linjc16/ctgov huggingface dataset:
Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).

Official Title
-----------------
Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA

Conditions
-----------------
Urine Toxicology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide written informed consent Pharmacogenomic testing within the last 60 days Planned UDT Exclusion Criteria: Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5 Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST or ALT >1.5x normal, or suspected cirrhosis) Subject has a history of malabsorption (short gut syndrome); Subject has a history of any gastric or small bowel surgery; Subject is currently hospitalized; Subject is currently receiving intravenous medication.

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 |
| --- | --- | --- |
| Influence of CYP450 drug metabolism on quantitative UDT | Occurrence of genetically-determined abnormal metabolism of drugs tested with UDT, classified as genetic effects on metabolism (GEM) + for rapid metabolizers, GEM 0 for normal metabolizers, and GEM - for slow metabolizers. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of illicit drugs detected on UDT and the GEM classification associated with these medications |  | 24 months | 
| Non-prescribed drugs detected on UDT and the GEM classification associated with these medications |  | 24 months | 
| False positive immunoassay results, defined as positive immunoassay concurrent with negative quantitative testing |  | 24 months | 
| Frequency of target drug regimen changes by the treating physician due to pharmacogenomic test results |  | 24 months | 
| Frequency of illicit drug changes by the subject due to UDT results, as observed at the time of repeat UDT |  | 24 months | 
| Frequency of non-prescribed drug changes by the subject due to UDT results, as detected at the time of repeat UDT |  | 24 months |
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis

Study Overview
=================
Brief Summary
-----------------
This is a three year open-label study in subjects with axillary hyperhidrosis.

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Biological: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Marked axillary hyperhidrosis Exclusion Criteria: Previous use of botulinum toxin for hyperhidrosis

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Botulinum Toxin Type A | Biological: Botulinum Toxin Type A<br>* 100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period<br>* Other names: BOTOX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of axillary sweat production |  | Every 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported health outcome measures |  | 1 Month Post-Treatment Visit |
Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department

Official Title
-----------------
Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants 2 to 24 months of age acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15) only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized Exclusion Criteria: previous wheezing and/or bronchodilator therapy hospitalization at 240 minutes critically ill patients needing airway stabilization patients with low or very high baseline disease severity (RDAI <5 and >16) patients under 8 weeks of age patients on corticosteroids prior to arrival at Emergency Department contact with varicella within 21 days past history of ventilation for greater than 24 hours existing cardiopulmonary disease, multisystem disease or immunodeficiency insufficient command of the English language

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 24 Months

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: dexamethasone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Assessment Change Score (RACS) at 96 and 144 hours |  |  | 
| Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period |  |  | 
| Proportion of infants with no signs of respiratory distress at 96 and 144 hours |  |  | 
| Proportion of infants who are symptomatic at 14 days |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchiolitis, pediatrics, corticosteroids
The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the effect of a new biomechanical device and treatment methodology (AposTherapy) on gait patterns, pain, function and quality of life of patients with musculoskeletal and neurological disorders. Based on previous reports the investigators hypothesis that this therapy will have a positive effect on these measurements.

Conditions
-----------------
Osteoarthritis, Spinal Diseases, Ligament Rupture, Lower Extremity Fracture, Neurological Disorders

Intervention / Treatment
-----------------
* Device: AposTherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoarthritis Lower limb joint replacement Lower limbs fractures Spinal disorders including LBP w/wo refered symptoms, radiculopathy, spinal stenosis ligaments tear Meniscal tears Exclusion Criteria: lack of balance (3 falls in the last year) incapable to complete a questionnaire •>age 85

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AposTherapy|a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. patient are instructed to walk indoor with the device. time of exercise is gradually increase|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatio-temporal Gait parameters |  |  | 
| WOMAC |  |  | 
| SF-36 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAOS questionnaire |  |  | 
| Oswestry questionnaire |  |  | 
| Clinical measurements |  |  |
Relationship Between Dysfunctions of Movement in the Lower Back and Pelvis With Overuse Injuries in Handball Players

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the relationship between the presence of overuse injuries and failure to control of movement in those areas. For this, participants will perform some tests related to movement dysfunction lumbar-pelvic area to check for faults in one or more movement planes.

