linjc16/ctgov huggingface dataset:
Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Detailed Description
-----------------
The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Official Title
-----------------
A Phase 1, Single-Site, Double-Blind,Randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus or Intravenous Bolus Followed by Continuous Infusion Administration of ARC1779 Compared to Placebo in Healthy Volunteers

Conditions
-----------------
Thrombosis

Intervention / Treatment
-----------------
* Drug: ARC1779


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 to ≤ 65 years of age Weight ≤ 110 kg Negative qualitative urine drug/alcohol test Female volunteers must be of non-childbearing potential Male volunteers must agree to use a medically acceptable contraceptive Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document Exclusion Criteria: Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.) Tendency to bleed easily History of recent trauma or surgery History of gout or renal stones Clinically significant abnormal lab parameters for the following: PT INR > 1.4 aPTT > reference laboratory values Serum creatinine > 1.3 mg/dL Platelet count of ≤ 100,000/mm3 ALT/AST > 2 times ULN WBC ≤ 3000 x 109/L Hemoglobin < 11 g/dL Total bilirubin > 1.2 mg/dL CBT > 15 min

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARC1779|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Memantine in Patients With Chronic Glaucoma

Study Overview
=================
Brief Summary
-----------------
Randomized double-masked clinical trial of memantine in patients with glaucoma

Conditions
-----------------
Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: memantine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma damage on examination of visual field and optic disc Good visual acuity (with glasses if needed)

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of glaucoma |  |  |
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease

Study Overview
=================
Brief Summary
-----------------
This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.

Official Title
-----------------
Phase II Study of Gemcitabine and Trastuzumab Therapy in Patients With HER2 Overexpressing Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms, Cancer of the Breast, Breast Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease Tumors tested by IHC must be 3+ positive for HER2 overexpression. Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2. Tumors that are 3+ by IHC but negative by FISH assay are ineligible Patients must have measurable disease Patients may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer. Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. Patients may NOT have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months. Exclusion Criteria: Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval Patients with known leptomeningeal carcinomatosis

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: Trastuzumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Overall response rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression,Time to treatment failure, Overall survival, Toxicity of the combination |  |  |
Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to evaluated the feasibility and reproducibility of the measurement of lung elasticity report / fetal liver according to gestational age in a group of patients with a normal course of pregnancy and in a group of Patients at risk of preterm delivery.

Official Title
-----------------
Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat

Conditions
-----------------
Pregnancy Complications, Obstetric Labor, Premature

Intervention / Treatment
-----------------
* Other: lung and liver elastography measurement of fetus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for control group : major pregnant women singleton pregnancy Inclusion Criteria for control group : major pregnant women singleton pregnancy hospitalized for threatened premature birth between 24 and 34 WA Indication of a cure corticosteroid betamethasone Exclusion Criteria: maternal conditions of pregnancy: diabetes gestational, pregnancy-induced hypertension, preeclampsia fetal lung diseases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preterm labor group<br>Pregnant women hospitalized for preterm labor | Other: lung and liver elastography measurement of fetus<br> <br> |
| Other: control group<br>Pregnant women with a normal pregnancy | Other: lung and liver elastography measurement of fetus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution over 48 hours of the fetal lung elasticity coefficient measure in kilopascals (kPa) (compared to the fetal liver) | The dates of elastography exams controls patients will be distributed a week of amenorrhea (WA) between 24 and 34 WA. | For pretern larbor group: day of hospitalization for preterm labor, then 2 days later. For control group, both measurements at 2-day intervals | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elastography
Follow-up Study of Small-intestinal Mucosal Injuries in Chronic Non-steroidal Anti-inflammatory Drugs (NSAIDs)-Users

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.

Conditions
-----------------
Enteropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent 20 to 85 years of age RA, OA, or low back pain taking oral diclofenac sodium over 3 months No change of drugs before 3 months under 5 mg of corticosteroid use CRP < 1mg/dl Exclusion Criteria: known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis prostaglandins, metronidazole or salazosulfapyridine can not swallow with pacemaker after gastrointestinal operation serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease. any other conditions that the investigator feels would interfere with data interpretation or create under risk

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
Prevalence of Hyperuricemia in Pakistan

Study Overview
=================
Brief Summary
-----------------
The prevalence of hyperuricemia has rarely been investigated in developing countries Hyperuricemia, or raised serum uric acid (SUA), is the condition closely associated with gout due to the deposition of monosodium urate crystals in peripheral joints and soft tissues. Hyperuricemia is associated with an increased risk for incident hypertension, independent of traditional hypertension risk factors. This risk appears more pronounced in younger individuals and women. Cross-sectional studies show an association of hyperuricemia with the presence of CKD. Insulin resistance plays a potentially key role in the causal relationship between metabolic syndrome, type 2 Diabetes and hyperuricemia. Furthermore, it is likely that hyperuricemia and insulin resistance share a bidirectional causal effect. The rationale of this study is to determine prevalence of hyperuricemia in Pakistan.

