linjc16/ctgov huggingface dataset:
Nanofat in Post Burn Scars on the Face

Study Overview
=================
Brief Summary
-----------------
Quasi-Experimental Study: Unfiltered Nanofat Injected into Postburn Facial Scars Number of Patients: 48 Outcome Assessed on POSAS And with Imaje J Scanning Preop And Postop Statistical Comparison of Scar Done

Detailed Description
-----------------
Objective: To compare the quality of post burn facial scars before and after injection of unfiltered nanofat. Place and Duration of Study: Plastic Surgery Department, Mayo Hospital, Lahore, from January 2016 to December 2016. Methodology: 48 patients with post burn facial scars were included, age range 4 to 32 years with Fitzpatrick skin types between 3 and 4. Patients with hypertrophic scars, contractures or keloids were excluded. Scars were assessed by a senior plastic surgeon and the patient on the POSAS. Fat was harvested from the abdomen and/or thighs with a 3 mm multi-port liposuction cannula (containing several sharp side holes of 1 mm) using Coleman's technique, emulsified, and transferred into 1 ml Leur lock syringes for injection into the subdermal or intradermal plane. Final follow up was scheduled at 6 months and scar was rated by the patient and the same surgeon on the POSAS. Pre and post op scar scores were compared and p-values calculated.

Official Title
-----------------
Rejuvenation of Post Burn Scars on the Face With Unfiltered Nanofat Injection

Conditions
-----------------
Burn Scar

Intervention / Treatment
-----------------
* Biological: Unfiltered Nanofat Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post burn scars on the face Fitzpatrick skin types between 3 and 4 Exclusion Criteria: Hypertrophic scars Contractures Keloids
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

| Intervention/Treatment |
| --- |
|Biological: Unfiltered Nanofat Graft|Nanofat created from microfat, skipping the filtration step. Intradermal and subdermal injections in post burn scars on the face.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rejuvenation of post burn scars on the face with unfiltered nanofat injection | Pre and post-operative POSAS score | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post burn scar face, Unfiltered nanofat, Adipose tissue growth factors, Adipose stem cells, Image J, Face, POSAS
Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Official Title
-----------------
A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Pandemic influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects 18 years of age who signed the informed consent Exclusion Criteria: Receipt of another investigational agent within 4 weeks Receipt of influenza vaccination for current season 2006/2007. any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1) Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control Surgery planned during the study period Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination History of (or current) drug or alcohol abuse Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pandemic influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion and seroprotection after two doses of H5N1 vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza H5N1, pandemic
Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to investigate the physiological responses associated with deqi during stimulation of the LI11 and LI4 acupuncture points and the correlation between the intensity of the deqi sensation to such responses.

Official Title
-----------------
Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Electroacupuncture to right LI4 and LI11 (ITO, EX-160)
* Device: Sham Electroacupuncture to knee caps
* Device: Sham electroacupuncture to LI4 and LI11


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy subjects who were naïve to acupuncture Able to read Chinese and no communication barrier Exclusion Criteria: Subjects with medical disorders, including neurological and psychologic disorder Use of medications that may affect the cardiovascular system within one week Subjects with painful or uncomfortable sensations of upper and lower limbs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture to right LI4 and LI11<br> | Device: Electroacupuncture to right LI4 and LI11 (ITO, EX-160)<br>* Electroacupuncture at 2Hz, 0.4m/sec pulse duration<br>* Other names: Electroacupuncture device, ITO, EX-160, Hannover, Germany;|
| Sham Comparator: Electroacupuncture to knee caps<br>Electroacupuncture to knee caps | Device: Sham Electroacupuncture to knee caps<br>* Electroacupuncture at 2Hz, 0.4m/sec pulse duration<br>|
| Placebo Comparator: Sham electroacupuncture to LI4 & LI11<br> | Device: Sham electroacupuncture to LI4 and LI11<br>* Electroacupuncture at 2Hz, 0.4m/sec pulse duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological Changes Associated with Deqi during Electroacupuncture to Right LI4 and LI11 | heart rate variability | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deqi electroacupuncture, BP HR HRV
Phase 1, Multiple Dose Study of MPC-6827 in Subjects With Refractory Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.

Official Title
-----------------
Phase I Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Solid Tumors.

Conditions
-----------------
Refractory Solid Tumors

Intervention / Treatment
-----------------
* Drug: MPC-6827


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced or Metastatic Cancer Measurable / Evaluable Disease Karnofsky score greater than or equal to 70% Adequate Hematology / Organ function No Baseline peripheral or central neuropathy above grade 1 Exclusion Criteria: Hypersensitivity to Cremophor EL Pregnant or Lactating Spinal Cord Compression Pre-existing Dementia / Cognitive Disfunction Require Neupogen or Neulasta to Maintain Neutrophil Count Have Primary Brain Cancer Have history of Ischemic Heart Disease Have Diabetes

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MPC-6827|2-hour intravenous infusion given once weekly for 3 consecutive weeks on a 28 day cycle|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose |  | 1 year | 
| Pharmacokinetics |  | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor Activity |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain, Solid Tumors, Refractory
Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens. The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. Secondary objectives include: To further evaluate the safety of EKB-569 To explore additional clinical activity parameters To explore subject survival To evaluate the pharmacokinetics of EKB-569 To assess subject reported outcomes EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.

