linjc16/ctgov huggingface dataset:
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two). An historic matched-control group of 20 patients will be compared retrospectively

Official Title
-----------------
A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence

Conditions
-----------------
Dehiscence Wound

Intervention / Treatment
-----------------
* Device: ActiGraft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Women that had a laparotomy no more than 3 weeks before accrual. Surgical wound dehiscence that requires a secondary closure. Time from wound dehiscence >24 hours and <6 days. The open wound includes epidermis, dermis and sub cutaneous fat. The patient can sign an informed consent form. Exclusion Criteria: Patients with necrotizing fasciitis Patients with fascial dehiscence Cannot withdraw blood in the required amount (up to 18 mL per week). Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded. Pregnancy Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (Prednisone- more than 10mg/d or equivalent).

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

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

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: ActiGraft<br>Whole blood clot (WBC) gel | Device: ActiGraft<br>* Whole blood clot (WBC) gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete wound closure | Skin re-epithelialization without drainage or dressing requirements | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Percent Area Reduction (PAR) | The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage. | 2, 4 and 6 weeks | 
| Mean time of complete wound closure | Skin re-epithelialization without drainage or dressing requirements | 4 weeks | 
| Durability of wound closure 2 weeks after complete healing | No wound dehiscence | Up to 6 weeks | 
| Comparison of time to complete closure between study cases and historic control | Skin re-epithelialization without drainage or dressing requirements | 4 weeks |
Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU

Study Overview
=================
Brief Summary
-----------------
Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included. Arterial blood gases (ABG), partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FiO2 ) ratios, partial pressure of carbondioxide (PaCO2), positive end expiratory pressure (PEEP), and fraction of inspired oxygen (FiO2) values will be recorded before (bPP), during (dPP)and after (aPP) every prone positioning. Eye, skin, nerve and tube complications related to prone positions wll be recorded

Official Title
-----------------
Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU: A Retrospective Study

Conditions
-----------------
Acute Respiratory Distress Syndrome, COVID-19 Respiratory Infection

Intervention / Treatment
-----------------
* Other: prone position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. - Exclusion Criteria: negative test result for SARS-CoV-2 RNA -

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 |
| --- |
|Other: prone position|thirty-one patients who had a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. Medical datas of the patients will be obtained from patients' files which are strictly filled during pandemic. Prone position indication of intensive care unit (ICU) is in case of severe ARDS with PaO2/FiO2 <150 despite a PEEP >10 cmH2O.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of prone position | The investigators will evaluate the arterial blood gase results and ventilator settings before after and during prone position | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prone position, intensive care unit
cArdiac Non Invasive MApping in resynchronizaTION

Study Overview
=================
Brief Summary
-----------------
Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.

Detailed Description
-----------------
Non-invasive mapping using the Cardio Insight system is prospectively performed routinely in heart failure patients requiring cardiac resynchronization therapy. Control patients are included, requiring chronic permanent right ventricular pacing. Specific focus include: optimization of programming parameters, pacing-induced cardiomyopathy, ventricular arrhythmias, defibrillation threshold testing and electrical shocks.

Official Title
-----------------
cArdiac Non Invasive MApping in resynchronizaTION Registry

Conditions
-----------------
Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Diagnostic Test: Non invasive epicardial mapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients implanted with a biventricular pacing device (CRT) device Patients chronically implanted with a right ventricular pacing device. Exclusion Criteria: Age <18 years

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biventricular Pacing<br>Patients implanted with a device enabling cardiac resynchronization therapy. | Diagnostic Test: Non invasive epicardial mapping<br>* Non invasive mapping using Cardio Insight system is performed in all included patients.<br>* Other names: ECG imaging;|
| Right Ventricular Pacing<br>Patients implanted with a right ventricular pacing device. | Diagnostic Test: Non invasive epicardial mapping<br>* Non invasive mapping using Cardio Insight system is performed in all included patients.<br>* Other names: ECG imaging;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular activation map | Differences (qualitative and quantitative measurements) in ventricular activation patterns are identified. | Up to 6 months | 
| Response to CRT | Composite endpoint : volumetric response, heart failure hospitalizations, and all-cause mortality. | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non invasive mapping, cardiac resynchronization therapy, pacing-induced cardiomyopathy, electrical shock
Tympanometric Analysis in Cleft Palate

Study Overview
=================
Brief Summary
-----------------
Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.

Official Title
-----------------
Tympanometric Analysis in Post Surgical Individuals With Cleft Palate

Conditions
-----------------
Bilateral Complete Cleft Lip and/or Alveolus

Intervention / Treatment
-----------------
* Other: Tympanometry measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cleft incisive trans unilateral or bilateral post-foramen complete or incomplete Exclusion Criteria: isolated cleft lip associated syndromes malformation of ear

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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: Tympanometry measurement<br> | Other: Tympanometry measurement<br>* The tympanometry measurement will be verify and compared with the time of palatoplasty.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanic membrane mobility | Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml. | 3 months to 33 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of palatoplasty |  | 3 months to 33 years |
Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a clinical trial to evaluation the effect of a menopausal health training for Husbands of 45-60 years women on the women's quality of life and marital satisfaction during transitional period to menopause.

