linjc16/ctgov huggingface dataset:
Clinical Follow-up After ACL Reconstruction

Study Overview
=================
Brief Summary
-----------------
No former studies have done long-term evaluation on patients reconstructed with hamstrings graft, the use of Howells tibial guide and transtibial drilling of the femoral graft tunnel. The investigators aim to evaluate clinical, radiographic and subjective outcome at a minimum of 10 years after surgery. According to former published studies on alike methods, the use of transtibial drilling of the femoral graft tunnel causes an increased rotational instability of the knee. The investigators aim to map the clinical stability of this group as well as evaluating the general outcome at the long-time horizon.

Detailed Description
-----------------
Patients will be invited to a clinical follow-up with x-ray of the knee, scoring of Lysholm and IKDC subjective scores, clinical examination including instrumented testing with a KT-1000. After informed consent data will be collected from patient records and stored in a secured internal database. Analysis will be done with the SPSS package.

Official Title
-----------------
10-year Follow-up After ACL Reconstruction With Howells Guide, Transtibial Drilling and Hamstrings Graft

Conditions
-----------------
Deficiency of Anterior Cruciate Ligament, Injury of Anterior Cruciate Ligament

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients reconstructed with the given technique Exclusion Criteria: Patients reconstructed with other techniques Concomitant ligamental surgery Bilateral ACL injury Revision surgery

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Revision surgery | When patients have had a new ACL reconstruction of the ACL | 10 years |
Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.

Official Title
-----------------
Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Bixalomer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic kidney disease<br>Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time. | Drug: Bixalomer<br>* Oral<br>* Other names: ILY101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the serum concentrations of phosphate |  | Baseline and up to Month 12 | 
| Change from baseline in the corrected serum concentrations of calcium |  | Baseline and up to Month 12 | 
| Change from baseline in the serum concentrations of intact parathyroid hormone |  | Baseline and up to Month 12 | 
| Safety assessed by incidence of adverse events |  | Up to Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kiklin, Bixalomer, Chronic Kidney Disease
Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)

Study Overview
=================
Brief Summary
-----------------
This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.

Detailed Description
-----------------
Gilenya modulates expression of the sphingosine-1-phosphate receptor and inhibits egress of several lymphocyte subsets from lymph nodes. This results in immunosuppression that has a beneficial effect in patients with multiple sclerosis. Our laboratory reported that increased expression of a possible biomarker signature, consisting of TLR2, TLR4 and CCR1, in a T-subset is associated with rapid MS progression. The investigators will test whether a significant proportion of patients at baseline upregulate this biomarker signature in one or more T-subsets, whether expression of this biomarker signature changes with treatment with Gilenya and whether expression levels of this signature predict disease activity or progression over a 12 month followup period. The investigators will study patients who are already being treated with Gilenya by their neurologists or who are already being treated with Gilenya as part of a clinical trial sponsored by Novartis Pharmaceuticals Canada. Patients will not be treated with Gilenya for the purposes of our study.

Official Title
-----------------
Analysis of a Biomarker Signature, Consisting of Toll-like Receptor 2 (TLR2), TLR4 and CCR1, by Flow Cytometry in Patients With MS Treated With Gilenya (FTY720)

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with Gilenya Exclusion Criteria: Subject is under 18 or over 65. Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse. Subject cannot communicate reliably with investigator. Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in expression of a biomarker signature |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker, disease progression
Fetal Brain Asymmetry: in Utero and Early Neonatal Follow up

Study Overview
=================
Brief Summary
-----------------
Fetal brain asymmetry is considered a normal developmental processes. The size and shape of the lateral ventricles are interdependence with the brain parenchyma. Abnormal development of the fetal brain may cause unilateral or bilateral ventriculomegaly. Fetal cerebral ventricle measurement is one of the most frequently used sonographic tool for the evaluation of brain development. It is easier to evaluate and measure the distal cerebral ventricle, and therefore data concerning the normal range of asymmetry and the normal progress of the asymmetry are limited. The objective of the study is to follow up the incidental finding of fetal ventricle brain asymmetry between 19-30 weeks of pregnancy.

