linjc16/ctgov huggingface dataset:
Dose-Dense Therapy in Aggressive Lymphoma

Study Overview
=================
Brief Summary
-----------------
To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.

Detailed Description
-----------------
Patients are randomized to receive dose-dense CEOP/IMVP-Dexa chemotherapy or standard 3-weekly CHOP.

Official Title
-----------------
Phase 3 Study of Dose-Dense Therapy Versus CHOP in Aggressive Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: CEOP/IMVP-Dexa chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 and 70 years of age Centrally reviewed, histologically proven diffuse large B-cell, anaplastic large-cell, or peripheral T-cell unspecified Measurable disease All stages Exclusion Criteria: Lymphoblastic or Burkitt histology CNS-disease HIV-positive pregnant or lactating women Pretreatment Other malignancy Concomitant diseases that forbid chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CEOP/IMVP-Dexa chemotherapy|Cyclophosphamide 750 mg/m2 i.v. d 1, epirubicin 70 mg/m2 i.v d 1, vincristine 1.4 mg/m2 i.v. d 1+8, prednisolone 100 mg p.o. d 1-5, ifosfamide 2000 mg/m2 i.v. d 15-17, etoposide 100 mg/m2 i.v. d 15-17, dexamethasone 40 mg p.o. or i.v. d 15-19, methotrexate 800 mg/m2 i.v. d 22. Mesna was given with ifosfamide, calcium-folinate rescue after methotrexate. Filgrastim was given on days 2-7, 9-12, 18-21, 23-28|

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
-----------------
lymphoma, aggressive, chemotherapy, dose-dense
To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.

Official Title
-----------------
A Phase I, Multi-center, Open-label, Single Dose Study, to Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients With or Without Renal Impairment

Conditions
-----------------
Glucose Lowering

Intervention / Treatment
-----------------
* Drug: AZD1656


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any OAD or insulin Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal Exclusion Criteria: Clinically significant progression of current disease or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP Clinically significant neuropathy according to the Investigator. However subjects with diabetic neuropathy which is not clinically significant according to the Investigator may be included.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD1656|Single dose oral tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline |  | The baseline values will be as follows: | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of AZD1656 in T2DM patients with various degrees of renal impairment. To describe the pharmacodynamics of AZD1656 in T2DM patients with various degrees of renal impairment by assessment of 24-hours glucose profile |  | blood samples will be collected for up to 48 hours postdose and urine samples for up to 12 hours postdose for measurement of plasma and urine concentrations of AZD1656 and its metabolite | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Feather Edge Versus Deep Chamfer Finish Line Marginal Design in Complete Coverage Bruxzir Zirconia Crowns

Study Overview
=================
Brief Summary
-----------------
Evaluation of patient satisfaction, color difference, marginal integrity and survival of Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line marginal design. (Randomised Controlled Trial)

Official Title
-----------------
Evaluation of Patient Satisfaction, Color Difference, Marginal Integrity and Survival of Bruxzir Zirconia Complete Coverage Crowns With Feather Edge Versus Deep Chamfer Finish Line Marginal Design.

Conditions
-----------------
Premolars Need Full Coverage Restoration

Intervention / Treatment
-----------------
* Other: deep chamfer
* Other: feather edge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-50 years. Males or females. Co-operative patients approving to participate in the trial. Exclusion Criteria: Patients younger than 19 years old Disabilities Systemic diseases or severe medically compromised Lack of compliance of the patient contributed in the study

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: feather edge finish line marginal design<br>intervention | Other: feather edge<br>* finish line marginal design of a full coverage crown preparation<br>* Other names: knife edge;|
| Active Comparator: deep chamfer finish line marginal design<br>comparator | Other: deep chamfer<br>* finish line marginal design of a full coverage crown preparation<br>* Other names: rounded shoulder;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | patient satisfaction will be measured by questionnaire | one year |
A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.

Detailed Description
-----------------
A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil. Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.

Conditions
-----------------
Pancreatic Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV) No previous systemic chemotherapy(unless given as a radiosensitizer). ECOG Performance Status 0-2 Life expectancy equal to or greater than 12 weeks Adequate laboratory and organ functions Stabilizable pain (stable analgesic intake) No radiotherapy during 4 weeks prior to trial entry No evidence of ascites, pleural effusion or third space fluid accumulation Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Virulizin®|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
-----------------
Virulizin, Immunotherapy, Pancreas, Pancreatic Cancer, clinical trial
Genetic Etiology in Premature Ovarian Insufficiency

Study Overview
=================
Brief Summary
-----------------
Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function leading to an early menopause (<40 years of age).Today, only 35% of POI's etiology can be explained. Causes enlightening POI may be enumerated as follows, according to their frequency: genetic mutations, autoimmune defects and abnormalities detected on the X chromosome.The purpose of the study is to determine the frequency of the genetic abnormalities and polymorphisms described above in the POI Turkish population

Official Title
-----------------
Genetic Etiology in Premature Ovarian Insufficiency

Conditions
-----------------
Primary Ovarian Insufficiency, Genetic Predisposition to Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosed premature ovarian failure patients 20-40 years old female patients Exclusion Criteria: Surgical surgical menopause Female patients who can't meet the age range criteria

