linjc16/ctgov huggingface dataset:
Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.

Detailed Description
-----------------
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. It will also provide the research team with improved understanding of how patients interact with and prefer to receive QOL information. Improved understanding of patient predictions and perceptions of information display will allow us to incorporate predicted future PROs into the shared decision making process as well as allow us to provide this important information to patients in a meaningful way.

Official Title
-----------------
Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-surgical female breast cancer patients Female breast cancer survivors Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Surgical Breast Cancer Patients<br>Adult female patients newly diagnosed with stage 0-III breast cancer seen as a surgical consultation from 06/01/2019 to present. | |
| Breast Cancer Survivors<br>Breast Cancer Survivors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predicted patient reported outcomes up to 1 year after | Predicted patient reported outcomes for each domain six-months and 1 year after breast surgery. | 12 months | 
| Actual patient reported outcomes for each domain after surgery | Actual PRO scores for each domain six-months after surgery | 6 month | 
| Compare predicted and actual outcomes | Comparison of predicted versus actual PRO scores in patients undergoing surgery | 12 months | 
| Patients preferred method of communicating results | Patients' preferred means of receiving and communicating PRO results. | 12 months |
High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps

Study Overview
=================
Brief Summary
-----------------
From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.

Detailed Description
-----------------
From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.

Official Title
-----------------
High Myopia Macular Hole and Retinal Detachment Accepted Internal Limiting Membrane Flip Packing and Free Flap Was the Internal Limiting Membrane (ILM Flap Was Double)

Conditions
-----------------
High Myopia, Macular Holes, Retinal Detachment

Intervention / Treatment
-----------------
* Procedure: Inverted and free ILM insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular hole with retinal detachment in high myopia Exclusion Criteria: History of trauma, peripheral retinal breaks

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Inverted and free ILM insertion<br>Both inverted and free ILM flaps were inserted into the macular hole | Procedure: Inverted and free ILM insertion<br>* ILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of macular hole | Closure of macular hole demonstrated by optical coherence tomography | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal reattachment | Retinal reattachment observed by fundoscopy | 3 months |
A Randomized Controlled Trial of the Treatment of Mallet Fractures

Study Overview
=================
Brief Summary
-----------------
Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually referred to as Mallet fractures. Treatment of Mallet fractures remains controversial. Although no differences in clinical results are reported between conservative treatment and operative treatment, operative treatment is suggested for fractures involving more than 30% of articular surface. There are many different operative techniques, all with specific disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet splint.

Official Title
-----------------
A Randomized Controlled Trial of the Treatment of Mallet Fractures: Conservative Versus Operative Using One Meniscus Arrow®

Conditions
-----------------
Mallet Fracture

Intervention / Treatment
-----------------
* Procedure: Biodegradable Meniscus Arrow®
* Device: Mallet splint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: avulsion fracture involving more than 30% of articular surface Exclusion Criteria: (sub)luxation of the distal phalanx patients with a Mallet fracture developed 3 weeks or more prior to presentation patients with a Mallet fracture with failure of conservative treatment

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operative<br>operative treatment of a Mallet fracture with a biodegradable Meniscus Arrow® | Procedure: Biodegradable Meniscus Arrow®<br>* Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow®<br>|
| Active Comparator: Conservative<br>Conservative treatment of a Mallet fracture with a Mallet splint | Device: Mallet splint<br>* Conservative treatment of the Mallet fracture with the traditional Mallet splint.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extension deficit | To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria. | 1 year | 
| extension deficit | at every visit, the extension in the DIP joint, is measured | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing disturbances | at every control, this is noted | 1 year |
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography

Official Title
-----------------
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

Conditions
-----------------
IHD, Acute Kidney Injury, Contrast-induced Nephropathy

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to angiography unit over 18 informed consent Exclusion Criteria: acute renal failure before 7 days spironolactone contraindications hyperkalemia (S.K. >5.5 mEq/L) documented tumor actively taking NSAIDs, Ciclosporin, Cisplatin,

