linjc16/ctgov huggingface dataset:
Role of Adiponectin and Endothelial Progenitor Cells in Reperfusion Injury in Patients With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
There is experimental evidence that low levels of adiponectin are associated with more reperfusion injury. In addition experimental studies have demonstrated that endothelial progenitor cells may have a favorable effect on remodeling, mainly through stimulation of neo-revascularisation. Clinical data on these issues are lacking. This clinical project studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a population of 250 infarction patients treated with primary PCI. If the role of these factors could be confirmed in this clinical setting, those factors might represent a new target for therapeutic interventions in AMI patients.

Official Title
-----------------
Reperfusion Injury and Cardiac Remodelling After Myocardial Infarction in Relation to Adiponectin Level, Circulating Endothelial Progenitor Cells and Endothelial Microparticles

Conditions
-----------------
Myocardial Infarction, Reperfusion Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STEMI treated with primary PCI Exclusion Criteria: ischemia time >12h use of immunosuppressive therapy unsuccessful recanalisation not-interpretable ST-T segment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEMI patients<br>Patients with ST elevation myocardial infarction,lasting <12 hour, who were succesfully treated with primary PCI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of reperfusion injury after succesfull primary PCI | Serial ECG measurements (before and after PCI to assess extent of ST segment resolution as marker of reperfusion injury | within 90 min after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular event rate | combined endpoint of hospitalisation (or extension of hospitalisation) for heart failure and cardiac death in a period of one year | at 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Infarction, Reperfusion injury, Adiponectin, endothelial progenitor cells
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Ketotifen with a Contact Lens (generic name not yet established)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more Exclusion Criteria: active ocular infection; clinically significant blepharitis; follicular conjunctivitis; pterygium; narrow angle glaucoma; dry eye syndrome; ocular surgery within past 6 months; pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Ketotifen with a Contact Lens (generic name not yet established)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic conjunctivitis, ophthalmology, multicenter, controlled
Treatment for Insomnia During Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.

Official Title
-----------------
The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Behavioral: Arousal Based Therapy for Insomnia
* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month) Pregnant with gestational age between 18-32 weeks. Adequately fluent in English or Spanish. Exclusion Criteria: Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea) Co-morbid psychiatric disorder Use of medications, herbs or other drugs with known effects on sleep Unstable medical conditions Currently engaged in psychotherapy or other treatments for insomnia

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ABTI<br>Arousal Based Therapy for Insomnia | Behavioral: Arousal Based Therapy for Insomnia<br>* Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal<br>|
| Other: CBTI<br>Cognitive Behavioral Therapy for Insomnia | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of insomnia remission |  | Baseline to 30 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity |  | Baseline to 30 weeks postpartum | 
| Depression severity |  | Baseline to 30 weeks postpartum | 
| Sleep Characteristics | Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration. | Baseline to 30 weeks postpartum |
A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis

Official Title
-----------------
A Phase I, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis Over a Treatment Period of Three Weeks

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: pimecrolimus 10 mg/g cream
* Drug: Vehicle cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Male and female subjects, 18 years or older 2. Subject with atopic dermatitis with mild to moderate disease severity 3. Two symmetrical and comparable atopic dermatitis treatment areas 4. Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception Exclusion Criteria: 1. Any condition in the target areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than atopic dermatitis, sunburn, hyper- or hypopigmentation, scars 2. Dark-skinned persons whose skin colour prevents reliable clinical assessments 3. Any permanent (or transient within 28 days prior to dosing) disease that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments 4. Pregnancy or breastfeeding

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pimecrolimus 10 mg/g cream<br>Active drug | Drug: pimecrolimus 10 mg/g cream<br> <br> |
| Placebo Comparator: Vehicle cream<br>Placebo drug | Drug: Vehicle cream<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events during the 3 weeks treatment period |  | 3 weeks |
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus

Study Overview
=================
Brief Summary
-----------------
Assess whether the application of electrical stimulation in patients undergoing subcutaneous colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of postoperative ileus, improving the results of morbidity and mortality, hospitalization and health care costs.

Detailed Description
-----------------
Prospective randomized study on the application of subcutaneous abdominal electrical stimulation in the postoperative of colonic surgery and its relationship with the appearance of postoperative ileus.