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premature ovarian Insufficiency<br>4ml whole blood sample is going to collect from premature ovarian Insufficiency group for the assessment of genetic abnormalities | |
| healthy control group<br>4 ml of whole blood is going to taken from healthy control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic etiology in Premature ovarian Insufficiency | In the framework of our project, abnormalities on the X chromosome will be studied by karyotyping, follicle-stimulating hormone receptor (FSHR),nuclear receptor subfamily 5,group A,member 1 (NR5A1),Newborn ovary homeobox gene (NOBOX),Bone morphogenetic protein 15 (BMP15) genes will be analyzed by sequencing and finally repeat size analysis for FMR1 gene will be performed fragment analyses, on 75 POI and 25 healthy control population.Collected data will enable us to determine the frequency of the abnormalities and polymorphisms described above in the POI Turkish population. Patients free of those genetic variants will help us to identify new loci or genes implicated in POI. | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Ovarian Insufficiency (POI)
Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the influence of the APOE genotype on brain morphology, function and metabolism, related to other factors such as cognitive reserve, cognition and episodic memory, in subjects at greater risk of developing AD.

Detailed Description
-----------------
The purpose of this study is to investigate the influence of age and the APOE genotype on brain morphology and function, in 700 cognitively healthy individuals, 45 to 75 years old, recruited from an ongoing longitudinal cognition study exploring memory and executive functions (ClinicalTrials.gov ID: NCT01835717). All subjects have been APOE genotyped and underwent a clinical and cognitive assessment. Within this study, the subjects will be submitted to an MRI scanning protocol including morphological and resting state acquisitions. An identical follow-up MRI session will be performed in 2 years' time. The analyses will be focused on detecting the effect of the APOE allelic variants on the change rate of the neuroimaging variables as well as its interaction with aging.

Official Title
-----------------
Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant included in the study ClinicalTrials.gov ID: NCT01835717 APOE genotype obtained before MRI acquisition Be willing to perform an MRI and agree to a 2 years longitudinal follow up Sign informed consent Exclusion Criteria: Contraindication to MRI scanning: claustrophobia, pacemaker, history of ocular cerclage, heart valves, aneurysm clips and carrying any metal prosthesis incompatible with MRI. Incidental MRI findings that result in the images not being included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>The population of this study is 45 to 75 years old at the time of inclusion in the parent study (ClinicalTrials.gov ID: NCT01835717). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hippocampal atrophy |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's, MRI, APOE
The Role of Daily Disposable Contact Lenses in Ocular Allergy

Study Overview
=================
Brief Summary
-----------------
Patients with seasonal allergic conjunctivitis are normally advised to avoid contact lens wear when they are having symptoms. However, modern soft contact lenses which are disposed of daily offer the potential to protect and lubricate the ocular surface. This study examines this possible effect.

Official Title
-----------------
The Role of Daily Disposable Contact Lenses in Ocular Allergy

Conditions
-----------------
Grass Pollen Ocular Allergy

Intervention / Treatment
-----------------
* Device: Acuvue (Standard Daily Disposable Contact Lens)
* Device: CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: contact lens wearer proven allergy to grass pollen Exclusion Criteria: eye disease ocular medication allergy medication asthma

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acuvue (Standard Daily Disposable Contact Lens)|nan|
|Device: CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Subjective rating of itchyness, dryness, burning, watering and discomfort | 4 hours | 
| Signs | Signs of bulbar, limbal and palpebtal hyperaemia and staining | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic conjunctivitis
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.

Official Title
-----------------
A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: diquafosol tetrasodium Ophthalmic Solution, 2%
* Drug: Non-preserved saline solution (Placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent prior to any study procedures being performed. Have a best corrected visual acuity (BCVAof +0.7 or better. Have a history of dry eye (keratoconjunctivitis sicca) in both eyes Have ongoing dry eye disease, in the same qualifying eye or both eyes. Exclusion Criteria: Have previously had LASIK refractive surgery. Use of topical ophthalmic medications, preps, gels and lid scrubs during study. Have had penetrating intraocular surgery in the past 90 days. Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year. Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid. Any serious ocular systemic disease or uncontrolled medical condition. Exposure to any investigational drug within 30 days of study start.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: diquafosol tetrasodium Ophthalmic Solution, 2%<br>* 1-2 drops administered in each eye 4 times a day for 6 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Non-preserved saline solution (Placebo)<br>* 1-2 drops administered in each eye 4 times a day for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fluorescein staining scores of the cornea |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | 6 weeks |
Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

Study Overview
=================
Brief Summary
-----------------
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.

Official Title
-----------------
Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study

Conditions
-----------------
Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Intervention / Treatment
-----------------
* Procedure: core decompression with autologous bone marrow implantation
* Procedure: core decompression of the femoral head


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have a non traumatic ON of the femoral head Stage 3 ON (subchondral fracture). Age > 18 years Be able and willing to participate in the study Exclusion Criteria: evidence of malignant disorder in the past five years Patient unable to undergo a MRI. Patient who is positive for an HIV, hepatitis B or C infection.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Core decompression | Procedure: core decompression of the femoral head<br>* core biopsy with injection of 40 ml saline solution in place of bone marrow.<br>|
| Experimental: Bone marrow<br>core decompression plus autologous concentrated bone marrow | Procedure: core decompression with autologous bone marrow implantation<br>* core biopsy with injection of 40 ml concentrated autologous bone marrow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of total prosthesis | Need to undergo a surgical treatment total prosthesis | 24, 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Visual analogue scale | 24, 60 months | 
| functional status | Lequesne and WOMAC scores | 24, 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteonecrosis, cell-based therapy, bone marrow, mesenchymal stem cell, hip, core decompression