linjc16/ctgov huggingface dataset:
Predisposing Factors for Chronic Postherniotomy Pain

Study Overview
=================
Brief Summary
-----------------
Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method. The current study will assess the above factors in a prospective study.

Official Title
-----------------
Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain

Conditions
-----------------
Chronic Postherniotomy Pain

Intervention / Treatment
-----------------
* Procedure: Open sutured mesh repair
* Procedure: Laparoscopic mesh glue fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>18 years) Male Primary unilateral groin hernia Ability to use pain scales Exclusion Criteria: Neurological disease Diabetes with late stage complications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Open sutured mesh repair | Procedure: Open sutured mesh repair<br>* Open sutured mesh repair<br>|
| Active Comparator: B<br>Laparoscopic mesh glue fixation | Procedure: Laparoscopic mesh glue fixation<br>* Laparoscopic mesh glue fixation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of chronic pain |  | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sensory function |  | 6 months | 
| Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Groin hernia, Chronic postsurgical pain, open mesh repair, laparoscopic mesh glue fixation, Sensory changes after groin hernia repair
Diathermy Compared With Sham Diathermy in Doms Management

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of hand massage, switched on diathermy or sham/switched off diathermy on DOMS in a group of athletes suffering DOMS after a ski mountaineering race.

Detailed Description
-----------------
This study examine DOMS in athletes following a ski mountaineering race, pain measured with numbering pain rating scale NPRS and perceived global improvement (PGIC) after treatment have been measured after a massage treatment, a diathermy treatment and a sham diathermy treatment.

Official Title
-----------------
Diathermy Compared With Sham Diathermy in Doms Management

Conditions
-----------------
Musculoskeletal Diseases

Intervention / Treatment
-----------------
* Device: Diathermy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy patients who complaints about D.O.M.S. after a skimountaneering race Exclusion Criteria: - Patient who complain of pathology such trauma or declaring consuming drugs for pain management where excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Switched on diathermy<br>Switched on diathermy was used on DOMS compared to sham diathermy | Device: Diathermy<br>* Sham diathermy vs switched on diathermy effect on pain where assessed<br>|
| Sham Comparator: Switched OFF diathermy<br>Switched OFF diathermy was used on DOMS compared to REAL diathermy | Device: Diathermy<br>* Sham diathermy vs switched on diathermy effect on pain where assessed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numering pain rating scale | Numering pain rating scale was assessed pre e post treatment | Day 1 |
To Identify HLA-A1101-restricted Peptide Epitopes Derived From Novel Oncoantigens (URLC10, KIF20A, and CDCA1) Applicable for Cancer Vaccine in Singapore

Study Overview
=================
Brief Summary
-----------------
Aim: To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore. Methods: The panel of candidate peptides are synthesized and tested for their ability to induce peptide-specific CTL responses, in order to screen the peptide epitopes applicable for the cancer vaccination. Briefly, peripheral blood lymphocytes (PBLs) derived from HLA-A1101(+) healthy donors are taken and cultured in the presence of the each candidate peptide with recombinant IL-2 for 2 weeks, and then, re-stimulated with dendritic cell pulsed with the peptide following another 2 week culture. Thereafter, CD8(+) T lymphocytes were negatively selected with CD4-magnetic beads from cultured lymphocytes and tested for their peptide specificity employing enzyme-linked immunospot (ELISPOT) assay. These conditions are completely performed in in-vitro system. Importance in medicine: If one could identify the peptide epitopes from novel Oncoantigens, it is applicable for clinical trials of cancer vaccination. Benefits & Risks : There is no risk except for the matter of venipuncture in each individuals. The ideal target molecules for cancer vaccination are thought to be selectively expressed in tumor cells, but not in the normal cells, with high frequent and homogenous expression within tumor. We have proved that novel Oncoantigens, URLC10, KIF20A and CDCA1, have these characters as ideal target molecules for the cancer vaccination and are highly expressed in a variety of tumor type such as gastric, lung, and pancreas cancer. Since HLA-A1101 haplotype is most frequent in Singaporean, it is essential to indentify the HLA-A1101-restriced peptides derived from these Oncoantigens to develop cancer vaccination.

