linjc16/ctgov huggingface dataset:
Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following primary chemoradiation for locally advanced cervical cancer.

Detailed Description
-----------------
Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following primary chemoradiation (3 cycles per 3 weeks) for locally advanced cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Official Title
-----------------
A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Primary Chemoradiation for Locally Advanced Cervical Cancer

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent three cycles of concurrent chemoradiation therapy with paclitaxel and carboplatin for non-small cell type cervical cancer stage IB2, bulky size (>4cm) IIA,IIB-IVA above 20 years GOG performance status 0-2 Informed consent Platelet>100K, Hb> 10.0 g/dl, ANC>1500/mm3, Cr <1.25*upper normal limit, bilirubin<1.5mg/dl, AST & ALT<*3 upper normal limit Expected life > 6 months Exclusion Criteria: Peripheral neurotoxicity > NCI CTCAE grade 2 Sever infection Previous history with chemotherapy or radiation therapy Pleural effusion, pericardial effusion, and ascites which could cause dyspnea > NCI grade 2 Paraaortic lymph node metastasis Allergy with platinum Previous history of atrial or ventricular arrhythmia or congestive heart failure Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
MRI Maker of Perioperative Neurocognitive Disorder

Study Overview
=================
Brief Summary
-----------------
Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. The purpose of this study is trying to find the functional MRI marker of PND.

Official Title
-----------------
MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery

Conditions
-----------------
Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Lower Limb

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 60 years Spoke proficient Chinese Selected to lower limb osteopathic surgery Informed consent signed by the patient Underwent general anesthesia Exclusion Criteria: Existing cerebral disease, or have a history of neurological and psychiatric diseases including AD, stroke, and psychosis Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 Several audition or vision disorder With standard contraindications to MRI examinations Unwillingness to comply with the protocol or procedures.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| MRI markers of PND before 7th day after surgery | To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 7th day after surgery | From the day before surgery to the 7th day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI markers of PND before 12 month after surgery | To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 12 months after surgery | From the 7th day after surgery to 12 month after surgery |
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States of America (USA). Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

Official Title
-----------------
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate facial atopic dermatitis Patients intolerant of, or dependent on, topical corticosteroids Exclusion Criteria: Concurrent skin diseases (infections) Immunocompromised Recently received phototherapy or systemic therapy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 11 Years

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

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 |
| --- | --- |
| Experimental: 1<br>Pimecrolimus | Drug: Pimecrolimus<br>* Pimecrolimus 1 % cream<br>* Other names: Elidel;|
| Placebo Comparator: 2<br>Pimecrolimus vehicle cream | Drug: Placebo<br>* Pimecrolimus vehicle cream (placebo)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score |  |  | 
| The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score |  |  | 
| The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild) |  |  | 
| Time to clearance of facial IGA (score of 0 or 1) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic dermatitis, T-cell, pimecrolimus, children, facial, Facial atopic dermatitis
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

Study Overview
=================
Brief Summary
-----------------
To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer To evaluate PSA (tumor marker) response rate To evaluate safety

Official Title
-----------------
A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: ARD6562, Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy. Exclusion Criteria: 1.Body temperature > 38 degree centigrade. 2.Prior radiotherapy to > 25% of bone marrow. 3.Prior isotope therapy and/or brachytherapy 4.Prior gene therapy. 5.Active double cancer. 6.Known brain or leptomeningeal involvement. 7.History of hypersensitivity reaction to drug 8.Other serious illness or medical condition 9.Subjects whom the investigators consider inappropriate from social or medical aspects.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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: ARD6562, Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate by modified WHO criteria, PSA response rate, safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, HRPC, AIPC, Hormone refractory, Androgen independent, Docetaxel, Taxotere, prednisolone
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.

Detailed Description
-----------------
For complete information about the clinical trial, see link in the reference section.

Official Title
-----------------
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants in Women Who Are Undergoing Primary Breast Augmentation or Replacement of Existing Augmentation Implants

Conditions
-----------------
Breast Implants

Intervention / Treatment
-----------------
* Device: Saline-filled breast implant [IDEAL IMPLANT (R)]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral primary breast augmentation-dissatisfaction with breast size Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants Exclusion Criteria: Diagnosis of active cancer of any type Has ever been diagnosed with breast cancer Has pre-malignant breast disease Has tissue characteristics incompatible with an implant Has unrealistic or unreasonable expectations of the procedure results

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

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

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

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: breast augmentation<br>breast implant | Device: Saline-filled breast implant [IDEAL IMPLANT (R)]<br>* Breast augmentation<br>* Other names: IDEAL IMPLANT (R) Saline-filled Breast Implant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants. |  | 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast implants, saline
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a study site. Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.

