linjc16/ctgov huggingface dataset:
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: SER120 750 ng
* Drug: SER120 1500 ng
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 50 years or older Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night Exclusion Criteria: CHF Diabetis Insipidus Renal insufficiency Hepatic insufficiency Incontinence Illnesses requiring systemic steroids Malignancy within the past 5 years Sleep apnea Nephrotic syndrome Unexplained pelvic mass Urinary bladder neurological dysfunction Urinary bladder surgery or radiotherapy Pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SER120 750 ng<br>SER120 750 ng | Drug: SER120 750 ng<br>* SER120 750 ng<br>|
| Experimental: SER120 1500 ng<br>SER120 1500 ng | Drug: SER120 1500 ng<br>* SER120 1500 ng<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment | Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12 | 12 weeks | 
| Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes | Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period | 12 weeks |
Yasmin Post Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.

Official Title
-----------------
Yasmin Regulatory Post Marketing Surveillance

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: EE30/DRSP (Yasmin, BAY86-5131)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who need oral contraceptive Exclusion Criteria: Patient who belongs to contraindication listed on the product label.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: EE30/DRSP (Yasmin, BAY86-5131)<br>* Patients in daily life clinical practice treatment receiving Yasmin according to indication on the label.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy in real practice |  | After 6 cycle of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demography |  | At initial visit | 
| Medical History |  | At initial visit | 
| Administration period of Yasmin |  | After 6 cycle of treatment or at the point of withdrawan | 
| Patient's compliance |  | After 6 cycle of treatment or at the point of withdrawan | 
| Adverse Event / Serious AE collection |  | At point of the occurence | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral contraceptive
The Effects of Training and Relaxation on Fibromyalgia.

Study Overview
=================
Brief Summary
-----------------
Effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients.

Detailed Description
-----------------
A multi-center trial examining the effects of progressive resistance group exercise compared with an active control group (relaxation). A person-centred model of exercise was used. The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists. Secondary aims off this multi-center study was to improve the understanding of pain mechanisms in fibromyalgia and how these are affected by physical exercise. Please see references of published articles for details.

Official Title
-----------------
The Effects of Training and Relaxation on Fibromyalgia.

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Physcial activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACR 1990 criteria for fibromyalgia - Exclusion Criteria: Other dominating pain condition, severe disease preventing from participating in physical exercise -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physcial exercise<br>15 weeks of progressive resistance group exercise, twice/week supervised by physical therapist | Behavioral: Physcial activity<br>* Strenght training Relaxation exercise<br>|
| Active Comparator: Relaxation exercise<br>15 weeks of relaxation exercise, twice/week supervised by physical therapist | Behavioral: Physcial activity<br>* Strenght training Relaxation exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | isometric knee-extension force (Steve Strong®) | 2010-2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia impact questionnaire | Ratings on FIQ, total score | 2010-2013 | 
| VAS pain | Pain intensity ratings on VAS | 2010-2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Strength exercise, Physical exercise, Physiotheraphy
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males

Study Overview
=================
Brief Summary
-----------------
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.

Official Title
-----------------
A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects

Conditions
-----------------
Carcinoid Syndrome

Intervention / Treatment
-----------------
* Drug: 500 mg [14C]-LX1606


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 30 to 65 years of age. Male subjects and their partners must agree to use an adequate method of contraception Historically able to produce a minimum of 1 bowel movement every day on most days Exclusion Criteria: Female subjects Use of any medication or supplement within 5 days prior to Dosing Radiation exposure exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years Current smokers or the use of cigarettes within 90 days prior to Screening History or renal disease or abnormal kidney function History of hepatic disease Acute diarrhea or constipation within 7 days of dosing Positive urine glucose at Screening

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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: 500 mg LX606<br>All subjects will receive a single oral 500 mg dose of [14C]-LX1606. | Drug: 500 mg [14C]-LX1606<br>* 500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration of LX1606 and LX1033 |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum plasma concentration of and LX1033 |  | 7 days | 
| Determination of total radioactivity in blood and plasma |  | 7 days | 
| Mass balance recovery of total radioactivity in urine and feces |  | 7 days | 
| Metabolite profiling and identification in plasma |  | 7 days | 
| Metabolic profiling and identification in urine |  | 7 days | 
| Metabolic profiling and identification in feces |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Absorption, Metabolism, Excretion
Effect of Quality Improvement Tools in Congestive Heart Failure (CHF)

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Quality Improvement tools like Heart Failure Discharge Checklist which emphasizes on proper education to patients, ensure appropriate dose titration and counselling improve outcome in congestive heart failure (CHF).