Conditions
-----------------
Anonymous Donors at Blood Donation Center (NUH)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participants should be healthy, non-pregnant adults who weigh at least 50kgs Exclusion Criteria: Age of < 22 and > 80 years old. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Decision of unsuitableness by Principal Investigator or physician-in-charge.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore. |  |  |
Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.

Official Title
-----------------
Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

Conditions
-----------------
Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: fondaparinux sodium injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients who are 18 years or older estimated creatinine clearances between 20-50 ml/min current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery able to give informed consent need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode Exclusion Criteria: Use of the following clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study) body weight < 50 kg anticoagulation therapy for thrombosis or other indication pregnant or breast-feeding hypersensitivity to Arixtra® thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Arixtra® bacterial endocarditis brain malignancy increased risk of bleeding.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arixtra<br> | Drug: fondaparinux sodium injection<br>* 1.5mg subcutaneously every day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples to measure specific Arixtra® concentration | peak level will be collected 2-3 hours after the dose interval level will be collected between peak and midpoint midpoint level will be collected 12 hours after the dose interval level will be collected midpoint and trough trough level will be collected just prior to the next scheduled dose | • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of bleeding events and new thrombotic events | events will be used to compare to rates in patients without renal dysfunction | Daily assessments will be made for bleeding and thrombosis |
Efficacy of Shotblocker in Spinal Needle Related Pain

Study Overview
=================
Brief Summary
-----------------
This was a single-blind, randomized controlled trial. Seventy-six patients who underwent spinal anesthesia for surgery were randomized into the Shotblocker group or Control group. Before the insertion of a 25-gauge spinal needle, Shotblocker was applied just before the spinal needle insertion in the Shotblocker group. 10-cm visual analog scale to evaluate the pain intensity of spinal needle insertion and a five-point scale for patient satisfaction were compared between the two groups.

Official Title
-----------------
The Effect of Shotblocker on Pain and Patient Satisfaction for Spinal Anesthesia

Conditions
-----------------
Needle Phobia, Spinal Anesthesia, Pain

Intervention / Treatment
-----------------
* Procedure: Shotblocker
* Procedure: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery Exclusion Criteria: contraindications to regional anesthesia refusal of the patient's regional anesthesia intellectual disabilities that prevented completion of a visual analog scale (VAS)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shotblocker Group<br>Patients spinal injections were performed with Shotblocker placed onto injection site | Procedure: Shotblocker<br>* Patients spinal injections were performed with Shotblocker placed onto injection site<br>|
| Placebo Comparator: Placebo Group<br>Patients spinal injections were performed without Shotblocker | Procedure: Placebo<br>* Patients spinal injections were performed without Shotblocker<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale) | Assessment of pain during spinal needle insertion will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five point scale for patient satisfaction | 5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant | 1 minutes | 
| Five point scale for anesthesists satisfaction | 5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant | 1 minutes |
Working Toward Wellness

Study Overview
=================
Brief Summary
-----------------
Working toward Wellness is a telephone care management and outreach monitoring program designed to help Medicaid recipients who are experiencing major depression to enter and remain in evidence-based treatment. To study the effects of Working toward Wellness, individuals receiving Medicaid in Rhode Island who are eligible for mental health services through United Behavioral Health were screened by telephone for depression. Those who were found to have major depression and who agreed to be in the study were randomly assigned. Program participants received intensive monitoring from Master's level clinicians called care managers to facilitate and support clinical treatment. The control group received usual care that included only referrals to mental health treatment providers. The study hypothesis is that telephonic care management would increase visits to mental health professionals and use of appropriate medication, which in turn would reduce depression severity and lead to greater employment and productivity at work.