Official Title
-----------------
A Phase 2 Study of EKB-569 in Subjects With Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung, Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: EKB-569


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy Exclusion Criteria: Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas) Prior radiotherapy to >25% of bone marrow Prior epidermal growth factor receptor-targeting therapy

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EKB-569|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
-----------------
Advanced Non-Small Cell Lung Cancer
Correlation Between SFRP1 and Colorectal Cancer and Adenoma

Study Overview
=================
Brief Summary
-----------------
In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1_16_17_18 CpG site was good performance as a diagnostic marker of colorectal cancer.

Official Title
-----------------
Correlation Between Methylation Site of SFRP1 Gene Promoter and Colorectal Cancer and Adenoma

Conditions
-----------------
Early Diagnosis of Colorectal Cancer and Adenoma

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive adult patients undergoing an outpatient endoscopy and histopathologically diagnosed as colorectal cancer or adenoma. Also, healthy individuals were invited to be enrolled. Exclusion Criteria: Lynch syndrome Familial adenomatous polyposis MUTYH associated polyposis Peutz-Jeghers syndrome Juvenile polyposis syndrome Serrated polyposis syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| normal control<br>healthy volunteers | Other: no intervention<br>* no intervention<br>|
| adenoma<br>pathologically reported colorectal adenoma | Other: no intervention<br>* no intervention<br>|
| colorectcal cancer<br>pathologically reported colon cancers | Other: no intervention<br>* no intervention<br>|
| High risk group<br>pathologically reported inflammatory bowel diseases | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of methylation markers from stool samples | assess the effectiveness of methylation markers from stool samples in colon cancer patients, colorectal adenoma patients, compared with normal volunteers | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the capacities of RF model in screening potential clinical biomarkers. |  | 3 years |
Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat

Study Overview
=================
Brief Summary
-----------------
Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity. Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max. In addition to this we will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.

Official Title
-----------------
Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Exercise
* Other: Fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men Body mass index (BMI) 20-26 age 18-45 years Exclusion Criteria: any kind of disease any use of medicine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>control: muscle and fat biopsies and basal aminoacid and glucose turnover | |
| Experimental: Exercise<br>1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1. | Other: Exercise<br>* 1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1.<br>|
| Experimental: Fasting<br>3 days of fasting and then the same as arm 1 | Other: Fasting<br>* 3 days of fasting and then the same as arm 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth hormone and insulin signal pathways |  | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aminoacid and glucose turnover |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth hormone insulin signaltransduction signalpathways, growth hormone and insulin signalpathways
Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of PERMIT is to collect information on the treatment of radiotherapy patients using a new radiotherapy machine that includes magnetic Resonance (MR) imaging (MR linac) to guide treatment. The aim is to use this information to support the introduction of MR Linac into clinical practice. PERMIT will collect details on patients treated on the MR linac plus details on their side effects and other outcomes. This information plus technical and imaging information will be combined with information from other centres using this machine. By doing so this will help us learn how best to use the MR Linac in the future and design new radiotherapy protocols

Official Title
-----------------
Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: MR Linac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiotherapy treatment suitable to be delivered on the MR Linac. Patient provides written, informed consent and/or authorization. Patients between the ages of 5 and under 16 years old may enter protocol with parental/guardian consent. Exclusion Criteria: Contra-indications to MR imaging. Radiotherapy not suitable for delivery on the MR Linac e.g. those with extended field lengths (exceeding 20 cm).

Ages Eligible for Study
-----------------
Minimum Age: 5 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
Interventional Model Description: To assess delivery of radiotherapy on the MR Linac for multiple tumour sites
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy delivered on the MR Linac<br>MR Guided radiotherapy treatment | Device: MR Linac<br>* MR guided radiotherapy treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical feasibility of undertaking MRL based radiotherapy at multiple clinical sites: The percentage of treatment fractions delivered successfully on the MR linac | The percentage of treatment fractions delivered successfully on the MR linac, if more than 20 % of patients (depending on treatment site) need to be treated on alternative machine or treatment protocol changed will lead to the MRL protocol at that site to be judged not feasible. | 2 years |
Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
The goal of the current study is to evaluate the potential of the selected PET tracers to detect sarcoidotic lesions in lungs. The tracers are already in clinical use for the detection of certain inflammatory processes or malignant tumors, and their targets present similarities with molecular mechanisms of sarcoidosis.

Detailed Description
-----------------
The diagnosis of sarcoidosis is difficult since there is no specific noninvasive method available to diagnose sarcoidosis. FDG-PET imaging is in use, however, FDG is not a specific tracer for sarcoidosis and other inflammatory diseases may interfere with the imaging findings. The aim of the current protocol is to evaluate the potential of other inflammatory PET-tracers in the detection of sarcoidotic lesions. The patients with active sarcoidotic lesions in lungs will be recruited. First, the patient undergoes PET-FDG scan and then the patient undergoes the PET scan either with C11-methionine or 68Ga-DOTANOC. The results with the latter tracers will be compared to the imaging results with FDG.

Official Title
-----------------
Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis

Conditions
-----------------
Pulmonary Sarcoidosis

Intervention / Treatment
-----------------
* Drug: Methionine
* Drug: DOTANOC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with sarcoidosis Exclusion Criteria: any malignant disease any significant other inflammatory or infectious disease affecting lungs pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C11-methionine<br>To compare FDG and C11-methionine in the detection of sarcoidotic lesions. | Drug: Methionine<br>* Subject undergoes imaging studies with FDG and with methionine.<br>* Other names: PET tracers;|
| Experimental: 68Ga-Dotanoc<br>To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions. | Drug: DOTANOC<br>* Subject undergoes imaging studies with FDG and with DOTANOC.<br>* Other names: PET tracers;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC. | Qualitative assessment of tracer uptake in sarcoidotic lesions. | baseline |