linjc16/ctgov huggingface dataset:
Psychometric Validation of Cognitive Endpoints

Study Overview
=================
Brief Summary
-----------------
The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.

Official Title
-----------------
Psychometric Validation of Cognitive Endpoints

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 years old (inclusive). History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis Physically able to see the testing materials and complete the tests Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire. Exclusion Criteria: A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset. Untreated major depression or untreated anxiety disorder. History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation. History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded. A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month. History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day 1. Active bacterial or viral infection. Use of marijuana within 2 months prior to Study Day 1or at any time during the study Alcohol consumption within 24 hours of either test session. Unable to comply with study requirements. Expected survival time of less than 3 months.

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?
-----------------
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
-----------------
MS, Neuropsychological tests
A Study to Evaluate Whether Correction of Anemia Using Recombinant Human Erythropoietin Reduces the Progression of Atherosclerosis and Cardiac Hypertrophy in Pre-dialysis Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to evaluate the effects of correction of anemia using erythropoietin on the progression of atherosclerosis and cardiac muscle thickening in patients with chronic kidney disease

Official Title
-----------------
A Prospective Randomised Controlled Trial to Study the Effects of Recombinant Human Erythropoietin on the Progression of Atherosclerosis, Cardiovascular Function, Nutrition and Residual Renal Function in Pre-dialysis Chronic Renal Failure Patients

Conditions
-----------------
Chronic Disease, Kidney Diseases, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic renal failure with serum creatinine between 150umol/L and 800umol/L and at the same time Hb Patients with regression line of 1/serum creatinine versus time showing that they may not require dialysis within the coming 12 months Patients below the age of 75 Exclusion Criteria: Patients with valvular heart disease/congenital heart disease Patients with ischemic heart disease/history of myocardial infarction/coronary artery bypass surgery Patients with history of heart failure Patients with regression line of 1/serum creatinine versus time showing that the estimated date of end stage renal disease is within 12 months Patients with thalassemic trait or haemoglobinopathies Patients with underlying haematological malignancies Patients with active bleeding Patients with uncorrected iron or other vitamins deficiencies Patients with poor general condition

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

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

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: erythropoietin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function and atherosclerosis |  | 6 month, 1 year | 
| cardiac hypertrophy and cardiac function |  | 6 month, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutrition status |  | 6 month, 1 year | 
| residual renal function |  | 6 month, 1 year | 
| quality of life |  | 6 month, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic kidney disease, cardiovascular disease
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.

Official Title
-----------------
A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03893787 In Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: PF-03893787
* Drug: PF-03893787
* Drug: PF-03893787


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-03893787 5 mg<br> | Drug: PF-03893787<br>* oral solution, 5 mg, QD for 14 days<br>|
| Experimental: PF-03893787 15 mg<br> | Drug: PF-03893787<br>* oral solution, 15 mg, QD for 14 days<br>|
| Experimental: PF-03893787 50 mg<br> | Drug: PF-03893787<br>* oral solution, 50 mg, QD for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination. |  | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio, |  | 22 days |
Olanzapine Versus An Active Comparator in the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how Olanzapine compares to an active comparator in the treatment of schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: You must be between the ages of 18 and 75. If you have reached your 76th birthday, you will not be able to participate You must have been diagnosed with schizophrenia You must be able to visit the doctor's office as scheduled for the next 7 months Exclusion: You have a serious medical illness, such as heart, liver, or kidney disease (Note: If you are uncertain about a particular condition, discuss it with your doctor.) You are either pregnant or breastfeeding

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity

Study Overview
=================
Brief Summary
-----------------
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma

Official Title
-----------------
Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity

Conditions
-----------------
Drug Safety Biomarkers

Intervention / Treatment
-----------------
* Other: Test meal (breakfast)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer; not known with cancer or current treatment for cancer Age at least 18 years Able and willing to give written informed consent Able and willing to consume the prescribed breakfast Able and willing to undergo blood sampling Exclusion Criteria: Any treatment with investigational drugs within 30 days before the start of the study Any condition that may interfere with the study protocol Women who are pregnant Allergies or intolerance for components of the prescribed breakfast

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A (fasting)<br>Fasting condition | |
| Experimental: B (fed)<br>Fed condition (test meal) | Other: Test meal (breakfast)<br>* Standardized test meal, in accordance with high-fat and high-calorie meal as described in the FDA guidance, but ingredients are changed to Dutch standards and ingredients are added that are expected to have the largest effects on dihydrouracil and uracil levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition | 12 blood samples taken on both test days (fed and fasting condition), to investigate the effect of food on uracil and dihydrouracil levels | 2 test days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h) | Dihydropyrimidine dehydrogenase enzyme activity is assessed at baseline to rule out any potential influence of dihydropyrimidine dehydrogenase deficiency on uracil and dihydrouracil levels | baseline |
Follow-up Study of COVID-19 Patients in the District Konstanz

Study Overview
=================
Brief Summary
-----------------
This is a prospective single-center study for the follow-up of SARS-CoV-2 positive patients in the district of Konstanz (LKN). As part of the coronavirus pandemic, patients with SARS-CoV-2 infection are currently being treated in the clinics of the LKN's health network at the Singen (Hegau-Bodensee Clinic) and Konstanz (Konstanz Clinic) locations. So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part of this study, the disease progression of these patients will be monitored. Study objective: Prospective, controlled follow-up observation of SARS-CoV-2 positive patients regarding their secondary diseases and quality of life.

