linjc16/ctgov huggingface dataset:
The Effects of Core Stabilization Exercises in Addition to Balance Exercises in Adult Hemophilia Patients on Balance, Quality of Life, Lower Limb Muscle Strength and Functional Level

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of core stabilization exercises in addition to balance exercises on balance, quality of life, lower extremity muscle strength and functional level in adult hemophilic patients.

Detailed Description
-----------------
The aim of this study is to investigate the effects of core stabilization exercises in addition to balance exercises on balance, quality of life, lower extremity muscle strength and functional level in adult hemophilic patients.

Official Title
-----------------
The Effects of Core Stabilization Exercises in Addition to Balance Exercises in Adult Hemophilia Patients on Balance, Quality of Life, Lower Limb Muscle Strength and Functional Level

Conditions
-----------------
Hemophilia

Intervention / Treatment
-----------------
* Other: Balance exercises
* Other: Core Stabilization exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemophilia Patients Exclusion Criteria: Acute Bleeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balance Exercises<br>Balance Exercises | Other: Balance exercises<br>* Balance Exercises<br>Other: Core Stabilization exercises<br>* Core Stabilization exercises<br>|
| Active Comparator: Core Stabilization Exercises<br>Balance and core stabilization exercises | Other: Balance exercises<br>* Balance Exercises<br>Other: Core Stabilization exercises<br>* Core Stabilization exercises<br>|
| No Intervention: Control<br>Assessments only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance Tests | Functional Reach Test | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality Tests | Timed up and go | 8 Weeks |
Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the combination of low doses of alemtuzumab and rituximab are effective in the treatment of patients with autoimmune cytopenias who has failed on steroids, relapsed after steroids withdrawal or required continuous steroids treatment.

Detailed Description
-----------------
Autoimmune cytopenias are a common entities with good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependant on steroids to maintain an acceptable level of hemoglobin or platelets, and the treatment becomes more difficult increasing the secondary effects. The current study evaluates the safety and efficacy of the combination of low doses of alemtuzumab (anti CD52) and Rituximab (anti CD 20) as a second line treatment option for this subset of patients improving the cytopenias without increasing the adverse effects.

Official Title
-----------------
Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Conditions
-----------------
Idiopathic Thrombocytopenic Purpura, Anemia, Hemolytic, Autoimmune

Intervention / Treatment
-----------------
* Drug: Alemtuzumab, Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: > or = 16 years Weight: more than 40 Kg Autoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis refractory to treatment, in relapse or steroids dependant Idiopathic thrombocytopenic purpura with platelet counts < 50,000, refractory to treatment, in relapse or steroids dependant Exclusion Criteria: Current viral or bacterial infection. Positive serology for HIV, HCV, HBV.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: A<br> | Drug: Alemtuzumab, Rituximab<br>* Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.<br>* Other names: mabthera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (CR: complete remission, PR: partial remission, relapse rate. |  | 1, 2, 4 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Thrombocytopenic Purpura, Anemia, Hemolytic, Autoimmune, Alemtuzumab, Rituximab
Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)

Study Overview
=================
Brief Summary
-----------------
It is commonly accepted that the characteristics of the organ donor impact on the future post transplant. In lung transplantation (LP), the defining characteristics of the ideal donor includes an age less than 55 years. However, before the pulmonary graft shortage with a corresponding mortality still too high waiting list, the lung graft acceptance criteria were reassessed permitting criteria extension ( marginal graft). And were grafted, depending on the urgency and accessibility problems in the registry of potential candidate, organs from donors aged 55 and older with quite comparable to those obtained from younger donors . Nevertheless, it is common practice that the grafts from older donors are more readily allocated to older candidates and the most severe, as many confounding factors to assess the real impact of donor age on post-transplant evolution on small cohorts. The main goal of this study is to compare the survival of lung transplant patients depending on the age difference between donor and recipient. The study will be conducted from a broad national cohort of lung transplant patients registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on French territory. It provides a standardized common longitudinal monitoring of the recipient from his transplant. Currently more than 1,000 patients included in this study are transplanted.

Conditions
-----------------
Lung Transplantation

Intervention / Treatment
-----------------
* Procedure: Lung transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult patients, included in COLT cohort, thus having given a signed written consent Who received a lung transplant Exclusion Criteria: Lung transplanted patients in a context of national priority Lung transplanted patients who died within 3 months after the surgery Patients for whom it is a second lung transplantation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung transplanted patients<br> | Procedure: Lung transplantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age difference in years between donor and recipient | The age difference will then be able to define two groups of patients: 1 group with an age difference < 10 years 1 group with an age difference > 10 years | 1 day |
Caudal Epidural Block for Postoperative Analgesia in Adolescents Following Major Hip Surgery.

Study Overview
=================
Brief Summary
-----------------
This retrospective chart review will demonstrate the feasibility of performing caudal epidural blockade in adolescents undergoing major orthopedic hip surgery and provide information regarding the feasibility of this technique's use on a regular basis.

