linjc16/ctgov huggingface dataset:
Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.

Detailed Description
-----------------
In this phase II study, patients with solid tumors will receive treatment with intratumoral hiltonol and two cycles of autologous dendritic cells loaded with autologous tumor and administered subcutaneously. A new cohort will explore the role of radiation therapy, looking for an abscopal effect.

Official Title
-----------------
Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Biological: Hiltonol and autologous dendritic cells
* Radiation: Hiltonol, dendritic cells and radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of advanced solid tumors Measurable disease Performance status 0, 1 or 2. Adequate renal, hepatic and bone marrow function Availability of tumor tissue, for maturing dendritic cells Exclusion Criteria: Clinically relevant diseases or infections. concurrent participation in other clinical trial or administration or other antitumoral treatment Concurrent cancer, with the exceptions allowed by the PI. Pregnant or breast feeding women immunosuppressant treatment known uncontrolled central nervous system metastasis

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: Hiltonol and autologous dendritic cells<br>Hiltonol and autologous dendritic cells | Biological: Hiltonol and autologous dendritic cells<br>* Hiltonol and autologous dendritic cells<br>|
| Experimental: Hiltonol, dendritic cells and radiation<br>Hiltonol, dendritic cells and radiation. | Radiation: Hiltonol, dendritic cells and radiation<br>* Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 8-10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Common Toxicity Criteria 4.0) |  | 8-10 weeks |
Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail. We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men.

Official Title
-----------------
Sono-Electro-Magnetic Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Pilot Study

Conditions
-----------------
Chronic Pelvic Pain Syndrome

Intervention / Treatment
-----------------
* Device: sono-electro-magnetic therapy (Sonodyn Medico Star)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CPSS III symptomatic >3 months NIH-CPSI total score =/>15 NIH-CPSI pain =/>8 Exclusion Criteria: post void residual >100mL urinary tract infection urethral stricture age <18 years

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Combined sono-electro-magnetic therapy | Device: sono-electro-magnetic therapy (Sonodyn Medico Star)<br>* twice a day for 10 minutes during 6 or 12 weeks<br>* Other names: Sonodyn Medico Star;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) |  | before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain visual analogue scale |  | before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pelvic pain syndrome, Neuromodulation
Prophylactic Antibiotic in Treatment of Fingertip Amputation

Study Overview
=================
Brief Summary
-----------------
Fingertip amputation is a common injury. Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury. The investigators goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment. The study hypothesis was that infection rates were similar in the two groups.

Official Title
-----------------
The Use of Prophylactic Antibiotic in Treatment of Fingertip Amputation: A Randomized Prospective Trial

Conditions
-----------------
Infection Rate After Fingertip Amputation

Intervention / Treatment
-----------------
* Drug: Cephazolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fingertip amputation with bone exposed Exclusion Criteria: under the age of 18 years if the patient had diabetes oncological disorder immune deficiency bleeding disorder used steroids regularly presented with a grossly contaminated wound or other injury requiring antibiotic treatment were currently taking antibiotics, or had a previous allergic reaction to cephalosporins.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no antibiotic<br> | |
| Active Comparator: Cephazolin<br>cefazoline | Drug: Cephazolin<br>* Cephazolin<br>* Other names: Cefamezine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection rate |  | 1 month |
To Establish a Blood Transfusion Prediction Model for Liver Transplantation Patients Based on PBM

Study Overview
=================
Brief Summary
-----------------
Based on the principle of patient blood management, this study aims to reduce the risk of blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood transfusion, and to provide new methods and basis for restrictive blood transfusion.

Detailed Description
-----------------
Preoperative variables and statistical analysis of a large number of intraoperative blood transfusions in allogeneic liver transplantation patients were performed to screen preoperative variables. Models were established by machine learning algorithms to predict a large number of blood transfusions during surgery, providing a reference for preoperative blood preparation and postoperative outcome.

Official Title
-----------------
To Establish a Prediction Model of Massive Blood Transfusion for Liver Transplantation Patients Based on Patient Blood Management

Conditions
-----------------
Blood Transfusion Complication

Intervention / Treatment
-----------------
* Procedure: Liver transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 48h preoperative biochemical indicators, blood general indicators, coagulation test complete Exclusion Criteria: 1. Inspection information is not detailed 2. Blood transfusion information is not detailed 3.Postoperative medical record information is not detailed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver transplant<br>18 years to 65 48h preoperative biochemical indicators, blood general indicators, coagulation test complete | Procedure: Liver transplant<br>* blood transfusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one year mortality | All-cause mortality | 2019-2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood transfusion | Intraoperative blood component input | 2019-2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplantation, blood transfusion, Patient blood management
Pulse Sequence Development on 3T Magnetic Resonance Imaging/Spectroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find ways to improve the appearance of tumours or markers that indicate the presence of tumours in Magnetic Resonance Imaging (MRI). Although based on the same technology, there are many ways to obtain images using MRI. The type of image that will be produced by the scanner depends on the instructions sent to the machine. These instructions tell different components of the machine when to turn on and off and all together are called a pulse sequence. These pulse sequences can get quite lengthy and intricate and small changes in them can produce considerable changes in the resulting image. the aim of this protocol is to alter existing pulse sequences to improve image appearance. This protocol will involve only healthy volunteers.

