linjc16/ctgov huggingface dataset:
Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment

Study Overview
=================
Brief Summary
-----------------
This study involves the comparison of two treatment approaches for patients with chronic pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a counseling intervention that addresses opioid dependence only.

Official Title
-----------------
Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence

Conditions
-----------------
Chronic Pain, Opiate Dependence

Intervention / Treatment
-----------------
* Behavioral: Cognitive-Behavioral Therapy for Pain and Opioid Dependence
* Behavioral: Methadone Drug Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older prescription opioid or heroin addiction moderate to severe chronic pain enrolled in methadone maintenance at the APT Foundation for opioid addiction understand English Exclusion Criteria: current suicide or homicide risk life-threatening or unstable medical problem

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methadone Drug Counseling<br>Methadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs | Behavioral: Methadone Drug Counseling<br>* Methadone Drug Counseling (MDC)is provided by skilled drug counselors over a 12-week period. The primary goal of MDC is cessation of illicit drugs.<br>|
| Experimental: Cognitive-Behavioral Therapy for Pain and Opioid Dependence<br>CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management. | Behavioral: Cognitive-Behavioral Therapy for Pain and Opioid Dependence<br>* CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction |  | 16 weeks | 
| Reduce illicit opioid use |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finalization of treatment manuals |  | 16 weeks | 
| Development and modification of therapy training and process rating measures |  | 16 weeks |
Behavioral Markers of Pre-operative Anxiety

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the characteristics of patients' behavioural patterns related to declared anxiety levels in a day-care surgical unit using ethological analysis of video-recordings of the pre-operative interview with the nurse.

Detailed Description
-----------------
Guidelines in anaesthesia recommend systematic preoperative anxiety management to prevent negative perioperative impact, including impaired memory of important instructions and high incidence of post-operative acute and chronic pain. Self-administered questionnaires linked to scales to assess anxiety in the preoperative setting are usual practice. Yet, they are time consuming and rely on patient willingness to comply with instructions, which is not always reliable. The effects of acute anxiety on behaviour are poorly explored in the preoperative context. Quantifying and characterizing behavioural patterns in anxious patients using an applied ethological approach may provide useful information for reliable, accurate and objective assessment before surgery.

Official Title
-----------------
Behavioral Markers of Pre-operative Anxiety : a Prospective Observational Study in Ambulatory Setting

Conditions
-----------------
Preoperative Anxiety

Intervention / Treatment
-----------------
* Other: Filming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients scheduled for elective ambulatory surgery Exclusion Criteria: communication difficulties

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: Filming|Behavioural markers selection from video-recordings of the interview|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between behaviour and anxiety | Correlation between behavioural markers and declarative anxiety | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preoperative anxiety, ethology, behavioural markers, objective detection
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo

Study Overview
=================
Brief Summary
-----------------
This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.

Official Title
-----------------
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)

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

Intervention / Treatment
-----------------
* Drug: Forteo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with osteoporosis Exclusion Criteria: Any therapies or products affecting bone turnover within 12 months of Screening. Bisphosphonate treatment >1 month in total duration at any time in the past. In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Forteo<br> | Drug: Forteo<br>* Open label single arm study with Forteo as an intervention<br>* Other names: Recombinant Human PTH 1-34;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BMD and bone biomarkers following 12 months of therapy with Forteo |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.

Study Overview
=================
Brief Summary
-----------------
Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome. There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement. The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social. The aim of this study is: to evaluate the quality of life of these patients, by using the MacNew questionnaire to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up to assess the mortality within this group of patients.

Official Title
-----------------
Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: MacNew questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Experimental: Congenital cardiopathy<br>Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015. | Other: MacNew questionnaire<br>* Patients will be asked to fill in the MacNew questionnaire on quality of life (phone contact).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MacNew questionnaire | Quality of life assessment | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MacNew questionnaire, Quality of life
Intramedullary Nailing of Tibia Fractures

Study Overview
=================
Brief Summary
-----------------
Currently, the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. In concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.

