linjc16/ctgov huggingface dataset:
Postoperative Care of Sutured Wounds

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the efficacy of hydrogen peroxide versus normal saline in postoperative care of sutured wounds. Subjects will be randomly assigned to standard of care hydrogen peroxide or standard of care normal saline in postoperative care of sutured wounds followed by applying petroleum jelly and sterile gauze bandage. Data will be collected at day 0 and between days 7 to14. Subjects will provide irritation scale rating (0-4) with 0 being none/absent and 4 being severe/extreme.

Official Title
-----------------
Comparing the Efficacy of Hydrogen Peroxide Versus Normal Saline in Postoperative Care of Sutured Wounds

Conditions
-----------------
Wound Healing

Intervention / Treatment
-----------------
* Drug: 3% H2O2 solution
* Drug: 0.9% normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are undergoing sutured wound after dermatologic procedure. Males and females ages 18-65 years old. Patients who are in good health. Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff. Exclusion Criteria: History of keloids or hypertrophic scars. History of bleeding tendency or coagulopathy. Pregnant or lactating or intends to become pregnant in the next 3 months. Active skin disease or skin infection in the treatment area. Unable to understand the protocol or to give informed consent. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to the subject.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrogen Peroxide<br>Post-operative wound will be treated with 3% H2O2 solution, Subjects will also clean the sutured wounds with 3% H2O2 solution or twice daily then dress the wounds with petroleum jelly and a bandage. | Drug: 3% H2O2 solution<br> <br> |
| Active Comparator: Saline<br>Post-operative wound will be treated with 0.9% normal saline. Subjects will also clean the sutured wounds with normal saline twice daily then dress the wounds with petroleum jelly and a bandage. | Drug: 0.9% normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation scale rating from 1-2 weeks compared to baseline | Subjects will provide irritation scale rating (0-4) with 0 being none/absent and 4 being severe/extreme. | Baseline and 1-2 weeks |
Cognitive and Hormonal Treatment of Sex Offenders

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.

Detailed Description
-----------------
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders. In the first part of study we are studying changes in the offenders cognitive distortions and in the second part we are studying changes in sexual activities and sexual thoughts after treatment with Leuprorelin. The study is an open pre and post study.

Official Title
-----------------
Cognitive Group and Hormonal Treatment of Sex Offenders.

Conditions
-----------------
Paraphilia

Intervention / Treatment
-----------------
* Drug: cognitive and hormone treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men sentenced for paraphilia Exclusion Criteria: Men above 70 years and men that does not speak english

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: cognitive and hormone treatment<br>cognitive and hormone (Leuprorelin) treatment | Drug: cognitive and hormone treatment<br>* cognitive and hormone (Leuprorelin) treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of cognitive distortions after treatment |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locus of control after treatment in part one. |  | 8 months | 
| Degree of mental health problems (SCL-90) |  | 8 months | 
| The testosterone levels before, during and after treatment | measured each 3rd month | baseline upto 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paraphilia, Hormonal treatment, Cognitive treatment
Fracture and Fall Prevention in Elderly With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.

Official Title
-----------------
Fracture and Fall Prevention in Elderly With Osteoporosis: Long-term Follow up

Conditions
-----------------
Osteoporosis, Osteopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
osteopenia or osteoporosis group: Inclusion Criteria: able to stand and walk for 5 minutes independently having normal or corrected to normal vision having age between > 50 years already have DEXA and X-ray exam with osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5) Exclusion Criteria: being pregnant sensory-motor deficits inability of communication lack of access to a telephone t-score <-2.5 combine with existing fracture control age-matched group: Inclusion Criteria: able to stand and walk for 5 minutes independently having normal or corrected to normal vision having age between > 50 years already have DEXA and X-ray exam without osteopenia or osteoporosis (t-score > -1.0) Exclusion Criteria: being pregnant sensory-motor deficits inability of communication lack of access to a telephone t-score <-2.5 combine with existing fracture

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Muscle activation during balance recovery | Data collection will be carried out in 2 sessions in 2 different days within the span of a week. The first day of data collection includes basic information, anthropometric measure, clinical tests, and functional tests. The second day of data collection includes muscle and joint assessment, and biomechanical tests. Each session last approximately 2.5 hours in duration. | every 3 month, up to 1 year |
A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Official Title
-----------------
A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Conditions
-----------------
Anemia, Cancer

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol Exclusion Criteria: Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy Subjects who have other diagnoses not related to the cancer which can cause anemia Known history of seizure disorder Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia Uncontrolled hypertension Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment Subject of reproductive potential who is not using adequate contraceptive precautions Concerns for subject's compliance with the protocol procedures

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darbepoetin alfa<br> | Drug: Darbepoetin alfa<br>* Q4W<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Q4W<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed antibody formation to investigational product |  | throughout study | 
| Deaths on study |  | on study | 
| Laboratory parameters |  | throughout study | 
| Vital signs (blood pressure) |  | throughout study | 
| Change in PRO scores |  | from baseline to end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncology, Cancer-related anemia
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus. This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study. Participation in the study is for 24 weeks.

