linjc16/ctgov huggingface dataset:
Phase 2 AMG 714 in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Twelve week treatment of AMG 714 in RA patients who failed at least one DMARD, followed by a 3 month observational period.

Official Title
-----------------
A Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic Drugs

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: AMG 714


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of RA - Exclusion Criteria: No prior biologic treatment for RA -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AMG 714|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

Official Title
-----------------
A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: [S,S]-reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) Exclusion Criteria: Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

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: Open Label<br> | Drug: [S,S]-reboxetine<br>* S_S reboxetine dosed daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-lead ECG |  | 68 weeks | 
| Hematology/Biochemistry |  | 68 weeks | 
| Adverse events |  | 68 weeks | 
| Physical examination |  | 68 weeks | 
| Vital signs |  | 68 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change |  | 68 weeks |
Patients With Renal Impairment Undergoing CT

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.

Official Title
-----------------
Isovue and Visipaque in Renally Impaired Patients Undergoing CT

Conditions
-----------------
Contrast Induced Nephropathy

Intervention / Treatment
-----------------
* Drug: Iopamidol 370 mgI/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred for MDCT of liver or peripheral CTA stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min Exclusion Criteria: unstable renal function required prophylactic drugs to receive contrast (other than hydration) uncontrolled diabetes currently on dialysis

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iopamidol 370 mgI/mL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in SCr at 48-72 hours post dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare incidence of delayed hypersensitivity type reactions |  |  | 
| Compare changes in heart rate |  |  | 
| Compare efficacy of key vessels |  |  |
Brain Reaction to Treatment of Nicotine Dependence

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to determine how the treatments for cigarette craving work. Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.

Detailed Description
-----------------
PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.

Official Title
-----------------
Neural Substrates of Treatment for Nicotine Dependence

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Drug: Zyban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heavy smoker, more than one pack per day Free of medical conditions or medications that affect brain activity Not pregnant Exclusion Criteria: Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: Zyban<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-FA PET scan results | Brain activity and activation in response to cigarette-related cues | Within the first few weeks of study initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Position Emission Tomography (PET), Nicotine dependence, functional magnetic resonance imaging, cigarette cues
Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).

Official Title
-----------------
A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.

Conditions
-----------------
Rheumatoid Arthritis, Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)
* Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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: 1<br>Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.) | Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)<br> <br> |
| Active Comparator: 2<br>Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.) | Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 55 days |
A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.

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

Intervention / Treatment
-----------------
* Drug: APD791


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult men and women, ages 19-45 Non smokers Exclusion Criteria: History of a bleeding disorder Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening Recently donated blood or had significant blood loss Current use of a prescription medication Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>APD791 or placebo | Drug: APD791<br>* APD791 or matching placebo in escalating doses<br>|
| Experimental: 2<br>APD791 or placebo | Drug: APD791<br>* APD791 or matching placebo in escalating doses<br>|
| Experimental: 3<br>APD791 or placebo | Drug: APD791<br>* APD791 or matching placebo in escalating doses<br>|
| Experimental: 4<br>APD791 or placebo | Drug: APD791<br>* APD791 or matching placebo in escalating doses<br>|
| Experimental: 5<br>APD791 or placebo | Drug: APD791<br>* APD791 or matching placebo in escalating doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters |  | Throughout study duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessments |  | Throughout study duration | 
| Pharmacodynamic assessments (e.g., platelet function) |  | Throughout study duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy adult volunteers
Effect of Choline Fenofibrate (SLV348) on Macular Edema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME)

Official Title
-----------------
Effect of Choline Fenofibrate (SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects With Diabetic Macular Edema - a One-year, Placebo-Controlled, Randomized Study

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Choline Fenofibrate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria With DME in at least one eye of the subject and this eye presenting with macula thickness ≥ 300 µm on OCT examination at baseline in at least one of the 5 following zones: center zone, or superior inner zone, or nasal inner zone, or inferior inner zone, or temporal inner zone, confirmed after central reading of the OCT; When laser treatment can be safely postponed by up to at least 3 months; With established T2DM and HbA1c < 10%; With systolic blood pressure (SBP) or diastolic blood pressure (DBP) < 160/90 mmHg; With documented elevated triglyceride levels (TG >=150 mg/dL [1.70 mmol/L]) at the screening visit or in the previous 3 months. Exclusion Criteria Previous laser photocoagulation; Eye retinal thickening results from epiretinal membranes or vitreomacular traction; glaucoma; Poor visual acuity: visual acuity of 20/800

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Choline Fenofibrate<br>* 135 mg<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT variables (Retinal Thickness, Retinal thickening) |  | 12 months | 
| ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema |  | 12 months | 
| Lipids |  | 12 months | 
| SBP/DBP, Urinary albumin excretion rate |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Macular Edema, OCT
A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects

Study Overview
=================
Brief Summary
-----------------
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.

