linjc16/ctgov huggingface dataset:
Flavopiridol in Treating Patients With Recurrent Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description
-----------------
OBJECTIVES: I. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen independent adenocarcinoma of the prostate. II. Assess the toxic effects of flavopiridol in this patient population. OUTLINE: Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation. Patients are followed every 3 months until death.

Official Title
-----------------
A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: alvocidib


Participation Criteria
=================
Eligibility Criteria
-----------------
PATIENT CHARACTERISTICS: Performance Status: ECOG 0-2 Life Expectancy: At least 3 months WBC at least 3,000/mm3 Absolute neutrophil count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal Creatinine no greater than 1.5 mg/dL Prostate-specific antigen at least 10 ng/mL (if bone only disease) No prior or concurrent maligancies within 5 years, except nonmelanoma skin cancer No serious medical illness No cord compression symptoms PRIOR CONCURRENT THERAPY: No prior chemotherapy No prior suramin therapy Prior or concurrent use of luteinizing hormone-releasing hormone allowed (no other concurrent hormonal therapy) No prior anti-androgen therapy within 4 weeks of study At least 4 weeks since prior radiotherapy No prior strontium therapy
Sexes Eligible for Study
-----------------
Male

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: Arm I<br>Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation. | Drug: alvocidib<br> <br> |

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
-----------------
adenocarcinoma of the prostate, stage IV prostate cancer
Controlling Asthma at School

Study Overview
=================
Brief Summary
-----------------
To implement and evaluate a coordinated set of activities for asthma identification, education, management, and prevention in the predominantly minority inner city schools in the Detroit metropolitan area.

Detailed Description
-----------------
BACKGROUND: The study was part of an initiative Interventions to Improve Asthma Management and Prevention at School. The Broad Agency Announcement was released in June, 1994. DESIGN NARRATIVE: The intervention was a combination of: targeted education for children with asthma, other children in the school, families, physicians and school personnel; concerted effort to change school policies working against effective self-management of asthma; community action/education to create awareness and support for the schools' efforts to control the disease. Open Airways for School, a proven educational program, was adapted for students in the Detroit metropolitan area as part of the intervention. This program was based on social cognitive theory while modeling effective asthma management behavior, involving students in activities where they mastered skills relevant to asthma management, and developing the students' sense of confidence to carry out asthma management tasks. For education of all students, a learning module called Environmental Detective was developed to complement the Michigan Model of comprehensive health education offered in classrooms in Michigan. The Environmental Detective game sensitized children without asthma to the problems of children with asthma. The intervention was evaluated through a controlled research design to determine if it had an impact on asthma morbidity, the number of days of limited activity of the child with asthma, and his or her academic performance. The project was a collaboration of the University of Michigan School of Public Health and School of Medicine, the Henry Ford Hospital Center of Detroit, the Washtenaw County Health and Human Services Department, the American Lung Association of Michigan, and the State of Michigan Department of Education. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Testing for COVID-19 Infection in Asymptomatic Persons

Study Overview
=================
Brief Summary
-----------------
Intensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.

Official Title
-----------------
Testing for COVID-19 Infection in Asymptomatic Persons

Conditions
-----------------
COVID-19 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DKFZ employee Exclusion Criteria: Non DKFZ employee

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 infection |  | 6 weeks |
Pioglitazone and Losartan Provides Additional Renoprotection

Study Overview
=================
Brief Summary
-----------------
Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.

Official Title
-----------------
Combination Therapy With Pioglitazone and Losartan Provides Additional Renoprotection in Subjects With Type 2 Diabetic Nephropathy

Conditions
-----------------
Type 2 Diabetes, Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: pioglitazone+losartan
* Drug: losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting plasma glucose (FPG) level of 3.3-9.0mmol/L 2h plasma glucose level of 7.5-13 mmol/L serum creatinine values between 190 and 660umol/L Two occasions of a ratio of urinary albumin to urinary creatinine≥300 or 24 hours urinary protein concentration is >150mg Informed consent Exclusion Criteria: Type1 diabetes or nondiabetic renal disease abnormal liver function heart dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pioglitazone+losartan|Pioglitazone (30 mg/daily) losartan (100 mg daily)|
|Drug: losartan|losartan (100 mg daily)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr) | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pioglitazone, losartan, proteinuria, end stage renal disease (ESRD)
Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.

Official Title
-----------------
An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: PLA-695


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years RA disease onset after 16 years of age and has had the disease for at least 6 months Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months Exclusion Criteria: Evidence of unstable clinically significant disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PLA-695|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together. |  |  |
Prospective Becker-Heart-Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.

