linjc16/ctgov huggingface dataset:
Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort

Study Overview
=================
Brief Summary
-----------------
Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

Detailed Description
-----------------
Susceptibility to SPA has been shown to be largely genetically determined but the contribution of environmental factors to disease evolution has not yet been elucidated. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

Official Title
-----------------
Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort

Conditions
-----------------
Spondylarthritis, Primary Systemic Vasculitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years SPONDILARTHRITIS: modified New York criteria Systemic vasculitis: ACR criteria Exclusion Criteria: no internet access

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on a disease activity rating scale | Score on a disease activity rating scale (quaterly,than monthly basis) | Six years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ancillary studies will be possible with the available database | Ancillary studies will be possible with the available database | six years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Environment, spondylarthritis, vasculitis, stress, life event, vaccine
4-methylpyrazole and Acetaminophen Metabolism

Study Overview
=================
Brief Summary
-----------------
Oxidative metabolism of APAP will be studied with and without 4-MP.

Official Title
-----------------
The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers

Conditions
-----------------
Healthy Adult Volunteers

Intervention / Treatment
-----------------
* Drug: Fomepizole
* Drug: APAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy No APAP use in previous 2 weeks No ingestion of alcohol or drugs that affect CYP 2E1 over previous 5 days No allergy to APAP or fomepizole BMI < 29 Exclusion Criteria: Pregnant or lactating History of alcohol abuse Allergy to APAP or fomepizole Screening LFTs above normal range

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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Oral APAP and IV Fomepizole. | Drug: Fomepizole<br>* IV 4-MP.<br>Drug: APAP<br>* Oral APAP<br>|
| Active Comparator: B<br>Oral APAP. | Drug: APAP<br>* Oral APAP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative metabolism of APAP | Measurement of oxidized metabolites of APAP | 24 hours |
An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study

Study Overview
=================
Brief Summary
-----------------
The primary objective is to provide continued access to PRO 140 to a subject who has completed participation in PRO140_CD02.

Detailed Description
-----------------
This is an open label, single center study designed to provide continued access to PRO 140 to a subject who have completed participation in PRO140_CD02 and continue to receive clinical benefit. The subject will receive weekly PRO 140 SC injection along with oral ART regimen during the Treatment Phase. The study treatment (PRO 140 SC injections) will be administered by a qualified medical professional or self-administered by the subject.

Official Title
-----------------
An Expanded Compassionate Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PRO140_CD02 Study

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: PRO 140


Participation Criteria
=================
Eligibility Criteria
-----------------
This study will recruit one treatment-experienced, HIV-1 infected patient with CCR5-tropic virus, who has participated in PRO 140_CD02 clinical trial and is continuing to derive clinical benefit from PRO 140 treatment.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 56 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PRO 140|PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Blood Donation on Blood Pressure, Iron Metabolism, Oxidative Stress

Study Overview
=================
Brief Summary
-----------------
The investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress. There are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress.

Detailed Description
-----------------
The regular application flow of blood donation at that blood bank of Charité is not disturbed. There are only some more questions and measurement of blood pressure, iron metabolism, fat metabolism and oxidative stress. No extra puncture of the vein is necessary.

Official Title
-----------------
Prospective Observational Study on the Effects of Blood Donation on Blood Pressure, Iron Metabolism and Oxidative Stress

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first time donating blood or after a break of 12 months to last blood donation voluntary attending blood donation and study fulfilling the criteria of the blood donation center Exclusion Criteria: criteria of the blood donation center (e. g. low haemoglobin, fever, acute infection, having spent in tropical countries for the last months,general bad health condition,...) missing informed consent to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| blood pressure | seated blood pressure will be measured baseline and after 3 months by trained professionals | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | seated blood pressure will be measured baseline and after 12 months by trained professionals | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Ferritin, Phlebotomy, Blood donation
Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease. Observational study case-only

Detailed Description
-----------------
Objectives how many patients will experience motor or nonmotor fluctuation during follow-up period? in how many patients, does motor fluctuation precede nonmotor fluctuation? in how many patients, does nonmotor fluctuation precede motor fluctuation? Participants: persons with Parkinson disease in early stage who does not have motor or nonmotor fluctuation Recruitment period: 3 years from the commencement of the study Follow-up period: 3 years for each participants

Official Title
-----------------
Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria early stage Exclusion Criteria: dementia (MMSE<26) persons who refuse participating
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 |
| --- | --- | --- |
| time period from the onset of disease to the occurrence of motor or nonmotor fluctuation | The proportion of participants with motor and/or nonmotor fluctuation will be evaluated at 6, 12, 18, 24, 30, and 36 months after the enrollment of each participant in order to determine the time course of motor/nonmotor fluctuation in persons with early stage of Parkinson's disease. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation | The participants will be checked regularly for the development of motor/nonmotor fluctuation during study period by both of self-diagnostic questionnaire and clinician. The validation of self-diagnostic questionnaire of motor/nonmotor fluctuation will be conducted compared to the clinician-evaluated occurrence of motor/nonmotor fluctuation. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson disease
Vulvar Scarring Grading Scale for Lichen Sclerosus

Study Overview
=================
Brief Summary
-----------------
The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).

