linjc16/ctgov huggingface dataset:
Collaborative Care for Opioid Dependence And Pain Pilot Study

Study Overview
=================
Brief Summary
-----------------
This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care.

Official Title
-----------------
Collaborative Care for Opioid Dependence And Pain Pilot Study

Conditions
-----------------
Opioid Dependence, Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Telecare Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic pain for at least 6 months Receiving daily opioid treatment Exclusion Criteria: Not speaking English Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder Known life expectancy of less than 6 months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Patients will receive the telecare intervention. | Behavioral: Telecare Intervention<br>* Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.<br>|
| No Intervention: Usual Care Arm<br>Patients will receive usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Reduction | Percentage reduction in daily opioid dose taken | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Interference | Change in PROMIS 4-item pain interference scale | 12 weeks |
Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions

Study Overview
=================
Brief Summary
-----------------
Official title: Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions Background: Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of a normal wound healing. However in some patients adhesions cause severe complications such as chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At present no validated diagnostic tool mapping adhesions exists. Purpose: To define the sensitivity and specificity of functional cineMRI in detecting and mapping adhesions in patients undergoing reoperation. Design: Prospective multicenter observational trial Primary outcome: Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall Secondary outcome: Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions. Estimated enrollment: 100 Estimated study completion date: dec 2019 Estimated primary completion date: dec 2019

Official Title
-----------------
Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions

Conditions
-----------------
Tissue Adhesions

Intervention / Treatment
-----------------
* Other: CineMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a median abdominal scar due to a previous open abdominal surgical procedures with a length of at least 10 cm and have given written consent. Exclusion Criteria: Severe claustrophobia. No MRI allowed

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 |
| --- | --- |
| 1<br>Patients with laparotomy in history | Other: CineMRI<br>* CineMRI scan of the abdomen at 1.5 Tesla.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | diagnsotic accuracy for detecting adhesions | 2 weeks |
Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

Study Overview
=================
Brief Summary
-----------------
This is a clinical research study using I-131 Iodocholesterol which is an experimental radioactive chemical that when injected into the vein, is picked up in the adrenal glands and permits visualization with gamma imaging devices. These images are used in diagnosing a variety of adrenal abnormalities.Prior to the injection of I-131 Iodocholesterol, the patient will receive perchlorate capsules to block any uptake of I-131 by the thyroid gland if this is deemed important. The patient will continue to take these capsules throughout the period of imaging, which may last up to 1 week. The injection of I-131 Iodocholesterol will be given into a vein and the patient will return for images on at least 1 and possibly 2 occasions between 3-7 days after injection. If the case requires it, the patient may also be given a steroid in tablet form, dexamethasone, to take orally prior to and after the injection to suppress normal adrenal function so that the abnormal tissues can be more easily detected.

Official Title
-----------------
Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

Conditions
-----------------
Adrenal Gland Diseases, Adrenal Gland Neoplasms

Intervention / Treatment
-----------------
* Drug: I-131 Iodocholesterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Adults with suspected adrenal disease, such as adrenal adenoma, carcinoma, hyperplasia, or Addison's Disease.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: I-131 Iodocholesterol|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
-----------------
adrenal diseases
Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

Detailed Description
-----------------
The goals of this project are to determine the independent risk factors for hospital mortality and acute organ injury, and to identify treatment strategies associated with improved survival. Additionally, we will assess outcomes according to differences in geographic and institutional parameters.

Official Title
-----------------
Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

Conditions
-----------------
Coronavirus Infection

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (each of the following): Adults (aged ≥18 years) Laboratory-confirmed diagnosis of COVID-19 Hospitalized in the ICU for illness related to COVID-19 Exclusion Criteria: -None

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

| Intervention/Treatment |
| --- |
|Other: No intervention|Observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-Day Mortality |  | 28-days from the day of ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60-Day Mortality |  | 60-days from the day of ICU admission | 
| 90-Day Mortality |  | 90-days from the day of ICU admission |
Finnish Spinal Cord Injury Study (FinSCI)

Study Overview
=================
Brief Summary
-----------------
The purpose of the Finnish Spinal Cord Injury Study (FinSCI) is to identify factors related to the health and functioning of people with spinal cord injury (SCI), their challenges with accessibility and how such factors are interconnected. The International Classification of Functioning, Disability and Health (ICF) is used in the study as a structured framework. The study participants will be recruited from three SCI outpatient clinics, which together are responsible for the life-time care of the SCI population in Finland. Mixed methods are used including a questionnaire and interviews. The survey will be formed from patient-reported instruments; SCI-specified Spinal Cord Injury Secondary Condition Scale, Spinal Cord Independence Measure, Nottwil Environmental Factors Inventory Short Form and selected items of the generic instruments of Patient-Reported Outcomes Measurement Information System and National study of health, well-being and service. The survey covers 51 ICF categories. The study results can help develop care and rehabilitation policies with SCI, the planning of training models and information provided to various parties involved.

Detailed Description
-----------------
The detailed description of the protocol has been published. Please, see the reference Tallqvist et al.

