linjc16/ctgov huggingface dataset:
Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice

Study Overview
=================
Brief Summary
-----------------
This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.

Official Title
-----------------
Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice

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

Intervention / Treatment
-----------------
* Biological: HPV 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening Exclusion Criteria: Unable to provide written informed consent Any woman who is known being pregnant at screening Subject who is participating or going to participate in another study which involves GARDASIL administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| 1000 subjects receive the HPV 4 vaccine<br> | Biological: HPV 4<br>* 1000 subjects will be received the HPV 4 vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice | Adverse reactions associated with vaccine will be observed in females Aged 20-45 Years after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy | 24 months | 
| Number of participants with adverse events following any dose of vaccine | Number of participants with adverse events following any dose of vaccine | within 30 days after each dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, safety
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Study Overview
=================
Brief Summary
-----------------
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Detailed Description
-----------------
This trial is a prospective non-interventional observational study. The Chinese patients with lymphoma were included and the study data on driver gene abnormalities, demographic characteristics, clinicopathological characteristics and treatment were collected to evaluate the relevance of efficacy and disease prognosis.

Official Title
-----------------
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Conditions
-----------------
Lymphoma, Gene Abnormality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as lymphoma (according to WHO 2017 classification criteria) Life expectancy no less than 3 months Agreeing to sign the written informed consents Exclusion Criteria: Other malignant tumor history or active malignant tumor need be treated Researchers determine unsuited to participate in this trial
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 |
| --- | --- | --- |
| Incidence of driver gene abnormalities | the incidence of driver gene abnormalities by fixed gene testing technology | from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | the total proportion of patients with complete response (CR) and partial response (PR) | from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months | 
| 5-year overall survival | from the date of first patient was included to the date of death by any cause | from the date of the first patient was included to the date of the end of this trial, assessed up to 5 years | 
| Clinicopathological Characteristics | study data on clinicopathological characteristics related to incidence of driver gene abnormalities | from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Driver Gene Abnormalities, Disease Prognosis
Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

Study Overview
=================
Brief Summary
-----------------
There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.

Detailed Description
-----------------
GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.

Official Title
-----------------
Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Biological: GM-CSF (verum)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe sepsis or septic shock, Presence of infection, 2 SIRS criteria, Acute organ dysfunction, Immunoparalysis, Informed consent Exclusion Criteria: Pregnancy, Known allergies to study medication or components, Moribound patient, Autoimmune disease, HIV-infection, Acute MI or pulmonary embolism, Cpr during last 72 hours, Patients who participate in a different clinical 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>GM-CSF therapy | Biological: GM-CSF (verum)<br>* sagramostim<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9 |  | after therapy |
Ultrasound of the Diaphragm in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients. Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.

Official Title
-----------------
Ultrasound Evaluation of Diaphragmatic Dysfunction in Critically Ill Patients. An Observational Study.

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Other: diaphragm ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult plus admitted in ICU plus invasive or non-invasive mechanical ventilation or adults aortic vascular surgery Exclusion Criteria: < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| critically ill ICU patients<br>critically ill intensive care unit patients | Other: diaphragm ultrasound<br>* we'll perform diaphragm ultrasound in ICU critically ill patients<br>* Other names: echography of diaphragm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic dysfunction | Diaphragmatic dysfunction will be measured as thickness and inspiratory excursion of the diaphragm | participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound, diaphragm, intensive care, critical care
Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared. Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival. A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.

Official Title
-----------------
Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20-80 years Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery Exclusion Criteria: Patients with distal metastases confirmed at diagnosis Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer If patients do not agree with this study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| K-RAS Mutation | K-RAS Mutation status | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiomics - MR image findings | Radiologic features | 4 weeks |
Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics in Femoral Nerve Block

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl combined with local anesthetics in the post operative pain control with continuous femoral nerve block after total knee arthroplasty.

Official Title
-----------------
Femoral Nerve Block in Patient With Total Knee Arthroplasty; Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: rocaine
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who scheduled to receive knee arthroplasty with general anesthesia ASA physical status 1 or 2 Exclusion Criteria: allergy to drug refuse to the study ASA physical status 3 and 4 history of drug abuse cognitive disfunction such as dementia patients who do not adequate for general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: rocaine<br>continuous femoral nerve block with ropivacaine alone. | Drug: rocaine<br> <br> * Other names: ropivacaine HCL;|
| Active Comparator: rocaine with fentanyl<br>continuous femoral nerve block with combination of ropivacaine and fentanyl. | Drug: rocaine<br> <br> * Other names: ropivacaine HCL;Drug: Fentanyl<br> <br> * Other names: fentanyl citrate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Analogue Scales by time sequence |  | baseline(just after operation), 15, 30, 60 minute and 24 hour after intervention |
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

Study Overview
=================
Brief Summary
-----------------
Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.