Conditions
-----------------
Abdominal Wall Defects

Intervention / Treatment
-----------------
* Device: Permacol Surgical Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Equal or over 18 years of age Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant. At least 12 months of follow-up post date of surgery (-30 days) Undergone open or laparoscopic repairs Exclusion Criteria: Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair Any prior use of Permacol in abdominal wall repair

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 |
| --- | --- |
| Permacol Patients<br>Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. | Device: Permacol Surgical Implant<br>* Permacol Surgical Implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Hernia Recurrence | Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Unconfirmed Hernia or Hernia Recurrence | Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage) Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review | 12 Months | 
| Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed | Year 2 to Year 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Repair of patients' abdominal wall defects
The Glucose Transporter Type I Deficiency (G1D) Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to create a registry for patients diagnosed with Glucose Transporter Type 1 Deficiency (G1D), or patients experiencing symptoms consistent with G1D but not yet diagnosed, to enter medical information for physicians and other health researchers to analyze to increase the understanding of G1D and any sub-diagnoses.

Detailed Description
-----------------
This is a registry for patients diagnosed with G1D, or experiencing symptoms G1D but not yet diagnosed. The registry will be available online for patients to provide consent, register, enter data, and modify data as necessary. The registry will be programmed by programmers at UT Southwestern Medical Center. The registry will provide the opportunity for patients to enter a comprehensive medical history, from symptoms to lab results to medications and other treatment regimens. This registry is entirely patient-driven; no medical records will be requested by the investigator, nor are visits with the investigator or any other research personnel required. The registry database will be periodically cleaned; that is, records will be reviewed for duplication of entries and consistency of data. Many data validation checks are incorporated into the registry. Additional data clarification may be requested from users if users have chosen to provide an email address for contact.

Official Title
-----------------
The Glucose Transporter Type I Deficiency (G1D) Registry

Conditions
-----------------
GLUT1 Deficiency Syndrome, Glucose Transporter Type 1 Deficiency Syndrome, Glucose Transporter type1 (GLUT-1) Deficiency, GLUT-1 Deficiency Syndrome

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females G1D diagnosis Patients experiencing symptoms of G1D but who have not yet received a diagnosis Exclusion Criteria: Patients who are not experiencing any symptoms of G1D
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glucose Transporter Type I Deficiency<br>No interventions | Other: No intervention<br>* This is an observational registry. No interventions are required or provided.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Severity | It is hypothesized that symptom severity will correspond to the degree of biochemical dysfunction or mutation type (when available). A broad range of symptoms and severity ratings are collected both retrospectively and prospectively. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose Transporter Type I Deficiency, Glucose Transporter Type 1 Deficiency, G1D, Glut1 Deficiency
Implantation Failure and PGD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to performed a randomized controlled trial to evaluate the usefulness of preimplantation genetic diagnosis (PGD) in patients with repetitive implantation failure. Patients will be prospectively randomized in two groups: standard IVF with blastocyst transfer on day-5 and transfer day-5 after PGD for aneuploidy screening for chromosomes 13, 15, 16, 18, 21, 22, X and Y. The end points of the study are: Cancellation rate; implantation rate and ongoing implantation rate. Inclusion criteria are: patients with ≥2 previous IVF failure without clinical or biochemical pregnancy with transfer of at least 2 good quality embryos per transfer. Exclusion criteria will be uterine abnormalities , abnormal karyotypes, abnormal result in thrombophilia screening and low responder patients (less than 4 expected oocytes).

Conditions
-----------------
IMPLANTATION

Intervention / Treatment
-----------------
* Procedure: PGD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any age with ≥2 previous cycles, negative TIG or biochemical pregnancy with fresh transfer of at least 2 embryos in each cycle. Exclusion Criteria: Patients with PGD indication (age, repetitive miscarriage, chromosomal anomalies, etc. ) Patients with ectopic pregnancies in previous cycles. Recipient of oocyte donation. Patients in which 4 or less oocytes are to be retrieved.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PGD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |