linjc16/ctgov huggingface dataset:
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications

Study Overview
=================
Brief Summary
-----------------
Pancreatic resections carry a high risk for complications, especially pancreatic fistula. Both hydrocortisone and pasireotide have been shown to be effective in reducing complications in earlier RCTs. The aim of this study is to compare the effectiveness and safety of these two drugs in preventing complications of pancreatic surgery.

Official Title
-----------------
HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial

Conditions
-----------------
Pancreatic Fistula, Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Hydrocortisone
* Drug: Pasireotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection) Exclusion Criteria: Preoperative exclusion criteria: Atrophic pancreas and/or dilated pancreatic duct at the site of planned pancreatic transsection (applies only to patients undergoing pancreaticoduodenectomy) Total pancreatectomy planned Allergy or other contraindication for hydrocortisone or pasireotide Age < 18 years No informed consent Intraoperative exclusion criteria: Pancreatic resection cancelled (e.g. disseminated cancer) Hard pancreas and/or dilated pancreatic duct discovered during operation (applies only to patients undergoing pancreaticoduodenectomy) Total pancreatectomy is performed

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br> | Drug: Hydrocortisone<br> <br> |
| Active Comparator: Pasireotide<br> | Drug: Pasireotide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication Index |  | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications (Clavien-Dindo classification) |  | 30 days postoperatively | 
| Postoperative pancreatic fistula (ISGPS-classification) |  | 30 days postoperatively | 
| Postoperative delayed gastric emptying (ISGPS-classification) |  | 30 days postoperatively | 
| Post-pancreatectomy hemorrhage (ISGPS-classification) |  | 30 days postoperatively | 
| Length of hospital stay, days |  | During hospital stay, on average 7-14 days | 
| Readmissions |  | 30 days postoperatively |
Internet-delivered Group Counseling for Chronic Tinnitus

Study Overview
=================
Brief Summary
-----------------
In the treatment of chronic tinnitus, psycho-education plays an import role to provide more insights into the symptoms of tinnitus. However, the need for e-health is increasing. As such, it is important to investigate if these psycho-education sessions can be delivered online, with the same efficacy compared to the traditional face-to-face delivery.

Official Title
-----------------
Internet-delivered Group Counseling for Chronic Tinnitus

Conditions
-----------------
Tinnitus, Subjective

Intervention / Treatment
-----------------
* Behavioral: Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with subjective, chronic tinnitus Exclusion Criteria: Enrollment in other tinnitus treatments simultaneously at the time of the intervention

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjective, chronic tinnitus<br>Tinnitus patients who received internet-based psycho-educational counseling | Behavioral: Counseling<br>* Online delivered group counseling session, providing insights into the tinnitus symptoms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Functional Index (TFI) | Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus. | before intervention, 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue scale (VAS) for tinnitus loudness | Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus | before intervention, 3 months follow-up | 
| Change in Hospital Anxiety and Depression Scale (HADS) | Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder. | before intervention, 3 months follow-up | 
| Change in Hyperacusis Questionnaire (HQ) | Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity. | before intervention, 3 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus treatment, delivery method, psycho-educational counseling, internet-based
Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.

Official Title
-----------------
Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: NPC-16 Standard Dosing Regimen Group
* Drug: NPC-16 Continuous Dosing Regimen Group
* Drug: Placebo Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dysmenorrhea Exclusion Criteria: severe hepatopathy pregnant woman

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-16 Standard Dosing Regimen Group<br>Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg | Drug: NPC-16 Standard Dosing Regimen Group<br> <br> * Other names: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg;|
| Experimental: NPC-16 Continuous Dosing Regimen Group<br>Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg | Drug: NPC-16 Continuous Dosing Regimen Group<br> <br> * Other names: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg;|
| Placebo Comparator: Placebo Group<br>Placebo for NPC-16 | Drug: Placebo Group<br> <br> * Other names: Placebo for NPC-16;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea |  | 52 weeks |
Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate an educational program that has been pretested for cultural appropriateness and literacy requirements in patients with systemic lupus erythematosus (SLE). II. Assess the impact of this educational program on patients with SLE, with an emphasis on recognizing cardinal symptoms, coping with fatigue, regulating medications, and communicating with the physician.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 groups. One group participates in an educational program administered and coordinated by a health educator. The program includes 1 or 2 educational sessions emphasizing practical advice, each lasting approximately 1.5 hours; social support from a patient-identified management partner; and behavioral reinforcement from health center staff, the patient partner, and written and audio materials. The control group receives patient educational materials consistent with usual care (pamphlets). Patients are followed at 6, 12, 24, and 36 months.

Official Title
-----------------
Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Procedure: Tailored educational program
* Procedure: Educational materials


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria Recruitment from the Medical College of Virginia SLE registry

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

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tailored educational program|nan|
|Procedure: Educational materials|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
-----------------
arthritis & connective tissue diseases, disease-related problem/condition, educational needs, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients

Study Overview
=================
Brief Summary
-----------------
The records of patients who were diagnosed with ARN between April 2010 and February 2017 were analyzed.A retrospective review of the treatment options and outcomes of the these patients was performed.