Detailed Description
-----------------
The investigators applied a menopausal health training program for Husbands of 45-60 years women. The content of menopausal health training program was about the nature of menopause, signs and symptoms, complications, treatment option and health behavior during transitional period. Training program lasted 3 sessions. The investigators assessed quality of life and marital satisfaction using Hildich marital satisfaction questionnaire and Menopause Quality of Life questionnaire(MENQOL), respectively, three month after intervention.

Official Title
-----------------
Effect of Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction During Transitional Period

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Other: Training program about menopausal health isues


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living with their spouse no history of premature menopause no history of hysterectomy no history of oophorectomy no history of acute disease no history of burden chronic disease Exclusion Criteria: no participation of spouse in all of training session uncompleted all of equation favorite to exclude from study

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Training program about menopausal health isues | Other: Training program about menopausal health isues<br>* A three sessions raining program about health issues during menopause for spouses of 45-60 years old<br>|
| No Intervention: Control group<br>No training program about menopausal health isues | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | assessing with MENQOL | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marital satisfaction | Hildich Marital satisfaction questionnaire | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Quality of Life, Marital Satisfaction, training
Evaluation of Primary Congenital Glaucoma at Asyut University Hospital

Study Overview
=================
Brief Summary
-----------------
Evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at Asyut University Hospital

Official Title
-----------------
Evaluation of Primary Congenital Glaucoma Management at Asyut University Hospital

Conditions
-----------------
Primary Congenital Glaucoma

Intervention / Treatment
-----------------
* Procedure: Combined trabeculotomy-trabeculectomy with mitomycin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Typical symptoms of epiphora , photophobia and blepharospasm Corneal diameter > 13 mm Increased ocular tension > 25 mmHg UGA using schiotz tonometer Exclusion Criteria: Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infants with primary congenital glaucoma<br> | Procedure: Combined trabeculotomy-trabeculectomy with mitomycin C<br>* Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP follow up | postoperative measurment of Intra ocular pressure by shoitz tonometer | 1 year |
Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content

Study Overview
=================
Brief Summary
-----------------
This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.

Official Title
-----------------
Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Behavioral: video assisted group
* Behavioral: non-video group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being a being bariatric metabolic surgery candidate according to international guidelines Exclusion Criteria: illiterate previous bariatric surgery age <18

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: only informed consent<br>The first group was given verbal-written informed consent and a 15 question quiz about the informed consent content afterwards. | Behavioral: non-video group<br> <br> |
| Experimental: video assisted group<br>The second group got an additional information video presentation and then the same quiz. | Behavioral: video assisted group<br> <br> Behavioral: non-video group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | In the video group : verbal-written consent + video presentation In the conventional consent group: only verbal-written consent The video consisted of a summary of the written informed consent. Questionnaire consist of 15 questions quiz was given to both groups. Each question was rated on 15 points. 1point = bad score means don't understand informed consent. 15 point = full score means good understanding. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multimedia, informed consent, metabolic surgery, Roux-en-Y gastric bypass
Rehabilitation Coordinators in Orthopedic Care

Study Overview
=================
Brief Summary
-----------------
REKO-O is a study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic.

Detailed Description
-----------------
REKO-O is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic

Official Title
-----------------
Rehabilitation Coordinators in Orthopedic Care

Conditions
-----------------
Back Problems or Pain, Foot Problems or Pain, Shoulder Problems or Pain

Intervention / Treatment
-----------------
* Behavioral: Intervention with rehabilitation coordinator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not recovered in accordance with care plan or cannot be operated and wants an extension of his sick leave Exclusion Criteria: Obvious medical complications for surgery (wound infection, prosthetic dislocation, stopper or the like) Permanent disability pension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with rehabilitation coordinator<br>Intervention with rehabilitation coordinator (RECO) | Behavioral: Intervention with rehabilitation coordinator<br>* Intervention with rehabilitation coordinator in orthopedic care<br>|
| No Intervention: Control<br>TAU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RTW | Number of Participants that Return to work (RTW) | 0.5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Back pain
A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.

Official Title
-----------------
An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: EMD 72000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease Immunohistochemical evidence of tumor EGFR (HER-1) expression At least one measurable lesion according to the WHO criteria Life expectancy ≥ 12 weeks ECOG performance status 0-1 Exclusion Criteria: History of prior MAb therapy History of prior treatment with an EGFR (HER-1) directed therapy Known brain metastases Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted) Known intercurrent infections or immunosuppression Actively infected with, or chronic carriers of HBV Evidence of HCV disease Previous diagnosis of autoimmune disease Known hypersensitivity to the administered drugs or any of their components Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EMD 72000|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
-----------------
EGFR; HER-1; monoclonal antibody; targeted therapy