linjc16/ctgov huggingface dataset:
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Detailed Description
-----------------
Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.

Official Title
-----------------
A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery

Conditions
-----------------
Ovarian Cysts, Endometriosis, Adhesions

Intervention / Treatment
-----------------
* Biological: ADHEXIL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients aged 18-45 years at screening. Patients undergoing elective laparoscopic surgery involving at least one adnexa. Exclusion Criteria: Pregnant (including ectopic pregnancy) or breastfeeding patient. Patients with a documented diagnosis of cancer. Patients with a lymphatic, hematologic or coagulation disorder. Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™. Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. Patients who have participated in another clinical study within 30 days of enrolment. Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>patients who will be treated in accordance with standard of care | |
| Experimental: 2<br>patients for which Adhexil will be applied to prevent/reduce adhesions | Biological: ADHEXIL<br>* Adhesions prevention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesions will be assessed according to incidence, extent and severity. |  | 8 weeks post surgery |
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.

Official Title
-----------------
Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT

Conditions
-----------------
Acute Leukemia

Intervention / Treatment
-----------------
* Biological: Genetically modified DCs plus CIK cells
* Biological: Donor leukocyte infusions (DLI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AL patients according to the WHO criteria expected survival duration of more than 3 months age between 8 and 61years Exclusion Criteria: underlying autoimmune disease positive serology for HIV infection chronic active hepatitis

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 61 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genetically modified DCs plus CIK cells<br>Patients received four subcutaneous injections of 2-5×10e7 cells of DCs at the groin, axilla, and neck respectively on days 7, 9, 11, and 13 and i.v. infusions of 2-15×10e9 CIK on days 11 and 13 per cycle. The cycle was repeated until Wilms' tumor 1(WT1) turned negative by polymerase chain reaction(PCR) or graft-versus-host disease(GVHD) appeared. | Biological: Genetically modified DCs plus CIK cells<br> <br> |
| Active Comparator: Donor leukocyte infusions (DLI)<br>Patients received DLI at a dose of 2×10e7/kg, 5×10e7/kg and 1×10e8/kg cluster of differentiation 3(CD3)+ cells at months 1, 2 and 3 respectively unless GVHD appeared. | Biological: Donor leukocyte infusions (DLI)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gvhd incidence |  | 100 days |
Hyperspectral Imaging Pre and Post Endovascular Intervention

Study Overview
=================
Brief Summary
-----------------
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.

Detailed Description
-----------------
This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.

Official Title
-----------------
Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).

Conditions
-----------------
Chronic Limb Ischemia, Non-Healing Ulcers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization. Age group between 50-85 Gender - Male or Female Race - all race and ethnicities Exclusion Criteria: Patients with known cardiac disease - new MI (within 3 months). Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing Patients on supplemental O2 for chronic obstructive lung disease Bed-ridden subjects - either due to chronic disability or neurological problems

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- |
| One Cohort<br> | |

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
-----------------
revascularization, claudication, hyperspectral, oxygenation, limb ischemia
Role of Dopamine Receptors in Primary Focal Dystonias

Study Overview
=================
Brief Summary
-----------------
Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather rudimentary. A better understanding of neural mechanisms of dystonias is not only an invaluable prerequisite for developing better treatment options but also a step toward better understanding of the complex network of basal ganglia. In this study I will investigate if there is any difference between the dopamine receptors and dopamine in people with dystonia and healthy subjects.

Official Title
-----------------
Role of Dopamine Receptors in Primary Focal Dystonias

Conditions
-----------------
Healthy, Focal Dystonias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >20 Male or Female Any race or ethnicity Primary focal dystonia (arm or cranial) Ability to give informed consent Exclusion criteria: Family history of dystonia Pregnancy (confirmed with negative urine pregnancy test in women of child bearing potential), breastfeeding Exposure to radiation therapy Any MRI contraindications such as foreign metallic implants, pacemaker, and aneurysm clip etc. History of cardiac disease, uncontrolled hypertension, abnormal EKG during screening phase History of exposure to any drugs affecting dopaminergic systems within the last 6 months (e.g. dopamine receptor blocking agents, cocaine, amphetamine, tetrabenazine, reserpine, L-dopa, dopamine agonists, as they might affect the dopamine receptor binding or endogenous dopamine). Active depression (Beck Depression Inventory_II >14) Cognitive impairment (Mini-Mental State Score <27) CNS active medications such as gabapentin or narcotics, muscle relaxants which might be given for pain in the 3 days prior to study History of stroke, seizure, cerebral palsy, generalized dystonia, parkinsonism, inability to hold head still during the scanning time.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| healthy controls<br> | |
| patients with focal dystonias<br> | |

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
-----------------
focal, dystonia, dopamine, receptor
Early Prevention of Conduct Problems

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the immediate and long-term effects of a prevention program in children at risk for developing conduct problems and antisocial behavior.