Official Title
-----------------
A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers

Conditions
-----------------
Foot Ulcer, Diabetes

Intervention / Treatment
-----------------
* Device: KC-002
* Other: Conventional Wound Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants included in the study must: Have Type 1 or Type 2 diabetes mellitus Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study Be able to visit the study doctor regularly for 24 weeks Exclusion Criteria: Participants may not be included if: The diabetic foot ulcer is infected They have poor circulation in their study foot Cannot or will not wear a special boot to take pressure off the study ulcer They have certain other diseases or laboratory values which are not within a specified range

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>KC-002 | Device: KC-002<br>* Determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.<br>|
| Other: 2<br>Conventional Wound Therapy | Other: Conventional Wound Therapy<br>* Normal Saline Dressings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment |  | 12 weeks |
Results of Ocular Compression and Suture Release in Trabeculectomy and Combined Surgery

Study Overview
=================
Brief Summary
-----------------
The use of ocular compression and suture release have helped to improve the safety and decrease the risks of glaucoma filtering surgery. This study looks at the decrease in intraocular pressure and glaucoma medications required following glaucoma filtering surgery.

Detailed Description
-----------------
A retrospective review of surgical results in eyes with at least six months followup was performed for trabeculectomy and combined phacoemulsification-trabeculectomy surgery. A total of 141 eyes were studied.

Official Title
-----------------
A Retrospective Study of Surgical Outcomes.

Conditions
-----------------
Primary Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Open Angle Glaucoma Six Months Followup No previous surgery Exclusion Criteria: Less Than Six Months Followup Previous glaucoma surgery

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
POAG, Primary Open Angle Glaucoma, Trabeculectomy, Combined Phacotrabeculectomy, Combined Glaucoma Cataract Surgery, Releasable Suture, Ocular Compresssion
Effectiveness of Metal Protheses Covered in Diabolo in Treatment of Necrosis of Origin Pancreatic: Trial DIABOLOPIG

Study Overview
=================
Brief Summary
-----------------
Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal or gastric) has become a standard technique validated. The rate of high technical and clinical success (76 to 91% in 3 months) and the lower morbidity in the literature explains that validation. However this treatment is done at the cost of a higher median number of treatment sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and potentially high costs. The constant improvement of therapeutic endoscopy equipment was allowed to see the advent of metal prosthesis completely covered by a membrane allowing them endoscopic extraction with ease. It has thus been recently developed short prostheses, of large diameter (up to 15/16 mm), with broad flange (or stent diabolo) to be considered for use in the drainage of digestive peri collections. Few studies respectively determined the effectiveness of this type of prosthesis in the drainage of peri digestive collections Under echo endoscopy and treatment of necrosis of pancreatic origin. The purpose of this work is to evaluate multicenter prospective clinical and technical efficiency of laying completely covered stent diabolo in echo endoscopy for the treatment of necrosis of pancreatic origin.

Conditions
-----------------
Pancreatic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of peri gastric or duodenal collection type WOPN to imaging according to the Atlanta criteria (Banks Gut 2013) with predominantly solid component (> 50%) for imaging, requiring necrosectomy for: Pain and / or, necrosis infection (positive necrosis culture, gas bubble presence in the collection on imaging, persistent sepsis or deterioration of the patient's condition despite optimal reanimation support without documented infection) and / or, High Occlusion (vomiting, food intolerance and gastric stasis at imaging) Exclusion Criteria: Severe coagulation disorders or hemostasis

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who complete treatment of pancreatic necrosis | Rate of patients who complete treatment of pancreatic necrosis was obtained (> 80% and amendment of symptoms) after a single necrosectomy endoscopic session with a covered metal prosthesis. | 3 months |
Vibratory Anesthesia in Trigger Finger Injections

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the effectiveness of the use of no topical anesthesia, topical coolant, and the use of vibration in the reduction of pain during trigger finger injections. This will be done by randomizing patients who are diagnosed with trigger finger, warrant and choose to continue with a steroid injection into each of the respective anesthetic (or lack thereof) methods described. After conducting this and gathering data on the subjects pain felt, we will compare the analgesia from each of the anesthetic methods.

Official Title
-----------------
Investigation of the Effectiveness of Vibratory Stimulus in Trigger Finger Injections

Conditions
-----------------
Trigger Finger, Pain, Anesthesia, Local

Intervention / Treatment
-----------------
* Device: Vibration Anesthesia Device by Blaine Labs
* Drug: Gebauers Ethyl Chloride 100% Topical Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Adult Diagnosed with trigger finger Warrants a trigger finger injection Exclusion Criteria: Subjects with known decreased light touch sensation in the territory of the trigger finger injection. Not diagnosed with trigger finger or does not warrant a trigger finger injection per the typical treatment algorithm adopted by the attending physician.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No topical anesthesia<br>No topical anesthesia will be given during the trigger finger injection. | |
| Experimental: Topical coolant<br>The subject will have 5 seconds of sterile ethyl chloride sprayed at the site of the trigger finger injections just prior to the administration of the injection. | Drug: Gebauers Ethyl Chloride 100% Topical Spray<br>* Sterile ethyl chloride spray<br>* Other names: P/N 0386-0001-03;|
| Experimental: Vibration<br>The subject will have a vibration device placed just proximal to the site of the trigger finger injection concurrent with the administration of the injection. | Device: Vibration Anesthesia Device by Blaine Labs<br>* Device which vibrates on top of skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Felt | Visual Analog Pain Scale Rating (Hayes and Patterson 1921) Scale Title: Pain scale Maximum Value: 10 - The worst pain Minimum value: 0 - No pain *A lower number indicates a better outcome (less pain felt). | Immediately after the trigger finger injection is completed |