linjc16/ctgov huggingface dataset:
Gene Function in Bone Marrow Cells From Patients With Fanconi Anemia and From Healthy Participants

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of bone marrow from patients with Fanconi anemia and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to Fanconi anemia. PURPOSE: This laboratory study is evaluating gene function in bone marrow cells from patients with Fanconi anemia and from healthy participants.

Detailed Description
-----------------
OBJECTIVES: Describe the complete hematopoietic transcriptomes of Fanconi cells of every common complementation group (e.g., A, C, G, and F) as well as transcriptomes of neoplastic cells derived from bone marrow of patients with Fanconi anemia. Define large-scale dynamic gene expression data in these patients. OUTLINE: This is a multicenter study. Patients and healthy volunteers undergo bone marrow aspiration or biopsy for biological studies. Samples are analyzed for gene expression profiles using microarray assays. PROJECTED ACCRUAL: A total of 80 patients and 10 healthy volunteers will be accrued for this study.

Official Title
-----------------
Analysis of Fanconi Anemia Gene Function by Microarray Analysis of Bone Marrow Cells

Conditions
-----------------
Fanconi Anemia

Intervention / Treatment
-----------------
* Genetic: microarray analysis
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Diagnosis of Fanconi anemia Requires bone marrow aspiration or biopsy for clinical purposes Healthy volunteer Over 18 years of age No known blood abnormality PATIENT CHARACTERISTICS: Platelet count > 150,000/mm^3 White Blood Cell(WBC) > 4,000/mm^3 Hemoglobin > 13 g/dL No clinical signs or symptoms of acute or subacute infection (e.g., viral, bacterial, or fungal) No allergies to lidocaine or xylocaine PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: microarray analysis|nan|
|Procedure: biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Fanconi anemia (FA) hematopoietic cells vs normal hematopoietic cells |  |  | 
| Comparison of FA hematopoietic cells from children with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) vs children (siblings) with FA but without MDS/AML |  |  | 
| Comparison of FA cells from different complementation groups |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fanconi anemia
Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.

Study Overview
=================
Brief Summary
-----------------
A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients as well as of 30 controls. Skin biopsy from patients (psoriasis lesional and non lesional) & control will be kept in lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis & PCR.

Official Title
-----------------
Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Diagnostic Test: RT-PCR for ERAP1 detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with psoriasis vulgaris patients over 18 years of age both sexes Exclusion Criteria: patients on treatment for psoriasis within the last two months assoiciated autoimmune diseases eg SLE pregnancy

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cases of psoriasis<br>group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR | Diagnostic Test: RT-PCR for ERAP1 detection<br>* Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection<br>|
| Experimental: normal controls<br>group of 30 age and sex matched healthy controls o subjected to skin biopsy from normal skin for detection of expression of ERAP1 by RT-PCR | Diagnostic Test: RT-PCR for ERAP1 detection<br>* Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of lesional ERAP1 in psoriatic skin | DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT- | Maximum 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of non lesional ERAP1 in psoriatic skin | Detection of level of expression of ERAP 1 in non lesional skin of psoriasis patients by RT-PCR. | Maximum 2 years |
Stem Cell Therapy in Mental Retardation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.

Conditions
-----------------
Mental Retardation

Intervention / Treatment
-----------------
* Biological: Stem Cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed cases of mental retardation age above 6 months Exclusion Criteria: presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus malignancies bleeding tendencies pneumonia renal failure severe liver dysfunction severe anemia [Hemoglobin < 8] any bone marrow disorder space occupying lesion in brain other acute medical conditions such as respiratory infection and pyrexia

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell<br>Bone marrow mononuclear cell transplantation | Biological: Stem Cell<br>* Autologous bone marrow mononuclear cell transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in common clinical symptoms of mental retardation | Change in symptoms such as cognition, remote memory, problem solving,understanding of relationships,social interaction,communication,self care, activities of daily living will be recorded at 1 year follow up. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mental retardation, Autologous mononuclear cell therapy, Stem cell
Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.

Official Title
-----------------
Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis, Sinusitis

Intervention / Treatment
-----------------
* Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a confirmed diagnosis of cystic fibrosis Exclusion Criteria: current systemic therapy against Pseudomonas aeruginosa
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cross sectional CF study<br>Multicentric study, including 187 CF patients of all age groupr in 5 CF centres. | Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.<br> <br> * Other names: nasal lavage and induced sputum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathogen colonization in upper and lower airways |  | 3yrs | 
| Sinonasal symptoms (SNOT-20) |  | 3 yrs | 
| rhinomanometry and rhinoscopy |  | 3yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis with Chronic Rhinosinusitis
A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.

