linjc16/ctgov huggingface dataset:
The Evaluation of OrCel for the Treatment of Venous Ulcers

Study Overview
=================
Brief Summary
-----------------
This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care consists of currently accepted compression therapy. Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional 12 weeks to assess durability of the healed wound.

Official Title
-----------------
A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers

Conditions
-----------------
Leg Ulcer, Venous Insufficiency

Intervention / Treatment
-----------------
* Device: Bilayered Cellular Matrix (OrCel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any race, between 18 and 85 years of age Male or female Chronic venous insufficiency Ulcer size between 2 and 20 sq cm, inclusive Ulcer present for at least one month ABI >0.7 Exclusion Criteria: Decrease in wound size >35% during Screening Phase Infection at ulcer site Uncontrolled diabetes mellitus Malnutrition Previous treatment with excluded medications

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bilayered Cellular Matrix (OrCel)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Assessment of wound healing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Planimetric assessment of wound healing |  |  | 
| Photographic assessment of wound healing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous leg ulcer, Venous insufficiency, OrCel
Formula PTX Renal Stent Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.

Official Title
-----------------
Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis

Conditions
-----------------
Renal Artery Stenosis

Intervention / Treatment
-----------------
* Device: Formula PTX Stent - Dose 1
* Device: Formula PTX Stent - Dose 2
* Device: Formula PTX Stent - Dose 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal artery stenosis appropriate size and location of the lesion Exclusion Criteria: pregnant or breast feeding failure or inability to give informed consent simultaneously participating in another drug or device study

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group A<br> | Device: Formula PTX Stent - Dose 1<br>* Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.<br>|
| Experimental: Study Group B<br> | Device: Formula PTX Stent - Dose 2<br>* Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.<br>|
| Experimental: Study Group C<br> | Device: Formula PTX Stent - Dose 3<br>* Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Diameter Stenosis of the Treated Renal Artery |  | 9 months |
[11C]NOP-1A and Cocaine Use Disorders

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compared [C-11]NOP-1A binding in recently abstinent cocaine use disorders and controls.

Detailed Description
-----------------
This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse of cocaine in humans.

Official Title
-----------------
Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Cocaine Use Disorders

Conditions
-----------------
Cocaine Use Disorder

Intervention / Treatment
-----------------
* Radiation: [C-11]
* Drug: NOP-1A


Participation Criteria
=================
Eligibility Criteria
-----------------
[A]Cocaine use disorders Inclusion criteria: Males or Females 18-50 Fulfill DSM-5 Diagnosis for Cocaine use disorder Medically Healthy Major exclusion criteria: Pregnancy or lactation Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use) Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year Currently on any psychotropic medications that can influence nociceptin transmission in the brain (e.g., morphine, suboxone, SSRIs, etc.) [B] Healthy controls Inclusion criteria: Males or Females 18-50 Absence of present or past psychiatric conditions (including alcohol or drug use disorders) A negative urine drug screen Medically Healthy Major exclusion criteria Pregnancy or lactation Medical, psychiatric or drug & alcohol use disorders Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year Currently on any psychotropic medications that can influence nociceptin transmission in the brain Family history of a psychotic disorder, manic episode, drug use disorders in first-degree relatives.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: [C-11]NOP-1A
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocaine use disorders<br>PET scan | Radiation: [C-11]<br>* Radiolabel<br>Drug: NOP-1A<br>* Tracer<br>|
| Experimental: Controls<br>PET scan | Radiation: [C-11]<br>* Radiolabel<br>Drug: NOP-1A<br>* Tracer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [C-11]NOP-1A VT | VT-volume of distribution expressed relative to total plasma | Baseline |
Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The researchers are trying to determine pain medication consumption in the first 24 hours after surgery in patients given the standard continuous infusion of local anesthetic versus patients given the same total dose via programmed intermittent dosing. Both groups will receive the option of patient controlled pain medication as well as the same dose of pre-programmed pain medication. The only difference is the rate of administration: continuous vs. hourly intervals.

Official Title
-----------------
A Comparison Between Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery: A Randomized Controlled Trial

Conditions
-----------------
Thoracic Diseases

Intervention / Treatment
-----------------
* Other: Programmed Intermittent Bolus
* Other: Continuous Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documentation of planned thoracic surgery for which a paravertebral catheter is indicated based on surgeon request as well as appropriateness of location of surgical site. Ability for subject to comply with the requirements of the study. Exclusion Criteria: Pregnancy. Coagulopathy at time of evaluation or surgery. Infection at the site of needle insertion. Allergy to local anesthetic. Patient refusal. Chronic opioid use

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Programmed Intermittent Bolus<br>6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus | Other: Programmed Intermittent Bolus<br>* 6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus<br>|
| Active Comparator: Continuous Infusion<br>6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion | Other: Continuous Infusion<br>* 6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption 24 hours postoperatively | morphine equivalents of opioids in mg will be obtained from medical record | first 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption 48 hours postoperatively | morphine equivalents of opioids in mg will be obtained from medical record | first 48 hours postoperatively |
Evaluation of the Interest of a Specialist in Dermatology for Dermatopediatric Consultations

Study Overview
=================
Brief Summary
-----------------
Dermatologic diseases, of very different etiology and variable severity, represent a major motivation for consultation (in private consultations and in emergency departments), thus leading pediatricians to frequently turn to dermatologic advice. The principal aim is to estimate the degree of concordance of the main diagnosis between a pediatrician and a pediatric dermatologist. The secondary aims is to estimate the degree of concordance of the treatment, advices and follow-up.

