linjc16/ctgov huggingface dataset:
Cardiac Rehabilitation After Pacemaker Implantation

Study Overview
=================
Brief Summary
-----------------
The investigators assessed whether short-term cardiac rehabilitation following pacemaker implantation was enough to improve both physical function and quality of life.

Detailed Description
-----------------
Exercise-based cardiac rehabilitation (CR) improves clinical outcomes in patients with cardiovascular diseases. However, few data exist regarding the role of early short-term CR in patients undergoing pacemaker (PM) implantation. The investigators assessed whether short-term CR following PM implantation was enough to improve both physical function and quality of life (QOL).

Official Title
-----------------
Role of Early Short-term Cardiac Rehabilitation in Patients Undergoing Pacemaker Implantation

Conditions
-----------------
Bradycardia, Pacemaker

Intervention / Treatment
-----------------
* Behavioral: cardiac rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were scheduled to undergo new PM implantation Exclusion Criteria: patients older than 75 years patients who are contraindicated to exercise patients who refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CR group<br>participants who have exercise-based cardiac rehabilitation program after PM. | Behavioral: cardiac rehabilitation<br>* cardiac rehabilitation after pacemaker implantation<br>* Other names: exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer;|
| Placebo Comparator: non-CR group<br>participants who have only routine regular follow-up after PM instead of CR program | Behavioral: cardiac rehabilitation<br>* cardiac rehabilitation after pacemaker implantation<br>* Other names: exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in physical function based on cardiopulmonary exercise test | VO2 max in mL/kg/min | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in physical function based on muscle power test | knee extension in kilogram | 1 month | 
| changes in quality of life | SF-36 questionnaire score | 1 month |
Study of Gene Associations and Infertility

Study Overview
=================
Brief Summary
-----------------
The purpose of this this study is to use DNA screening strategies to identify genes and localize genomic regions that are differentially expressed in patients with infertility to further understand the genetic basis for reproductive competence.

Detailed Description
-----------------
Experimental strategies seek to discover small variants in DNA sequences, which are associated with certain infertility parameters. The alleles being analyzed in in vitro fertilization (IVF) population are sought to be associated with functional differences in the expression of the gene product that are then mechanistically linked to infertility.

Official Title
-----------------
Genes and Gene Polymorphisms Associated With Infertility: Utilization of DNA Characteristics to Better Understand Reproductive Competence

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing fertility care Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 undegoing infertility treatment<br>Male and female patients undergoing infertility treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Number of oocytes that are fertilized | 1 month | 
| Number of available embryos | Number of embryos that are available for transfer on day 3 or day 5 | 1 month | 
| Pregnancy rates | Clinical pregnancy rates (detection of pregnancy hormone bHCG in blood) and delivery rates. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, infertility, DNA
Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions

Study Overview
=================
Brief Summary
-----------------
vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester

Official Title
-----------------
Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions

Conditions
-----------------
MISED ABORTION- Vaginal PH

Intervention / Treatment
-----------------
* Other: PH meassurment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion missed abortion under 8 weeks by sac diameter over 18 years old informed concent given Exclusion Criteria: missed abortion over 8 weeks hypersensitivity for PG vaginal bleeding suspected EUP IUD heart disease, HTN, cerebral vascular disease, epilepsy intrauterine infection clooting disorder under 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ph above cutoff<br> | Other: PH meassurment<br>* meassuring ph USING PROBE<br>|
| PH under cutoff<br> | Other: PH meassurment<br>* meassuring ph USING PROBE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment failure- need for D&C |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects, need foe analgetics, time for compliting abortion |  | 2 weeks |
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks.

Official Title
-----------------
A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea

Conditions
-----------------
Clostridium Enterocolitis, Pseudomembranous Colitis

Intervention / Treatment
-----------------
* Drug: tolevamer potassium-sodium (GT267-004)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD Baseline serum potassium > 3.0 mmol (meq)/L Patient considered sufficiently stable clinically to likely complete a 6 week study period

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tolevamer potassium-sodium (GT267-004)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of diarrhea |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of diarrhea |  |  | 
| Recurrence rate |  |  | 
| Number of stools |  |  | 
| Average stool consistency |  |  | 
| Treatment success |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clostridium Enterocolitis, Pseudomembranous Colitis, Clostridium difficile-associated diarrhea, C. difficile, CDAD
Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. To evaluate the pain relief rate of patients with different initial pain.

Official Title
-----------------
Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain

Conditions
-----------------
To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence

Intervention / Treatment
-----------------
* Other: regular follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to the OA diagnostic criteria of knee joint, the side with higher WOMAC score is defined as observing knee joint for patients with both knees conforming to OA diagnostic criteria. Repeated knee pain in the past month X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin. Joint fluid (> 2 times) is cool and sticky, WBC < 2000/ml Age over 40 Morning stiffness less than 30 minutes Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or 1+4+5+6, OA of knee joint can be diagnosed. The informed consent has been signed Exclusion Criteria: (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe internal medical complications and other inability to participate in the research (4) Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: regular follow-up|we give a regular follow-up and supervision on the study group|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence | We will calculate adherence with medication use | 6-8 weeks | 
| pain relief rate | We will calculate the pain relief rate on all participants | 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| womac score | We will calculate the womac score on all participants | 6-8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee osteoarthritis pain; Adherence; Diclofenac; Follow up
Comparison of Digital Breast Tomosynthesis to Conventional Mammography