Detailed Description
-----------------
Handball is considered a high intensity sport even though the 70% of the time the game is standing or walking. The large number of repetitions of high intensity activities such as sprinting or jumping, associated with physical contact with opposing players, make this sport in a physically demanding activity. Furthermore, overuse injuries have been widely described but poorly quantified. In addition, is necessary to know the influence of static lumbar-pelvic position in low back pain and its correlation with stability. Not only strength is important for a good quality of movement, there should also be a specific muscle activation in order for a correct motor pattern. This coordinated action must be I just by the action of muscles agonists, antagonists and synergists.The aim of this study is to assess the relationship between the presence of overuse injuries and failure to control of movement in those areas. For this, participants will perform some tests related to movement dysfunction lumbar-pelvic area to check for faults in one or more movement planes.

Official Title
-----------------
Relationship Between Dysfunctions of Movement in the Lower Back and Pelvis With Overuse Injuries in Handball Players

Conditions
-----------------
Dysfunction;Joint, Overuse Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Players from the first team Without injury that does not allow movement tests Exclusion Criteria: Spinal cord injury or tumor, myelopathy, neuropathy and spondylitis and spondylolisthesis in the lumbar spine. Tumors or major injuries in the knee or hip.
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Control of lumbopelvic movement | It is seven tests to check the control of lumbopelvic movement. They are low-intensity tests to assess the ability to control movement of the stabilizing musculature. The mobilizing muscles should not have a dominant role in these tests. The test were recorder on video to be analyzed later | Once, at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensation | Pain sensation measured with a visual analog scale | Once, at baseline | 
| Epidemiological registry | Information related to injuries suffered by players | Through study completion, an average of 2 year |
MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.

Official Title
-----------------
Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Conditions
-----------------
Inflammation, Nutrition, Peritoneal Dialysis

Intervention / Treatment
-----------------
* Drug: tinzaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage renal disease Peritoneal dialysis without complication for minimum of three months 18 years or above Informed consent Exclusion Criteria: Known coagulatory defects including anticoagulation therapy Known bleeding tendency Peritonitis within two months prior to inclusion Pregnancy Breast feeding Active infection Non-informed consent Allergy to heparin or prior heparin induced thrombocytopenia

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of inflammation, local and systemic |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular compliance |  |  | 
| Nutritional state |  |  | 
| Efficacy of Peritoneal Dialysis |  |  | 
| Change in local cellular distribution |  |  | 
| Change in local and systemic generation of thrombi |  |  |
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate
* Drug: Escitalopram oxylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a documented clinical diagnosis of Generalized Anxiety Disorder. Be able to understand and comply with the requirements of the study. Able to understand and provide written informed consent Exclusion Criteria: Patients (female) must not be pregnant or lactating Current or past diagnosis of stroke or transient ischemic attack (TIA).

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine Fumarate|nan|
|Drug: Escitalopram oxylate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization in the HAM-A total score at Day 57 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization in CGI-S score at Day 57 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GAD, anxiety
Long Term Vitamin D Therapy in HCV Treated Patients

Study Overview
=================
Brief Summary
-----------------
Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.

Detailed Description
-----------------
Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.

Official Title
-----------------
Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic HCV infection (positive HCV Ab more than 6 months) Treated with pegylated interferon and ribavirin Exclusion Criteria: Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus Previous non response to antiviral therapy. Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCV patients under treatment<br>Fifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D. Dose of vitamin D 15,000 IU/week | Drug: Vitamin D<br>* vitamin D was given to 50 patients (HCV under treatment)<br>* Other names: ribavirin;|
| No Intervention: HCV without Vit D<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C infection, vitamin D
A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects

Official Title
-----------------
A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics Between UI058 and UIC202004 in Healthy Subjects

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: administration of UI058
* Drug: administration of UIC202004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects able to read and understand a written informed consent, and willing to decide to participate in the study Healthy subjects between the ages of 19 and 55 years at screening Body weight more than 50.0kg(male)/45.0kg(female) Body Mass Index more than 18.0kg/m2 and under 30.0kg/m2 Exclusion Criteria: Have clinically significant disease that hepatobiliary system, kidney, respiratory system, nervous system, hemato-oncology disease, cardiovascular system Have a gastrointestinal disease history that can effect drug absorption or surgery Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UI058<br> | Drug: administration of UI058<br>* Test<br>|
| Active Comparator: UIC202004<br> | Drug: administration of UIC202004<br>* Reference<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state | evaluation PK for Rabeprazole after multiple dose | Day 7, 0 24hours | 
| percent change from baseline in integrated gastric acidity for 24-hour interval after 7th dose | evaluation PD for ambulatory 24hour pH monitor | baseline versus multiple dose during 7days |