linjc16/ctgov huggingface dataset:
Studying Genes in Samples From Younger Patients With Relapsed Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
This laboratory study is looking into genes in samples from younger patients with relapsed acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Detailed Description
-----------------
OBJECTIVES: I. To identify global changes in the epigenome and various underlying histone modifications that characterize relapsed acute lymphoblastic leukemia (ALL). II. To identify specific transcription factor-binding sites associated with histone alterations. III. To correlate gene expression changes of differentially regulated genes at relapse with underlying chromatin modifications. OUTLINE: Archived bone marrow samples, collected at the time of diagnosis and relapse, are analyzed for gene expression and histone modifications by microarray, chromatin immunoprecipitation (ChIP) sequencing, and quantitative real-time polymerase chain reaction (qRT-PCR).

Official Title
-----------------
Molecular Taxonomy of Pediatric Cancer

Conditions
-----------------
B-cell Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of B-cell acute lymphoblastic leukemia Paired diagnosis-relapse primary patient samples obtained from the Children's Oncology Group (COG) cell bank

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Observational<br>Archived bone marrow samples, collected at the time of diagnosis and relapse, are analyzed for gene expression and histone modifications by microarray, chromatin immunoprecipitation (ChIP) sequencing, and quantitative real-time polymerase chain reaction (qRT-PCR). | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular origins of relapse and the underlying epigenetic mechanisms associated with drug resistance |  | 1 month | 
| Genes associated with histone modification |  | 1 month | 
| Biological pathways involved in relapse |  | 1 month |
An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.

Detailed Description
-----------------
This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

Official Title
-----------------
A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

Conditions
-----------------
Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Drug: BPS804


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinical diagnosis of OI Type I, III or IV Capable of giving signed consent Exclusion Criteria: History of skeletal malignancies or other bone diseases (other than OI) History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism Treatment with bisphosphonates within 3 months of randomisation Treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation

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
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPS804 Dose 1<br>BPS804 IV Infusion | Drug: BPS804<br>* IV administration of BPS804 in 5% Dextrose solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) | High Resolution Peripheral Quantitative Computated Tomography | 12 months | 
| Change in radial bone strength on Finite Element Analysis (N) | High Resolution Peripheral Quantitative Computated Tomography | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) | High Resolution Peripheral Quantitative Computated Tomography | 12 months | 
| Change in tibial bone strength on Finite Element Analysis (N) | High Resolution Peripheral Quantitative Computated Tomography | 12 months |
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome

Study Overview
=================
Brief Summary
-----------------
CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder. To test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.

Official Title
-----------------
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome

Conditions
-----------------
Immune Effector Cell Associated Neurotoxicity Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be ≥ 18 years of age at signing of informed consent. Subjects are scheduled to receive CAR T-cell treatment. Exclusion Criteria: Refusal to sign the informed consent Subjects having previously been treated with CAR-T therapy. Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding Subjects presenting primary CNS lymphoma Pacemaker or other implanted electrical device incompatible with the MR environment Subjects with a neurodegenerative disease (PD, AD) Subjects with a previous or evolving neurological pathology Pregnant or breastfeeding women

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CAR-T-associated Neurotoxicity | The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT | up to 3 years post CAR T-cell infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify biomarkers for ICANS | Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment) | up to 1 years post CAR T-cell infusion | 
| MRI scans for ICANS | Lesion location associated with severity of ICANS | up to 1 years post CAR T-cell infusion |
Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.

Detailed Description
-----------------
This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly allocated to receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.

Official Title
-----------------
Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.

Conditions
-----------------
Diabetic Ulcer, Foot Ulcer Unhealed

Intervention / Treatment
-----------------
* Drug: Polydeoxyribonucleotide
* Other: 0.9% NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 45-80yrs Minimum schooling 5yrs Type I or II diabetes since at least 5yrs with a stable metabolic control Foot ulcer since minimum 2 weeks Ulcer >1cm and <16cm at day 0 Ulcer grade 1 or 2 wagner scale Wound free of necrotic debris TcPO2 >29mmHg Not pregnant or lactant Exclusion Criteria: Non-consenting patient History of alcohol or drug abuse Gangrene on any part of the affected foot Ongoing untreated infections Ulcer over a charcot deformity Use of a systemic cicatrizant drug in the past 10 days Malnutrition Neurological or psychiatric pathologies Liver or kidney insufficiency Corticosteroid or immunosuppressive or cytotoxic therapy Other severe pathologies Proven hypersensitivity to the drug or to any related component

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PDRN | Drug: Polydeoxyribonucleotide<br>* 3 times a week perilesional or intramuscular injections<br>|
| Placebo Comparator: placebo<br>placebo | Other: 0.9% NaCl<br>* same as PDRN<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of ulcer rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of the compound |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, foot ulcer, polydeoxyribonucleotide
Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken from the nasal passages.