Detailed Description
-----------------
A cohort of 100 patients with mutations in the dystrophin gene associated with Becker muscular dystrophy and/or dilated cardiomyopathy will be included (patients with Duchenne muscular dystrophy are excluded). Patients with undergo at baseline the following workups: electrocardiogram, echocardiography, cardiac MRI, sera biomarkers measurement. At 3 years and 5 years, patients will be investigated according to the same protocol and occurrence of cardiac adverse events in the meanwhile will be recorded. Statistical analysis will assess correlations between cardiac phenotype and DMD mutations and prognostic value of cardiac investigations.

Official Title
-----------------
Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)

Conditions
-----------------
Dilated Cardiomyopathy, Lef Ventricular Dysfunction, Heart Failure

Intervention / Treatment
-----------------
* Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mutation in the DMD gene Becker muscular dystrophy and/or dilated cardiomyopathy age>18 years affiliation to the French medical insurance Exclusion Criteria: Duchenne muscular dystrophy Any other chronic disease that may be associated with heart disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dystrophinopathy<br>Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy | Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint: hospitalisation for heart failure, death due to heart failure |  | 3 years |
Validation of Chinese SRI Questionnaire

Study Overview
=================
Brief Summary
-----------------
Assessment of health-related quality of life in COPD patients with severe chronic respiratory failure requires appropriate and highly specific measurement tools. We attempt to validate the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)

Official Title
-----------------
Validation of Chinese Severe Respiratory Insufficiency （SRI）Questionnaire for COPD Patients With Chronic Hypercapnic Respiratory Failure

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult COPD Patients with chronic hypercapnic respiratory failure established on home noninvasive ventilation for at least 1 month Patients are in a clinically stable state,without any changes of medication during the previous 4 weeks. Exclusion Criteria: patient's refusal to participate Patients with evidence of acute respiratory failure i.e.patients with worsening of symptoms during the previous 2 weeks, a pH ,7.35, or with signs of respiratory infection

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 |
| --- | --- | --- |
| Reliability of Severe Respiratory Insufficiency Questionnaire |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Construct validity of Severe Respiratory Insufficiency Questionnaire |  | 2 weeks | 
| Criterion validity of Severe Respiratory Insufficiency Questionnaire |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD;SRI;Reliability;validity;
Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

Study Overview
=================
Brief Summary
-----------------
This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).

Official Title
-----------------
Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: alagebrium chloride (ALT-711)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women at least 45 years of age with uncontrolled systolic hypertension measured by office cuff and by an ambulatory blood pressure monitoring device Willingness to be taken off any current antihypertensive treatment to be placed on hydrochlorothiazide in combination with study medication. Exclusion Criteria: Any significant history, systemic illnesses, or medical condition(s) that could lead to difficulty complying with the protocol or that could confound interpretation of the data.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: alagebrium chloride (ALT-711)|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
-----------------
blood pressure, antihypertensive agents/therapeutic use, hypertension/drug therapy
Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus

Study Overview
=================
Brief Summary
-----------------
Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.

Conditions
-----------------
Hydrocephalus

Intervention / Treatment
-----------------
* Procedure: retrobulbar ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Ⅰ-Ⅱ aged between 20 and 70 year hydrocephalus general anesthesia for undergoing drainage of cerebrospinal fluid Exclusion Criteria: 1. an anatomical or functional abnormality in optic nerve

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| both optic nerve sheath diameter<br>both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement | Procedure: retrobulbar ultrasound<br>* both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| both optic nerve sheath diameter (the posterior 3mm of the papilla) |  | from induction of general anesthesia to average 15 min after recovery of general anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optic nerve sheath diameter, Hydrocephalus, Intracranial hypertension
Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation is to evaluate acute and longlasting side effects in patients undergoing radiotherapy for cancer treatment in the head and neck area.

Detailed Description
-----------------
The Dental Team at the Department for Oral and Maxillofacial Surgery in Trondheim takes care of patients before, during and also after radiotherapy in the head and neck area. In spite of the use of advanced radiation protocols and prevention measures such as fluoridation splints the team observes significant side effects, both under radiation and also on the long term after concluding treatment. Common problems are for example dermal and mucosal damages, reduced salivation, dysphagia and lesions of the teeth. Aim of the study is the investigation and documentation of side effects and complications in relation to the oral cavity. During the acute and postradiation phase a continuous follow-up over a longer lasting period is proceeded with registration of all relevant parameters. This includes among others dental status and evaluation of quality of life.

Official Title
-----------------
Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: radiation concerning the oral cavity follow-up at the Dental Team Exclusion Criteria: refused approval survival prognosis under one year

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 |
| --- | --- |
| radiation patients<br>cancer patients with radiotherapy concerning the head and neck area/oral cavity | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary flow |  | 3 months | 
| salivary flow |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mouth, Mucositis, Dysphagia, malnutrition, Xerostomia, saliva, tooth injuries