linjc16/ctgov huggingface dataset:
Effect of Neck Strength Training on Health-related Quality of Life in Females With Neck Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intensive one-year neck strength training can enhance health related quality of life in females with chronic neck pain.

Official Title
-----------------
Effect of Neck Strength Training on Health-related Quality of Life in Females With Chronic Neck Pain: A Randomized Controlled 1-year Follow-up Study

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Behavioral: Neck endurance training
* Behavioral: Stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female aged 25 to 53 years office worker permanently employed motivated to continue working motivated for rehabilitation constant or frequently occurring neck pain for more than 6 months Exclusion Criteria: severe disorders of the cervical spine disk prolapse spinal stenosis postoperative conditions in the neck and shoulder areas history of severe trauma instability spasmodic torticollis frequent migraine peripheral nerve entrapment fibromyalgia shoulder diseases (tendonitis, bursitis, capsulitis) inflammatory rheumatic diseases severe psychiatric illness and other diseases that prevent physical loading pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 53 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neck strength training<br> | Behavioral: Neck endurance training<br> <br> |
| Experimental: Neck endurance training<br> | Behavioral: Neck endurance training<br> <br> |
| Active Comparator: Stretching<br> | Behavioral: Stretching<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15 Dimensional instrument |  |  |
A Prescription-Event Monitoring (PEM) Study of Tiotropium

Study Overview
=================
Brief Summary
-----------------
This prescription-event monitoring study was based upon 'event' monitoring and so capable of identifying signals of events that might be associated with the use of tiotropium, which none of the participating general practitioners (GPs) suspected to be an adverse drug reaction. The methodology of this study readily permits follow up of specific events and the obtaining of additional data as appropriate.

Official Title
-----------------
A Prescription-Event Monitoring (PEM) Study of Tiotropium Based on Prescription Data Collected by the Prescription Pricing Authority (PPA) in England for Tiotropium (Spiriva®)

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Tiotropium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were prescribed tiotropium Exclusion Criteria: not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tiotropium<br> | Drug: Tiotropium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence density of events | incidence density per 1000 patient-months of treatment | up to sixth month of treatment |
Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)

Study Overview
=================
Brief Summary
-----------------
The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.

Detailed Description
-----------------
Participants with social anxiety disorder (MINI telephone interview) will be recruited via mass media and randomly allocated to psychodynamic Internet--delivered psychological treatment or to a waiting list control condition.

Official Title
-----------------
Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder: A Randomized Controlled Trial

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Psychodynamic Internet Treatment
* Other: Waiting list


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Social anxiety disorder as diagnosed by the MINI diagnostic interview Exclusion Criteria: Severe depression

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychodynamic Internet Treatment<br>Psychodynamic Internet Treatment for social anxiety disorder during 10 weeks and guided by a psychologist | Behavioral: Psychodynamic Internet Treatment<br>* Psychodynamic Internet Treatment for patients social anxiety disorder<br>|
| Active Comparator: Waiting list with support<br>Behavioral: supportive check-ups via the Internet during 10 weeks | Other: Waiting list<br>* Waiting list, where participants wait for delayed treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale |  | Baseline and End of treatment (10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire Depression 9 item |  | Baseline | 
| Patient Health Questionnaire Depression 9 item |  | End of treatment (10 weeks) | 
| Patient Health Questionnaire Anxiety 7 item |  | Baseline | 
| Patient Health Questionnaire Anxiety 7 item |  | End of treatment (10 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Test, psychodynamic, Internet-delivered psychodynamic treatment, patients with social anxiety disorder
Integrated Interdisciplinary Program for Fall Prevention in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Falls are very common accidents in Hospital. It not only results in injuries, less mobility among patients but increases their length of stay, cost and family burdens. Reducing the rates and injuries of falls is an urgent issue around hospitals. An integrated multidisciplinary fall prevention program (IMFPP) was implemented from 2006 in CCH. Members include physicians, nurses, case manager therapists, engineers and staffs of maintenance. The aim of this study is to determine whether IMFPP efforts support interventions with multiple components do reduce the fall rates and severity of injuries.

Conditions
-----------------
the Fall Rates, the Severity of Injuries

Intervention / Treatment
-----------------
* Behavioral: integrated multidisciplinary fall prevention program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in CCH's fall incidence reports system Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: integrated multidisciplinary fall prevention program<br> | Behavioral: integrated multidisciplinary fall prevention program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severities of injury as fall | Severities of injury was according to Taiwan Quality Indicator Project (TQIP) mild injury (contusion, abrasion wound) moderate injury (sprain, laceration wound) severe injury (fracture, conscious loss) | within 1 day after fall | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrent fall |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma

Study Overview
=================
Brief Summary
-----------------
This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Dose Ascending Crossover Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled GSK159797 Delivered by Dry Powder Inhaler in Mild to Moderate Asthmatic Subjects

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: GSK159797


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with mild to moderate stable asthma but no other lung problems. Male subjects or females who are not able to get pregnant (e.g. post-menopausal or surgically sterile). Non-smokers. Subjects that show a measurable improvement in the function of their lungs after a single dose of salbutamol. Exclusion criteria: Any significant illness. Subjects with heart problems. Subjects who have had a cold or chest infection 2-4 weeks prior to the study. Subjects who take medication for their asthma, or other conditions, not compatible with the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK159797|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inhaled, asthmatic subjects, GSK159797, safety and tolerability, efficacy, dry powder
How Orally Consumed 3-hydroxybuturate Alters Metabolism

Study Overview
=================
Brief Summary
-----------------
This study evaluate the metabolic effects of orally ingested ketone bodies. The study is conducted as a randomized, cross over study.