Study Overview
=================
Brief Summary
-----------------
In March 2009, Health Canada approved Tomosynthesis for use in screening and diagnosis of breast cancer. The Tomosynthesis technology is designed as a complementary imaging model that is incorporated into the 2D Mammography system. This new imaging system has the capability to provide 2D, 3D and combination mode models. It consists of generating thin slice images that can be viewed individually as multiple images from the same breast. Tomosynthesis provides improved visibility of possible lesions within the breast. The study aims to compare the performance of Tomosynthesis to the conventional Digital Mammography in detecting and characterizing suspicious findings in subjects who will be having breast biopsies.

Official Title
-----------------
The Performance of Digital Breast Tomosynthesis Compared to Conventional Mammography in Visualization and Characterization of Suspicious Breast Abnormalities

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: 2D/3D Tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female of any race and ethnicity Following routine mammography imaging, subject is categorized as Breast Imaging Reporting and Data System (BI-RADS®) 4 or 5 because of calcifications / masses and architectural distortion will undergo study imaging within 30 days of routine imaging Subject will undergo 2D/3D digital breast tomosynthesis prior to biopsy Exclusion Criteria: Subject unable or unwilling to undergo informed consent Subjects who are unable or unwilling to tolerate compression Subjects who are pregnant or who think they may be pregnant Subjects who are breast-feeding The subject is too large to be imaged on the large 24 x 30 cm detector

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2D/3D Tomosynthesis<br>2D/3D Tomosynthesis images will be obtained in addition to standard mammographic images. | Other: 2D/3D Tomosynthesis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Tomosynthesis to Standard Digital Mammography | To compare the sensitivity, specificity, positive and negative predictive values of tomosynthesis to conventional digital mammography in visualization and characterization of suspicious abnormalities. | 2 years |
ATAC - Quality of Life Sub-Protocol

Study Overview
=================
Brief Summary
-----------------
To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.

Official Title
-----------------
A Randomised, Double-Blind, Parallel Group Trial to Assess Quality of Life With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Drug: Anastrozole
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for entry into the main ATAC trial 1033IL/0029 Completion of a baseline questionnaire Exclusion Criteria: Excluded from entry into the main ATAC trial (1033IL/0029) If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Arimidex 1mg + Nolvadex placebo | Drug: Anastrozole<br>* 1mg, orally, once daily<br>* Other names: Arimidex;|
| Active Comparator: 2<br>Arimidex placebo + Nolvadex 20mg | Drug: Anastrozole<br>* 1mg, orally, once daily<br>* Other names: Arimidex;Drug: Tamoxifen<br>* 20mg, orally, once daily<br>* Other names: Nolvadex;|
| Active Comparator: 3<br>Arimidex 1mg + Nolvadex 20mg | Drug: Tamoxifen<br>* 20mg, orally, once daily<br>* Other names: Nolvadex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to withdrawal |  |  | 
| Time to recurrence |  |  |
Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study

Study Overview
=================
Brief Summary
-----------------
Simultaneous execution of motor and cognitive tasks is embedded in the daily life of children. An EEG study will be conducted on healthy children and children with cerebral palsy to study the neural correlates during dual tasking while walking

Detailed Description
-----------------
Children will walk at their preferred speed on a treadmill. During dual tasking, they will listen to animals cries and will have to count the number of specified animals cries.

Official Title
-----------------
Processus Attentionnels impliqués Dans la Locomotion Chez l'Enfant à développement Typique et l'Enfant Atteint de Paralysie cérébrale : Une étude EEG.

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Behavioral: EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal walking For children with cerebral palsy: diplegia or hemiplegia, GMFCS 1 or 2, no botulinium injection since 4 months Exclusion Criteria: medical problem

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 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 |
| --- | --- |
| Children with cerebral palsy 7-9 years<br>21 children | Behavioral: EEG<br>* EEG + walking task + auditory task<br>|
| Children with cerebral palsy 10-12 years<br>21 children | Behavioral: EEG<br>* EEG + walking task + auditory task<br>|
| Healthy children 7-9 years<br>21 children | Behavioral: EEG<br>* EEG + walking task + auditory task<br>|
| Healthy children 10-12 years<br>21 children | Behavioral: EEG<br>* EEG + walking task + auditory task<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural correlates during dual tasking in children | EEG, locomotion parameters, cognitive performances | 2 years |
I-125 Versus Pd-103 for Medium Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication. A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Detailed Description
-----------------
Objective: The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication. Research plan: A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy). Methodology: Randomization will be accomplished by the method of random permuted blocks. Cancer status will be monitored by yearly serial serum PSA. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. Primary endpoint: Time to treatment failure. Patients with serum PSA above 0.5 ng/ml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: I-125 versus Pd-103 radioactive seed insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PSA 4-10 ng/ml Gleason score 5 or 6

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: I-125 versus Pd-103 radioactive seed insertion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA-based cancer eradication |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation, brachytherapy, prostate, cancer