapy in Iodine-refractory Differentiated Thyroid Cancer

Conditions
-----------------
Differentiated Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: detectable thyroglobulin (Tg), negative post-metabolic radiotherapy whole body scintigraphy, no surgical indications. Exclusion Criteria: prior radiotherapy in the head and neck area pregnancy

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 |
| --- | --- |
| differentiated thyroid cancer<br>Patients with locally recurrent thyroid cancer, treated with radical radiotherapy after total thyroidectomy +/- central compartment and/or laterocervical lymphadenectomy, previously treated with one or more cycles of 131 Iodine-ablation (RAI) and TSH suppression. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan. Also laboratory tests are performed (HTG serum level evaluation in case of biochemical recurrence). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicities | Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03 and EORTC-RTOG scales, respectively. | 6 months |
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

Detailed Description
-----------------
This is a phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.

Official Title
-----------------
A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Drug: MEBO Wound Ointment
* Procedure: Standard of Care (sterile saline moistened gauze)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age Able and willing to provide informed consent Able and willing to comply with protocol visits and procedures Target ulcer duration of ≥4 weeks Exclusion Criteria: Ulcer of a non-diabetic pathophysiology Known or suspected allergies to any of the components of MEBO Malignancy on target ulcer foot Non-compliance in the screening or run-in period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEBO Wound Ointment<br>Topical application twice daily | Drug: MEBO Wound Ointment<br>* Topical application twice daily<br>|
| Active Comparator: Standard of Care (sterile saline moistened gauze)<br>Topical application twice daily | Procedure: Standard of Care (sterile saline moistened gauze)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of complete healing of the target ulcer. |  | 8 weeks of treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to achieve complete healing (days). |  | 8 weeks treatment period | 
| Absolute and percentage change in ulcer surface area from baseline to endpoint. |  | 8 weeks treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Foot Ulcers (DFUs)
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.

Official Title
-----------------
A Phase III, Randomized, Double-Blind, Placebo-controlled, Multicenter Study To Evaluate The Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Glimepiride With or Without Metformin

Conditions
-----------------
Diabetes Mellitus, Type II

Intervention / Treatment
-----------------
* Drug: Dutogliptin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1) BMI 20 to 48 kg/m2, inclusive HbA1c 7.0% - 10.0%, inclusive Age 18 to 85 years, inclusive Exclusion Criteria: Currently on 3 or more oral antidiabetic drugs or insulin. Type 1 diabetes mellitus

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dutogliptin<br>Dutogliptin | Drug: Dutogliptin<br>* Dutogliptin oral administration once daily on background of glimepiride with or without metformin<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo, oral administration once daily on background of glimepiride with or without metformin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) |  | HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) |  | FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26). |
Follicular Phase Stimulation vs. Luteal Phase Stimulation in Patients Diagnosed With Suboptimal Response

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the difference in the number of oocytes obtained by performing ovarian stimulation in follicular phase vs. luteal phase in a population of patients with previous suboptimal response. This is a controlled randomized clinical study. We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian stimulation in order to vitrify and accumulate oocytes. The main variable for evaluating the efficacy in this exploratory study will be the number of oocyte cumulus complexes obtained.

Official Title
-----------------
Conventional Stimulation in Follicular Phase vs. Luteal Phase Stimulation in Patients With Suboptimal Response. Randomized Clinical Trial. SUBLUTEAL Study

Conditions
-----------------
Improving Ovarian Stimulation; Suboptimal Responders

Intervention / Treatment
-----------------
* Drug: time of administration of Corifollitropin Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets Bologna criteria to be diagnosed as poor responder Less than 10 oocytes obtained in a prior controlled protocol of conventional ovarian stimulation Age < 41 years Body Mass Index (BMI) between 18 and 32 kg/m2 Regular menstrual cycles between 21 and 35 days. Indication for in vitro fertilization Indication to start stimulation with 150mcg of corifollitropin alpha Presence of both ovaries Ability to participate and comply with study protocol Signing an informed consent form Exclusion Criteria: Presence of follicles larger than 10 mm in the randomization visit Endometriosis stage III/IV Patients with less than 4 oocytes in previous ovarian stimulation and poor ovarian reserve parameters (as per Bologna criteria) Concurrent participation in another study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 Years

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

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

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 |
| --- | --- |
| No Intervention: follicular phase stimulation<br> | |
| Experimental: luteal phase stimulation<br> | Drug: time of administration of Corifollitropin Alfa<br>* The treatment will be identical in both arms. The difference between the arms is the moment of the Administration of Corifollitropin Alfa: follicular phase of the menstrual cycle (control group) vs. luteal phase of the menstrual cycle (study group).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes | number of oocytes after ovarian stimulation | at the end of stimulation |
A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.

Study Overview
=================
Brief Summary
-----------------
Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.

