linjc16/ctgov huggingface dataset:
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

Study Overview
=================
Brief Summary
-----------------
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects.

Detailed Description
-----------------
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. An additional P. acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI decision to explore whether there is a correlation between P. acnes bacterial presence and fluorescent signal.

Official Title
-----------------
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans

Conditions
-----------------
Acne

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between 14 to 50 years of age inclusive at the time of signing the informed consent Able to provide written informed consent Subjects who are willing to undergo pore strip treatment using the cosmetically acceptable pore strip product Subjects who are willing to provide comprehensive demographic data using questionnaires Exclusion Criteria: Unwilling or unable to follow the procedures outlined in the protocol Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1 Subjects treated with immunosuppressant agents Pregnant subjects

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 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 |
| --- | --- |
| P. acne subjects<br>14-50 year of age, P. acne diagnosed subjects | |
| None P. acne subjects<br>14-50 year of age, none P. acne diagnosed subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection and analysis of facial P. acnes presence |  | Day 0 and week 8 (optional) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision. |  | Day 0 and week 8 (optional |
Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

Study Overview
=================
Brief Summary
-----------------
Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy.

Detailed Description
-----------------
Eligible denovo CML patients will be treated by combination drug therapy of imatinib 400 mg plus pioglitazone (15 - 30mg).They will be on follow up for their complete blood count (CBC), chemistry profile and random blood sugar every 2 weeks. After 3, 6 and 12 months of treatment the patients response will be evaluated and compared with the obtained responses of a historical control group. Assessment of the hypoxia induced factor 2 alpha (HIF2a) gene and CBP/p300-interacting transactivator with glutamic acid (E) and aspartic acid (D)-rich tail 2 (CITED2) gene expression levels before and after 6 months of treatment will be additionally evaluated.

Official Title
-----------------
Potential Utility of Peroxisome Proliferator-activated Receptor Gamma Agonists in the Eradication of Chronic Myeloid Leukemia Stem Cells: Myth or Truth?

Conditions
-----------------
Chronic Myelogenous Leukemia, BCR-ABL Positive, CML, Chronic Phase

Intervention / Treatment
-----------------
* Drug: Pioglitazone 15mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CML cases (BCR-ABL1 positive) Exclusion Criteria: Accelerated or blastic crisis Atypical CML (BCR-ABL1 negative) Chronic myelomonocytic leukemia (CMML) Pregnant or breastfeeding females. Patients with severe organ dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional no<br>Patients treated with both drugs ( imatinib and pioglitazone) | Drug: Pioglitazone 15mg<br>* pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months<br>* Other names: Imatinib 400mg;|
| No Intervention: Control<br>Historical control (treated with imatinib only) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major molecular response(MMR) at 12 months | Percentage of patients obtaining MMR at 12 months | 1 year | 
| Impact of treatment on the expression levels of stemness genes | Follow up the expression of CITED2 and HIF2a genes pattern | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of treatment on the rate of transformation | Progression into accelerated or blastic phases | 1 years |
NGS in AML Relapse

Study Overview
=================
Brief Summary
-----------------
Acute myeloid leukemia (AML) relapse is often associated with a clonal evolution at the cytogenetic and molecular level and therefore represents a challenge in the treatment of AML. Targeted sequencing is now usually done at diagnosis in AML, as only a small core group of genes is frequently mutated in AML and myelodysplastic syndromes. This approach, contrary to WGS is cheaper, together with a rapid turnaround and high sequencing coverage depths allowing the detection of variant allele fractions as low as 2%. In the investigator's center, targeted analysis of AML patients is routinely realized at diagnosis and at relapse. In thses patients, five different clonal evolution patterns including cytogenetic and molecular analysis at relapse will be evaluated: (1) Stability, defined by no clonal change, (2) Gain, strictly defined by acquisition of additional variations (mutations or cytogenetic alterations), (3) Loss, strictly defined by loss of variants or regression, (4) Gain and Loss, indicating the combination of both Gain and Loss patterns, (5) Emergence, defined by the emergence of alterations that were unrelated to those found at diagnosis. Karyotype and the mutations of up to 40 AML patients benefited from targeted NGS in the clinical hematology laboratory of the Hopitaux Universitaires de Strasbourg both at the time of the diagnosis of and the relapse will be studied, together with clinical and other biological characteristics.

Official Title
-----------------
Retrospective Study of AML Relapses Using Targeted NGS Analysis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients with AML that relapsed studied in the clinical laboratory of hematology of the Hopitaux Universitaires de Strasbourg, France given consentment or non-opposition for retrospective anonymous analysis of clinical and data Exclusion criteria: person under tutorship- persons who asked to withdraw from the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival of the different clonal evolution patterns |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myeloid leukemia, Relapse, Mutations
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine whether the memory impairment and manic symptoms (feelings of agitation, overexcitement or hyperactivity) typically seen in those on corticosteroid therapy is decreased with a seizure medication called levetiracetam compared to placebo (an inactive substance). Since increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with memory impairment interventions that may prevent or reverse this are of great importance. It is hypothesized that patients who are scheduled to receive prescription corticosteroid therapy who are given levetiracetam pretreatment will show lesser memory impairment and manic symptoms than those receiving placebo.