Detailed Description
-----------------
Utilizing the vulvar disorders registry, protocol #STU00001056, the research team seeks to analyze the medical record data, including standard of care vulvar photographs, of the vulvar LS population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of Northwestern Medicine (NM). These photographs will be used to develop a vulvar scarring grading scale for LS. The objective measurement of scarring severity in LS deidentified standard-of-care patient photographs will be correlated with clinical examination findings to assess validity of the grading scale. The development of an objective and standardized grading scale will assist with the longitudinal evaluation of individual disease, assessment of impact of therapy on scarring, and inform treatment modifications. Further, objective grading of scarring would also provide the opportunity to search for potential correlation between QoL scores and severity of clinical states in scarring dermatoses.

Official Title
-----------------
Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus

Conditions
-----------------
Lichen Sclerosus, Lichen Sclerosus et Atrophicus

Intervention / Treatment
-----------------
* Other: Photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen at Northwestern Medicine Department of Dermatology and/or Department of Obstetrics and Gynecology, who were seen by Dr. Bethanee Schlosser, and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings and underwent complete mucocutaneous examination. Patients with histologically confirmed vulvar LS. Exclusion Criteria: Patients who refuse complete mucocutaneous examination. Patients who refuse recommended diagnostic procedures. Pregnant women or prisoners.

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Photography|Photos will be taken of the vulvar lichen sclerosus lesions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scarring severity grading scale for vulvar lichen sclerosus |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of severity of vulvar LS scarring, as documented at time of clinical examination and compared to scores on the LS grading scale, with the patient quality of life at the time of examination. |  | one year |
Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.

Detailed Description
-----------------
The purpose of this study is to evaluate the effect of Anple-one SR Tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of Anpl-one SR Tablet (sarpogrelate hydrochloride agent) using PAQ.

Official Title
-----------------
Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease

Conditions
-----------------
Arteriosclerosis Obliterans

Intervention / Treatment
-----------------
* Drug: Sarpogrelate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 19 and under 80 years of age. Patients who first administered Sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (Burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.). Patient who voluntarily signed a written consent form approved by the Clinical Trial Review Committee or Ethics Committee and agreed to participate in the study by the patient or the subject's agent. Exclusion Criteria: Patient who is expected to have less than two years of life expectancy. Patient who have bleeding within a week of participation in the study Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.). A female patient who is likely to be pregnant or pregnant. Female patients who are lactating or are scheduled to be lactated at the time of participation in the study. Patients with severe renal disease and liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anpl-one SR Tablet<br>Patients who prescribed Anpl-one SR Tablet | Drug: Sarpogrelate<br>* Anpl-one SR<br>* Other names: Anpl-one SR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Peripheral Artery Questionnaire | change in PAQ, scale in numbers, high score means no symptom | at 24 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Peripheral Artery Questionnaire | change in PAQ, scale in numbers, high score means no symptom | 12 weeks and 24 weeks from baseline |
The MI-HEART Project

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine ways in which a clinical information system can help patients better recognize the signs and symptoms of an acute myocardial infarction (heart attack) and to take actions to decrease morbidity and mortality that may be related to delay in seeking treatment. The software-based intervention will use the best scientific evidence to create tailored strategies using a patient's specific health data. This approach is based on well-established cognitive and behavioral educational models.

Conditions
-----------------
Myocardial Infarction, Coronary Disease

Intervention / Treatment
-----------------
* Behavioral: Tailored Education Messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients at high-risk for an acute myocardial infarction, including any 2 of these risk factors: males age > 45; females age >55; family history of premature coronary heart disease (CHD); current cigarette smoker; hypertension; or elevated total cholesterol with low HDL and/or high LDL. OR have: Active angina (chest pain due to coronary heart disease) History of coronary heart disease according to the treating physician Past history of myocardial infarction documented by electrocardiogram or arteriography Diabetes Mellitus Renal dialysis Exclusion Criteria Hospitalization within previous 4 weeks Persons living in a home with previously enrolled patients Patients disoriented to person, place, or time at onset of study

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tailored Education Messages|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
-----------------
Acute Myocardial Infarction, Diabetes Mellitus, Renal Dialysis, Heart Attack, Coronary Heart Disease
Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.

Detailed Description
-----------------
Nitrous oxide is a widely used anesthetic agent. The mechanism of its central action is not completely understood and its importance is questioned. Total intravenous anesthesia can be driven by a computer using bispectral index as a controller. Such a system matches anesthetic agent requirements to the needs of each individuum and thus allows an unbiased evaluation of the influence of nitrous oxide. Two groups of patients are compared: one ventilated with a oxygen-air mixture and one with oxygen-nitrous oxide mixture. Anesthesia is provided by a dual-loop which adapts propofol and remifentanil target concentrations to maintain a bispectral index between 40 and 60 in both groups.

Official Title
-----------------
Anesthésie Totale Intraveineuse en  Boucle d'Asservissement  guidée Par l'Index Bispectral : Effet de l'Adjonction de Protoxyde d'Azote (Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia)

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: air
* Drug: Nitrous oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General anaesthesia with controlled ventilation Exclusion Criteria: Age lower than 18 years Pregnant woman Allergy to the propofol or to a muscle myorelaxant Patients receiving a psychotropic treatment Presence of a central neurological disorder or a lesion cerebral Patients having an anomaly of blood cells count preoperative biological assessment Patients having had an anaesthesia in the previous month

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
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ventilation with air and oxygen | Drug: air<br>* 60% air combined with 40% oxygen for ventilation<br>|
| Experimental: 2<br>ventilation with nitrous oxide and oxygen | Drug: Nitrous oxide<br>* 60% nitrous oxide combined with 40% oxygen for ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. |  | during anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: consequences of the use of nitrous oxide on the performance of the automated administration system. |  | during anesthesia | 
| Influence of Gender |  | during anesthesia |