Detailed Description
-----------------
Subject participate for two separate days; i) intervention, ii) placebo. Intervention: subjects drink ketone body solution. Tracer kinetics on glucose and lipid metabolism is applied. Muscle tissue and adipose tissue biopsies are taken. Placebo: subjects drink saline. Same sampling as on intervention day.

Official Title
-----------------
Ketone Bodies Ingested Orally Alter Metabolism for Glucose, Lipid, and Protein

Conditions
-----------------
Acute Ketosis

Intervention / Treatment
-----------------
* Other: 3-hydroxybuturate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 20-30 Exclusion Criteria: Smoking alcohol or drug abuse Critically ill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Subjects drink 3-hydroxybuturate | Other: 3-hydroxybuturate<br>* Drink of ketone bodies<br>|
| Placebo Comparator: Placebo<br>Subjects drink saline | Other: Placebo<br>* Drink of saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-hydroxybuturate | blood level of 3-hydroxybuturate | 0-270 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Glucose tracer kinetics, endogenous glucose production, muscle biopsy | 0-270 minutes | 
| lipid metabolism | Palmitate tracer kinetics, free fatty acid accumulation, adipose tissue biopsies | 0-270 minutes |
Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup. PURPOSE: Genetic trial to determine whether different forms of the UGT1A1 gene are related to the body's ability to break down drugs and to the gastrointestinal side effects seen in patients previously treated with flavopiridol.

Detailed Description
-----------------
OBJECTIVES: Determine the relationship between UGT1A1 genotypes and drug pharmacokinetics and occurrence of gastrointestinal toxicity in cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C. OUTLINE: Genomic DNA from pre-existing samples of serum or plasma from each patient is analyzed for UGT1A1 gene by polymerase chain reaction and DNA sequencing. Results are then analyzed for a possible association between UGT1A1 genotypic variation and susceptibility to flavopiridol. Patients do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
-----------------
Retrospective Analysis Of Promoter Polymorphism Of UGT1A1 Gene In Cancer Patients Enrolled On Clinical Trials With Flavopiridol At National Cancer Institute To Assess The Pharmacokinetics And Pharmacodynamics Of Flavopiridol

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Genetic: mutation analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

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 |
| --- |
|Genetic: mutation analysis|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
-----------------
unspecified adult solid tumor, protocol specific
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure

Study Overview
=================
Brief Summary
-----------------
The main purpose of this research study is to evaluate the safety and dosing of CG0070.

Detailed Description
-----------------
Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.

Official Title
-----------------
A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure

Conditions
-----------------
Carcinoma, Transitional Cell, Bladder Neoplasms

Intervention / Treatment
-----------------
* Biological: Oncolytic adenovirus (serotype 5) - CG0070


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease. Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment ECOG performance status 0-1 Adequate bone marrow, renal, liver and coagulation function Exclusion Criteria: Pregnant or nursing HIV positive Use of anticoagulants such as coumadin or heparin History of bleeding disorder Active systemic autoimmune disease or chronic immunodeficiency Prior gene therapy Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Oncolytic adenovirus (serotype 5) - CG0070<br>* Intravesical administration of CG0070 (in suspension) directly into the bladder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration |  | Study End | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the amount of CG0070 in the urine and blood over time by PCR |  | Study End | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superficial Transitional Cell Carcinoma, Bacillus Calmette-Guerin (BCG), Superficial Bladder Cancer, Gene Therapy, Vaccine, Adenovirus, Carcinoma in situ
Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

Study Overview
=================
Brief Summary
-----------------
We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

Detailed Description
-----------------
Prospective study for a 12 month period in Paris (France) and London (UK). Inclusion criteria : seizure within 24h of attendance to an Emergency department (ED) or seizure in the ED Exclusion Criterie : pregnancy prisoneer Primary endpoint : - recurrence of seizure, hospitalisation more than 24 hours or death within seven days Secondary endpoint : Hospital free days at day 7 and day 28 Death, ICU admission, or neurosurgical intervention at day 7 and day 28 Return visit to the ED or re admission at day 7 and day 28 data collection: demographics past medical history, medication vital signs (Heart rate, temperature, Pulse oxymetry, blood pressure, GCS) on arrival Pathology (White cell count, Sodium, Calcium, Glucose, lactate) Protein S100B and Copeptin Seizure characteristics (Witnessed, simple, partial, complex, provoked, acute symptomatic, idiopathic) Discharge plan, outcomes Follow up at day 7 and day 28, hospital visit or phone call

Official Title
-----------------
Study of Prognosis Value of Protein S100Beta and Copeptine in Seizure in the Emergency Department

Conditions
-----------------
Seizures, S-100b Protein, Copeptin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seizure within 24 hours of ED attendance Or Seizure in the ED Exclusion Criteria: Pregnancy Prisoner age < 18 years old

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 |
| --- | --- | --- |
| Combined hospital admission, seizure recurrence, or death at day 7 |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital free days | number of days out of hospital, death corresponding to 0 | 7 days | 
| Hospital free days |  | day 28 | 
| death or ICU admission |  | day 7 | 
| Death or ICU admission |  | 28 days | 
| Recurrence of seizure |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers, Emergency Department, Seizures, epilepsy, S100b, copeptin