linjc16/ctgov huggingface dataset:
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).

Detailed Description
-----------------
The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.

Official Title
-----------------
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx Patients who did not undergo surgery for the primary tumor location Patients with a Karnofsky performance score of 70% or more Written informed consent for participation in this trial Exclusion Criteria: Other malignancy except for non-melanoma skin cancer Prior irradiation to the head and neck region

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensity modulated radiation therapy (IMRT).<br> | Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).<br>* FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy |  | until 3 months after the end of the radiotherapy | 
| Observation of chronic toxicity |  | until 3 months after the end of the radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy response (2-4 months after end of radiotherapy) |  | 2-4 months after end of radiotherapy | 
| Local control at 2 years |  | at 2 years | 
| Pattern of recurrence |  | at 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoplasms (squamous cell carcinoma of the head and neck region)
A Comparative Study of Kinesiology Taping Versus Taping in the Treatment of Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
Plantar fasciitis is a very studied pathology and treated with taping. There are studies that assess the effectiveness of Kinesio taping, as well as taping or low-dye taping, few studies that compare the two treatments and assess which is more effective. In the present work the effectiveness of Kinesio taping and taping will be assessed, as well as whether possible differences among intervention effects exist in terms of pain improvement, comfort and durability of the bandage.

Official Title
-----------------
A Comparative Study of Kinesiology Taping Versus Taping in the Treatment of Plantar Fasciitis

Conditions
-----------------
Plantar Fasciitis

Intervention / Treatment
-----------------
* Other: kinesiology taping
* Other: taping or Low-dye taping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with plantar fasciitis. People of legal age. Exclusion Criteria: Healthy people Minors. People with pathologies other than plantar fasciitis in the foot. People who have treatment for fasciitis at the time of starting the study

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kinesiology taping<br>Application of a neuromuscular bandage on the plantar fascia | Other: kinesiology taping<br>* To apply kinesiology taping in plantar fascia<br>|
| Active Comparator: taping or Low-dye taping<br>Application of a taping on the plantar fascia | Other: taping or Low-dye taping<br>* To apply taping or Low-dye taping in plantar fascia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale of Pain | It is rated on a scale of 0 to 10, where 0 is no pain and 10 is extreme pain. | seven days | 
| comfort | Comfort is rated on a scale of 0 to 10, where 0 is no comfotable and 10 is very comfortable | seven days | 
| Visual Analogue Scale of Mobility | the degree of MOBILITY that the foot has had when using the bandage, rated from 0 no mobility to 10 | seven days | 
| Visual Analogue Scale of comfort | The degree of COMFORT IN HYGIENE of the bandage: (for example at the time of showering or personal hygiene), rated from 0, no comfort to 10, maximum confort | seven days |
Effect of Medium Chain Triglyceride Consumption on Appetite

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effects of medium chain triglyceride consumption, relative to long chain triglycerides, on hormones involved in appetite regulation and food intake in overweight men. We expect medium chain triglycerides to reduce appetite and food intake and to do so by increasing levels of hormones known to be involved in satiety and reduce levels of those involved in appetite.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Test breakfast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males Weight stable (<10 lb over previous 3 months) Overweight (body mass index 25-29.9) Exclusion Criteria: Smokers Excessive caffeine users Severe health conditions Allergy to food products/ingredients in the study Taking medications known to affect energy expenditure or gastrointestinal function

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MCT<br>MCT oil (20 g) was included in the test breakfast | Dietary Supplement: Test breakfast<br> <br> |
| Placebo Comparator: LCT<br>Corn oil (20 g) was included in the test breakfast | Dietary Supplement: Test breakfast<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake | Intake at an ad libitum meal 3 h after test oil consumption (Study 1) or 1 h after a pre-load containing the test oil (Study 2) | up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ghrelin |  | 3 hours | 
| Peptide YY |  | 3 hours | 
| Glucagon-like peptide 1 |  | 3 hours | 
| Insulin |  | 3 hours | 
| Triglycerides |  | 3 hours | 
| Leptin |  | 3 hours |
A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate clinical and serologic outcomes after the discontinuation of liatermin therapy as assessed by development of new clinical conditions beyond those expected in patients with advancing Parkinson's disease. In addition, the development or resolution of anti-r-metHuGDNF binding and neutralizing antibodies will be monitored.

Official Title
-----------------
A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin

Conditions
-----------------
Idiopathic Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Safety observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects must have a diagnosis of bilateral, idiopathic Parkinson's Disease who have been enrolled and treated with intraputaminal infusion of liatermin in a previous Amgen/Medtronic-sponsored trial (protocols 20010109 or 20030160) or the Bristol open-label study - At time of implant (Study 20030168), subjects need to have been 35 to 70 years of age

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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 |
| --- | --- |
| Observational Group<br>Subjects previously administered GDNF and have discontinued the drug. | Drug: Safety observation<br>* Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 24 months |
A Retrospective, Natural History Study in Children With CLN2

Study Overview
=================
Brief Summary
-----------------
This is a multi center, retrospective, chart review study to document the evolution of ocular disease progression in pediatric patients with CLN2.

