linjc16/ctgov huggingface dataset:
Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

Study Overview
=================
Brief Summary
-----------------
The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service. Safety data will largely be monitored by investigating changes in the patients' well-being during the study. The study will pilot and test a Patient Registry and Infusion Service process, which will allow zoledronic acid to be administered to trial patients in the investigators' private rooms by a team of roving nurses.

Official Title
-----------------
A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Female after menopause with osteoporosis either: 70 years of age or older with a bone mineral density T-score of -3.0 or less OR with a fracture due to minimal trauma. Exclusion Criteria: Intravenous bisphosphonate within the past 12 months Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection Abnormal liver function tests greater than twice normal Evidence of high bone turnover Abnormal calcium blood levels Low Vitamin D levels Poor renal function Abnormal parathyroid function or uncontrolled, abnormal thyroid function History of eye inflammation History of diabetes leading to kidney or eye problems A history of cancer except some non-invasive cancers of skin, colon, breast and cervix Patients with severe dental problems or current dental infections Or requiring dental surgery Known sensitivity to zoledronic acid or bisphosphonates Other protocol defined inclusion/exclusion criteria may apply

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoldronic<br> | Drug: zoledronic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | at baseline and month 12 | 
| Bone turnover |  | at baseline and month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, zoledronic acid, postmenopausal women
Satiety Response After Mixed Fiber Doses

Study Overview
=================
Brief Summary
-----------------
People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones. The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.

Official Title
-----------------
Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release

Conditions
-----------------
Satiety

Intervention / Treatment
-----------------
* Dietary Supplement: Mixed Fiber Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking healthy men and women 18 and 65 years of age non-smoking not taking medications non-dieting (weight stable over last 3 months) BMI between 18 and 27 able to give blood through an IV Exclusion Criteria: irregular or erratic breakfast eating patterns food allergies to ingredients commonly found in muffins or pizza distaste for muffins or pizza BMI less than 18 or greater than 27 weight change > 5 kg in last 3 months (intentional or unintentional) cardiovascular disease diabetes mellitus (fasting blood sugar > 126 mg/dl) cancer in prior 5 years (except basal cell carcinoma of skin) renal or hepatic disease Crohns disease ulcerative colitis any other gastrointestinal conditions that may affect digestion or absorption recent bacterial infection (< 3 months) chronic medication use history of drug or alcohol abuse in prior 6 months concurrent or recent intervention study participation vegetarians people who ate more than approximately 15 g of fiber per day pregnant or lactating women women with irregular menstrual cycles

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Mixed Fiber Supplement|Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety and Food Intake |  | November 2007 thru May 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose, Insulin, Gut Hormone Response |  | November 2007 thru October 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food intake, Gut hormones, Fiber, Visual analog scales
Respiratory Motion Related Ablation Gap and Clinical Outcome After Catheter Ablation for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This is the evaluation which is associated with apnea symptom, one of the recurrence factors, after AF ablation to patients who diagnosed AF. This is the evaluation which is associated with excessive respiration exercise during AF ablation to patients who diagnosed AF. This is the evaluation which is associated with excessive respiration exercise to make a gap during AF ablation to patients who diagnosed AF.

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20 80 Left atrium size <55mm Exclusion Criteria: Permeant AF which is uncontrolled by cardioverting Valvular AF (mitral stenosis> grade 2, mitral valvuloplasty) Structural heart disease which is necessary operation to be healed. The patients who had history of ablation or maze operation The patients who have abnormal respiration by spinal or chest modification. accompany Severe disease in present Under age <20

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Yonsei AF Cohort<br>Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recurrence of atrial fibrillation (AF) after catheter ablation | We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Any ECG documentation of AF recurrence after 3 months was diagnosed as clinical recurrence. | after 90 days of catheter ablation and thereafter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, sleep apnea
Genetics of CVD Risk Factors in Samoans

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of known genes involved in lipid metabolism on serum lipid and apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to the biobehavioral changes of modernization.

Detailed Description
-----------------
BACKGROUND: Modernizing Samoans are characterized by high levels of certain cardiovascular disease (CVD) risk factors such as extreme adiposity and high prevalences of obesity and hypertension. However, lipid levels in Samoans such as total cholesterol and high density lipoprotein (HDL) cholesterol are not consistent with their obesity and not always consistent with ecological measures of modernization. DESIGN NARRATIVE: The cross-sectional study used serum lipid and lipoprotein and dietary data collected in 1994 and 1995 in American and Western Samoa to compare the American and Western Samoans. Quantitative determinations were made of lipid and apolipoprotein levels differences between the two groups. Estimates were made of the effects of dietary intake, body size, and smoking on lipid and apolipoproteins. Cross-sectional analyses were performed on genetic factors influencing lipid and lipoprotein levels. Statistical analyses were conducted to test hypotheses about gene-environment interactions and gene-gene interactions in polynesians from American Samoa and Western Samoa. Diet, physical activity and body size vary with exposure to the influences of economic modernization and the adoption of non-traditional behaviors. Although adiposity and its central distribution, insulin, blood pressure and dietary cholesterol increase from Western Samoa to American Samoa, saturated fat intakes due to coconuts and cigarette smoking are greater in Western Samoa. Thus, modernization does not produce simple unilineal changes in risk factors. The investigators examined very specific hypotheses, based on the cross-sectional data collected in 1994 and 1995, about the influence of genes on lipids, about genetic interactions on lipids and about concrete environmental and specific gene interactions on lipid outcomes. 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
-----------------
Obesity, Cardiovascular Diseases, Heart Diseases, Atherosclerosis