Detailed Description
-----------------
Protocol Objectives include: Determine the proportion of patients with HCC in whom the treatment plan can be completed Evaluate the response to therapy Evaluate toxicities and adverse experiences associated with TheraSphere treatment Evaluate survival time

Official Title
-----------------
Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Device: Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age of any sex, race Histological proof of HCC Able to give Informed Consent ECOG performance equal or less than 2 Life expectancy equal to or greater than 3 months Non- pregnant with acceptable contraception in premenopausal women Greater than 4 weeks since prior radiation therapy or surgery 1 month post chemotherapy Serum Bilirubin < 2.0 Acceptable white blood count Exclusion Criteria: Co-morbid disease that would place patient at undue risk. Pre-existing diarrhea/illness Pregnant Fail preliminary MAA testing

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Brachytherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| - Response to treatment |  |  | 
| - Survival time from treatment |  |  | 
| Safety: |  |  | 
| - Adverse experience |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver cancer, Brachytherapy
An Evaluation and Factor Analysis for Maternal Mental Health

Study Overview
=================
Brief Summary
-----------------
An Evaluation and Factor Analysis for Maternal Mental Health - The Analytic Study of the Shin Kong Wu Ho-Su Memorial Hospital - Objectives： To construct a screening tool for domestic maternal mental health To expect to find the screening timing for early assessment or intervention of domestic maternal mental health status. To explore the impact of domestic maternal mental health factors.

Detailed Description
-----------------
-Study Design： This project will be conducted at the Shin Kong Memorial Hospital for pregnant women or mothers within six months after birth, with the base of existing domestic and foreign screening tools for postpartum depression and the related scale modeled, and select respective women during different pregnant period and after birth as postpartum study, by longitudinal study and cross-sectional study of the advantages to be able to plan time for up to twelve months of data collection, able to undertake within-subjects comparison and the between-subjects comparison, to view depression during pregnancy , pregnancy depression, postpartum blues, postpartum depression, postpartum psychosis such as prevalence, risk factors or any other factors. To establish the screening tool and screening time for national early assessment of maternal mental health status of women in pregnancy and after birth. -Effect： Expected to construct the applicable domestic early assessment screening or intervention time of maternal mental health status. Expected to develop different screening tools for a domestic early assessment of the maternal mental health status. Expected to identify the important factors of maternal depression to provide a reference for locking in a high risk group for early intervention. The implementation of women's health policy on mental health care of pregnant women with specific feasible approach. To provide mental health counseling, the implementation of the operation of the network of community resources to reduce maternal stress in coping to new life.

Official Title
-----------------
An Evaluation and Factor Analysis for Maternal Mental Health - The Analytic Study of the Shin Kong Wu Ho-Su Memorial Hospital

Conditions
-----------------
Postpartum Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the pregnant women or mothers within six months after birth Exclusion Criteria: Minor

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum depression, maternal mental health
Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery

Detailed Description
-----------------
Postoperative renal dysfunction is a predictor of significant morbidity and mortality among patients undergoing cardiac surgery. The mortality associated with coronary artery by-pass surgery increases from 2% to almost 19% in patients with renal failure and approaches 60% in patients who require hemodialysis. Patients with preoperative renal dysfunction referred for coronary artery by pass surgery have an extraordinarily high risk of requiring postoperative dialysis. For example, among those patients with preoperative creatinine >2.5 mg/dL, almost 50% require hemodialysis. Comparison: N-Acetylcysteine is superior to placebo in preventing renal failure after cardiac surgery

Official Title
-----------------
Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure

Conditions
-----------------
Kidney Failure

Intervention / Treatment
-----------------
* Drug: N-Acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pts with baseline chronic kidney disease (eGFR<60 ml/min/1.73m2)undergoing cardiac surgery Exclusion Criteria: Patients on hemodialysis preoperatively IV contrast within 4 days prior to surgery Urgent/emergent surgery History of renal transplantation

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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-Acetylcysteine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rise in creatinine above baseline |  | 7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine increase >25% or =/> 0.5 mg/dl above baseline |  | Postoperative days 5, 7 and 30 | 
| Length of stay in the ICU and the hospital |  |  | 
| Operative mortality |  | 30-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney failure, Thoracic surgery, Acetylcysteine
Role of PACAP in Nehprotic Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will identify the role of PACAP (pituitary adenylate cyclase-activating polypeptide) deficiency in patients with nephrotic syndrome. PACAP is a neuropeptide that has a putative role as an inhibitor of megakaryopoiesis and platelet function. Patients with nephrotic syndrome show decreased PACAP plasma levels, due to urinary loss. We hypothesize that in severe nephrotic syndrome, plasma deficiency of PACAP enhances megakaryopoiesis and causes blood platelet activation, which contribute to the increased rate of thromboembolic disease in these patients. To test our hypothesis, the role of PACAP deficiency on pro-thrombotic state in patients with nephrotic syndrome will be studied using patient blood and urine samples.

Official Title
-----------------
Role of PACAP in Increased Platelet Count and Aggregability in Childhood Nephrotic Syndrome

Conditions
-----------------
Nephrotic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New patient with nephrotic syndrome of patient during relapse of nephrotic syndrome Under 16 years old Treatment for nephrotic syndrome not yet started by first sample collection Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| PACAP levels in plasma and urine |  | 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count |  | 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months | 
| Platelet aggregability |  | 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PACAP (pituitary adenylate cyclase-activating polypeptide), Nephrotic syndrome, Thrombosis, Platelets