linjc16/ctgov huggingface dataset:
Facilitators to Keeping Colonoscopy Appointments

Study Overview
=================
Brief Summary
-----------------
To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy.

Detailed Description
-----------------
The potential to reduce the morbidity and mortality from colorectal cancer, the second most common cause of cancer death in the U.S. has been compromised because only about half of eligible patients have been appropriately screened. Patients contribute to inadequate colorectal cancer screening by failing to complete ordered tests. Several studies have reported low rates of attendance to scheduled sigmoidoscopy and colonoscopy studies. Because physicians offer limited counseling when ordering these tests, approaches are needed to address patient concerns and to promote adherence to scheduled colon studies. Therefore, we conducted a trial of a theory-based telephone intervention by patient 'peer coach' who was trained to address barriers to colonoscopy attendance versus a mailed professional brochure. The support was targeted to those at greatest risk of non-attendance.

Official Title
-----------------
Peer Coach Intervention to Improve Attendance to Scheduled Colonoscopy

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

Intervention / Treatment
-----------------
* Behavioral: Peer coach phone call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50 No prior colonoscopy in our health system records Patient in one of four primary care clinics within the University of Pennsylvania Health System Attended <75 of their primary care physicians visits within the past year Exclusion Criteria: Colonoscopy not ordered by a primary care physician in a study clinic High readiness for the procedure A health care professional Had a prior colonoscopy outside of our health care system

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Peer coach phone call|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attending the colonoscopy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient navigator, peer support, colonoscopy, adherence, None: have to be scheduled for screening or diagnostic colonoscopy
Prevention of Parastomal Hernia With a Mesh

Study Overview
=================
Brief Summary
-----------------
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

Detailed Description
-----------------
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes. A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection. Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis. Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.

Official Title
-----------------
Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia

Conditions
-----------------
Parastomal Hernia

Intervention / Treatment
-----------------
* Procedure: Prophylactic mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical need of an enterostoma Exclusion Criteria: Patients denies inclusion in the trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Prophylactic mesh|A low weigth partly absorbable mesh in a subaly posistion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection,mesh infection, parastomal hernia. |  | Within five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula formation, stenosis,pain. |  | Within five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parastomal hernia, wound infection, stoma care.
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Breast cancer is the second most common cancer in Sweden with an incidence of 8000 per year. The role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver. The purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. The primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. The secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. The aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. The overall purpose is to ameliorate treatment for advanced breast cancer.

Official Title
-----------------
Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases

Conditions
-----------------
Breast Cancer, Liver Metastases

Intervention / Treatment
-----------------
* Procedure: Surgical intervention
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent >18 years old ECOG 0-1 Breast cancer history Breast cancer liver metastasis verified by biopsy Patient amendable for liver surgery and pre- and postoperative oncological treatment 1-4 liver metastasis amendable to surgery with functional liver remnant volume >30% Liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment Exclusion Criteria: Non-skeletal extrahepatic disease Non-resected primary tumour Pregnancy Progression of disease upon oncological treatment

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical intervention<br>Surgical and oncological treatment | Procedure: Surgical intervention<br>* Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment<br>|
| Active Comparator: Control<br>Oncological treatment | Drug: Control<br>* Oncological treatment in control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Time to death from any cause | Three years after randomization |
Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)

Study Overview
=================
Brief Summary
-----------------
This study will examine the safety and efficacy of posaconazole in general use in Korea. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of NOXAFIL Oral Suspension in Usual Practice

Conditions
-----------------
Fungal Infections

Intervention / Treatment
-----------------
* Drug: Posaconazole oral suspension 40 mg/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with posaconazole oral suspension within current local label Exclusion Criteria: Contraindication to posaconazole oral suspension according to current local label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>All participants treated with posaconazole oral suspension during the pre-specified surveillance period. | Drug: Posaconazole oral suspension 40 mg/mL<br>* Posaconazole oral suspension prescribed according to the current local label<br>* Other names: NOXAFIL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Serious Adverse Experiences |  | During treatment and for 30 days following cessation of treatment | 
| Number of participants with drug-related adverse experiences |  | During treatment and for 30 days following cessation of treatment | 
| Number of participants with unexpected drug-related adverse experiences |  | During treatment and for 30 days following cessation of treatment | 
| Number of participants with Non-Serious Adverse Experiences |  | During treatment and for 30 days following cessation of treatment | 
| Number of Participants with Responses of Improved, Not Improved, and Worsened |  | After at least 14 days of treatment |
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).

