linjc16/ctgov huggingface dataset:
Corneal Densitometry Changes With Adenoviral SEI

Study Overview
=================
Brief Summary
-----------------
Adenoviral Sub epithelial infiltrates (SEI) affect ocular function.They lead to reduced vision, photophobia, glare, halos, and foreign body sensation.

Detailed Description
-----------------
first group of patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.S econd group underwent transepithelial PTK for subepithelial infiltrates. Baseline and post-treatment full ophthalmic examination was done.

Official Title
-----------------
Corneal Densitometry Changes With Adenoviral Keratoconjunctivitis Sub Epithelial Infiltrates

Conditions
-----------------
Corneal Disease

Intervention / Treatment
-----------------
* Drug: Tacrolimus ointment
* Procedure: phototherapeutic keratectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adenoviral SEI Exclusion Criteria: Other corneal diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tacrolimus<br>Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months. | Drug: Tacrolimus ointment<br>* Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.<br>* Other names: Protopic ointment;|
| Phototherapeutic Keratectomy<br>Patients underwent transepithelial PTK for subepithelial infiltrates. | Procedure: phototherapeutic keratectomy<br>* Patients underwent transepithelial PTK for subepithelial infiltrates.<br>|
| Control<br>patients received only artificial tears eyedrop | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of corneal densitometry | Sub epithelial infiltrates was examined with the densitometry programme of the Pentacam (Fa. Oculus,Weimar, Germany) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenoviral, infiltrates, PTK, tacrolimus
Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegfilgrastim on the Incidence of Febrile Neutropenia in Subjects With Advanced Breast Cancer Treated With Single Agent Docetaxel

Conditions
-----------------
Neutropenia

Intervention / Treatment
-----------------
* Drug: pegfilgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Advanced breast cancer 18 years of age or older Patients who will be receiving Taxotere (docetaxel) chemotherapy

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Breast cancer patients receiving docetaxel chemotherapy and placebo. | Drug: pegfilgrastim<br>* Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.<br>|
| Experimental: Pegfilgrastim<br>Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim. | Drug: pegfilgrastim<br>* Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects developing febrile neutropenia |  | Through 4 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time |  | Through 4 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Neutropenia, Chemotherapy
A Pilot Study to Explore the Role of Gut Flora in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding colorectal cancer.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding colorectal cancer.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Colorectal Cancer

Conditions
-----------------
Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Adenocarcinoma, Colorectal Cancer Metastatic, Colorectal Sarcoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients of any age (interest is given to children to compare with mothers). Diagnosis of colorectal cancer Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who have been diagnosed with colorectal cancer. | Other: No intervention<br>* There is no intervention for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year |
Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.

Official Title
-----------------
A Randomized, Double-Blind, Placebo and Moxifloxacin (Open-Label) Controlled, 4-Period, Crossover Study of the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

Conditions
-----------------
Healthy, Long QT Syndrome

Intervention / Treatment
-----------------
* Drug: ERB-041


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and ECG. Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Exclusion Criteria: A family history of long QT syndrome and/or cardiac death. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematological, neurological, or psychiatric disease.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ERB-041|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, Cardiac, Pharmacokinetics
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha, MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and alters viral load.

Detailed Description
-----------------
Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will include patients who have decided not to take anti-retro viral drugs. Groups III and IV will include patients receiving the same types of antiretroviral drugs. Patients in groups I and III will receive thalidomide while patients in group II and IV will receive placebo. The placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4, 5 and 6.

Official Title
-----------------
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients

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

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood. Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: Fertile females. Patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer. Patients with any of the following prior conditions are excluded: HIV related pre-existing peripheral neuropathy. Prior Medication: Excluded: Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide. Required: 10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide|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
-----------------
Adjuvants, Immunologic, Thalidomide, Cytokines, Viral Load
Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins (VARIABLE).

