linjc16/ctgov huggingface dataset:
Case Management - Active Telephone Support to Patients With COLD

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of patient counseling by telephone on Quality of Life and the use of Health care system.

Detailed Description
-----------------
By analyzing patient data, patients with risk of high consumption of the Health system are identified. These patients are invited to take part in the study. If the patient accept the invitation, oral and written information of the study is given. If the patient give informed consent to participate, the inclusion and exclusion criteria and the patient record are examined. If the patient meet the criteria the patient is randomized to active treatment or control 1:1. Patient in the Intervention Group have a in depth interview of Health and social status and possible interventions are planned. Following that, the patient is contacted by telephone on weekly intervals for 6 to 9 months. Patients in both Groups fill out questionaire Short-Form Health Survey-36 (SF-36) and COPD Assessment Test (COPD) and the consumption of Health care is monitored.

Official Title
-----------------
Active Support to Patient With COLD

Conditions
-----------------
COLD

Intervention / Treatment
-----------------
* Behavioral: Lifestyle behavioral. Health plan, telephone support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient living in The Zealand Region. A COLD-related contact with hospital with-in 6 months. Predicted to be in high risk of new hospital admission. Exclusion Criteria: Dementia. Psychosis. Drug-addiction. Cancer with metastasis. Terminal illness. Language difficulties demanding translator.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Only SF-36 and CAT | |
| Active Comparator: Active<br>Lifestyle behavioral. Health plan, telephone support | Behavioral: Lifestyle behavioral. Health plan, telephone support<br>* 'Lifestyle behavioral. Health plan, telephone support'<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life questionnaire SF-36 (Short-Form Health Survey) |  | Participants will be followed an expected avarage of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of patients use of Health Care system |  | 1 year |
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Study Overview
=================
Brief Summary
-----------------
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Official Title
-----------------
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: Alendronate
* Drug: Denosumab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health. Must have low bone mineral density and meet specific eligibility criteria. Key Exclusion Criteria: -Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3<br>Placebo for denosumab and placebo for alendronate | Drug: Placebo<br>* Placebo for alendronate and placebo for denosumab<br>|
| Experimental: 1<br>denosumab and placebo for alendronate | Drug: Denosumab<br>* denosumab 60 mg SC q 6 mos<br>|
| Active Comparator: 2<br>Placebo for denosumab and alendronate | Drug: Alendronate<br>* Alendronate 70 mg PO QW<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 | Cortical Thickness measured by XtremeCT. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 | Cortical Thickness measured by XtremeCT. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Menopausal, Osteoporosis, MicroCT, Amgen, denosumab, Extreme CT, XCT, Fosamax, Alendronate
Antitetanus Vaccination for People Older Than 65 Years.

Study Overview
=================
Brief Summary
-----------------
In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. In France tetanus vaccination is mandatory since 1940. Nowaday none study looked specifically for the vaccination of people older than 65 years. The hypothesis is: there is a difference in the tetanus vaccination coverage for people older than 65 years depending on the demographic and medical practice of their general practitioner.

Official Title
-----------------
Antitetanus Vaccination for People Older Than 65 Years in the Auvergne-Rhône-Alpes (France) Region Depending on the Demographic and Medical Practice of Their Medical Practitioner.

Conditions
-----------------
Tetanus

Intervention / Treatment
-----------------
* Other: Questionnaire Patients
* Other: Questionnaire General practitioner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 65 years consulting their attending physician in and who agreed to participate in the study. The doctors included are general practitioners located in a liberal office in the Auvergne Rhône Alpes region for which the URPS (Union régional des Professionnels de Santé) has an email address. Exclusion Criteria: None

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>People older than 65 years in the Auvergne-Rhônes-Alpes region who are consulting their general practitioner. | Other: Questionnaire Patients<br>* Patient will have to answer a quiz which is about their vaccination against tetanus.<br>|
| General practitioner<br>General practitioner of the Auvergne-Rhônes-Alpes region | Other: Questionnaire General practitioner<br>* General practitioner will have to answer a quiz which is about their medical practice concerning vaccination against tetanus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tetanus vaccination coverage | Patient will have to answer a quiz which is about their vaccination against tetanus. | About 5 minutes |
Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.

Detailed Description
-----------------
Costoclavicular brachial plexus block is a recently developed approach of infraclavicular brachial plexus block. Using ultrasound, all of 3 cords are well visible in single plane. Compared to conventional infraclavicular block, it needs smaller amount of local anesthetics. Supraclavicular brachial plexus block is known as spinal anesthesia of upper extremities. It provides fast and good quality of anesthesia and analgesia. But some studies showed that there are over 50% of phrenic nerve palsy in supraclavicular block. In this study, the investigator will compare phrenic nerve palsy incidence and block quality between Costoclavicular block and supraclavicular block using ultrasound.