Detailed Description
-----------------
Informed consent will be obtained from all patients and their attendant coming to clinics. Those who will agree to be part of this study were asked a questionnaire about co-morbidity and symptoms. Uric acid levels will be assessed by using UASure Blood Uric Acid Monitoring System. Male with uric acid levels greater than 7 mg/dl and female greater than 6 mg/dl were classified as hyperuricemia.

Official Title
-----------------
Prevalence of Hyperuricemia in Pakistan

Conditions
-----------------
Hyperuricemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent given Exclusion Criteria: No Informed consent provided

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 |
| --- | --- | --- |
| Prevalence of Hyperuricemia | To find out the frequency uric acid levels in Pakistani general population | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uric acid, prevalence, pakistan
Breath Analysis by Ion Mobility Spectrometry

Study Overview
=================
Brief Summary
-----------------
Recognition of disease specific clusters of volatile organic compounds in patients with different lung diseases, using breath analysis with ion mobility spectrometry. Lung diseases of interest are: COPD tumors airway infection interstitial lung disease sleep apnea Hypothesis: Breath analysis with ion mobility spectrometry can differentiate pulmonary disorders.

Detailed Description
-----------------
Recruitment of patients with different lung diseases goes on. First sub-group analysis of patients with COPD,lung cancer and sarcoidosis is done in order to create a training set of VOC-clusters for further validation in a bigger population of patients.

Official Title
-----------------
Detection of Clusters of Volatile Organic Compounds (VOC)in Patients With Different Lung Disorders by Ion Mobility Spectrometry. Different Clusters of VOC in the Diagnosis of Different Lung Disorders Using Ion Mobility Spectrometry

Conditions
-----------------
Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient Ages 18-90 years old Exclusion criteria: - Patient who are not able to perform an exhalation manoever.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>COPD | |
| 2<br>lung cancer | |
| 3<br>airway infection | |
| 4<br>interstitial lung disease | |
| 5<br>sleep apnea | |
| 6<br>pulmonary disorders with pleural infusions | |
| 7<br>sarcoidosis | |
| 8<br>healthy persons | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of diseases specific VOCs |  | years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of disease specific VOCs under therapy |  | years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung tumor, pleural tumor, interstitial lung disease, airway infection, COPD, sleep apnea, ion mobility spectrometry, breath analysis
National Survey on Coronary Patients and Heart Failure Performed in 2 Patient Groups

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to compare frequency of attainment control goals through the more represented cardiovascular factor risk, dyslipidemia, among coronary patients with or without heart failure in cardiology consulting.

Official Title
-----------------
Comparison and Description of Coronary Patients Management With or Without Heart Failure in Cardiology Consulting

Conditions
-----------------
Coronary Patients, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with coronary disease diagnosed since at least 1 year Echocardiography done less than 1 year ago patient with or without documented heart failure Exclusion Criteria: None

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 |
| --- | --- |
| 1<br>patients with heart failure | |
| 2<br>patients without heart failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of attainment control goals through the more represented cardiovascular factor risk, dyslipidemia, among coronary patients with or without heart failure in cardiology consulting. |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary patients, heart failure, dyslipidemia
Self-consciousness in Dementia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to characterize the deficit in critical components of personal identity (self-consciousness and social cognition) in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study. We posit that the alteration of some aspects of self-consciousness (autobiographical memory, nosognosia, metacognition) and social cognition (theory of mind and facial) results in personality changes in the patients, primarily due to the alteration of self-consciousness in AD and to social cognition in FTLD.

Official Title
-----------------
Self-consciousness in Dementia

Conditions
-----------------
Alzheimer Disease, Fronto-temporal Lobar Dementia

Intervention / Treatment
-----------------
* Other: Questionnary and IRM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AD (McKhann et al, 1984 and Dubois et al, 2007) or FTLD (Neary et al, 1998 or Rascovsky et al, 2011) MMSE > or = 18 Relative avaible Exclusion Criteria: Contraindication to MRI Major depression Other central neurological condition

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Alzheimer disease<br>Patients with Alzheimer disease | Other: Questionnary and IRM<br> <br> |
| Other: Fronto-temporal lobar dementia<br>Patients with Fronto-temporal lobar dementia | Other: Questionnary and IRM<br> <br> |
| Other: Control<br>Control group | Other: Questionnary and IRM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the deficit in critical components of personal identity in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study. |  | each month for 3 month |
Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting

Study Overview
=================
Brief Summary
-----------------
This study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. This study will consist of a chart review of the results of the screens performed by substance use counselors and correlating them to institutional variables such as wait time in the emergency room and length of stay as well as to patient variables obtained by chart review such as medical diagnosis and sociodemographic variables.

Official Title
-----------------
Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting (Screening and Brief Treatment for Substance Use Disorders in the Emergency Room Department)

Conditions
-----------------
Substance Use

Intervention / Treatment
-----------------
* Behavioral: Motivational interviewing and referral to treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and older Presentation to UAB Emergency Department Exclusion Criteria: Younger than 19 Prisoners

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

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Counseling<br>motivational interviewer | Behavioral: Motivational interviewing and referral to treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substance use |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
substance use treatment