Official Title
-----------------
Decreased Readmissions and Improved Quality of Care With Use of Inexpensive Checklist in Heart Failure

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: Checklist cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to SJMO with principal diagnosis of acute decompensated heart failure Exclusion Criteria: Age less than 18 years Pregnant women

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

Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>This arm which was control group, was randomly selected among patients with acute decompensated heart failure in whom the checklist was not used. This group was managed as per the standard guidelines. | |
| Active Comparator: Checklist (intervention) cohort<br>checklist was used in this group arbitrarily by their treating physician | Other: Checklist cohort<br>* CHF discharge checklist was used arbitrarily by their treating physicians in addition to the standard therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmissions | Readmission to the hospital for CHF within 6 months of discharge | 6 months | 
| Dose titration | up titration of medications including Beta blocer, ACE inhibitor or ARB was assessed during the hospital stay | patients were followed during the time of hospital stay, average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medications prescribed | during the hospital stay and at discharge this outcome is measured/assessed | patients were followed during their hospital stay from admission to discharge, on an average of 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality, Improvement
Physical Activity and Health of Children With Cancer in Remission

Study Overview
=================
Brief Summary
-----------------
Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. The interventional group will perform two supervised, 60-minute weekly exercise sessions. Outcome measures of the exercise intervention will be quality of life, mood, cardiorespiratory fitness, body composition and bone mineral density.

Official Title
-----------------
The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission

Conditions
-----------------
Children, Cancer, Exercise

Intervention / Treatment
-----------------
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged 6-16 remission from cancer >6 months after completion of all therapy Exclusion Criteria: informed consent not given in writing refusal of tests: blood, fitness, questionnaires or DEXA locomotive handicaps extreme fatigue, nausea, dyspnea concurrent acute illness recent (less than 3 months) hospitalization documented (echocardiographic or nuclear medicine) decrease in cardiac function abnormal blood tests: Hb < 10 gr/dl, neutropenia < 500/mm3, thrombocytopenia < 50,000/mm3 additional chronic health conditions unrelated to cancer (e.g. celiac disease, cerebral palsy, Down's syndrome)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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: exercise<br>two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day | Behavioral: exercise<br>* two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day<br>|
| No Intervention: control<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life |  | 6months | 
| mood |  | 6months | 
| cardiorespiratory fitness |  | 6months | 
| body fat percentage |  | 6months | 
| bone mineral density |  | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, cancer, exercise, fitness, body composition
Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.

Official Title
-----------------
A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically documented colorectal adenocarcinoma ECOG performance status of 2 or lower Adequate bone marrow function Adequate kidney function Adequate liver function Informed consent Exclusion Criteria: Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start Known allergy to study drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab<br>Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment | Drug: Bevacizumab<br>* Bevacizumab, Capecitabine, Oxaliplatin<br>* Other names: Capecitabine, Oxaliplatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival, safety, response |  | 1 year |
Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril

Study Overview
=================
Brief Summary
-----------------
This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake. This should contribute to our understanding of the pathomechanisms involved in diabetes and the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.

Official Title
-----------------
Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ramipril
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Healthy defined as absence of relevant disease Caucasian Aged 18-45 years BMI: 18-28 kg/m2 Signed informed consent Blood pressure between 110/45 and <140/90 (twice at screening) Exclusion Criteria: History of renal artery stenosis angioneurotic edema psoriasis relevant renal diseases RR at screening < 110/45 mmHg. Diabetes, history of hypertension, RR > 140/90 at screening, cardiovascular disease Known Diabetes mellitus of parents HIV or Hepatitis B/C positive virology Allergy or hypersensitivity against ACE-inhibitors / ramipril or to xylocain Contraindications against the use of the drug according to the SmPC, history of angioedema Any drug intake 3 weeks prior to first study day History of excessive bleeding tendency / hemophilia Presence of relevant illness within the last 3 weeks Suspected non-compliance with study instructions and life-style requirements Alcohol or drug abuse Blood/Plasma donation within 4 weeks prior to study day Previous exposure to antihypertensive drugs, ACE-inhibitors, in particular ramipril Current smoking (any quantity), (at least 6 months of non-smoking required)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ramipril | Drug: ramipril<br>* oral intake<br>|
| Placebo Comparator: 2<br>Placebo | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake. |  | 1 year |
Genetics Education: Preparing Physicians for the Future

Study Overview
=================
Brief Summary
-----------------
This study examines the best way to teach genetics to family medicine residents. First year family medicine residents at the University of Toronto will be taught basic clinical genetics as well as a specific disease in genetics via 3 different educational methods. All participants will undergo an oral examination and written knowledge test 3 months after this education. Results between groups will be compared, and the best way to teach genetics to residents determined.

Detailed Description
-----------------
An educational module will be prepared by the investigators outlining important genetic fundamentals and hereditary colorectal cancer. Sixty four family medicine resident participants will take part in this study. Participants will be divided into 4 groups. Group 1 will be the control and receive no education. Group 2 will be given access to the self-study web-based educational module to do on their own time. Group 3 will be given a lecture on the material using the educational module, followed by a discussion. Group 4 will also be given this lecture and discussion, followed by an interactive standardized patient role-play experience. Three months later, all participants will complete an simulated oral examination, an written knowledge test and an attitude survey. By comparing the results between the 4 groups, the best way to teach genetics will be determined. This template can then be used to develop a curriculum for teaching clinical genetics to family medicine residents.

Conditions
-----------------
Primary Care Genetics, Hereditary Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: web-based learning, didactic lecture and role-play


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all first year family medicine residents in the Department of Family and Community Medicine at the University of Toronto Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: web-based learning, didactic lecture and role-play|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge in approach to family medicine genetics |  |  | 
| attitude towards family medicine genetics and genetic testing |  |  | 
| skill in discussing these issues with patients |  |  |