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

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy

Study Overview
=================
Brief Summary
-----------------
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.

Official Title
-----------------
A Phase II, Randomized, Double Blind, Placebo-controlled, Parallel Design, Dose Ranging, Multi-center Trial of Four Levels of Exposure of QGE031 s.c. for 16 Weeks in Subjects Aged 18-50 Years of Age With Peanut Allergy

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Drug: QGE031
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours). Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test. Main Exclusion Criteria: Prior exposure to any monoclonal antibody treatment Asthma patients on maintenance long acting beta-agonists Use of systemic corticosteroids Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QGE031 A<br> | Drug: QGE031<br>* QGE031 liquid for subcutaneous injection.<br>|
| Experimental: QGE031 B<br> | Drug: QGE031<br>* QGE031 liquid for subcutaneous injection.<br>|
| Experimental: QGE031 C<br> | Drug: QGE031<br>* QGE031 liquid for subcutaneous injection.<br>|
| Experimental: QGE031 D<br> | Drug: QGE031<br>* QGE031 liquid for subcutaneous injection.<br>|
| Placebo Comparator: Placebo A<br> | Drug: Placebo<br>* Placebo liquid for subcutaneous injection.<br>|
| Placebo Comparator: Placebo B<br> | Drug: Placebo<br>* Placebo liquid for subcutaneous injection.<br>|
| Placebo Comparator: Placebo C<br> | Drug: Placebo<br>* Placebo liquid for subcutaneous injection.<br>|
| Placebo Comparator: Placebo D<br> | Drug: Placebo<br>* Placebo liquid for subcutaneous injection.<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
-----------------
Peanut Allergy
HRV in Patients Treated With Spinal Cord Stimulation

Study Overview
=================
Brief Summary
-----------------
This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

Official Title
-----------------
Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation

Conditions
-----------------
Failed Back Surgery Syndrome

Intervention / Treatment
-----------------
* Other: SCS is switched off
* Other: SCS is switched on


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years old. Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation. Cognitive and language functioning enabling coherent communication between the examiner and the participant. Exclusion Criteria: The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)). The use of medication that directly modifies autonomic control (for example beta-blockers).

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCS off<br> | Other: SCS is switched off<br>* Spinal cord stimulator is switched off for 12 hours<br>|
| Experimental: SCS on<br> | Other: SCS is switched on<br>* Spinal cord stimulator is on<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability changes | The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off) | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity scores | Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain). | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Stimulation, Heart rate variability
Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder

Study Overview
=================
Brief Summary
-----------------
Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD). Comparing real to sham treatment.

Official Title
-----------------
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD diagnosis per DSM IV Exclusion Criteria: Schizophrenia Bipolar I severe Axis II diagnosis risk factors to convulsions drug / alcohol abuse

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exposure-Stimulation<br> | Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham<br> <br> * Other names: Brainsway H-Coil;|
| Active Comparator: Sham exposure - Real stimulation<br> | Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham<br> <br> * Other names: Brainsway H-Coil;|
| Active Comparator: Exposure - Sham Stimulation<br> | Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham<br> <br> * Other names: Brainsway H-Coil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS SCORE [TOTAL, INTRUSION] |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD
A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction

Study Overview
=================
Brief Summary
-----------------
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion, as it provides an alternative to renal clearance as a route of elimination.

Detailed Description
-----------------
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion, as it provides an alternative to renal clearance as a route of elimination.

Official Title
-----------------
A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Drug: carboxypeptidase-G2


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients of any age at risk for life-threatening toxicity following MTX administration secondary to delayed drug excretion as defined by: Plasma MTX concentration at least 10 micromoles/liter more than 42 hours after the start of the MTX infusion; OR Creatinine at least 1.5 times the upper limit of normal or creatinine clearance less than 60 ml/sqm/min and delayed MTX excretion documented by plasma MTX concentration measurements (at least 2 standard deviations above the mean) at least 12 hours following MTX administration.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboxypeptidase-G2|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
-----------------
Antibody, DAMPA, Enzyme, Kidney, Pharmacokinetics, Thymidine, Toxicity