Official Title
-----------------
Evaluation of the Interest of a Specialist in Dermatology for Dermatopediatric Consultations

Conditions
-----------------
Dermatologic Disease, Pediatric ALL, Collaboration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under 18 years old consultating for dermatologic problem in emergency department (1 department) or private pediatric center (1 center) signed consent consécutives consultations Exclusion Criteria: no consent

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

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 |
| --- | --- | --- |
| principal diagnosis | % of concordance between diagnosis (dermatologist/pediatric) | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treament | % of concordance between treatment (dermatologist/pediatric) | baseline | 
| advices | % of concordance between advices(dermatologist/pediatric) | baseline | 
| follow-up | % of concordance between follow-up (dermatologist/pediatric) | baseline |
Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.

Study Overview
=================
Brief Summary
-----------------
To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.

Detailed Description
-----------------
To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide. With transcranial Doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of the superficial temporal artery (STA), the radial artery and facial skin perfusion.

Official Title
-----------------
Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Other: Carbon monoxide
* Other: AIR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Aged 18-50 50-100 kg Exclusion Criteria: Tension type headache more than once/month Other primary headaches Daily medication except contraceptives Drug taken within 4 times the halflife for the specific drug except contraceptives Pregnant or lactating women Exposure to radiation within the last year Headache within the last 24 hours before start of trial Hypertension Hypotension Respiratory or cardiac disease Smoking Primary relatives with current or previous migraine

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

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active carbon monoxide<br>Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22% | Other: Carbon monoxide<br>* carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass<br>|
| Placebo Comparator: Air<br> | Other: AIR<br>* Room air will be administered as placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache scores, 12 hours | Comparison between carbon monoxide and placebo (atmospheric air) | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial blood flow | Carbon monoxide induced changes in facial blood flow before and after inhalation. | [ Time Frame: 0-180 min ] |
Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The elimination of the carbohydrate galactose is used in daily clinical work with liver patients as a quantitative measure of metabolic liver function, as the liver test The Galactose Elimination Capacity, GEC. We are working to develop a PET/CT scanning procedure for providing 3D images of the hepatic galactose elimination and measurement of regional values. This may be used for example for planning resection or stereotactic radiotherapy of a patient with malignant tumor in the liver. Will the patient be able to tolerate removal of the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6 healthy human subjects. Direct measurements of the hepatic galactose elimination (successive constant iv infusions of galactose in increasing doses with measurements of blood concentrations of galactose in blood from an artery and a liver vein, and measurements of liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements after iv injection of a 18F-labelled galactose analog, FDGal. Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose elimination kinetics by the two methods, including estimation of a factor (lumped constant) for recalculating PET/CT data to data for natural galactose. Besides possible practical clinical importance, the project elucidates basic problems concerning liver metabolism using PET.

Official Title
-----------------
Determination of Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects

Conditions
-----------------
Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver cirrhosis Exclusion Criteria: hepatic encephalopathy pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Liver cirrhosis / healthy subjects<br>10 patients with liver cirrhosis and 10 sex and age-matched healthy subjects | |
| Liver cirrhosis and healthy subjects<br>Patients with liver cirrhosis and healthy subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose |  | May 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Galactose, PET/CT, Liver physiology, Liver pathophysiology
Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Treatment of rectal cancer often consists of surgical resection of the tumor. Chemotherapy and/or radiotherapy are frequently given before or after surgery. In this study, we wish to learn if there are differences in the treatment effectiveness or in the quality of life of patients based on their type of treatment (e.g. Radiotherapy and chemotherapy before or after surgery). Information from this questionnaire collected from you and other patients may help improve the quality of life of rectal cancer patients in the future. Medical information on your tumor, treatment received, and side effects will be compiled and maintained in a database to learn more about outcomes of treatment for rectal cancer.

Detailed Description
-----------------
There exists little published data studying the health related quality of life (HRQOL) of patients treated for the rectal cancer. Patients are commonly treated with surgery preceded or followed by chemo radiotherapy. Patients chart review and questionnaires administered during follow-up exam or by mailing will be use to compile data comparing the HRQOL of the two study groups(Preoperative versus Post operative chemotherapy). Our Radiation Oncologist will also informed all the new pts. under going radiotherapy regarding this study and will encourage them in become part of our study population. The prospective study will help us in increasing the number of participants and also it give us an opportunity following the patients as they go through their treatment. Through the use of department databases, a cohort or rectal cancer patients treated at Stanford will be identified. Patients demographics, treatment received ,disease outcomes, and treatment associated complications will be compiled from available data. HRQOL questionnaires will be answered through a mailing or during clinic visits. Treatment outcomes, toxicities and overall quality of life of preoperative and postoperative chemo radiotherapy treatment group will be compared in relation to the lesion location.

Official Title
-----------------
Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer

Conditions
-----------------
Rectal Cancer, Colon Cancer, Anal Cancer

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Questionnaire|Questionnaire form to be completed by patient|

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

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