Conditions
-----------------
Fetal Ventricle Brain Asymmetry

Intervention / Treatment
-----------------
* Other: fetal brain neurosonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-42 years old pregnant women 19-30 weeks of pregnancy No medical history of chronic disease No medical history of drug therapy No other findings on ultrasound examination Low risk pregnancy Exclusion Criteria: Fetal malformation Chronic maternal disease Fetal chromosomal aberration suspected fetal infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fetal ventricle brain asymmetry<br> | Other: fetal brain neurosonography<br>* fetal brain neurosonography according to the ISUG guidelines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.

Official Title
-----------------
A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: TJO-087
* Drug: Cyclosporine ophthalmic solution 0.05%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 20 or over Patients with moderate to severe dry eye Screening both eyes, the corrected visual acuity is 0.2 or more Written informed consent to participate in the trial Exclusion Criteria: Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) Intraocular pressure(IOP)> 25 mmHg Patient using or to use punctual plug within 1 months. Patients with contact lens.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TJO-087<br> | Drug: TJO-087<br>* Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily<br>|
| Active Comparator: Cyclosporine 0.05%<br> | Drug: Cyclosporine ophthalmic solution 0.05%<br>* Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Non-anesthetic Schirmer Test at Week 32 | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. | Baseline and Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24 | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. | Baseline, Week 8, 16 and 24 | 
| Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32 | Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure. | Baseline, Week 8, 16, 24 and 32 |
Endoscopic Treatment of Bronchial Carcinoid Tumors

Study Overview
=================
Brief Summary
-----------------
Carcinoid tumors of the lung are considered to be a low-grade malignancy. Surgical resection is considered the standard approach. Recent data has shown that a complete endoscopic treatment could be considered. An endoscopic treatment is can be a alternative to invasive surgery.

Detailed Description
-----------------
The objective of this study is to evaluate the feasibility and therapeutic method of endoscopic treatment of bronchial carcinoid tumors.

Official Title
-----------------
Feasibility and Therapeutic Method of Endoscopic Treatment of Bronchial Carcinoid Tumors: 22 Years Experience of Saint-Etienne

Conditions
-----------------
Carcinoid Tumor

Intervention / Treatment
-----------------
* Other: Medical data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated by endoscopic approach for a carcinoid tumor at the University Hospital Centre of Saint-Etienne between November 1995 to December 2017. Exclusion Criteria: Patients treated for a recurrence of carcinoid tumor. Patients with metastatic disease.

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 |
| --- | --- |
| endoscopic treatment<br>Patient with endoscopic treatment will be included. Some medical data collection by medical record will be collected. | Other: Medical data collection<br>* Medical data collection by medical record will be collected: demographics data, medical history, clinical symptoms, smoking, type of endoscopic method, complete treatment or not, type of surgeries if yes, anatomopathology of the injury and recurrence if yes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete endoscopic treatment | patients who have a complete endoscopic treatment | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of endoscopic method used | Analysis type of endoscopic method used. | Month 1 | 
| Tumor localization | Analysis the tumor localization. | Month 1 | 
| Deadline before recurrence | Analysis the deadline before recurrence of the tumor. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoid tumors, Endoscopic treatment, Recurrence
A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended

Study Overview
=================
Brief Summary
-----------------
The primary objective of this NIS is to assess the clinical benefit subjects derive from taking seroquel XR, using the CGI-CB. The secondary objective is to assess the effectiveness,safety and tolerability of seroquel XR tablets.