Detailed Description
-----------------
Methods In the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between Jan, 2011 to Oct ,2013. Polyaxial brace was used for the deformity correction. Then, during the following 1-3 years, the Dennis braces were used during the night in case of recurrence. Prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. The efficacy of the treatment was assessed by Pirani's scoring system before and after treatment.

Official Title
-----------------
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants

Conditions
-----------------
Clubfoot

Intervention / Treatment
-----------------
* Device: Polyaxial brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0-6 months infants parents would like to cooperate with the doctors. Exclusion Criteria: over 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Years

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

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: Brace goup<br>The infants who were brace group treated by braces which were designed and made by us. | Device: Polyaxial brace<br>* The Polyaxial brace were made by a technician trained by the China National Disabled Persons Federation. For all patients, gypsum models were prepared first, and then braces were fabricated according to the models. The detailed technique was fully in accordance with the Ponseti method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hindfoot | severity of the posterior crease, emptiness of the heel and rigidity of the equinus | 1 month | 
| midfoot | curvature of the lateral border of the foot, severity of the medial crease and position of the lateral part of the head of the talus | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital idiopathic clubfoot, Pirani score, infant, polyaxial brace
Cancer Detection in Pancreatic Cysts

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assist with early and accurate diagnosis of cancer in pancreatic cysts based on the analysis of DNA obtained by endoscopic ultrasound guided fine needle aspiration

Detailed Description
-----------------
The study of pancreatic diseases is hindered by the organ's deep seated location and especially lack of symptoms during the early stages of disease development and progression e.g. pancreatic cancer. This is particularly true of pancreatic cysts, the variety and the malignant potential of which encompass a broad spectrum. The radiological features distinguishing a benign from a pre-malignant to a frankly malignant cyst in the pancreas are frequently underwhelming and have lead to the clinical practice of sampling all but the most obvious. The yield of the aspirate in turn is frequently not of a quality upon which a clinical decision can be based. Most would agree that the best approach for management of pancreatic cystic neoplasm lies in early diagnosis, ideally at a precancerous stage. The effectiveness and applicability of this study is the based on the ability of the cyst DNA analysis to stratify the patients at risk of developing pancreatic cancer based on the extent of accumulated mutational damage.

Official Title
-----------------
Pancreatic Cyst DNA Analysis

Conditions
-----------------
Pancreatic Cyst, Pancreatic Pseudocyst, Pancreatic Neoplasm

Intervention / Treatment
-----------------
* Procedure: DNA analysis of pancreatic cyst fluid / buccal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously scheduled for Endoscopic ULtrasound for evaluation of pancreatic cyst Exclusion Criteria: Any condition that would preclude safe performance of EUS/FNA

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: DNA analysis of pancreatic cyst fluid / buccal swab|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
-----------------
Pancreatic Cyst, PANDA Study
REDucing Influenza Among University Students, University of California at Berkeley

Study Overview
=================
Brief Summary
-----------------
We will be testing the hypothesis whether online education for UC Berkeley students on respiratory hygiene, cough etiquette, hand hygiene/awareness, as well as face mask use (while ill) will reduce the acquisition and transmission of influenza-like illness. The study will be conducted during the flu seasons 2006-7 and 2007-8.

Official Title
-----------------
Effectiveness of Selected Non-pharmaceutical Interventions in Reducing Influenza-like Illness Among University Students

Conditions
-----------------
Influenza-like Illness, Influenza

Intervention / Treatment
-----------------
* Behavioral: Online education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered students Attending UC Berkeley at least half-time during the study period Exclusion Criteria: Enrolled but studying remotely or abroad for all or part of the study period Persons less than 17 years of age

Ages Eligible for Study
-----------------
Minimum Age: 17 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Online education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of influenza-like illness |  |  |
Longitudinal and Biological Study of Childhood Disintegrative Disorder

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the developmental course (language acquisition, diagnostic stability, predictors of outcome, and restricted interests and behaviors) of childhood disintegrative disorder versus autism and non-autistic developmental delays. II. Collect data on molecular genetics of proband and family members.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are evaluated with the following questionnaires at ages 2-3 years and again at ages 5-9: The Autism Diagnostic Interview (ADI); The Autism Diagnostic Observation Schedule (ADOS); Assessment of cognitive functioning; Expressive and receptive language; Adaptive functioning; Measures of burden and functional assessment; The Aberrant Behavior Checklist; The Connors Rating Scale - Parent and Teacher version; and Autism Behavior Checklist An MRI and EEG are performed, and blood samples are collected from patients and family members for molecular genetic studies.

Conditions
-----------------
Pervasive Child Development Disorders, Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Psychologically diagnosed (DSM-IV) as Childhood Disintegrative Disorder No known genetic or medical syndrome (Down syndrome or cerebral palsy) Must speak English

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 9 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
-----------------
autism, childhood disintegrative disorder, neurologic and psychiatric disorders, rare disease