linjc16/ctgov huggingface dataset:
A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

Official Title
-----------------
An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: Peginterferon alfa-2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants 18-70 years of age Positive test result for HBsAg for >6 months Naive to treatment for HBV On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis Exclusion Criteria: Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV) Decompensated liver disease Hepatocellular cancer Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug Medical condition associated with chronic liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Peginterferon alfa-2a<br>Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks. | Drug: Peginterferon alfa-2a<br>* 180 uG in 0.5 mL solution administered once weekly for 48 weeks<br>* Other names: Pegasys;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up |  | 72 Weeks | 
| Alanine Transaminase (ALT) Normalization at the End of Follow-Up |  | 72 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up |  | 72 Weeks | 
| Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up |  | 72 Weeks | 
| HBV DNA Suppression <20000 Copies/mL at the End of Treatment |  | 48 Weeks | 
| Alanine Transaminase (ALT) Normalization at the End of Treatment |  | 48 Weeks |
Selegiline in Treatment of Cocaine Dependence - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine dependence.

Official Title
-----------------
Selegiline in Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Selegiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
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: Selegiline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  |  | 
| Cocaine use |  |  | 
| Cocaine craving |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine Dependence, Selegiline
Impact of the Implementation of a Clinical Pharmacy Bundle on Intensive Care Unit Patient Outcomes and Cost Expenditures

Study Overview
=================
Brief Summary
-----------------
The aim of this before-after study was to assess the impact of a clinical pharmacy bundle of care activities on patient outcomes (length of hospital stay as a primary endpoint) and cost expenditure in two French ICUs.

Official Title
-----------------
Impact of the Implementation of a Clinical Pharmacy Bundle on Intensive Care Unit Patient Outcomes and Cost Expenditures

Conditions
-----------------
Intensive Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive Care Unit patients on weekdays
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation period before presence of clinical pharmacist<br>The group of patients was observed between Janary 2013 and December 2013 | |
| Period with presence of clinical pharmacist<br>The group of patients was observed between January 2014 and June 2015. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | expected average of 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit length of stay |  | Expected maximum of 10 days | 
| Mechanical ventilation duration |  | Expected maximum of 10 days | 
| Intensive care unit mortality rate |  | Expected maximum of 10 days | 
| Hospital mortality rate |  | End of hospital stay (expected average of 20 days) | 
| Patient cost expenditure |  | End of hospital stay (expected average of 20 days) |
Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

Study Overview
=================
Brief Summary
-----------------
The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).

Official Title
-----------------
An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas

Conditions
-----------------
Glioblastoma Multiforme, Astrocytoma Anaplastic Foci

Intervention / Treatment
-----------------
* Drug: MAB-425 radiolabeled with I-125


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 Years or Older Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions) Karnofsky performance status > 70% Hemoglobin > 10.0 g/dL, White Blood Cells > 4,000/mm3, Platelets > 100,000/mm3, BUN < 25 mg/dL, Creatinine < 1.5 mg/dL Signed informed consent Pathologic confirmation of GBM or AAF A negative beta hCG test for women of childbearing potential Negative HAMA test Exclusion Criteria: Metastases or Second Primary Cancer Iodine allergy Inability to tolerate oral intake of Lugol's solution HIV Infection Positive HAMA test Pregnancy Uncontrolled Seizures

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: Treated with MAB-425<br>All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections. | Drug: MAB-425 radiolabeled with I-125<br>* MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of disease progression | For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline | 3 months after first course with follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high grade gliomas of the brain, anti-body treatment, survival
Evaluation of Bone Length Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays.

Detailed Description
-----------------
The investigators would like to see how well the calculation of bone length using Lunar iDxa compares to conventional x-ray since the Lunar iXDA exposed patients to less radiation than conventional x-rays.

Official Title
-----------------
Evaluation of Bone Length Measurement Using Lunar iDXA

Conditions
-----------------
Bone Calcification, Osteoporosis

Intervention / Treatment
-----------------
* Procedure: Lunar iXDA scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 yrs. of age or older Have recent x-rays of lower extremity Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches. Exclusion Criteria: Are unwilling to read and sign the consent Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan Have severe deformities of your legs or back Unable to lay on the scanning table for the scan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: x-ray with iXDA scan<br>Tota body scan taken by the Lunar iXDA. During the scan, subject will be asked to lay on their back. Following the Lunar iDXA scan, the computer of the Luna iXDA will calculate bone length. The calculation of bone length will be compared to a calculation from the subject's conventional x-ray to determine accuracy. | Procedure: Lunar iXDA scan<br>* Subject will receive a total body scan taken by the Lunar iXDA. This scan will take approximately 8 minutes to complete. Following the scan, the computer of the Lunar iXDA will calculate the bone length.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg (Femur and Tibia) bone length measurement in centimeters using iDXA | Lunar iXDA computer will calculate the bone length following a total body scan taken by the Lunar iDXA and compare results from conventional x-ray to determine accuracy. | scan time is 8 minutes |
Genetic Mapping of Atherogenic Lipoprotein Phenotypes

Study Overview
=================
Brief Summary
-----------------
To map the major gene influencing low-density lipoprotein subclass phenotypes, denoted atherogenic lipoprotein (ALP) phenotypes, with a long term goal of cloning the ALP gene and understanding its role in genetic susceptibility to atherosclerosis.

