linjc16/ctgov huggingface dataset:
Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.

Detailed Description
-----------------
Study Further Study Details: Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed) Expected Total Enrollment: 400 subjects at 56 study sites in the U.S. Study Start: October 2005 This is a 5-month double-blind treatment study of male and female subjects with stable mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of heart failure. Eligibility: Must be stable on treatment with Coreg IR at a standard dose: 6.25, 12.5, 25 mg twice a day.

Official Title
-----------------
Prospective, Randomized, Controlled Assessment of Once-Daily Controlled Release COREG CR vs Twice-Daily COREG Immediate Release(IR)on Measures of Compliance and Quality of Life in Patients With Heart Failure and Left Ventricular Systolic Dysfunction

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to read English Stable symptoms of mild to severe heart failure Stable medical regimen for heart failure On a stable dose of Coreg for at least 2 months LVEF ≤40% within the previous 24 months Exclusion Criteria: Uncorrected obstructive or regurgitant valve disease Complex congenital heart disease Recent ICD or pacemaker placement Recent coronary artery bypass surgery or stroke Candidate for heart transplanct within 5 months of study start Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: carvedilol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing compliance: pill taking total taken vs number prescribed |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic heart failure, left ventricular systolic dysfunction
Outreach and Treatment for Depression in the Labor Force

Study Overview
=================
Brief Summary
-----------------
This study will assess the effects of depression treatment on employee productivity. This study will also evaluate the impact of depression screening and outreach on employees' receptivity to treatment.

Detailed Description
-----------------
This study is conducted in three phases. In the first phase, employees from various companies participate in an on-line Health Risk Assessment survey at a secure website. Those who display symptoms of depression participate in a brief telephone interview to confirm the depression diagnosis. In the second phase, depressed participants are randomly assigned to receive either intervention treatment or usual care for 18 months. The intervention consists of periodic telephone contact with a mental health clinician who provides education regarding depression and its treatment. Participants receiving the intervention are also provided with resources to obtain psychotherapy and/or pharmacotherapy. Those who do not seek treatment are monitored and supported. Participants in the usual care arm are informed of their possible depression and are encouraged to seek professional treatment. The final phase of the study involves data analysis and dissemination of aggregated results. Surveys and questionnaires are used to assess participants.

Official Title
-----------------
Outreach and Treatment for Depression in the Labor Force

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Care manager outreach and monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depressive episode Employed

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: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Care manager outreach and monitoring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.

Official Title
-----------------
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: imexon
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inoperable cancer of the pancreas. Blood cell counts and blood chemistries in or near normal range. Able to perform the activities of daily living. A projected life expectancy of at least 2 months. If female, neither pregnant nor nursing. Willing to use contraceptives to prevent pregnancy. No other serious illnesses. No other active malignancy. No serious infections. No current other drug therapy for the cancer or steroid therapy. Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease. Exclusion Criteria: Prior chemotherapy for metastatic disease. Brain metastases

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

| Intervention/Treatment |
| --- |
|Drug: imexon|30-60 minutes IV, days 1,8,15 every 28 days|
|Drug: gemcitabine|30 minutes IV, days 1,8,15 every 28 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine maximally tolerated dose (MTD) |  | until MTD reached | 
| determine dose limiting toxicities. |  | until MTD reached | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma thiol levels |  | until MTD reached | 
| pharmacokinetics |  | until MTD reached | 
| objective tumor responses. |  | until MTD reached |
Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.

Official Title
-----------------
Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department

Conditions
-----------------
Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-18 years Pain from recent shoulder/clavicle injury Intact neurovascular exam Radiographs performed as part of normal ED evaluation Exclusion Criteria: Hemodynamic instability Multisystem trauma Altered mental status Open wounds to injured shoulder Developmental delay Prior radiographs at another clinic/hospital for this injury Previous clavicle fracture on the affected side Ultrasound gel allergy Non-English-speaking parents/child (unable to give informed consent)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- | --- |
| Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs |  | Single visit to emergency department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unblinded real-time bedside US by the ED physician vs. radiographs |  | Single ED visit | 
| Interoperator reliability between the blinded reviewer and bedside ED physician |  | Single ED visit | 
| FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs |  | Single ED visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clavicle, Fracture, Ultrasound, Radiation
Assessment of Blood Glucose Monitoring Devices With New Insight Features

Study Overview
=================
Brief Summary
-----------------
To investigate whether novel insight features in new BGMs can improve glycemic control.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: OneTouch Verio®
* Device: OneTouch Verio® Flex
* Device: Subject's Own Blood Glucose Meter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Summary: Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening Currently performing SMBG at home for diabetes management decisions Willingness to notify the study staff if they become pregnant during the study Willing to sign an informed consent Exclusion Criteria Summary: Is unlikely to be compliant with the diabetes regimen in the opinion of study staff Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn Conflict of Interest

