linjc16/ctgov huggingface dataset:
BPK-S Integration (Ceramic) Post Market Clinical Follow-Up

Study Overview
=================
Brief Summary
-----------------
Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.

Official Title
-----------------
Prospektive, Klinische Studie Zur Marktbeobachtung (Post Market Follow-Up Study) Der Knieendoprothese BPK-S Integration Aus Keramikwerkstoff BIOLOX (R) Delta (Prospective Clinical Post Market Follow-up Study of the Total Knee Endoprosthesis BPK-S (Brehm Precision Knee System)Made of Ceramic Material BIOLOX (R) Delta

Conditions
-----------------
Restoration if Knee Joint Function

Intervention / Treatment
-----------------
* Device: BPK-S Integration (Ceramic)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement Defects or malfunctions of the knee joint Degenerative, rheumatic, post-traumatic arthritis/arthrosis Symptomatic knee instability Reconstruction of flexibility Patients with material hypersensitivity Exclusion Criteria: Obesity or overweight of the patient Acute or chronic infections near the implantation Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc. Sensitivity to foreign matter in the implant materials Bone tumors in the area of the implant anchoring Illnesses which can be treated without using a knee implant Lack of patient cooperation Abuse of medication, drug abuse, alcoholism or mental disease Pregnancy Serious osteoporosis Serious damage to the bone and soft tissue structures which impedes stable anchoring and joint function Systemic diseases and metabolic disorders Overload of the knee implant to be expected
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BPK-S Integration (Ceramic)|primary total knee endoprosthesis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Knee Society Score |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Knee Society Score over the course of the study |  | 3 months, 24 months | 
| Improvement of EQ-5D (Euroquol 5 dimension) score |  | 3 month, 12 months, 24 months | 
| Improvement of Oxford Score |  | 3 month, 12 months, 24 months | 
| Documentation of Complications |  | 3 month, 12 months, 24 months |
Pursestring Wound Closure vs Gunsight Skin Incision and Closure Technique to Reverse Stoma

Study Overview
=================
Brief Summary
-----------------
The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. The aim of this study is to compare the rates of superficial wound infection, healing time and patient satisfaction after pursestring closure vs gunsight skin incision and closure technique closure.

Official Title
-----------------
Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs Gunsight Skin Incision and Closure Technique to Eliminate the Risk of Wound Infection

Conditions
-----------------
Colostomy

Intervention / Treatment
-----------------
* Procedure: Pursestring Wound Closure
* Procedure: Gunsight Skin Incision and Closure Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: loop colostomy end colostomy Exclusion Criteria: other stomy
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pursestring Wound Closure group<br>use Pursestring Wound Closure technique to close the stoma | Procedure: Pursestring Wound Closure<br> <br> |
| Experimental: Gunsight Skin Incision and Closure group<br>use Gunsight Skin Incision and Closure Technique to close the stoma | Procedure: Gunsight Skin Incision and Closure Technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| superficial wound infection of stoma site |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time after stoma reversal |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reversal, Surgical technique, Pursestring Wound Closure, Gunsight Skin Incision and Closure Technique
Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)

Study Overview
=================
Brief Summary
-----------------
Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony prominence of their body, which is expected to break down into a pressure ulcer) will be place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the amount of tissue breakdown from their bruise.

Detailed Description
-----------------
Up to 15 centers will participate in this case series in acute care and long term acute care facilities. Patients who present with sDTI and consent for study will have the Clinitron® Rite HiteTM bed ordered and delivered within a 12 hour window to be able to participate. They will have their sDTI photographed, and an assessment of expected breakdown will be noted by the clinical team. The patient will be followed during the course of hospitalization and additional photographs and documentation will be performed by the clinical team to demonstrate the actual breakdown that occurred. Information including the pertinent history of current illness, co-morbid conditions, and demographic information will be shared with the sponsor in order to demonstrate each case.