Official Title
-----------------
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus in Colorectal Surgery

Conditions
-----------------
Ileus

Intervention / Treatment
-----------------
* Other: Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing colorectal surgery. Signing informed consent. Exclusion Criteria: Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis) Patients with contraindications for electrical stimulation. Psychiatric Disorders HIV Pregnant or breastfeeding intestinal obstruction uncontrolled infection ASA IV No acceptance or failure to follow protocol multimodal rehabilitation.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention, group control. | |
| Experimental: Stimulation<br>Subcutaneous Electrical Intervention | Other: Stimulation<br>* Subcutaneous abdominal electrical stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first flatus |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerance of single intravenous (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine. Finally, this study will also determine whether trodusquemine has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).

Official Title
-----------------
A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: trodusquemine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female subjects, between 18 and 55 years old (inclusive); body mass index (BMI) of 27-40 kg/m2; Exclusion Criteria: likely allergy or sensitivity to any components of Trodusquemine for Injection based on known allergies to drugs of the same class, or which, in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity to trodusquemine HCl; any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications; any subject with a history of severe allergy or bronchial asthma;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis

Study Overview
=================
Brief Summary
-----------------
This is a simple tissue collection study with no therapeutic intent. Colon tissues will be taken from standard of care procedures. Tissues will be tested for their functions, expression of immune co-signaling molecules and reactions to transduction with recombinant Listeria vectors to assess effects on expression of B7-H1 and cytokines.

Official Title
-----------------
Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis

Conditions
-----------------
Colon Cancer, Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent (or have consent provided through a guardian) No immune-modulating drug use during study or within 30 days prior to enrollment Having colon material collected as part of standard of care Exclusion Criteria: Unable to provide informed consent (or have consent provided through a guardian) Not having colon material collected as part of standard of care

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of B7-H1 | To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues | Baseline tissue collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue collection, colonoscopic surgical procedures
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.

Official Title
-----------------
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Device: Therasphere


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of </= 2, with a life expectancy of >/= 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy. Exclusion Criteria: Contraindications to angiography and selective visceral catheterization Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels) Significant extrahepatic disease representing an imminent life-threatening outcome Severe liver dysfunction or pulmonary insufficiency Active uncontrolled infection Significant underlying medical or psychiatric illness Pregnancy Patients will be excluded: if they have a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Therasphere|Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial administration to the liver.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Retrospective Evaluation of Liposarcoma

Study Overview
=================
Brief Summary
-----------------
Retrospective Evaluation of Survival after Liposarcoma

Official Title
-----------------
Retrospective Evaluation of Liposarcoma

Conditions
-----------------
Survival , Tumor

Intervention / Treatment
-----------------
* Procedure: Patients with Liposarcoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Liposarcoma treated surgically at our clinic Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Patients with Liposarcoma|Evaluation of Liposarcoma treated in a single center|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 2 years |
Study of Total Hip Arthroplasty Using Radlink Surgical Positioning Software

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on visual inspection of fluoroscopic images.

Official Title
-----------------
Prospective, Randomized Study to Evaluate Total Hip Arthroplasty With and Without Radlink Surgical Positioning Software

Conditions
-----------------
Total Hip Replacement

Intervention / Treatment
-----------------
* Other: Radlink Surgical Positioning Software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total hip arthroplasty Exclusion Criteria: -

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Intraoperative fluoroscopy of the hip is used to visually estimate the acetabular cup angle and make any necessary adjustments. | |
| Experimental: Radlink Surgical Positioning System<br>Fluoroscopic image of the hip joint is imported into the Radlink Surgical Positioning software. The software calculates a target cup position using bony landmarks, and the surgeon matches the cup to the target. | Other: Radlink Surgical Positioning Software<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic cup abduction angle | Angle of acetabular component in coronal plane measured on x-ray | 4 month postoperative | 
| Radiographic cup anteversion angle | Angle of acetabular component in sagittal plane measured on x-ray | 4 month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variance of cup angles measured on x-ray | Statistical homogeneity of angles and how spread out the data is. | 4 month postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total hip replacement