Detailed Description
-----------------
Participants are randomly assigned to a year-long family-based intervention or to a no contact control group. The intervention focuses on improving parenting practices, parent-child interactions, and child social competence. Children are assessed at the beginning of the study and again after one year. The development of conduct problems, social competence, and school functioning is assessed from second through fifth grade. Assessments are made through observations, parent and teacher ratings, and diagnostic interviews.

Official Title
-----------------
Early Primary Prevention of Conduct Problems

Conditions
-----------------
Conduct Disorder

Intervention / Treatment
-----------------
* Behavioral: Family-Based Preventive Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sibling of youth adjudicated in Family Court

Ages Eligible for Study
-----------------
Minimum Age: 33 Months
Maximum Age: 63 Months

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 |
| --- | --- |
| Experimental: Early Primary Prevention<br> | Behavioral: Family-Based Preventive Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| behavior problems |  | March 1997 - December 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Behavior Disorders
Exploratory Study Using Nanotechnology to Detect Biomarkers of Parkinson's Disease From Exhaled Breath

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. Exhaled breath testing may yield a breath-print that can be used to distinguish healthy and diseased states.

Official Title
-----------------
Exploratory Study to Detect Volatile Biomarkers of Idiopathic Parkinson's Disease and Parkinsonism From Exhaled Breath Using a Nanomedical Artificial Olfactory System.

Conditions
-----------------
Parkinson's Disease, Parkinsonism

Intervention / Treatment
-----------------
* Other: collection of exhaled breath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinsonism Exclusion Criteria: Severe dementia

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Patients with parkinsonism<br>Patients suffering from Parkinson's disease or parkinsonism | Other: collection of exhaled breath<br>* no intervention<br>|
| Healthy controls<br>Patients not suffering from Parkinson's disease or any other neurological disorder | Other: collection of exhaled breath<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nanosensory detection | analyze combinations of nanomaterial-based sensors (organically functionalized carbon nanotubes and gold nanoparticles) | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Parkinsonism, Biomarkers, Exhaled breath, Nanothechnology
Metabolic Effects of Enfuvirtide in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents. A short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.

Official Title
-----------------
Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Enfuvirtide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males BMI between 19-24.9 kg/m2 No active concomitant clinical conditions Negative HIV, HBV and HCV serologies Negative abuse drug urine test Exclusion Criteria: Prior psychiatric illness Prior dyslipemia Alcohol consumption > 30g/day Caffeine consumption > 5 units/day Current smoker Known drug allergies Participation in other drug trials in the previous 3 months No medications in the previous 30 days

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline solution 0.9% sc/12h for 7 days | Drug: Placebo<br>* 0.9% saline solution/12h sc for 7 days<br>|
| Experimental: Enfuvirtide<br>Enfuvirtide 90 mg/12h sc for 7 days | Drug: Enfuvirtide<br>* 90 mg/12h sc for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma total cholesterol |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA |  | 6 weeks |
Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.

Detailed Description
-----------------
A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.

Official Title
-----------------
Evaluation of Corneal Staining With Market Contact Lens/Solution Combinations

Conditions
-----------------
Corneal Epithelial Disruption, Corneal Staining

Intervention / Treatment
-----------------
* Device: Marketed contact lens care products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently wearing soft contact lenses daily wear for at least 2 weeks prior to study correct visual acuity of 20/30 or better each eye Exclusion Criteria: history of hypersensitivity to any components of solution being tested any ocular condition prohibiting contact lens wear excessive baseline staining as defined in protocol use of topical or OTC ocular medications during the study seasonal allergies with significant effect on contact lens wear

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Marketed contact lens care products|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of Corneal Staining |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type (severity) of Corneal Staining |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multipurpose solution, corneal staining, contact lens care
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to test the performance and safety of a newly developed intermittent catheter

Official Title
-----------------
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers

Conditions
-----------------
Incontinence, Urinary

Intervention / Treatment
-----------------
* Device: Coloplast Test Catheter
* Device: Speedicath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix: Leukocytes Nitrite Or if positive, subsequent negative for bacterial growth in urine culture Exclusion Criteria: Abnormalities, diseases or surgical procedures performed in the lower urinary tract Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation Known hypersensitivity toward any of the test products -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Coloplast Test Catheter; then Speedicath<br>The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter | Device: Coloplast Test Catheter<br>* This is a newly developed intermittent catheter<br>Device: Speedicath<br>* This is a marketed Catheter which is used as comparator<br>|
| Experimental: First Speedicath; then Coloplast Test Catheter<br>The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter | Device: Coloplast Test Catheter<br>* This is a newly developed intermittent catheter<br>Device: Speedicath<br>* This is a marketed Catheter which is used as comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain experienced by the subjects at catheterisation is measure with the VAS scale | 1 day |