Official Title
-----------------
Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block

Conditions
-----------------
Phrenic Nerve Paralysis

Intervention / Treatment
-----------------
* Procedure: Costoclavicular block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II Scheduled for surgery of hand or forearm Exclusion Criteria: Patient refusal Neuromuscular disease Pregnancy Previous history of surgery of periclavicular region Nerve injury history Bleeding tendency Allergy to local anesthetics Other contraindication of regional anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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 |
| --- | --- |
| Costoclavicular block<br>For anesthesia, this group of patients will be received ultrasound guided costoclavicular block | Procedure: Costoclavicular block<br>* Group C for costoclavicular block Group S for supraclavicular block<br>|
| Supraclavicular block<br>For anesthesia, this group of patients will be received ultrasound guided supraclavicular block | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm palsy | Using M-mode of ultrasound, compare diaphragm movement pre-block and 30min after block Paralysis : reduced movement more than 75% or paradoxical movement on sniffing Paresis : 25 75% movement Normal : reduced less than 25% | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
costoclavicular block
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 50 weeks.

Official Title
-----------------
An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients

Conditions
-----------------
Prurigo Nodularis, Nodularis Prurigo, Prurigo

Intervention / Treatment
-----------------
* Drug: nalbuphine HCl ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject completed participation in the TR03 study Exclusion Criteria: Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study. Subject is a pregnant or lactating female

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nalbuphine HCl ER<br>nalbuphine HCl ER | Drug: nalbuphine HCl ER<br>* nalbuphine HCl ER BID for up to 50 weeks<br>* Other names: nalbuphine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern. | 50 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Itch, Chronic Itch, Nalbupine
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
Open, prospective, uncontrolled, observational cohort study.

Official Title
-----------------
Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.

Conditions
-----------------
Thromboembolism, Arthroplasty, Replacement, Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients age 18 years or above undergoing elective total hip or knee replacement surgery Written informed consent obtained for data collection and source data verification. Exclusion criteria: According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.: age of > 75 years renal impairment (creatinine clearance <50ml/min) patients on concomitant therapy with amiodarone or verapamil. elevated liver enzymes >2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival anaesthesia with post-operative indwelling epidural catheters hypersensitivity to dabigatran etexilate or to any of the excipients active clinically significant bleeding organic lesion at risk of bleeding spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups concomitant treatment with quinidine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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 |
| --- | --- | --- |
| Venous Thromboembolic Events |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Bleeding Events (MBE) |  | From 12 To 37 Days | 
| Major Extra Surgical Site Bleedings |  | From 12 To 37 Days | 
| Volume of Wound Drainage |  | From 12 To 37 Days |
Clinical, Neurophysiological and Radiological Evaluation of Patients With Basal Ganglia Lesions

Study Overview
=================
Brief Summary
-----------------
Basal ganglia are involved in the control of motor, cognitive and emotional behaviours. The aim of this study is to precisely evaluate patients with basal ganglia focal lesions both with or without loss of psychic-self activation.

Conditions
-----------------
Basal Ganglia Lesions

Intervention / Treatment
-----------------
* Procedure: Magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Basal ganglia lesions Exclusion Criteria: Contraindication to magnetic resonance imaging (MRI) Dementia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Magnetic resonance imaging|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
-----------------
basal ganglia, loss of psychic self-activation
Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection

Study Overview
=================
Brief Summary
-----------------
The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. The antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial strains. Serological markers and synovial analysis are common use to exclude persistence of infection. The investigators therefore asked 1) is the serological testing of c-reactive protein and leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of synovial aspiration of PMMA Spacers on hip and knee joints.

Official Title
-----------------
Benefit of Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection

Conditions
-----------------
Diagnosis Prosthetic Joint Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Synovial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with periprostheitc joint infection Exclusion Criteria: Reinfection in history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Synovial biopsy|Biopsy of jint prior reimplantation of new joint prosthesis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reinfection rate | Reinfection rate after reimplantation of joint prosthesis | 2 years |
Lead Exposure, Genetics, and Osteoporosis Epidemiology

Study Overview
=================
Brief Summary
-----------------
This study's primary objective is to assess the effects of environmental lead exposures and genetic risk factors on the development of osteoporosis in middle-aged women.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy participants in the Nurses' Health Study who live in the greater Boston metropolitan area.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Lead
Study of the Psychological Development of Children of Parents With and Without Affective Disorders

Study Overview
=================
Brief Summary
-----------------
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders. In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.

Detailed Description
-----------------
The psychological development of offspring of parents with and without affective disorder is assessed from early childhood to young adulthood. Parents with a diagnosis of major depression or bipolar illness and well parents and their children are studied (SADS-L, RDC, and SCID, DSM-III). A sibling pair is studied in each family. Parent-child interaction is investigated through direct observation of behavior in naturalistic and controlled settings. Family history information is obtained through parent interviews. Behavioral observations, standard tests, physical examinations, and psychiatric interviews, and MRI procedures provide multiple assessments of the offspring. The study has been completed through preadolescence, adolescence, and late adolescence. Follow-up in young adulthood continues.

Official Title
-----------------
Affective Disorders and Affective Development: A Study of Child Rearing and Child Development in Normal Families and Families With Affective Disorders

Conditions
-----------------
Bipolar Disorder, Involutional Depression, Mood Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients will be drawn from an ongoing longitudinal study begun in 1979 of offspring of parents with affective illness (unipolar and bipolar) and children of normal control parents.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parental Psychopathology, Child Rearing, Depression, Bipolar Affective Disorders, Manic-Depression, Social-Emotional Development, Cognitive Development, Child Psychopathology, Affective Disorder, Children at Risk