Official Title
-----------------
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study

Conditions
-----------------
Memory Loss Associated With Corticosteroid Use, Manic State Associated With Corticosteroid Use

Intervention / Treatment
-----------------
* Drug: Levetiracetam, Keppra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years Scheduled to receive a corticosteroid burst of at least 10 mg of prednisone equivalents and for at least 5 days duration English- or Spanish-speaking Exclusion Criteria: History of allergic reaction or other contraindication to levetiracetam therapy Other unstable medical conditions (e.g. recent myocardial infarction, renal failure, diabetes with poor glycemic control) Pregnant or nursing women History of mental retardation, dementia or other severe cognitive disorders

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam, Keppra|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis

Study Overview
=================
Brief Summary
-----------------
Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis

Detailed Description
-----------------
Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand

Official Title
-----------------
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial

Conditions
-----------------
Exacerbation Copd, Bronchiectasis, Lung Function Decreased

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic Bronchiectasis history at least 2 exacerbation last year Exclusion Criteria: comorbidity with chronic obstructive pulmonary disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roflumilast<br>Roflumilast 500 microgram one tab oral per day | Drug: Roflumilast<br>* Active drug<br>* Other names: Daxas;|
| Placebo Comparator: Placebo<br>One tablet oral per day | Drug: Placebo<br>* Placebo one tablet oral od<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute deterioration of of bronchiectasis symptoms | acute dyspnea worsening respiratory of symptoms | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung functions | FEV1 | 6 months | 
| Exercise capacity | 6 minute walk distance | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiectasis, roflumilast, exacerbation, lung function
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

Official Title
-----------------
Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population

Conditions
-----------------
Kidney Failure, Graft Rejection, Aged

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage renal disease Kidney transplantation Both donor and recipient older than 60 years Exclusion Criteria: Prior or concurrent transplant of any organ other than the kidney Current clinically significant infections

Ages Eligible for Study
-----------------
Minimum Age: 60 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejections at 3 and 12 months |  |  | 
| Patient and graft survival at 3 and 12 months |  |  | 
| Incidence and duration of episodes of acute tubular necrosis |  |  | 
| Time to recover renal function (creatinine< 2 mg/dl) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplant, elderly
Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE (OSAS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS- on oxidative damage.

Detailed Description
-----------------
Obstructive sleep apnea syndrome (OSAS) is a sydrome which has characteristic upper way obstruction and a decrease in blood oxygen saturation as sleeping. uvulopalatopharngoplasty (UPPP)is one of the surgical approaches applied to the patients with OSAS, since the oxidative damage markers have been found high in patients with OSAS. Although antioxidant levels were higher in patients with OSAS than those in normal population, there is report about the effect of UPPP on antioxidant status in patients with OSAS. We performed this study to confirm whether is there a We performed the present study to confirm whether there is a relationship between the OSAS and oxidative damage before and after UPPP.

Official Title
-----------------
Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE

Conditions
-----------------
Sleep Apnea, Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS) Exclusion Criteria: Anormal nasopharyngeal computed tomography, chronic diseases such as diabetes mellitus, hypertension etc.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA oxidation, obstructive sleep apnea, lipid peroxidation, oxidative stresses
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Study Overview
=================
Brief Summary
-----------------
Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies. In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

Detailed Description
-----------------
The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood. The secondary objectives of this study will be: Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma. Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Official Title
-----------------
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Conditions
-----------------
Metastatic Melanoma

Intervention / Treatment
-----------------
* Other: patients with metastatic melanoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with melanoma confirmed histologically patient with metastatic melanoma (stage III unresectable or stage IV) patient consenting to participate to the study patient enrolled in the national healthcare insurance program patient older than 18 years Exclusion Criteria: - Metastatic tumor whose origin is doubtful (uncertain melanoma)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with metastatic melanoma<br>patients with metastatic melanoma (stage III unresectable or stage IV) | Other: patients with metastatic melanoma<br>* Blood sample to realize molecular characterization of melanoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood | Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel) | Day 0 |
RexMedical- Option* Vena Cava Filter IDE Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety and efficacy of the RexMedical Option* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.

Official Title
-----------------
RexMedical- Option* Vena Cava Filter IDE Study

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Device: Intravascular Filter Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Patient is at least 18 years of age Patient requires temporary or permanent caval interruption Key Exclusion Criteria: Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant Patient is currently enrolled in another investigational device or drug trial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intravascular Filter Device<br> | Device: Intravascular Filter Device<br>* Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Clinical Success | Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition. | up to 180 days | 
| Percentage of Participants With Retrieval Clinical Success | Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention. | upto 175 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placement Technical Success | Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism. | Immediately post placement procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
increased risk for PE require caval interruption