linjc16/ctgov huggingface dataset:
HCC Response Assessment by MRI After SBRT

Study Overview
=================
Brief Summary
-----------------
The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria

Official Title
-----------------
Tumor Response Assessment by MRI Following Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Radiation: SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the target


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the standard criteria for treating HCC patients with SBRT : an Eastern Cooperative Oncology Group (ECOG) score of 2, inoperable tumors (e.g. the patient being unfit for surgery, or tumor-related contraindications), and a maximum tumor diameter of 6 cm. The HCC diagnosis could be histological or based on the radiological criteria of the American Association for the Study of Liver Diseases (AASLD) Exclusion Criteria:no follow-up by MR imaging

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 |
| --- |
|Radiation: SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the target|Seven to ten days before the scheduled CT, 2-4 fiducial markers were implanted percutaneously 2 to 5 cm next to the lesion under sonographic guidance following administration of local anesthesia, thus allowing real-time tracking during treatment. The total dose delivered was 45 Gy on the 80% isodose, in three fractions over 10 days. Gross tumor volume (GTV) was defined as the tumor mass that could be discerned by diagnostic imaging. An isotropic margin of 5 mm was added to account for the microscopic extension (clinical target volume, CTV) and another 3 mm margin was added to compensate for uncertainties regarding the position (previsional target volume, PTV)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response assessments | The tumor response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Within the 24 months after SBRT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Stereotactic body radiation therapy
Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Study Overview
=================
Brief Summary
-----------------
The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral transfemoral walking with passive prostheses versus powered prostheses. The pilot study will collect data from three subjects with bilateral transfemoral amputations. Differences in kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered components may indicate benefits for clinical application of powered devices for persons with lower limb amputation.

Official Title
-----------------
Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Conditions
-----------------
Amputation, Artificial Limbs, Energy Expenditure, Kinetics

Intervention / Treatment
-----------------
* Device: Lower Limb Powered Knee-Ankle Prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection. All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short. Subjects currently walk with entirely passive type prostheses daily. Subjects walk without assistive devices OR with single point cane. High-activity level walkers Exclusion Criteria: Ages < 18 or > 45 years Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations. Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol. Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg. Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane. Low-activity level walkers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Individuals with Bilateral Transfemoral Amputation<br> | Device: Lower Limb Powered Knee-Ankle Prosthesis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sagittal Plane Hip Moment |  | During the stance phase of the gait cycle after two weeks of training with powered device. | 
| Metabolic Cost of Transport |  | 5 minutes of steady state walking after two weeks of training with powered device. |
A Self-Help Method for Nightmares

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition.

Official Title
-----------------
A Self-Help Method for Nightmares

Conditions
-----------------
Nightmares

Intervention / Treatment
-----------------
* Behavioral: IRT
* Behavioral: Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suffering from Nightmares Access to internet A valid e-mail address Be able to understand Dutch Exclusion Criteria: Severe posttraumatic complaints Severe depression High anxiety ratings In therapy for post traumatic stress disorder Being suicidal Schizophrenic or having a psychosis episode

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRT<br>Intervention based on Imagery Rehearsal Therapy | Behavioral: IRT<br>* Cognitive behavior intervention<br>|
| Active Comparator: Exposure<br>Treatment based on exposure | Behavioral: Exposure<br>* Exposure intervention<br>|
| No Intervention: Nightmare diary<br>Recording nightmares in a diary | |
| No Intervention: Waiting list<br>Waiting list | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightmare frequency |  | 1 year | 
| Nightmare distress |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality |  | 1 year | 
| Sleep complaints |  | 1 year | 
| Anxiety ratings |  | 1 year | 
| Posttraumatic complaints (low - moderate - high) |  | 1 year | 
| Depression ratings |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nightmares, treatment, self-help
Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

Study Overview
=================
Brief Summary
-----------------
This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation

Conditions
-----------------
Ventricular Tachycardia

Intervention / Treatment
-----------------
* Drug: amiodarone beta blocker sotalol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation - Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amiodarone beta blocker sotalol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICD shock for any cause |  |  |
A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

Detailed Description
-----------------
This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

Official Title
-----------------
A Randomized Phase II Trial of Strontium-89 With or Without Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer

Conditions
-----------------
Hormone Refractory Prostate Cancer, Bone Metastases

Intervention / Treatment
-----------------
* Drug: strontium-89
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adenocarcinoma of the prostate life expectancy > 3 months, symptomatic from bone metastases radiologic evidence of metastatic bone disease stable level of pain control >18 years ability to complete assessments prior treatment (chemo) > 4 weeks previous discontinued anti-androgens for > 4 weeks Exclusion Criteria: prior strontium therapy previous hemibody RT within 6 weeks previous cytotoxic chemotherapy within 4 weeks use of bisphosphonate medications within 4 weeks change in steroid dose within 4 weeks active uncontrolled infection impending or present spinal cord compression significant neurological disorder impending pathological fracture severe urinary incontinence

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: strontium-89|nan|
|Drug: cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palliative pain response |  |  | 
| analgesic response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, cisplatin, strontium-89, phase II
Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults

Study Overview
=================
Brief Summary
-----------------
Our group has shown that HAART increases the thymic production of naïve T cells in the healthy adult, thereby boosting the immune system. We propose to investigate the amount of and length of Nelfinavir therapy necessary to increase those cells in adults. Subjects will be treated with Nelfinavir, and blood will be sampled at variable times to determine the immune response in peripheral blood.