Conditions
-----------------
Cervical Dystonia, Blepharospasm

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years Treatment with Xeomin® and BOTOX® for at least 2 years each. Exclusion Criteria: Having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission Previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BOTOX®<br>Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. | Other: No Intervention<br>* No treatment (intervention) was administered.<br>|
| Xeomin®<br>Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. | Other: No Intervention<br>* No treatment (intervention) was administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of Botulinum Toxin Used to Treat Cervical Dystonia |  | 4 Years | 
| Dose of Botulinum Toxin Used to Treat Blepharospasm |  | 4 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Botulinum Toxin Inter-injection Intervals |  | 4 Years | 
| Number of Participants with Adverse Events |  | 4 Years | 
| Annual Botulinum Toxin Dose per Patient |  | 4 Years |
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.

Official Title
-----------------
An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage

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

Intervention / Treatment
-----------------
* Drug: Pimecrolimus cream 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed AD almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3) clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas Exclusion Criteria: Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pimecrolimus cream 1% | Drug: Pimecrolimus cream 1%<br>* Pimecrolimus cream 1% bid, as needed<br>* Other names: ASM981;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Epidermal thickness by optical coherence tomography at selected investigational centers |  | 48 weeks | 
| Skin thickness by ultrasound at selected investigational centers |  | 48 weeks | 
| Epidermal thickness by 3mm punch biopsies (optional) |  | 48 weeks | 
| Skin metabolism by suction blisters. |  | 48 weeks | 
| Investigator's Global Assessment (IGA) |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema
AEDV Registry of Primary Cutaneous Lymphoma

Study Overview
=================
Brief Summary
-----------------
Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.

Detailed Description
-----------------
Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies. Data is entered in the registry in each of the participating cutaneous lymphoma clinics. These data are updated at least yearly. Participants receive specific training before starting, and there is an online continuous monitoring system.

Official Title
-----------------
Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma

Conditions
-----------------
Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Sezary Syndrome, Lymphoma, Extranodal NK-T-Cell, Lymphoma, B-Cell

Intervention / Treatment
-----------------
* Other: Registry of patients (exposure is Cutaneous Lymphoma)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients with primary cutaneous lymphoma Exclusion Criteria: Not willing to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Registry of patients (exposure is Cutaneous Lymphoma)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum TNM stage | Proportion | Through study completion, an average every 1 year | 
| Therapeutic groups used | Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant) | Through study completion, an average every 1 year | 
| Mortality | Rate | Through study completion, an average every 1 year |
Primary and Secondary Hemostasis in Elective Coronary Artery Bypass Graft Surgery

Study Overview
=================
Brief Summary
-----------------
Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase perioperative bleeding. A retrospective analysis of the data in our institution has revealed a significant increase in transfusion requirements after elective CABG since 5 years. The aim of our study is to observe if this increase in transfusion requirements is due to platelet inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Other: screening coagulation abnormalities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery bypass graft surgery with or without cardiopulmonary bypass Exclusion Criteria: emergency; redo cardiac surgery; combined cardiac surgery; patients with renal insufficiency; patients with acquired coagulation abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| coronary artery bypass graft<br>patients undergoing elective coronary artery bypass graft with or without cardiopulmonary bypass | Other: screening coagulation abnormalities<br>* if specific coagulation abnormalities are observed which increase patient's risk of bleeding, appropriate treatment will start<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

Study Overview
=================
Brief Summary
-----------------
The investigators would like to examine the extent of gut microbiome rehabilitation in healthy people after the consumption of antibiotics. Outcomes of probiotic treatment versus bacteriotherapy will be compared.

Detailed Description
-----------------
The investigators would like to examine the extent of rehabilitation of the composition and functioning of the intestinal bacteria in healthy people after the consumption of antibiotics. Since the digestive mocus enables the connection between the host and the bacteria that live within it, the investigators would like to characterize the microbiome in the different areas along the digestive system - before antibiotic treatment and after rehabilitation by probiotic treatment versus bacteriotherapy.

Official Title
-----------------
Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

Conditions
-----------------
Antibiotic Side Effect, Gut Microbiome

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic treatment
* Biological: Bacteriotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age: 18 years and up Gender: women and men Exclusion Criteria: Pregnancy Age under 18 years antibiotic treatment 3 months prior to enrollment Viral Hepatitis HIV positive

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>No intervention after antibiotic treatment. | |
| Active Comparator: Probiotic microbiome rehabilitation<br>Probiotic treatment after antibiotic treatment. | Dietary Supplement: Probiotic treatment<br>* 4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin)<br>|
| Active Comparator: Bacteriotherapy microbiome rehabilitation<br>Bacteriotherapy after antibiotic treatment. | Biological: Bacteriotherapy<br>* Bacteriotherapy (autologous fecal microbiota transplantation) after 7 days of antibiotics (Metronidazole+Ciprofloxacin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome composition | stool samples | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome composition | Gastrointestinal tract biopsies | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome, intestinal bacteria