Official Title
-----------------
A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended-Release Tablets (SEROQUEL XRâ) in Subjects With Schizophrenia-An Observational, Multicentric Prospective Study

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as Schizophrenia according to DSM-IV-TR criteria Patients who are taking Seroquel XR no longer than 1 month Patients who get antipsychotics monotherapy at least 1 week before enroll in this study Exclusion Criteria: First episode, drug naive schizophrenic subjects. Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis,concomitant organic mental disorder or mental retardation that in the opinion of the Principal Investigator may interfere with study conduct or interpretation. Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the Clinical Global Impression score - Clinical Benefit Scale (CGI-CB) after 2 months of treatment with Seroquel XR |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-I score's change from 7th day to 8weeks |  | 8 weeks | 
| Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Seroquel XR, CGI-CB, SWN-K
Clinical Trial of Quantitative Detection Kit for Hsp90α in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients.

Detailed Description
-----------------
Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.

Official Title
-----------------
Clinical Trial of Quantitative Detection Kit for Hsp90α in Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: Hsp90


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colorectal cancer patients, healthy volunteers, benign colorectal diseases patients Exclusion Criteria: Patients who previously accepted radiotherapy
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectal cancer<br>Detect plasma Hsp90α concentration of patients, | Device: Hsp90<br>* Detect plasma Hsp90α concentration<br>* Other names: biomarker;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hsp90α Concentration(ng/ml) of plasma | Detect Hsp90α Concentration(ng/ml) of plasma and calculate the accuracy, specificity and sensitivity of Hsp90α kit | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer
The Dallas Hereditary Spherocytosis Cohort Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better characterize the short term and long term natural history of hereditary spherocytosis (HS) including diagnosis, complications, and indications for and response to splenectomy evaluate and describe the health-related quality of life in children with HS.

Detailed Description
-----------------
Patients with a new or established diagnosis of HS seen at Children's Medical Center will be asked to enroll in the study. Previous and current medical records will be reviewed to systematically catalogue their history of HS, including diagnosis, complications, hospitalizations, medications and laboratory data. Health-related quality of life questionnaires will be given to the patients and their parents at enrollment and periodically during the follow-up. Those who agree will have up to three small samples of blood collected and frozen for future laboratory studies of complications associated with HS and/or splenectomy. We anticipate enrolling approximately 200 children and young adults with HS in this study and following them until adulthood (age 18-21 years).

Official Title
-----------------
The Dallas Hereditary Spherocytosis Cohort Study

Conditions
-----------------
Hereditary Spherocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HS with or without prior splenectomy Age 0 - 21 years Spanish-speaking subjects are eligible to participate Exclusion Criteria: Unable to provide contact information for follow-up

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |
| Health related quality of life | PedsQL measurement | Approximately at 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary indications for splenectomy | Primary indication for splenectomy determined at time of splenectomy, if performed. | Approximately at 5 years | 
| Complications of HS |  | Approximately at 5 years and at 10 years | 
| Complications of splenectomy |  | Approximately at 5 years | 
| Diagnosis of HS |  | At enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HS, congenital hemolytic anemia, splenectomy, quality of life
Who is Falling? - Fall Risk Prediction Among Community Dwelling Elderly.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if the level of physical activity, selected physical and psychological risk factors can predict risk of falling in older (≥65) community dwellers.

Official Title
-----------------
The ≥65 Years NOrthern Jutland Cohort of Fall Risk Assessment With Objective Measurements (the NOCfao Study)

Conditions
-----------------
Accidental Fall

Intervention / Treatment
-----------------
* Other: Number of falls based on an one year follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Home dwelling Manage body transfer independently Walking ability for at least 10 meters with or without assistive devices Exclusion Criteria: Progressive neurological or rheumatologically illness Diagnosed vestibular problems Experienced pain in a substantial degree, limiting or obstructing everyday living Known uncorrected visual or hearing problems. Serious difficulties in speaking, understanding or reading Danish. Cognitive impairment equivalent to Mini Mental State Examination < 23

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fall accidents<br> | Other: Number of falls based on an one year follow-up<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported number of falls confirmed by monthly phone calls |  | One year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Gait, Postural Balance, Accelerometry, Physical Activity