Study Overview
=================
Brief Summary
-----------------
The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning intervention. It allows a long-term treatment of this arrhythmia with a success rate of about 80%. There are, nevertheless, some recidivism. Risk factors for recidivism are poorly codified and need further research. Indeed the identification of factors of poor prognosis could lead to not propose this procedure to the patients who present them and at least to inform them of an increased risk of failure. To date, aortic stiffness has not been studied in the context of assessing the risk factors for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic dysfunction and increased left atrial size. That may constitute a substrate for FA recurrence. In the literature, aortic stiffness can be measured in several ways: Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner or transesophageal Echography (ETO). Measuring of the Pulse Wave Velocity. Measurement of aortic calcifications. The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA 6 months after ablation procedure performed in the Croix-Rousse cardiology's department.

Official Title
-----------------
Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins.

Conditions
-----------------
First Ablation of Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : 18 years old of both sexes, Patient carrying a paroxysmal or persistent atrial fibrillation, benefiting from a first procedure of atrial fibrillation's ablation in the in the Croix-Rousse cardiology's department. Patient who signed the consent to participate in the study. Exclusion Criteria : Patient carrying a permanent atrial fibrillation Patient who're in atrial fibrillation during the ablation Atrial fibrillation relapse's history after ablation Pregnant and nursing women Patients refusal.

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 |
| --- | --- | --- |
| Atrial fibrillation recurrences | Atrial fibrillation recurrences after 6 months of ablation by Holter ECG | Month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, First Ablation
Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics.

Study Overview
=================
Brief Summary
-----------------
Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial dentures is unknown. The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in the posterior and anterior regio of the jaw.

Detailed Description
-----------------
30 patients with at least 2 missing posterior or anterior teeth will be included in the study. All patients will receive all-ceramic fixed partial dentures.

Official Title
-----------------
Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics

Conditions
-----------------
Tooth Loss, Teeth Replaced Using All Ceramic FPDs

Intervention / Treatment
-----------------
* Device: All ceramic FPDs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients older 18 years At least two missing posterior teeth Tooth wear<3 Exclusion Criteria: Bruxism Mental disorders Pregnancy Tooth mobility>1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Device: All ceramic FPDs|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of the FPDs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetical and functional performance of the FPDs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FPD, all-ceramic
Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)

Study Overview
=================
Brief Summary
-----------------
Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.

Official Title
-----------------
Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Drug: Tegeline®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 Cutaneous and/or mucous eruption Polyadenopathy Body temperature > 38°C Hematology disorders : Hypereosinophily > 1.5 G/l, lymphocytosis > 5G/l, atypical blood lymphocytes Consent obtained from patient Exclusion Criteria: Age < 18 No consent obtained from patient IgV allergy Dress with very sérious visceral attack and vital diagnostic (sharp cardiac insufficiency, sharp respiratory insufficiency, hepatic insufficiency, sharp renal insufficiency) Oral therapy or immunosuppressive therapy (Methotrexate, cyclosporine, cyclophosphamide, etc.) IgA deficiency, MCI >=35 Sharp renal insufficiency before Dress with creatinaemia < 60 ml/min (Cockroft)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tegeline®|2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypersensitivity, Syndrome, Tegeline
UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling

Study Overview
=================
Brief Summary
-----------------
: Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.

Detailed Description
-----------------
A blood sample of approximately 30 cc will be collected prior to the patients standard of care radical prostatectomy surgery. This blood will be used for the SELDI analysis. The remainder of the blood sample will be stored and may be used for the PSA test at a later date. The patient will have a final blood draw 3 months to 1 year following surgery.

Official Title
-----------------
Prostate Cancer Detection by Serum Proteomic Profiling

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For all subjects: Men 50 years of age or older. Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist. It has been determined by the treating physician that a prostate biopsy is clinically indicated. Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy. For study on treatment effect Men with clinically localized prostate cancer (total PSA < 20 ng/ml and clinical T2b or less). Men with organ confined prostate cancer as determined by final pathologic diagnosis. Exclusion Criteria: Exclusion criteria for all subjects: Known prostate cancer or prior treatment for prostate cancer. Acute prostatitis. Untreated urinary tract infection. Presence of Foley catheter or any urethral instrumentation in the previous 48 hours. Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months. Exclusion Criteria (for study on treatment effect) Men with non-organ confined prostate cancer. Men with detectable serum PSA levels more than 1 months following radical prostatectomy.

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

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

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
-----------------
Prostate Cancer Detection by Serum Proteomic Profiling