linjc16/ctgov huggingface dataset:
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.

Official Title
-----------------
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Adaptive Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histologically or cytologically proven newly diagnosed small cell lung cancer chest-confined disease (including bulky intrathoracic disease) adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%) patients of childbearing potential must practice adequate contraception Age > or = 18 years Karnofsky performance status > or = 70 eligible for concurrent chemoradiotherapy Exclusion Criteria: patients who have undergone complete or subtotal tumour resection evidence of non-small cell histology prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years prior RT to the thorax or neck compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%) pregnant women

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Adaptive Radiation|Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach | Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray | 12-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control and patterns of failure | Local control and patterns of failure | 12-24 months | 
| Survival |  | 12-24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Small cell lung cancer, Adaptive radiotherapy, Thoracic radiotherapy
Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.

Detailed Description
-----------------
The functional changes of the retina can be recorded by an electroretinography (ERG).

Official Title
-----------------
Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) for Age-related Macular Degeneration

Conditions
-----------------
Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 45 years and above Clinical diagnosis of wet AMD First injection of ranibizumab protocol Best corrected visual acuity 20/32 - 20/320 Consent form obtained Exclusion Criteria: Previously treated wet AMD patients Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc. Pregnancy History of seizure

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ranibizumab|A single dose of 0.5 mg ranibizumab injected intravitreally.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height (Amplitude) of Multifocal ERG Signal | Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data. | baseline, 3 months | 
| Time to Response (Implicit Time) of Multifocal ERG Signal | Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data. | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complication | For instance, Endophthalmitis, retinal detachment | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age-related macular degeneration (AMD), choroidal neovascularization membrane(CNVM), ranibizumab, anti-vascular endothelial growth factor, electrophysiology, electroretinography
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient

Study Overview
=================
Brief Summary
-----------------
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).

Official Title
-----------------
Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery

Conditions
-----------------
Rheumatoid Arthritis (RA)

Intervention / Treatment
-----------------
* Drug: Methotrexate (Metoject® prefilled pen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis Male or female patient who is 16 years of age or older Exclusion Criteria: Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter Has any history of hypersensitivity to the investigational medicinal product Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA) Is unable to comprehend written labeling and training materials

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: Methotrexate<br> | Drug: Methotrexate (Metoject® prefilled pen)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation). | Questionnaires to assess the comprehension of the label (instruction for use of the prefilled pen) and device robustness evaluation after usage of the prefilled pen | 1 year |
Robotic Laparoscopic Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.

Detailed Description
-----------------
To establish a robotic-assisted laparoscopic radical prostatectomy programme at the University of Western Ontario/London Health Sciences Centre and to critically evaluate the role of this programme in the management of localized prostate cancer in surgical candidates Details of surgical procedure, operative outcome, patient outcome including quality of life will be collected.

Official Title
-----------------
Robotic Laparoscopic Radical Prostatectomy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Laparoscopic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent Locally confined, stage T1a, T2a or T2b prostate cancer Aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy. Serum prostate specific antigen equal to or less than 10mg/ml Histologically confirmed adenocarcinoma of the prostate Gleason score equal to or less than 7 Life expectancy of greater than 10 years. Prostate size on TRUS measurement less than 40 grams Exclusion Criteria: Patients who have undergone prior hormone therapy. Patients with a previous transurethral resectioning of the prostate (TURP) History of other cancers other than basal cell carcinoma. Patients with any prior abdominal surgery. Any condition, or history of illness or surgery than, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (eg significant cardiovascular conditions) Patients with a large median lobe of the prostate. - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic prostatectomy<br>Patients who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robotics. | Procedure: Laparoscopic<br>* Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas

Study Overview
=================
Brief Summary
-----------------
The aim of the planned research project is to find out the clinical significance of molecular genetic analyzes in gynecological malignomas. In particular, it will be investigated how the knowledge of a molecular-genetic finding affects the therapeutic decision of the physician. Furthermore, genetic changes in the tumor tissue will be compared with the changes in CTCs, DTCs and cfDNA.

Official Title
-----------------
Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: molecular genetic analyses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a solid tumor disease The presence of a molecular genetic diagnosis of the tumor tissue from practice for human genetics Age > 18 years informed consent Exclusion Criteria: life expectancy <12 months or worse general condition (Karnofsky <70)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: molecular genetic analyses|molecular genetic analyses|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of molecular genetic findings to the therapy decision | It will be analyzed if the physicians selection of a therapy is influenced by a present molecular genetic finding. Therapy recommondation based on molecular genetic analysis will be compared with the acutal therapy decision. | 3years |
Gastric Emptying of Maltodextrin Solution in Elderly and in Adults

Study Overview
=================
Brief Summary
-----------------
Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly.