Detailed Description
-----------------
CLN2 is a rare disease with limited available ocular natural history data. While current standard of care slows motor degeneration, it is not known to treat the ocular manifestations of disease. This study is planned to document, through retrospective data collection, ocular disease progression in children with a clinical presentation consistent with CLN2. No investigational product is administered in this retrospective, chart review study.

Official Title
-----------------
A Retrospective, Chart Review Study to Evaluate Ocular Disease Progression in Children With Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)

Conditions
-----------------
Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A participant is eligible to be included in the study only if all of the following criteria apply: The participant's legal guardian(s) is(are) willing and able to provide them written, signed informed consent. The participant has a documented diagnosis of CLN2 disease due to TPP1 deficiency, or has a relative clinically diagnosed with CLN2 disease who has the same CLN2 mutations as the participant The participant has had one or more eye examinations by an eye care specialist at any time since birth. Exclusion Criteria: No exclusion criteria apply to this study.
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 |
| --- | --- | --- |
| Characterize retinal structural changes in children with CLN2 | As assessed in by SD-OCT measures in ophthalmic records of children with CLN2 | From first available medical chart through informed consent, an average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize changes in visual function. | As measured by changes in visual acuity over time in ophthalmic records of children with CLN2. | From first available medical chart through informed consent, an average of 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLN2, Batten Disease
Rapid Rehabilitation to Treat Lower Extremity Trauma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.

Official Title
-----------------
Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma

Conditions
-----------------
Lower Limb Trauma

Intervention / Treatment
-----------------
* Behavioral: Promis Physical Function Questionnaire
* Behavioral: L Test
* Behavioral: Narrowing Beam Walking Test
* Behavioral: PEQ-A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Research participants will be eligible active duty service members and retired veterans. Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage). Are enrolled in conventional rehabilitation at the participating military treatment centers. Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls. For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4). For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program. Exclusion Criteria: - Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injured Service Members<br> | Behavioral: Promis Physical Function Questionnaire<br>* Patient reported physical function outcomes<br>Behavioral: L Test<br>* Performance based measure assessing general physical function and balance ability.<br>Behavioral: Narrowing Beam Walking Test<br>* Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.<br>Behavioral: PEQ-A<br>* Survey on confidence, stumbles and falls.<br>* Other names: Prosthesis Evaluation Questionnaire - Addendum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthesis Evaluation Questionnaire-Addendum (PEQ-A) | Fall incidence change between baseline and 6 months | 0, 6 months |
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.

Official Title
-----------------
A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Continuous or Daily Administration of Remodulin® (Treprostinil Sodium) Injection in Patients With CLI With No Planned Revascularization Procedures

Conditions
-----------------
Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain

Intervention / Treatment
-----------------
* Drug: Remodulin® (treprostinil sodium) Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remodulin® (treprostinil sodium) Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Limb Ischemia, Peripheral Vascular Disease, UT-15, Remodulin, treprostinil
Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram

Study Overview
=================
Brief Summary
-----------------
Heart failure from myocardial iron deposition is a severe complication for patients with transfusion-dependent beta thalassemia . Increased cardiac iron content impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis, and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited in the myocardium.Echocardiogram is used as noninvasive method to observe heart status. The objective of this study is to evaluate the heart status in patients of Beta Thalassemia from southern China.

Official Title
-----------------
Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram

Conditions
-----------------
Beta Thalassemia

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiogram and Hematological Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with beta-thalassemia Exclusion Criteria: Iron deficiency anemia
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| beta thalassemia patients<br> | Diagnostic Test: Echocardiogram and Hematological Analysis<br>* Echocardiogram and Hematological Analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiogram | Evaluation of heart function in beta thalassemia patients by left ventricular fraction shortening | 3 years |
Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.

Official Title
-----------------
VA-SENSE - BACTERIAL VAGINOSIS ONCE A WEEK SCREENING AND TREATMENT TO REDUCE INFECTIVE COMPLICATIONS, ABORTION AND PRETERM DELIVERY IN PREGNANT WOMEN WITH PREVIOUS PRETERM DELIVERY.

Conditions
-----------------
Vaginal Infections, Bacterial Vaginosis, Late Miscarriage, Preterm Birth, Preterm Premature Rupture of Membranes

Intervention / Treatment
-----------------
* Device: VA-SENSE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant subjects, aged 18-50 years, pregnancy week 10 or less or 20 or less, with history of previous preterm delivery. Subject is ready to sign an informed consent form. Exclusion Criteria: Subject with ruptured membranes. Subject with signs and symptoms of bacterial vaginosis or Trichomoniasis infections. Subject with blood in her vaginal secretions. Subject is currently participating in another clinical study. Subject is unable or unwilling to cooperate with study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VA-SENSE|The VA-SENSE contains a strip of pH indicator (color indicator) that is sensitive to the acidity level. A change in the color of the strip due to changes in the acidity level of vaginal secretions absorbed in the panty liner clearly indicates high probability of bacterial or parasitic vaginal infection. Any color change that results from contact with urine will disappear 10 minutes of drying out, and then the color of the indicator strip will fade back to the original color (yellow).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of preterm birth, gestational week at delivery. | Each participant will use at least 8 VA-SENSE (maximum 20 TPLs), once a week for at least 8 weeks (maximum 20 weeks), or will be screened by VS-SENSE once during pregnancy. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bacterial vaginosis, screening, abortion, preterm delivery