Official Title
-----------------
Enhanced Services for the Hard to Employ Demonstration: Telephonic Care Management for Depressed Medicaid Recipients

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Telephonic care management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Score of 5 or higher on Quick Inventory of Depression Symptomatology receiving Medicaid at least one child in household Exclusion Criteria: Bipolar disorder alcohol or substance abuse currently in active treatment for depression receiving Supplemental Security Income

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Telephonic care management|Individuals received intensive outreach from care managers, first to help them to enter treatment and then, if treatment began, to remain in it for an appropriate time. Treatment is based on the American Psychiatric Association's Evidence-Based Practice Guidelines for Major Depression, which includes psychotherapy and antidepressant medications. Outreach and care management took place by telephone.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of mental health services |  | Through 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity |  | 6, 18, and 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telephonic care management
Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development

Study Overview
=================
Brief Summary
-----------------
To evaluate 1) the extent of patient overestimation of breast cancer development risk in subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician counseling to improve patient risk perception and reduce psychological distress; 3) to identify factors relevant in clinical practice associated with increased distress and risk perception.

Detailed Description
-----------------
Patients referred to the Baystate Comprehensive Breast Center High-Risk Clinic wil, after giving consent, complete an intake evaluation of breast cancer risk, the patient's perceptions of breast cancer development risk, and the Brief Symptom Inventory-18. Physician history, physical and counseling then takes place, with sharing of risk estimates based on modified Gail model and Myriad tables regarding breast cancer risk and probability of BRCA1/2 mutation. After counseling, patients complete another assessment of risk perception and BSI-18, and again 2 months and 1 year post counseling. Recommendations for hormonal management and referral for formal genetic evaluation and testing will be tracked.

Official Title
-----------------
Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attendance at High-risk Clinic Ability to complete BSI-18 and risk perception questionnaire Exclusion Criteria: Diagnosis of invasive breast cancer Diagnosis of ductal carcinoma in situ.

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

| Intervention/Treatment |
| --- |
|Behavioral: Physician Counseling|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
-----------------
Anxiety, Breast Cancer Risk, Counseling, Prevention, BRCA1 mutation, BRCA2 mutation, Tamoxifen
Evaluation of a New Open Source Virtual Bronchoscope Navigation System

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of the Fraxinus Virtual Bronchoscope Navigation (VBN) System in the bronchoscopic access to target lesions. The study emphasizes the system´s efficacy in diagnostics of peripheral pulmonary lesions and the ease of use for the operator.

Detailed Description
-----------------
Multi-center study. The study explores Fraxinus which is an open source, software only, simple guiding system for bronchoscopy. The system provides 3D maps with centerline-to-target information extracted from preoperative computed tomography. The ability of the system to guide a user to a peripheral target lesion will be evaluated. During bronchoscopy any established method for diagnostic sampling is allowed. User Evaluation will be essential to decide if the Fraxinus VBN System is beneficial in a clinical setting.

Official Title
-----------------
Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System

Conditions
-----------------
Bronchial Neoplasms

Intervention / Treatment
-----------------
* Device: Fraxinus VBN system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred to thoracic department in any of the participating hospitals with undiagnosed peripheral pulmonary lesion(s) not visible by bronchoscopy voluntary signed an informed consent Exclusion Criteria: pregnancy Any patient that the Investigator feels is not appropriate for this study for any reason

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fraxinus VBN system|Open source planning tool for bronchoscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions | The proportion of cases in which the use of the system is considered beneficial | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Diagnostic success defined as cytology or biopsy with pathology | 1 week | 
| Duration of procedure | Time spent with preparations and bronchoscopy | 48 hours | 
| Adverse events | Procedure related adverse events or unexpected incidents registrated | 48 hours | 
| Operators-reported satisfaction | Enquiry on main operator´s experience after end of bronchoscopy | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchoscopy, Navigation, Feasibility Studies