Official Title
-----------------
Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series

Conditions
-----------------
Pressure Ulcers

Intervention / Treatment
-----------------
* Device: AFT bed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sDTI on the supine aspect of their body Patient does not require a pulmonary specialty bed for care Patient is expected to be in the hospital for at least 3 days Patient weighs between 30 and 350 Lbs. Patient's height is less than 75 inches tall Patient, or patient's representative, is willing and able to sign written informed consent Patient is expected to survive hospitalization. Exclusion Criteria: Patient is less than 18 years of age Patient has already participated in this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AFT bed|All identified patients will receive a AFT bed for a maximum of 21 days or until discharge|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of breakdown | This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sDTI, Pressure ulcers, Therapy surfaces, Mattresses, Deep Tissue Injury, pressure ulcer treatment
An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection

Study Overview
=================
Brief Summary
-----------------
This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.

Official Title
-----------------
Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients

Conditions
-----------------
Hepatitis C, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Chronic Hepatitis C infection (mono-infection or co-infection with human immunodeficiency virus [HIV]) Detectable level of hepatitis C RNA Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines Last liver biopsy performed no later than 3 months prior to enrolment to study Exclusion Criteria: Co-infection with hepatitis B virus Previous treatment with pegylated interferon and ribavirin Participation in another clinical study in the last 12 months prior to study start

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start |  | 24 months | 
| Correlation of liver elasticity evolution with viral kinetics |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: incidence of adverse events |  | 24 months | 
| Correlation of liver fibrosis stages with sustained virological response (SVR) |  | 24 months | 
| Correlation of patients characteristics with sustained virological response |  | 24 months | 
| Hepatic transient elastography (M-transducer) |  | 24 months | 
| Hepatic transient elastography (XL-transducer) |  | 24 months | 
| Correlation of hepatic steatosis score with sustained virological response |  | 24 months | 
| Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy |  | 24 months | 
| Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients |  | 24 months |
Monovision for the Treatment of Diplopia

Study Overview
=================
Brief Summary
-----------------
PURPOSE: The purpose of this study is to quantitatively assess the efficacy of monovision correction in the treatment of acquired small angle binocular diplopia in adult patients. METHOD: Twenty patients with symptomatic diplopia were enrolled in a prospective treatment trial. All had stable deviations of 10 prism diopters or less for over three months. Each received monovision spectacles and/ or contact lenses with distance correction in the dominant eye. Half received a +3.00 diopter (D) add and the others received +2.50 D. The validated and standardized Diplopia Questionnaire and Amblyopia and Strabismus Questionnaire (ASQE) were used to quantify the efficacy of monovision correction for diplopia by measuring the functional impact on vision-specific quality of life.

Official Title
-----------------
Monovision for Treatment of Diplopia

Conditions
-----------------
Strabismic Deviation

Intervention / Treatment
-----------------
* Other: Monovision Correction (with the help of glasses or contact lenses)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Strabismic Deviation less than 12 Prism Diopters Exclusion Criteria: Inability to sign informed consent

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monovision Correctoin<br>Monovision correction | Other: Monovision Correction (with the help of glasses or contact lenses)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction with monovision was measured by standardized diplopia questionnaire and results reported in statistical terms on multiple measures tested on the questionnaire. | To determine whether monovision correction was useful for the correction of small angle deviations in strabismic patients | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Strabismic deviation less than 12 prism diopeters
Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain

Study Overview
=================
Brief Summary
-----------------
this research will evaluate the effect of PRF with different bioactive materials in dentistry

Detailed Description
-----------------
PRF will be used with MTA and Theracal to evaluate its effect upon these materials in reliving pain and maintains the teeth vitality in permanent teeth with closed apices, in order to improve the materials outcome.