Detailed Description
-----------------
BACKGROUND: ALP phenotype B (ALP-B), characterized by a predominance of small, dense LDL particles as determined by gradient gel electrophoresis, has been associated with increased risk of myocardial infarction and a constellation of atherogenic lipid and apolipoprotein (apo) changes. Based on complex segregation analysis, ALP-B appeared to be influenced by a single major genetic locus with a dominant mode of inheritance and a common allele frequency. This project was designed to identify a new gene involved in susceptibility to coronary heart disease. DESIGN NARRATIVE: The investigators identified, collected and constructed a repository of immortalized cell lines and lipid and apo measurements from members of families informative for ALP. They tested genes implicated in lipoprotein metabolism as possible candidate ALP genes and used highly informative DNA probes to search the genome for linkage to the ALP gene. They also refined the model for the inheritance of ALP phenotypes and tested for genetic-environmental interactions. Forty informative families were recruited for the repository. The families were identified through two sources of probands: former participants in a cholesterol-lowering diet study and patients seen at the lipid clinics at the University of Washington. Each participating family member completed a medical history questionnaire and provided a blood sample for ALP phenotype determination, for DNA studies, and for lipid and apo measurements. Linkage studies and LOD score analyses began with a candidate gene approach, and continued by using DNA probes that revealed restriction fragment length polymorphisms (RFLPs) to search the genome for linkage to the ALP gene. When a linkage was found, ALP genotype information was used to refine the statistical model describing the inheritance of ALP phenotypes, and to evaluate genetic-environmental interactions involving lipid and apo levels and environmental and behavioral factors.

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Heart Diseases

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 |
| --- | --- | --- |
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).

Official Title
-----------------
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère

Conditions
-----------------
Multiple Sclerosis, Respiration Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis criteria of multiple sclerosis (MS) fulfilling revised McDonald criteria (2010) EDSS score from 6.5 no relapse during the 3 last months Informed consent prior to any study procedure Exclusion Criteria: Any severe Chronic Obstructive Pulmonary Disease (III or IV) Pregnancy or woman with childbearing potential contraindication to MRI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with severe MS<br>polysomnography and functional pulmonary testings. | Diagnostic Test: Polysomnography<br>* During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.<br>* Other names: functional pulmonary testings;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography | presence of phasic activation of respiratory muscles | Baseline only_during one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory function testing | difference between vital capacity upright and supine position (liter) | Baseline only | 
| Respiratory function testing | maximal inspiratory pressure (mmHg) | Baseline only | 
| Respiratory function testing | maximal expiratory pressure (mmHg) | Baseline only | 
| Respiratory function testing | SNIP (mmHg) | Baseline only | 
| Respiratory function testing | peak flow (liter) | Baseline only | 
| Cerebral and cervical spine MRI | cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE | Baseline only | 
| Expanded Disability Status Scale (EDSS) | Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10 | Baseline only | 
| BICAMS | Brief International Assessment for Multiple Sclerosis | Baseline only |
Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS)

Study Overview
=================
Brief Summary
-----------------
Prophylactic mesh reinforcement of the abdominal wall at the site of temporary ileostomy closure is effective in preventing postoperative incisional hernia. This prospective, multicenter, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .

Official Title
-----------------
Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure

Conditions
-----------------
Incisional Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be informed about the study, and will have read; understood and signed the informed consent Subjects of either gender that are at least the age of 18 years Subjects will be undergoing ileostomy reversal with retromuscular placement technique of the Phasix biosynthetic mesh reinforcement Exclusion Criteria: Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study Subjects with parastomal hernia or midline incisional hernia Subjects who required midline laparotomy during ileostomy reversal

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia rate | CT scan or Ultrasound as imaging to detect incisional hernia | at 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early and Long-term Complication Rates | Clavien-Dindo classification | after surgery to 24 months | 
| Postoperative pain | Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain | after surgery to 24 months | 
| Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires | CCS - Range: 0-115. Higher score correlates with worse outcome | after surgery to 24 months | 
| Budget Impact Analysis | Healthcare Cost Analysis including direct costs (fixed and variable) | after surgery to 24 months |
Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Detailed Description
-----------------
Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks. Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.

Official Title
-----------------
A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy

Conditions
-----------------
Diabetic Polyneuropathy

Intervention / Treatment
-----------------
* Drug: Capsaicin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of type 2 Diabetes mellitus Peripheral neuropathy Stabilized on pain medication for at least one month No previous invasive intervention for pain relief Exclusion Criteria: Local wound or skin abnormality in the applicable area Allergic to capsaicin Refuse to participate or give consent Has other significant disease or receive medication that may worsen neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsaicin<br> | Drug: Capsaicin<br>* 0.025% topical capsaicin applied 4 times per day for 8 weeks<br>* Other names: Capsika gel;|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* vehicle gel, applied 4 times per day for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief from pain score reduction, using visual analog scale (VAS) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsaicin, placebo, trial, diabetic polyneuropathy, neuropathic pain