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks. | Device: Subject's Own Blood Glucose Meter<br>* Subject's Own Blood Glucose Meter<br>|
| Experimental: OneTouch Verio®<br>Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks | Device: OneTouch Verio®<br>* Colour Enhanced Blood Glucose Meter.<br>|
| Experimental: Intervention 02<br>Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks. | Device: OneTouch Verio® Flex<br>* Colour Enhanced Blood Glucose Meter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c change from baseline after 12 weeks | A1c change from baseline after 12 weeks in subjects using BGMs with color range indicator and/or pattern messaging tools (i.e., OneTouch Verio® Flex and OneTouch Verio® combined) compared to subjects with either T1 or T2DM using their current BGM, i.e., without color range indicator and/or pattern messaging tools. | 12 weeks |
Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study has two primary objectives. The first objective is to determine the maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. Once the MTD is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.

Official Title
-----------------
Evaluation of the Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Tumors - A Phase I/II Study

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Stereotactic radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1.Lung tumor >= 5.0 cm. 2.Age > 18 years, 3.Histologic confirmation of malignancy (primary lung or metastatic tumor) 4.Deemed unresectable either by radiographic criteria (such as direct invasion of the mediastinum, heart, great vessels, or trachea), by virtue of excessive risk to patient, patient refusal to undergo surgery, or prior operative findings. 5.Performance status of 0-2 by Eastern Clinical Oncology Group criteria Exclusion Criteria:1. No chemotherapy within 2 weeks of radiation treatment. 2. Refusal to sign informed consent. 3. Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.

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

| Intervention/Treatment |
| --- |
|Procedure: Stereotactic radiosurgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors |  |  | 
| Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses |  |  |
Perianal Nerval Block in Proctological Interventions

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

Detailed Description
-----------------
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain. All patients will undergo surgery under general or spinal anesthesia. At the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. The experimental group will receive a local anesthetics and the control group a normal saline injection. All injections will be perianal, peripheral to the external anal sphincter.

Official Title
-----------------
Perianal Nerval Block in Proctological Interventions: a Prospective Randomized Double Blinded Study

Conditions
-----------------
Perianal Fistula, Fissure in Ano, Hemorrhoids

Intervention / Treatment
-----------------
* Drug: Placebo 40 mL Saline 0.9%
* Drug: 40 mL Ropivacain 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures. Age of 18 or above Exclusion Criteria: age under 18. Patients unable to understand an informed consent. Emergency operations Pregnant women. Patients with acute perianal infection. Patients allergic to any component of the local anesthetic

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo 40 mL Saline 0.9% | Drug: Placebo 40 mL Saline 0.9%<br>* Injection of 40 mL 0.9% saline<br>|
| Active Comparator: Ropivacain<br>40 mL Ropivacain 0.5% | Drug: 40 mL Ropivacain 0.5%<br>* Ropivacaine Hcl 0.5% Injection 40 mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Postoperative Pain assessed by visual analogue scale (max. 10, min.0 points, range: 0-10; 0 = no pain at all, 10 = worst pain ever experienced) | 24 hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life assessed by questionnaire | Quality of Life assessed by questionnaire | 2 weeks post-surgery |
A Study of Gaboxadol in Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of gaboxadol in primary insomnia.

Detailed Description
-----------------
To obtain long-term safety data in elderly patients with gaboxadol.

Official Title
-----------------
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: Gaboxadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a diagnosis of primary insomnia

Ages Eligible for Study
-----------------
Minimum Age: 66 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: Gaboxadol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary insomnia
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have compiled a database of more than 300 subjects that completed diagnostic testing for GER in the 1970's, 1980's, and 1990's. Subjects are being contacted initially by mail using a previously approved recruitment letter. Subjects that fail to respond to this recruitment letter are called by phone. In each case, contact information has been abstracted from the Children's Hospital database. Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. Subjects receive no compensation for their participation in this study. Subjects will be compared to controls. Controls will complete the same questionnaire as the subjects. Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. Controls will receive $25 to participate in the study.

Official Title
-----------------
The Natural History of Children With Persistent Gastroesophageal Reflux Disease (Ages 12 to 17 Years)

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Subjects: Patients who were evaluated for GERD at the age of 12-17 years, inclusive at Children's Hospital, Boston or Massachusetts General Hospital Positive for GERD per biopsies or pH probe results Exclusion Criteria for Subjects: None Inclusion Criteria for Controls: No GI diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,Hirschsprung's disease Date of birth is within 1 year of a subject's date of birth

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject with History of GERD<br>Children and adolescents ages 12-17 years, inclusive, seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 for symptoms of GERD and also had biopsies and / or a pH probe that was positive for GERD. | |
| Controls with out GERD<br>Individuals that do not have a history of GERD or other GI problems prior to age 21 and whose date of birth are with in a year of a subjects | |

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
-----------------
GER