Official Title
-----------------
Title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds

Conditions
-----------------
Malignant Wounds

Intervention / Treatment
-----------------
* Device: Mepilex Transfer Ag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment Both genders with an age ≥ 18 years at randomization Subjects with a suspected survival time of > 3 months Signed informed consent Exclusion Criteria: Any known or suspected systemic infection Use of metronidazole is not allowed during the investigation period Any known sensitivity to silver or other components/products used in this study. Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders. Participation in another investigational study while participating in 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepilex Transfer Ag<br>Non controlled investigation | Device: Mepilex Transfer Ag<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection in the Wound (Signs of Clinical Infection) | Weekly Visual inspection of the wounds by the investigators. | weekly, for 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
P53 Immunohistochemistry Abnormal Staining in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Objective: Calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types and grading. Patients and methods: 100 cases of endometrial cancer will be included in the study, recruited from Alexandria university hospital gyne-oncology unit. Surgical staging, histopathological examination and immunohistochemistry of p53 were done to all cases to calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types, grading. Keywords: P53 immunohistochemistry, endometrial cancer, clinicopathological relation.

Official Title
-----------------
P53 Immunohistochemistry Abnormal Staining in Endometrial Cancer and Its Relation With Disease Stages, Pathological Types and Grading

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Other: p 53 immunohistochemistry positive staining and relation to stages ,pathological types and grading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endometrial cancer patients Exclusion Criteria: patients unfit for surgery
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: p 53 immunohistochemistry positive staining and relation to stages ,pathological types and grading|p 53 immunohistochemistry positive staining and relation to stages ,pathological types and grading|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p53 immunohistochemistry | Incidence of abnormal staining of p53 in endometrial cancer | 1 month | 
| Relation of p53 abnormal staining with disease stages | Relation of p53 abnormal staining with disease stages | 1month | 
| Relation of p53 abnormal staining with disease pathological types | Relation of p53 abnormal staining with disease pathological types | 1 month | 
| Relation of p53 abnormal staining with disease pathological grades | Relation of p53 abnormal staining with disease pathological grades | 1 month |
Effects of Sensory and Motor Deprivation on Brain Plasticity

Study Overview
=================
Brief Summary
-----------------
Investigation of changes in gray and white matter during immoblisation after injury of the right upper extremity via two MR Investigations of the brain at two different times.

Detailed Description
-----------------
Investigation of changes in gray and white matter during immoblisation after injury of the right upper extremity via two MR Investigations of the brain at two different times. Immobilisation at least 12 days. Time between the 2 investigations: 12-14 d.

Official Title
-----------------
Effects of Sensory and Motor Deprivation on Brain Plasticity After Injury and Immobilisation of Right Upper Extremity

Conditions
-----------------
Injury of the Right Upper Extremity

Intervention / Treatment
-----------------
* Other: no intervention, MRI and motor skill test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Right handed Injury of right upper extremity where immobilisation is needed Exclusion criteria: TBI, neurological or psychatric deseases Other cerebral deseases Standard MRI Exclusion criterias such as pacemaker, epilepsia etc

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention, MRI and motor skill test|Two MR Investigations at two different times|

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
-----------------
extremity with immobilisation, brain platicity, deprivation, MRI
Effect of GABA on ADHD and Seizures in Children With Epilepsy.

Study Overview
=================
Brief Summary
-----------------
Effect of GABA on ADHD and seizures in Children with epilepsy.

Detailed Description
-----------------
Effect of Gamma aminobutyric acid on ADHD and seizures in Children with epilepsy.

Official Title
-----------------
Effect of Gamma Aminobutyric Acid on ADHD and Seizures in Children With Epilepsy.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: GABA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epilepsy ADHD Exclusion Criteria: Epilepsy without ADHD

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Before treatment<br>no intervention | |
| Active Comparator: After treatment<br>GABA | Drug: GABA<br>* Gamma amino butyric acid<br>* Other names: Gamma amino butyric acid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of seizures | Number of seizures | 6 months |
Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction

Study Overview
=================
Brief Summary
-----------------
This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.

Official Title
-----------------
Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction. A Randomized, Controlled Trial

Conditions
-----------------
To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven malignant biliary stenosis signs of biliary obstruction informed consent Exclusion Criteria: age under 18 Operations like Roux-Y, biliodigestive Anastomosis, BII life expectancy less than 3 months Karnfosky index less than 60%

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 |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to stent obstruction |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignant biliary obstruction, viaduct, self-expandable metal stents