Official Title
-----------------
Intramedullary Nailing of Tibia Fractures in the Presence of Medial or Posterior Malleolar Fractures

Conditions
-----------------
Tibial Fractures, Malleolar Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients, 18+ years of age, that have been treated at the University of Utah over the past five years for tibial fracture combined with medial or posterior malleolar fracture. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malleolar involvement in tibial fracture | Currently the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. | 6 Week Post-Op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tibia Fractures, Medial Fractures, Posterior Malleolar Fractures
A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC.

Official Title
-----------------
A Phase I/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Small-Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: PT-523 for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or recurrent disease, and failed therapy with a standard first line (Phase I/II) as well as second line chemotherapy regimen (Phase I), or be intolerant of standard chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II). Asymptomatic or treated brain metastases (including steroids) if last therapy was received > 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration. ECOG performance status 0 - 2. Adequate organ function and bone marrow reserve. Use of appropriate contraceptive method. Signed patient informed consent. Exclusion Criteria: Investigational agents within 30 days prior to Day 1 of study. Known symptomatic or uncontrolled brain metastases. Uncontrolled intercurrent illness. Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E. Patient has uncontrolled pleural effusions. Patient has received nitrosoureas or mitomycin-C within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.

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: PT-523 for Injection|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
-----------------
Talotrexin, PT-523, Non-Small Cell Lung Carcinoma (NSCLC)
Effect of High-calcium Intake on Appetite, Insulinemia and Incretins

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.

Detailed Description
-----------------
Participants will be provided with control and high-calcium meals. Insulin, appetite, glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be assessed, along with rates of substrate oxidation.

Official Title
-----------------
Effect of High-calcium Intake on Appetite, Insulinemia and Incretins

Conditions
-----------------
Nutritional and Metabolic Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recreationally active male Exclusion Criteria: food intolerances/allergies
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Breakfast consisting of milk-based porridge with a normal calcium content. | |
| Experimental: High-Calcium<br>As control, but with a high-calcium content. | Dietary Supplement: Calcium<br>* Milk-calcium supplement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings | Subjective ratings of appetite assessed by visual analogue scales. | 3 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin concentration | 2 hour area under the curve for serum insulin following breakfast consumption | 2 hour | 
| Plasma glucose-dependent insulinotropic peptide concentration | 2 hour area under the curve for plasma glucose-dependent insulinotropic peptide following breakfast consumption | 2 hour | 
| Plasma glucagon-like peptide-1 concentration | 2 hour area under the curve for plasma glucagon-like peptide-1 following breakfast consumption | 2 hour |
Standard Follow-up Program Cervix Cancer (SFP CERVIX)

Study Overview
=================
Brief Summary
-----------------
Standard evaluation and follow-up data regarding complications of curative radiation treatment for cervical cancer.

Official Title
-----------------
Standard Follow-up Program Cervix Cancer (SFP CERVIX)

Conditions
-----------------
Cervical Cancer Radiation Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every cervical cancer patient with curative intent for radiotherapy, treated at our department Exclusion Criteria: Non-curative treatment Part of the treatment is given in another hospital
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Complications | Physiological parameters, questionnaires | Five years |
Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)

Study Overview
=================
Brief Summary
-----------------
This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.

Detailed Description
-----------------
This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.

Official Title
-----------------
Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation

Conditions
-----------------
Cardiothoracic Surgery, Post-operative Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Atorvastatin 20 mg
* Drug: Atorvastatin 80 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 or older Undergoing elective cardiothoracic surgery Exclusion Criteria: Emergency cardiothoracic surgery History of permanent atrial fibrillation Acute coronary syndrome within 7 days Antiarrhythmic drug use in the past 3 months Receiving maximal tolerated dose of statin therapy Receiving fibrate therapy History of statin intolerance Significant liver impairment (aspartate aminotransferase/alanine aminotransferase(AST/ALT)>2x ULN) Serum Creatinine > 3 mg/dl Pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin 20 mg<br>atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery | Drug: Atorvastatin 20 mg<br> <br> * Other names: Lipitor;|
| Experimental: Atorvastatin 80 mg<br>atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery | Drug: Atorvastatin 80 mg<br> <br> * Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of atrial fibrillation by hospital discharge | Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings. | Hospital discharge, an expected 5-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Hospital discharge, an expected 5-7 days | 
| Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POAF, post-operative atrial fibrillation, A-Fib