Official Title
-----------------
Single Center Prospective Controlled Follow-up Study of COVID-19 Patients in the District Konstanz (FSC19-KN)

Conditions
-----------------
SARS-CoV-2 Positive Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A Inclusion Criteria of SARS-CoV-2 positive patients: Patient must meet all of the following criteria. Positive test for SARS-CoV-2 by PCR Signed informed consent and privacy policy B Inclusion Criteria of the control Group: Volunteer must meet all of the following criteria. No contact to SARS-CoV-2 positive patients negative SARS-CoV-2 antibody test Signed informed consent and privacy policy Exclusion Criteria: Patient/Volunteer will be excluded if any of the following conditions apply: Patient/Volunteer age < 18 years Patient/Volunteer who are unable to read the information and understand the nature of the study Patient/Volunteer participate in any other clinical study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients with positive test for SARS-CoV-2 by PCR | |
| Control group<br>Patients with negative SARS-CoV-2 antibody test | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hospitalization | Primary endpoint | Between 1 year after enrollment and 5 years after last patient in | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L | Secondary endpoint | Between 1 year after enrollment and 5 years after last patient in | 
| KCCQ-12 | Secondary endpoint | Between 1 year after enrollment and 5 years after last patient in | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, COVID-19 Virus disease, Hospitalization, Quality of life, EQ-5D-5L, Cardiomyopathy, Kansas City (KCCQ-12)
Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol intravenously versus multiple smaller dosages of tramadol during the first 6 hours post-operatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side-effects.

Official Title
-----------------
Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

Conditions
-----------------
Ambulatory Surgery

Intervention / Treatment
-----------------
* Drug: Administration of tramadol intravenously


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II female or male patients Aged 18-70 years Scheduled for ambulatory surgery requiring postoperative pain medication. Exclusion Criteria: Weight less than 70% or more than 130% of ideal body weight Neurological disorder Recent use of psycho-active medication, including alcohol Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's Use of chronic anti-emetic medication, use of chronic corticoid therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of tramadol intravenously|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of pain relief |  |  | 
| Accuracy of pain relief |  |  | 
| Onset of side-effects |  |  | 
| Duration of side-effects |  |  |
Single Cell Sequencing Analysis of Thymoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand how genetics play a role in thymoma. Intratumoral heterogeneity is among the greatest challenges in precision cancer therapy. However, developments in high-throughput single-cell RNA sequencing (scRNA-seq) may now provide the statistical power to dissect the diverse cellular populations of tumors. This study aims to find out how it affects genetic and protein expression in patients with malignant thymoma, compared to Benign thymoma, at a single-cell level using a flow cytometry and RNA-sequencing protocol.

Official Title
-----------------
Single Cell Sequencing Analysis of Thymoma

Conditions
-----------------
Thymoma

Intervention / Treatment
-----------------
* Diagnostic Test: Tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with thymoma Ability to provide written consent and comply with the protocol At least 18 years of age Exclusion Criteria: Patients undergoing thymoma treatment Patients with previous malignancy Known HIV positive status. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Malignant thymoma<br> | Diagnostic Test: Tissue<br>* Four 4-5 mm tissues of the thymoma<br>|
| Benign thymoma<br> | Diagnostic Test: Tissue<br>* Four 4-5 mm tissues of the thymoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of cell population from thymoma | The genes expression and the cell population | through study completion, an average of 1 year |
Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized. The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.

Official Title
-----------------
The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: doxycycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute exacerbation of COPD type I or II according to GOLD Ability to perform lung function tests Ability to take oral medication Exclusion Criteria: Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation. Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation. Progression or new radiographic abnormalities on the chest X-ray. Severe exacerbation that required mechanical ventilation. History of bronchiectasis Recent or unresolved lung malignancy. Other disease likely to require antibiotic therapy. Significant gastrointestinal or other conditions that may affect study drug absorption. Class III or IV congestive heart failure or stroke. Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks). Cystic fibrosis Tuberculosis. Impaired renal function (creatinine clearance < 20 ml/min).

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: doxycycline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy at the end of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure at follow up |  |  | 
| Number of exacerbation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute bronchitis, antibiotics