Detailed Description
-----------------
Pilot Study

Official Title
-----------------
A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Device: Urgent(R) PC Neuromodulation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter) Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.) Exclusion Criteria: Pregnancy or intention to become pregnant during the course of the study Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.) Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function Prone to excessive bleeding or bleeding diathesis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urgent(R) PC Neuromodulation System<br>Urgent(R) PC Neuromodulation System | Device: Urgent(R) PC Neuromodulation System<br>* The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline | 18 weeks | 
| Safety | To characterize adverse events experienced throughout the study | 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal Incontinence, Bowel Incontinence
Dexmedetomidine for Sedation Undergoing Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression. We hypothesized dexmedetomide is more suitable for sedation of bronchoscopy than other sedative drugs.

Detailed Description
-----------------
A retrospective chart review was conducted. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled.The primary analysis outcome was safety profile during procedure included incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension. The secondary outcome was measured by recovery profile (awake and ambulation time).

Official Title
-----------------
Comparison of Dexmedetomidine and Propofol for Sedation in Adult Patients Undergoing Flexible Bronchoscopy -A Retrospective Review

Conditions
-----------------
Safety Issues

Intervention / Treatment
-----------------
* Procedure: bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedation undergoing flexible bronchoscopy Exclusion Criteria: without sedation undergoing flexible bronchoscopy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with dexmedetomidine<br>Drugs provided moderate sedation during procedure including dexmedetomidine | Procedure: bronchoscopy<br>* during flexible bronchoscopy<br>|
| without dexmedetomidine<br>Drugs provided moderate sedation during procedure without dexmedetomidine | Procedure: bronchoscopy<br>* during flexible bronchoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety profile during procedure | Incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension | during procedure |
Endurance Training in Young Persons With Cerebral Palsy; Evaluation of Training Method and Effect

Study Overview
=================
Brief Summary
-----------------
The hypotheses of the study are that children / youth with CP will by possibly use of technical aids be able to perform high intensity endurance training by walking / running on a treadmill, and that this training will improve their health by increased aerobic capacity and quality of life.

Official Title
-----------------
Enthusiasm - Sweat - Satisfaction! In Youngster With CP

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Endurance training intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person with CP, GMFCS-level I-IV, age 10-17 years Living in Mid-Norway Wants to increase his / her level of physical activity Exclusion Criteria: Completes less than 75% of the total number of training sessions Not able to complete the testing and training procedures due to sickness, injury or other physical and psychological conditions

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal daily activity<br> | Other: Endurance training intervention<br>* High intensive interval training of walking / running on treadmill for 1 1/2 - 4 minute,repeated minimum 4 times, at an intensity equalling at least 80% of maximal heart frequency. Performed 2-5 times per week for 4-8 weeks, totally 24 sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic capacity |  | Sept. 2009 - april 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | Sept. 2009 - April 2010 |
Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Lipoprotein-associated phospholipase A2 (LP-PLA2) is a good marker of cardiovascular risk and inflammation. This study aims at the characteristic and clinical significance of LP-PLA2 test in patients with type 2 diabetes(T2D).

Detailed Description
-----------------
The investigators recorded clinical factors, serum levels of glucose, HbA1c, lipids and LP-PLA2 in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to August 2016. The relationship between levels of LP-PLA2 and diabetic complications are analysed.

Official Title
-----------------
Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999. Exclusion Criteria: Patients use systemic steroidal anti-inflammatory drugs. Patients are pregnant. Patients with an acute infection.
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipoprotein-associated Phospholipase A2 | the plasma lipoprotein-associated phospholipase A2 level of patients | Day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | the glycosylated hemoglobin level of patients | Day one | 
| LDL-c | low density lipoprotein cholesterol | Day one | 
| Diabetic Complication | the prevalence of atherosclerosis, diabetic Nephropathy, diabetic retinopathy and diabetic neuropathy | Day one | 
| C Peptide | fast and 120min postprandial C peptide | Day one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lipoprotein-associated phospholipase A2
Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.

Official Title
-----------------
Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers Dosed With Applesauce

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

Intervention / Treatment
-----------------
* Drug: Topiramate Sprinkle Capsules 25 mg
* Drug: Topamax® Sprinkle Capsules 25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topiramate Sprinkle Capsules 25 mg | Drug: Topiramate Sprinkle Capsules 25 mg<br>* 25mg, single dose applesauce<br>|
| Active Comparator: 2<br>Topamax® Sprinkle Capsules 25 mg | Drug: Topamax® Sprinkle Capsules 25 mg<br>* 25mg, single dose applesauce<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 144 hours |