Conditions
-----------------
Major Orthopedic Hip Surgery

Intervention / Treatment
-----------------
* Procedure: Caudal epidural block
* Other: General anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents that underwent major orthopedic hip surgery. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard general anesthesia<br>Patients receiving standard of care. | Other: General anesthesia<br> <br> |
| Caudal Epidural Block<br>Patients receiving a caudal epidural block in addition to standard of care. | Procedure: Caudal epidural block<br> <br> Other: General anesthesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Assessing pain scores post-operatively. | During 1st 24 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain medication requirement | Assessing amount of pain medication required. | During 1st 24 hours post-op | 
| Antiemetic medication requirement | Assessing need for antiemetic medications post-operatively. | During 1st 24 hours post-op |
Effect of Chest Compression on Respiratory Mechanics in ARDS Patients

Study Overview
=================
Brief Summary
-----------------
In some ARDS patients, a mild chest compression (5 kg) improves lung compliance. We aim to determine wether such an improvement is due to a better recruitment or to a reduction of overdistension

Official Title
-----------------
Effect of Chest Compression on Respiratory Mechanics in ARDS Patients

Conditions
-----------------
ARDS, Human

Intervention / Treatment
-----------------
* Other: 5kg bag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS (Berlin definition) Age >18y under invasive mechanical ventilation Exclusion Criteria: people protected by the law

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 |
| --- |
|Other: 5kg bag|a 5 kg bag is applied on the chest for 2 hours|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory mechanics |  | 2 hours |
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

Official Title
-----------------
An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment

Conditions
-----------------
Osteosarcoma, Leukemia, Lymphoma

Intervention / Treatment
-----------------
* Drug: glucarpidase, high-dose methotrexate, leucovorin
* Drug: high-dose methotrexate, leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination Require intravenous leucovorin Exclusion Criteria: Arm A only: allergic reactions to lactose Arm A only: hereditary fructose or galactose intolerance Arm B only: delayed elimination of MTX
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>High-dose methotrexate, leucovorin, and Voraxaze | Drug: glucarpidase, high-dose methotrexate, leucovorin<br>* single intravenous dose<br>* Other names: Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin;|
| Active Comparator: B<br>High-dose methotrexate and leucovorin without Voraxaze (glucarpidase) | Drug: high-dose methotrexate, leucovorin<br>* standard of care, leucovorin every 6 hours<br>* Other names: HDMTX, LV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of Leucovorin | Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point. | 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high dose methotrexate, Voraxaze, leucovorin, delayed elimination, methotrexate toxicity, rescue, renal insufficiency
Internet-Based Cervical Cytology Screening Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether a system that couples automated screening of Pap Tests with transmission of machine selected digital images, and review by cytologists at a remote location, performs to a clinically effective standard of accuracy.

Detailed Description
-----------------
This clinical study uses the automated screening capabilities of the FocalPoint Primary Screening System (BD) for gynecologic cytology specimens (Pap tests) to allow for automated field of view (FOV) selection, digital image capture, and subsequent Internet-based transmission to a custom designed computer-based image reading station. The system utilizes liquid-based cytology preparations (ThinPrep, SurePath). In such a system, no skilled cytology human resources are necessary at the scanning site, and all expertise can be centralized. Pilot studies showed that the task was feasible to a clinically relevant standard of care. Phase 1 trials on preselected and seeded specimens confirmed this clinical standard. The phase 2 trials extend the concept to a prospectively enrolled population of patients from 2 sites (Walter Reed, Mass General) thereby testing the concept in a population of normal disease prevalence. The final phase 3 will be a larger study with intended use design, siting a screening device at the 121st Army Hospital in Korea and interpreting the specimen images in the US. In addition to the reading of the specimens, the system is designed to give immediate loop closing results back to each specimen's originating point immediate upon completion of the test.

Official Title
-----------------
Internet-Based Cervical Cytology Screening Program

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female presenting to clinic for a Pap test for any reason Exclusion Criteria: Pregnant Prisoners Mentally unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| 1<br>Women obtaining routine Pap tests for cervical cancer screening | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical cytology abnormal cases | Identification of abnormalities compared to the initial interpretation | At enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical cancer, automation, Internet, telecytology
Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center

Study Overview
=================
Brief Summary
-----------------
The registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity in a real world.

Detailed Description
-----------------
The registry study is to obtain the long-term outcomes of the percutaneous coronary intervention state treatment for coronary heart disease patients in the center of the first hospital of sun yat-sen unversity in a real world. The data are collected using an uploading system through internet.

Official Title
-----------------
Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: percutaneous coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving coronal artery angiography or percutaneous coronary intervention therapy Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: percutaneous coronary intervention|All the patients receiving coronal artery angiography or percutaneous coronary intervention therapy by standard protocol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Major Adverse Cardiac Events (MACE) | All death All death, myocardial infarction, revascularization | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure | composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting) | 5 year |
Forgotten Joint Score After Reversed Gap Technique

Study Overview
=================
Brief Summary
-----------------
A new operation technique was established (reversed gap technique for implantation of total knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome shall be evaluated using the conventional gap technique as control in a RCT study.

Official Title
-----------------
Forgotten Joint Score After Reversed Gap Technique vs. Gap Technique

Conditions
-----------------
Total Knee Arthroplasty, Clinical Outcome

Intervention / Treatment
-----------------
* Procedure: TKA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for implantation a total knee arthroplasty Exclusion Criteria: indication for a constrained implant secondary type of arthritis (rheumatoid, post traumatic, post infectious) former open surgery on the joint using an arthrotomy or HTO (arthroscopy excluded)

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups: reversed gap technique vs. gap technique, randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TKA by reversed gap technique<br>new operative technique of positioning the femoral and tibial component based on soft tissue tension and femoral 3D geometry. | Procedure: TKA<br>* femoral and tibial positioning using the reversed gap technique<br>|
| Active Comparator: TKA by gap technique<br>standard operative technique serving as control. tibia component positioning according to the mechanical axis, femoral component positioning according to the mechanical axis and soft tissue tension in flexion | Procedure: TKA<br>* femoral and tibial positioning using the reversed gap technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forgotten Joint Score 12 | clinical score | one year after operation |