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: Placebo Oral Tablet<br>* Each patient will receive a placebo tablet as per his/her angiography premedications<br>* Other names: Control group;|
| Active Comparator: Spironolactone<br> | Drug: Spironolactone<br>* each patient will receive 200 mg of spironolactone as per his/her angiography premedications<br>* Other names: Active group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury by K-DIGO guidelines | an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline | 48-72 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury by NGAL | assessment of serum NGAL at admission and after 6 hrs to detect possible AKI in selected patients | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spironolactone
Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging

Study Overview
=================
Brief Summary
-----------------
Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the present study is to develop and evaluate a computer-based method for automated classification of small colorectal polyps on the basis of vascularization features.In a prospective study 207 polyps with a size of 10mm or smaller should be detected by a zoom NBI colonoscopy. These polyps were imaged and subsequently removed for histological analysis. the polyp images were analyzed by a computer algorithm. The proposed computer-based method consists of several steps: preprocessing, vessel segmentation, feature extraction and classification. The results of the automatic classification (sensitivity, specificity, negative predictive value, positive predictive value and accuracy)were compared to those of human observers, who were blinded to the histological gold standard.

Official Title
-----------------
Computer-based Classification of Small Colorectal Polyps

Conditions
-----------------
Colorectal Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who did not meet the exclusion criteria were included in the study Exclusion Criteria: Patients with chronic inflammatory bowel disease, adenomatosis coli, coagulopathy, insufficient bowel preparation, or previous colonoscopy within the last 3 years; age under 18 years; no written informed consent for participation in the 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with colorectal polyps<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy) |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interobserver variability |  | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small colorectal polyps, narrow band imaging, vascularization, computer-based classification
Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma.

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: Recombinant Human Interleukin-2 and Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens. Exclusion: Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment Clinically significant pulmonary dysfunction. Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment). Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism. History of autoimmune disease. History of positive serology for human immunodeficiency virus (HIV).

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Recombinant Human Interleukin-2 and Rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermediate and High-Grade Non-Hodgkin's Lymphoma
V930 First in Man (FIM) Study (V930-002)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.

Official Title
-----------------
A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA

Conditions
-----------------
Cancers Expressing HER-2 and/or CEA

Intervention / Treatment
-----------------
* Biological: V930


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer Patients will either be disease free following primary therapy or have advanced disease with a durable response (>3 months) after standard therapy Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis Exclusion Criteria: Patients with prior treatment with any HER-2 and/or CEA containing vaccine Patients who have significant cardiac disease Patients with autoimmune disorders Patients who are pregnant or lactating

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 |
| --- |
|Biological: V930|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity.

Official Title
-----------------
Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy

Conditions
-----------------
Immuno-monitoring

Intervention / Treatment
-----------------
* Other: Immuno-monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically defined metastatic melanoma patients (AJCC stage IV) aged 18 to 80 years at least one prior systemic anti-melanoma therapy; if BRAFV600 positive, at least one prior BRAFi therapy Exclusion Criteria: therapy-naive patients any contra-indications for (specific) systemic chemotherapy

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Immuno-monitoring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immuno-monitoring |  | Immediate |
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China

Study Overview
=================
Brief Summary
-----------------
Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, neonatal weight will be registered.

Official Title
-----------------
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China

Conditions
-----------------
Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: D-chiro inositol
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: During 12-16 weeks gestation Meet any of the following: prepregnancy BMI > 24, family history of diabetes (type 1 or 2), GDM history, history of delivering macrosomia, gestational history of stillbirth; Willing to participate Exclusion Criteria: Type 1 or type 2 diabetes mellitus diagnosed before pregnancy Multiple gestation Mental or cognitive impairment cannot complete the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D-chiro inositol<br>500 mg twice a day | Dietary Supplement: D-chiro inositol<br>* Active group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.<br>|
| Placebo Comparator: Placebo<br>500 mg twice a day | Dietary Supplement: Placebo<br>* Placebo (similar appearance but not containing myo-inositol) 1 gram per day before meals. Similar health guidance about diet and exercise. From recruitment until OGTT.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of gestational diabetes | The number of cases and incidence of gestational diabetes according to OGTT | 24-28th weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the perinatal outcomes-1 | the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg) | Delivery | 
| the perinatal outcomes-2 | weight gain during pregnancy (kg) | Delivery | 
| the perinatal outcomes-3 | the Caesarean-section incidence (%) | Delivery |