Official Title
-----------------
Finnish Spinal Cord Injury Study (FinSCI)

Conditions
-----------------
Spinal Cord Injuries, Health, Subjective

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16 years or over Traumatic or non-traumatic SCI ASIA-classification A,B,C tai D Time since onset of SCI over 6 months Client of HUS, Tays or Oys SCI outpatient clinic Exclusion Criteria: Innate SCI Progressive new non-traumatic SCI Neurodegenerative disease Multiple sclerosis amyotrophic lateral sclerosisGuillain-Barre syndrome Institutional care

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaire for all, interview for part of the respondents.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort Survey of Health, Functioning, and accessibility of spinal cord injury population in Finland | Survey includes parameters of secondary conditions of spinal cord injury, independency, environmental factors, health, well-being and services | 1.2.-31.7.2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient reported outcomes, ICF, Survey, Interview
Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy

Study Overview
=================
Brief Summary
-----------------
TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY

Detailed Description
-----------------
Patients whose proteinuria was > 0.5 g/day were to receive enalapril plus valsartan coupled with oral 0.5 g/day of methylprednisone for 6 months.

Official Title
-----------------
Phase IV Open Label Uncontrolled Trial of the Dual Blockade of the Renin Angiotensin System With Enalapril Plus Valsartan Combined With Oral Methylprednisolone for the Treatment of Proteinuria in IGA Nephropathy

Conditions
-----------------
IGA Nephropathy

Intervention / Treatment
-----------------
* Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY Exclusion Criteria: MALIGNANCY, RENAL FAILURE

Ages Eligible for Study
-----------------
Minimum Age: 21 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

| Intervention/Treatment |
| --- |
|Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAILY PROTEINURIA |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RENAL FUNCTION AS ASSESSED BY SERUM CREATININE |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IGA NEPHROPATHY, STEROIDS, ENALAPRIL, VALSARTAN, PROTEINURIA, IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)
Safety and Preliminary Efficacy Study of PDS-1.0 in Patients With Neovascular AMD

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients with neovascular AMD.

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: PDS 1.0


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated Retinal thickness due to edema of at least 300um in the study eye Best corrected visual acuity of 20/80 or worse in the study eye Best corrected visual acuity of 20/40 or better in the fellow eye Exclusion Criteria: Evidence of scarring CNV (e.g. geographic atrophy) in the study eye Fibrosis >75% of lesion area in the study eye

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: PDS 1.0<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retinal thickness measured by Optical Coherence Tomography |  | Monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best Corrected Visual Acuity |  | Monthly |
Registry of Pediatric Patients Diagnosed With Crohn's Disease in Belgium

Study Overview
=================
Brief Summary
-----------------
A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was created in Belgium. Over a 2 year period 257 patients are included. These patients will be follow up prospectively during 5 years. Demographic data, family history, disease presentation and disease course including medication are registered in CRF's.

Official Title
-----------------
Belgian Registry of Pediatric Crohn's Disease

Conditions
-----------------
Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible Associations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-18 yrs old belgian Crohn s disease informed consent Exclusion Criteria: no 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 |
| --- | --- | --- |
| disease course | describe patient characteristics, disease fenotype and course | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, crohn's disease, disease course, therapy
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).

Official Title
-----------------
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: 6-Mercaptopurine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included. Exclusion Criteria: Inability to have blood drawn for the screening lab tests Received methotrexate or folate supplement within the last 24 hours Pregnant or lactating females Inability to swallow a pill Hemoglobin less or equal to 8 gm/dl Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator Weight < or = 16 kg

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 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 |
| --- | --- |
| 4-17 years, receiving 6-MP<br> | Drug: 6-Mercaptopurine<br>* 75 mg/m2/dose/day<br>* Other names: 6-MP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of 6-MP | To compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL). | 8 hours post administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALL, acute lymphoblastic leukemia, 6-Mercaptopurine, Pediatric
Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy. The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.

Detailed Description
-----------------
description of the anaesthetic procedure (duration, volume of anaesthetic local, efficiency) realization of the surgery (pain, injection of anaesthetic local...) post operative evaluation (pain, satisfaction...)

Official Title
-----------------
Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy

Conditions
-----------------
Carotid Atherosclerosis, Regional Anesthesia Morbidity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult carotid endarterectomy performed under regional anaesthesia Exclusion Criteria: age < 18 years contralateral phrenic palsy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion to general anaesthesia |  | surgery time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of additional local anaesthetic | intraoperative supplementation by the surgeon | surgery time | 
| additional injection of remifentanil | In case of incontrolled pain : administration of remifentanil | surgery time | 
| complications | hoarseness, Horner syndrome, cough, facial palsy | anaesthesia time | 
| patient and surgeon satisfactions |  | after surgery | 
| additional injection of remifentanil | In case of uncontrolled pain : administration of remifentanil | surgery time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carotid endarterectomy, regional anaesthesia, ultrasound guided block