Detailed Description
-----------------
Thiamphenicol has been proposed to increase the levels of the excitatory amino acid transporter 2 (EAAT2) in the nervous tissue. This study evaluated the ability of two weeks of treatment with thiamphenicol to increase EAAT2 in a nasal biopsy as a surrogate of brain nervous tissue.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 14-Day Repeated-Dose Administration of Thiamphenicol (RUX 122) in Healthy Subjects

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal volunteers Exclusion Criteria: less than 18 years older than 55 years

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Matched tablets without active ingredient<br>|
| Active Comparator: Thiamphenicol<br>Active comparator | Drug: Thiamphenicol<br>* 750 and 1500 mg/day;tablets<br>* Other names: Thiamphenicol, Urfamycine (trade name in Belgium);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of EAAT2 RNA in nasal biopsy |  | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, biomarker, thiamphenicol, EAAT2
Study of the Cutaneous Microcirculation in Elderly People

Study Overview
=================
Brief Summary
-----------------
Pressure ulcers are a common and frustrating problem and their treatment is critical in elderly people. The interaction between external pressure and the skin vascular is central to the prevention of pressure ulcers. It is only through understanding of the physiology of cutaneous perfusion and its relation to external pressure or different stimuli that effective preventive measures to reduce skin beakdown can be adapted in clinical practice.

Conditions
-----------------
Elderly People

Intervention / Treatment
-----------------
* Behavioral: Cutaneous response


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteers Exclusion Criteria: pregnancy

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cutaneous response|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
-----------------
skin, pressure, age
Effects of Ramadan Fasting on Sleeping and Quality of Life

Study Overview
=================
Brief Summary
-----------------
Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .

Detailed Description
-----------------
All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits. The week before Ramadan (Pre-R). the last week of Ramadan (R). the last week of the month following Ramadan (Post-R). Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent. All patients benifit of a routine examen and evaluation of the quality of life by Short Form 36 (SF36) test and sleeping by Pittsburg Sleep Quality Index (PQSI) score .

Official Title
-----------------
Effects of Ramadan Fasting on Sleeping and Quality of Life

Conditions
-----------------
Fasting, Quality of Life, Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient intending to fast Ramadan. Exclusion Criteria: Age < 18 years old Hemodynamic instability. Myocardial infarction requiring urgent revascularization. Parkinsonism: tremor problem. Refusal, communication problem.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in sleeping quality | the score of sleeping is calculated for each participant in the day of inclusion , then it is recalculated in the two others visits. | the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan | 
| the change in the quality of life score | the score of quality of life is calculated for each participant in the day of inclusion , then it is recalculated in the two others visits. | the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ramadan Fasting, SF-36 score, sleeping score
Evaluation of Sodium Hypochlorite as a Denture Cleanser

Study Overview
=================
Brief Summary
-----------------
The present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing.

Detailed Description
-----------------
Considering that it is necessary to stipulate a simple and effective routine protocol for denture cleaning the aim of this study was to evaluate, in vivo, the efficacy of 0.5% sodium hypochlorite (NaOCl) as a denture cleanser and its effect on color stability and surface roughness of complete dentures. The patients' satisfaction with the denture cleaning method was also assessed.

Official Title
-----------------
Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm

Conditions
-----------------
Problems With Dentures

Intervention / Treatment
-----------------
* Other: Sodium hypochlorite immersion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complete denture wearers; adequate general health conditions ability to comply with the experimental protocol time of denture use: at least one year prior the study denture base material: heat-polymerized acrylic resin. Exclusion Criteria: the use of antifungal agents or antiseptic mouthwashes during the pre-experimental and experimental period.
Sexes Eligible for Study
-----------------
All

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

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

| Intervention/Treatment |
| --- |
|Other: Sodium hypochlorite immersion|Dentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microorganisms reduction | Quantitative analysis of total microorganisms and Candida spp. Samples for culture were collected from dentures and saliva. | Baseline, 30, 60 and 90 days | 
| Changes in base acrylic resin | Color stability and surface roughness evaluation | Baseline, 30, 60 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction with the denture cleaning protocol |  | 30, 60 and 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
denture, complete;, sodium hypochlorite;, disinfection;, surface roughness;, color stability.
A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.

Official Title
-----------------
Inhaled Versus Intravenous Pentamidine in Pneumocystis Carinii Pneumonia in the Acquired Immunodeficiency Syndrome

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Pentamidine isethionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Previous history of adverse reaction to pentamidine. History of asthma. Pulmonary Kaposi's sarcoma. Patients with the following are excluded: Previous history of adverse reaction to pentamidine. History of asthma. Pulmonary Kaposi's sarcoma. Inability to understand the consent procedure. All patients hospitalized at Cedars-Sinai Medical Center with AIDS and possible Pneumocystis carinii pneumonia (PCP) will be eligible. Patients with HIV antibody or AIDS and a clinical presentation suggesting PCP are eligible.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pentamidine isethionate|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
-----------------
AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Injections, Intravenous, Administration, Inhalation, Aerosols, Acquired Immunodeficiency Syndrome