Official Title
-----------------
Pulse Sequence Development on 3T Magnetic Resonance Imaging/Spectroscopy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult Exclusion Criteria: subject under 18 years of age subject pregnant, or may be pregnant

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnetic resonance imaging, magnetic resonance spectroscopy
Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.

Study Overview
=================
Brief Summary
-----------------
GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers.

Official Title
-----------------
A 2 Part Open-label, Randomised, Crossover Study to Compare the Effects of Formulation, Food and Particle Size on the Pharmacokinetic Profiles of a Single 175mg Dose of GW842166X in Healthy Male and Female Volunteers

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: GW842166X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive. Healthy as judged by a responsible physician. Exclusion Criteria: Positive pre-study urine screen for drugs of abuse or alcohol breath test.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW842166X|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GW842166 Cmax and AUC (O-Infinity) |  | Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GW842166 AUC (0-t), tlag,tmax and t1/2 |  | Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW842166,, Healthy volunteers,, Inflammatory Pain.
Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients

Study Overview
=================
Brief Summary
-----------------
The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients

Official Title
-----------------
Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients

Conditions
-----------------
Intermittent Urethral Catheterization

Intervention / Treatment
-----------------
* Device: Actreen Hydrolite Cath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patient patient is at least 18 years old patient having normal or impaired sensation in the urethra patient catheterizing at least 4 times a day patient using Ch 12 or 14 catheter for self clean urinary catheterization patient using a Nelaton catheter for self clean urinary catheterization patient using self clean urinary catheterization for at least one month patient covered with social insurance Exclusion Criteria: patient having a symptomatic urinary tract infection as assessed by the investigator (5 days after end of treatment for UTI, patient can be considered by the investigator for inclusion) patient with urethral hypersensitivity patient being mentally unstable not being assessed by the investigator as capable to follow the study procedure patient already participating in another clinical study or who have previously participated in this investigation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actreen Hydrolite Cath<br>a new hydrophilic coated catheter for Urinary Intermittent Catheterisation | Device: Actreen Hydrolite Cath<br>* Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence |  | All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered. |
Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.

Study Overview
=================
Brief Summary
-----------------
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.

Official Title
-----------------
Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

Conditions
-----------------
Ischemic Heart Failure, Ischemic Heart Disease, Ischemic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients recommended for coronary bypass surgery (preferably with cardiopulmonary support) Ejection fraction ≥15% and ≤35% Left ventricular myocardial infarction (MI - heart attack) ≥4 weeks prior to screening Exclusion Criteria: Need for a rapid surgical coronary revascularization Need for any other related cardiosurgical measure during coronary surgery (e.g. mitral valve repair or valve replacement) Patients with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery; patient receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy) Cardiomyopathy presumed to be of non-ischemic origin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-first major adverse cardiac event (cardiovascular related death, non-cardiovascular death, congestive heart failure, resuscitated sudden death, myocardial infarction (heart attack) and stroke. |  |  |
Fiber Health Benefits

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that fiber supplementation will provide measurable differences in indices of children's health (fewer complaints of abdominal pain and constipation, lower body mass index) compared to placebo.

Detailed Description
-----------------
This prospective study proposes supplementing children with fiber or placebo for four months. Children in elementary school, ages 5-12, will be randomized to receive fiber supplemented bars vs low-fiber snack bars (placebo).

Official Title
-----------------
Health Benefits and Tolerance of Dietary Fiber Supplements in Children

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

Intervention / Treatment
-----------------
* Dietary Supplement: Fiber
* Other: Placebo (low fiber bar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Children bewteen ages of 5-12 years Exclusion Criteria: History of allergy/intolerance to components of the snack bars (e.g. celiac disease) History of Hisrchsprungs disease, abdominal surgery to intestine or colon Unable to take a fiber bar by mouth

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber<br> | Dietary Supplement: Fiber<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo (low fiber bar)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stool frequency | Weekly stool frequency will be compared between baseline and study end in each group | 4 months | 
| Change in stool consistency | Stool consistency (using the Bristol scale) will be compared between baseline and study end in each group | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Weight will be measured and compared between baseline and study end in each group | 4 months | 
| Change in quality of life score | Pediatric Quality of Life Survey (PedsQL) score will compared between baseline and study end in each group | 4 months |