Official Title
-----------------
The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients

Conditions
-----------------
Acute Retinal Necrosis

Intervention / Treatment
-----------------
* Procedure: pars plana vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARN was diagnosed according to the American Uveitis Society Diagnostic Criteria (1994) Exclusion Criteria: -

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


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>there was no retinal detachment (RD) at the first visit. The group 1 patients were treated with systemic antiviral medications, as well as with intravitreal antiviral injections | |
| 2<br>there was no RD at the first visit. The group 2 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection. | Procedure: pars plana vitrectomy<br>* pars plana vitrectomy<br>* Other names: systemic antiviral medications;|
| 3<br>there was RD at the first visit. The group 3 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection | Procedure: pars plana vitrectomy<br>* pars plana vitrectomy<br>* Other names: systemic antiviral medications;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal detachement |  | 1 year |
Endometriosis Pelvic Pain Interdisciplinary Cohort Data Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this data registry is to prospectively collect data from patients referred to an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and endometriosis.

Detailed Description
-----------------
The BC Women's Centre for Pelvic Pain and Endometriosis is the tertiary referral centre for endometriosis/pelvic pain in British Columbia, Canada. The Centre offers a unique interdisciplinary approach including minimally invasive surgery, hormonal and other medical therapy, pain education, physiotherapy, and CBT/mindfulness. After informed consent, patients prospectively consent to data collection in the online registry. The registry consists of patient intake questionnaires (including validated measures), physical and ultrasound examination, review of medical records, surgical findings, and annual outcomes to 5 years. The online data registry is housed in the Research Electronic Data Capture (REDCap) platform located at BC Children's Hospital.

Official Title
-----------------
Endometriosis Pelvic Pain Interdisciplinary Cohort (EPPIC) Data Registry

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: Data Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All new and re-referred patients at the BC Women's Centre for Pelvic Pain and Endometriosis. Exclusion Criteria: Patients at the BC Women's Centre for Pelvic Pain and Endometriosis seen for reasons other than chronic pelvic pain and/ or endometriosis as well as patients who decline to complete the online questionnaire.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data Registry|Data Registry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported severity of chronic pelvic pain | Measured on a scale of 0 (no pain) to 10 (worst pain imaginable) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Chronic pelvic pain, Dyspareunia
Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

Study Overview
=================
Brief Summary
-----------------
The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release.

Official Title
-----------------
Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

Conditions
-----------------
Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lead Integrity Algorithm download; requires a Medtronic device that supports the LIA algorithm; requires an RV lead; selected as part of the identified cohort Exclusion Criteria: A device that does not support the Lead Integrity Algorithm,
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the LIA algorithm |  | 2 years | 
| Positive predictive value of the LIA algorithm |  | 2 years | 
| Number of false positives per patient-year of the LIA algorithm |  | 2 years | 
| Reduction in the percent of patients with the LIA algorithm with an RV lead fracture who receive at least one inappropriate shock |  | Event driven (analysis requires 50 events) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lead Integrity Algorithm
Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI

Study Overview
=================
Brief Summary
-----------------
Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction

Official Title
-----------------
Protective Effect of Beraprost Sodium Tablets on Coronary Microcirculation Function and Ventricular Remodeling After Reperfusion Therapy for Acute ST Segment Elevation Myocardial Infarction

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Beraprost Sodium Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: It meets the diagnostic criteria of acute ST segment elevation myocardial infarction: ischemic chest pain lasts for more than 30 minutes and can not be relieved by taking nitroglycerin; ST segment elevation of ECG with two or more adjacent leads, limb lead ≥ 1mm, chest lead ≥ 2mm; Or new left bundle branch block; The serum markers of myocardial necrosis increased at least twice the normal value Acute myocardial infarction was confirmed by coronary angiography The clinical and angiographic data were complete Direct PCI was performed within 12 hours after onset Exclusion Criteria: Those who do not cooperate in the inspection, have poor compliance and cannot guarantee the completion of the test Conscious disorder, obvious intellectual disorder and mental disorder With metal foreign bodies, such as metal prosthesis, intraocular metal foreign bodies, intracranial aneurysm clamp, etc People with claustrophobia Had a history of myocardial infarction, PCI and coronary artery bypass grafting Factors affecting ST segment changes of ECG: complete left bundle branch block, preexcitation syndrome, pacemaker ECG, etc

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 |
| --- | --- |
| Experimental: Beraprost Sodium Tablets<br> | Drug: Beraprost Sodium Tablets<br>* Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | The incidence of mace after 1 week of treatment | 1 weeks after baseline | 
| Major Adverse Cardiovascular Events | The incidence of mace after 6 months of treatment | 6 months after baseline | 
| Major Adverse Cardiovascular Events | The incidence of mace after 1 year of treatment | 1 year after baseline |
Nasal Swab Study to Explore the Nasal Microbia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques.

Official Title
-----------------
An Exploratory Study to Evaluate the Microbial Consortia and the Host Inflammatory Factors Present in the Nasal Passages of Patients During Upper Respiratory Symptomology and When Healthy

Conditions
-----------------
Common Cold

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, male or female, between the ages 18 - 60 Exhibiting symptoms of an upper respiratory ailment, which may include runny or stuffy nose, sore throat, fever, headache, cough, malaise, or loss of appetite with no indication or intention to treat with excluded medications. Exclusion Criteria: Use of antibiotics, antifungals, antivirals, antihistamines, anticholinergic, anti-inflammatory, any nasal inhaled medications (other than saline), or steroid medications within the four (4) weeks prior to enrollment and during the course of the study. Use of cough suppressants and herbal medications are permitted.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and amount of nasal microbes |  | Change from baseline compared to Day 21 |