Official Title
-----------------
Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain and Maintaining the Vitality of the Remaining Radicular Pulp Tissue in Permanent Posterior Teeth With Closed Root Apices: Randomized Controlled Trial

Conditions
-----------------
Neuritis

Intervention / Treatment
-----------------
* Other: PRF with Theracal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from Symptomatic pulpitis. Patients should be free from any systemic disease that may affect normal healing and predictable outcome. Patients who will agree to the consent and will commit to follow-up period. Patients with mature root. Patients with no periapical lesion. Patients with localized pain. Posterior teeth only will be involved Exclusion Criteria: Patients with immature roots. Patients with any systemic disease that may affect normal healing. Patients with periapical lesions or infections. Pregnant females. Patients who could/would not participate in a 1-year follow-up. Patients with fistula. Patients with necrotic pulp. Patients with old age.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 Years

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

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: PRF with MTA<br>PRF with MTA with PRF with Theracal as intervention | Other: PRF with Theracal<br>* using the PRF which is a new technique with an bioactive material which is the Theracal to evaluate its effect upon the radicular pulp tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain after the process | Questionnaire by asking the patient about the pain intensity | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dentin bridge formation | X-ray | 1 year | 
| no periapical radiolucency | X-ray | 1 year |
Safety and Effectiveness of Computer Screening for Intimate Partner Violence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if using a computer kiosk to screen men and women for intimate partner violence victimization and perpetration is safe and effective. We hypothesize that screening will not result in any adverse events.

Detailed Description
-----------------
All eligible ER patients will be screened during study times for IPV victimization and perpetration. All victims will be followed at 1 week and 3 months to determine any adverse outcomes. Perpetrators will only be followed in the ED for adverse outcomes after screening. All patients who disclose IPV victimization or perpetration will get a list of community resources. Victims will be asked at follow up what resources they used.

Conditions
-----------------
Domestic Violence, Perpetration

Intervention / Treatment
-----------------
* Procedure: Screening patients for IPV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age 18-55 who present to the emergency department waiting room during study hours - Exclusion Criteria: Acutely intoxicated, psychotic, unable to read, not English speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Screening patients for IPV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events in the ED |  |  | 
| Increased violence at follow up |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intimate partner violence, perpetration
Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P-12 Study

Study Overview
=================
Brief Summary
-----------------
This long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov.Identifier: NCT05042206).

Detailed Description
-----------------
This long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov.Identifier: NCT05042206). The long-term safety of Cellgram-CKD is evaluated by monitoring whether or not an adverse event of special interest (AESI) occurs for 5 years from the date of administration in Cellgram-CKD subjects who voluntarily consented in writing to participate in the long-term follow-up study.

Official Title
-----------------
Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P-12 Study

Conditions
-----------------
Renal Insufficiency, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who participated in the PMC-P-12 clinical trial and received Cellgram-CKD Subjects who consented in writing to this long-term follow-up study Exclusion Criteria: Not Applicable

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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 |
| --- | --- | --- |
| Observe the occurrence of Adverse Event of Special Interest (AESI). | AESI stands for Serious Adverse Event as follows. death Creation of neoplasms or malignancies in tissues or organs The development of an immune response, including the exacerbation or new development of a previous autoimmune disease Occurrence of Other delayed adverse events related to stem cell therapy | 5 years from the date of administration of Cellgram-CKD |
RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19

Study Overview
=================
Brief Summary
-----------------
the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients

Official Title
-----------------
RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19

Conditions
-----------------
SARS-CoV Infection, Pinkeye

Intervention / Treatment
-----------------
* Diagnostic Test: conjunctival RT PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women positive for SARS-Cov-2 on a RT-PCR test of a sample of respiratory airway Persons over 18 years of age patients of both sexes Member of a social security scheme Having signed the consent form Exclusion Criteria: Minors not emancipated, persons out of state to express their consent Participation in intervention research on Covid-19 involving experimental treatment History of chronic disease conjunctiva Patient with one of the one of the criteria of following gravity: EN > or =30/min, Pao2/Fio2 = or < 300, confusion and/or disorientation, hypotension (Tas90mmhg, requiring aggressive filling), need for a invasive ventilation, septic shock

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Diagnostic Test: conjunctival RT PCR<br>* conjunctival sample in covid-19 patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis | to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis | 3 months |