Detailed Description
-----------------
Gastric volume will be estimated before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly using antral ultrasound.

Official Title
-----------------
Gastric Emptying of Maltodextrin Solution in Elderly and in Adults: Clinical Trial

Conditions
-----------------
Aspiration; Liquids, Fasting, Perioperative Pulmonary Aspiration

Intervention / Treatment
-----------------
* Dietary Supplement: maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I or II; No known risk factor for slow or fast gastric emptying. Exclusion Criteria: Vomiting the study solution before completion. Wrong timing of assessment. Protocol violation.

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adults<br>Adults < 60 years-old maltodextrin solution 450ml | Dietary Supplement: maltodextrin<br>* maltodextrin solution 450ml<br>|
| Active Comparator: Elders<br>Elders 65 or more years-old maltodextrin solution 450ml | Dietary Supplement: maltodextrin<br>* maltodextrin solution 450ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antral Volume change | Antral volume in cm² assessed by ultrasound in semirecumbent position. | Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures) |
Per-Oral Endoscopic Myotomy

Study Overview
=================
Brief Summary
-----------------
This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.

Official Title
-----------------
Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: Per-oral enodscopic myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Diagnosis of achalasia Age 18-75 Mentally competent to give informed consent Scheduled to undergo a POEM procedure Exclusion: Pregnant women Any prior surgical treatment for achalasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Per-oral endoscopic myotomy<br> | Procedure: Per-oral enodscopic myotomy<br> <br> * Other names: POEM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the quality of life, pain, and complications of the POEM approach |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
achalasia, myotomy, endoscopic myotomy, difficulty swallowing
Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.

Official Title
-----------------
A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: hCBE-11


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory solid tumors not curable with standard therapy. At least one measurable lesion ECOG Performance Status less than or equal to 2 Acceptable hematologic status Albumin greater than or equal to 2.5 g/dL Normal calculated glomerular filtration rate (GFR) Acceptable liver function Exclusion Criteria: Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day Known history of hepatitis B or C, or HIV infection Clinically significant effusions, including pericardial, pleural, and ascites Serious non-malignant disease Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated Investigational therapies within 4 weeks of Study Day 1 Radiation therapy of tumors to be followed for this study Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1 Current Grade 3 or 4 neurological toxicity Concurrent anti-neoplastic therapy and/or steroids

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hCBE-11|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the recommended Phase II dose of hCBE-11 |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monoclonal antibody, Advanced solid tumors, Tumors, hCBE-11
Burn Outcomes in Young Adult Burn Survivors

Study Overview
=================
Brief Summary
-----------------
As part of Clinical Trials.Gov ID:NCT00253292 a psychometrically sound outcomes instrument was developed to study the outcomes of burn survivors in the 19-30 year old age group. This workgroup has come together to re-examine the data collected during the previous study and determine next steps in understanding the recovery for this population.

Detailed Description
-----------------
This study looks to understand previously collected outcomes scores. Identifying young adult burned patients at risk for poor outcomes remains an under-published field of study. We strive to identify problem areas for this population before they adversely effect their quality of life. How are these 19-30 year olds different from their non-burned counterparts and what interventions can we provide to equalize the balance?

Official Title
-----------------
Burn Outcomes in Young Adult Burn Survivors- A Multicenter Outcomes Study

Conditions
-----------------
Burns, Trauma

Intervention / Treatment
-----------------
* Other: Questionnaire self report


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All burn injured young adults with or without skin grafting. All burned young adults on or after their 18th birthday. Between the ages of 19-30 years. English speaking Present for inpatient or outpatient treatment. - Exclusion Criteria: Non-burn skin conditions. Non-English speaking young adults. Young adults less than 19 years of age. Young adults greater than 30 years of age. -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 30 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 |
| --- | --- |
| YA Burned Subjects<br>Any person between the years of 19-30 years old treated for a burn injury, having incurred within past 12 months. | Other: Questionnaire self report<br>* Burn specific outcome measurement and global health measurement<br>* Other names: Veterans Rand 12 Item Health Survey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form Young Adult Outcomes Questionnaire | Once existing data are massaged we will revise the stated outcome measure to make it more contemporary. | 12-24 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans Rand 12 Item Health Survey (VR-12) | The VR-12 instrument was developed based on data from the SF-36 survey. | 12-24 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, Trauma, Outcomes, Quality of Life