Detailed Description
-----------------
Blood will be collected at several time points during the study. DNA will be isolated from peripheral blood lymphocytes (PBL) and assessed for signal point (sj) TREC content relative to genomic CCR5 copies by real time PCR in a spectoflourometic thermal cycler. TREC values will be expressed as TREC copy number per copies of CCR5 or TREC/PBLs. We anticipate that we will confirm our previous observations that nelfinavir therapy will increase TRECs, indicating naive T cell production from the thymus. The proposed study will determine the time course of the anticipated increase in TREC/PBLs.

Official Title
-----------------
Investigating the Time of Nelfinavir Treatment Necessary for an Increase in Thymic Naive T Cells in Adults.

Conditions
-----------------
Immune Response

Intervention / Treatment
-----------------
* Drug: Nelfinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy individuals between the ages of 20 and 100. Exclusion criteria include the following: HIV, HBV/HCV positive, known sensitivity to protease inhibitors, oral intake contraindicated, diabetes mellitus diagnosed within the last six months, and any of the following medications: cisapride, amiodarone, terfenadine, rifampin/rifabutin, phenobarbital, pinozide, St. John's wort, ergot derivatives, quinidine, astemazole, carbemazapine, phenytoin, midazolam, triazolam, and simvastatin.

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

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

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

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: Nelfinavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Will confirm that HIV protease inhibitors increase thymic naïve T-cell production and determine the dose and time needed to increase thymic T-cell production in adults. |  |  |
Hypermetabolism in ALS Using Six REE Formulas

Study Overview
=================
Brief Summary
-----------------
Introduction: About 50-60% of Amyotrophic Lateral Sclerosis (ALS) is characterized by hypermetabolism, defined as 10% or more excess resting energy expenditure (REE) compared to theoretical values. Harris and Benedict's (HB) formula is the equation mainly used to predict REE, but others are also applied in current practice. The present study aimed to assess REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE. Nutritional assessments were performed in ALS patients and in two control populations without hypermetabolism: healthy elderly people (control 1) and patients with non-restrictive-eating disorders (control 2). Weight, height and body composition (by bioimpedance analysis) were assessed. EE was measured (mREE) by indirect calorimetry and calculated (cREE) using HB 1919 and 1984, World Schofield, De Lorenzo, Johnstone and Mifflin formulas. Mann-Whitney and Chi2 tests were used to compare the equations.

Official Title
-----------------
Increased Resting Energy Expenditure Compared to Six Predictive Theoretical Equations in Amyotrophic Lateral Sclerosis: a Study Versus Controls

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Other: Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALS patients 18 years old or more IC and nutritional assessment within 1.5 months delay between diagnosis and IC < 12 months Exclusion Criteria: -

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALS<br> | Other: Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.<br> <br> |
| control 1<br> | |
| control 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of REE | EE was measured (mREE) by indirect calorimetry and calculated (cREE) using Harris and Benedict's (HB) formula | indirect calorimetry (IC) and nutritional assessment within 1.5 months, and diagnosis and IC within 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic lateral sclerosis,, Resting energy expenditure, Predictive equation
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules

Study Overview
=================
Brief Summary
-----------------
A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

Official Title
-----------------
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules

Conditions
-----------------
Progression

Intervention / Treatment
-----------------
* Other: Ablation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 85 years; GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT); The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm; For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest The patient is able to understand and comply with the study and has provided written informed consent Exclusion Criteria: Patients who participated in any drug and / or medical device clinical trials within one month before the trial had severe disease conditions allergy to narcotic drugs had other autoimmune disease dementia or cognitive impairment can't cooperate with researchers any local treatment other than ablation was received within 4 weeks before the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: ablation therapy in the treatment of lung cancer presenting as ground-glass nodules<br> | Other: Ablation therapy<br>* Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | One year progression free survival after radiofrequency ablation of ground glass nodules | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival after radiofrequency ablation of ground glass nodules | 1 years, 3 years, 5years |
Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation

Study Overview
=================
Brief Summary
-----------------
Veno arterial extracorporeal membrane oxygenation (VA ECMO) is used, for cardiogenic shock, refractory cardiac arrest and post cardiotomy cardiac failure. Bleeding is frequent complications during VA ECMO and is associated with increased mortality. The aim of our study was to identify early factors associated with major bleeding in patients supported by VA ECMO

Official Title
-----------------
Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation

Conditions
-----------------
Extracorporeal Membrane Oxygenation, Bleeding, Complication

Intervention / Treatment
-----------------
* Device: ECMO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years treated by peripheral veno arterial membrane oxygenation Exclusion Criteria: None

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 |
| --- | --- |
| Veno arterial extracorporeal membrane oxygenation<br> | Device: ECMO<br>* ECMO installation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major hemorrhagic episodes defined as follows: loss of over 2g dl-1 of hemoglobin in 24 h, bleeding rate over 20 ml kg-1 day-1 or blood transfusion over 10 ml kg-1 day-1 | Our main objective was to evaluate risk factors independently associated with major hemorrhagic episode. We collected patient characteristics at the start of VA ECMO: age, gender, anthropometric information, medical history and chronic treatments. We also calculated SOFA and APACHE II scores on the day of VA ECMO implementation. We noted the indication for VA ECMO, any pre-cannulation treatments (fibrinolysis, aspirin, heparin), where VA ECMO was inserted and whether or not an intra-aortic balloon pump was present. With regard to various complications, we collected the quantity of delivered blood products , the site of bleeding initial temperature. The biological data were collected at initiation of VA ECMO. | Through study completion, an average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality |  | 30 day | 
| Duration of life support |  | Through study completion, an average of 10 years | 
| Length of stay |  | Through study completion, an average of 10 years | 
| Ischemic and thrombotic complications |  | Through study completion, an average of 10 years |