linjc16/ctgov huggingface dataset:
Extracorporeal Perfusion of Microvascular Free Flaps

Study Overview
=================
Brief Summary
-----------------
The perfusion of microvascular free flaps is inevitable for completion of reconstruction in the head and neck area. In some patients microvascular anastomosis is impossible because of arteriosclerotic changes, different oncological interventions, and consecutive vessel depletion at the neck. The aim of the project is to establish an innovative system for extracorporeal perfusion of microvascular free flaps after ingrowth of new vessels from the wound bed have taken place. Afterwards, no further perfusion of the vascular pedicle is required for free flaps to survive and provide functional and aesthetic reconstruction.

Official Title
-----------------
Extracorporal Perfusion of Free Flaps in the Head and Neck

Conditions
-----------------
Perfusion, Complication of Perfusion

Intervention / Treatment
-----------------
* Procedure: Perfusion of flaps by a special bypass system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vessel depleted neck defect in the head and neck area Exclusion Criteria: active oncological disease vessels suitable for microvascular anastomosis and reconstruction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: perfusion of flaps by a bypass system<br>Support of perfusion of microvascular free flaps until ingrowth of vessels from the wound bed has taken place. The System works with a pressure controlled bypass to ensure low grade perfusion. | Procedure: Perfusion of flaps by a special bypass system<br>* Free flaps are perfused via a special bypass perfused by a new technique supported by a intermittent perfusion support system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion of Free Flap from wound bed |  | Two Weeks |
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Co-administration of DWC20155/DWC20156
* Drug: DWC20163


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepts healthy volunteers Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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: Study effect of DWC20163 on DWC20155/DWC20156 PK<br>To study effect of DWC20163 on DWC20155/DWC20156 PK | Drug: Co-administration of DWC20155/DWC20156<br> <br> Drug: DWC20163<br> <br> |
| Experimental: Study effect of DWC20155/DWC20156 on DWC20163 PK<br>To study effect of DWC20155/DWC20156 on DWC20163 PK | Drug: Co-administration of DWC20155/DWC20156<br> <br> Drug: DWC20163<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | 0   24 hours | 
| Area under the time versus plasma concentration curve (AUC) |  | 0   24 hours |
Assessment of Surgically Removed Abdominal Wall Endometriomas

Study Overview
=================
Brief Summary
-----------------
A retrospective review of all patients who underwent surgery for an anterior abdominal wall mass which confirmed by pathology examination as an endometrioma will be completely performed. The clinical data will be recorded and pathology report diagnosis will be correlated with the clinical data to assess the possible causes of endometrioma in the women treated in our tertiary hospital and the efficacy of the surgical excision.

Detailed Description
-----------------
Our hospital is a tertiary center for performing Cesarean sections, external endometriosis (Endometrioma) is a challenging complication for this operation, many treatment choices are available and the most common is the surgical excision, however recurrence could be seen after the surgical operation. We assess all patients who underwent surgical excision for abdominal wall endometriomas in our hospital by retrieving the medical files and pathology reports to study the possible age group,causes and duration of endometriomas. Also the rate of enodmetriomas among the previously experienced females with cesarean section operations. Pathological diagnosis tools will be also assessed. Ethical approval was obtained from the local committee. Results will be statistically assessed using SPSS programm.

Official Title
-----------------
Clinico-pathological Assessment of Surgically Removed Abdominal Wall Endometriomas

Conditions
-----------------
Endometriosis Outside Pelvis

Intervention / Treatment
-----------------
* Other: Microscopic examination using H&E stained slides


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Surgically removed abdominal wall endometrioma Exclusion Criteria: Male (very very rare to occur) medically treated enodmetrioma Outside treated patients

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cesarean sectioned<br>All females who treated in our hospital by Cesarean section operation during two-years-period | |
| Complicated with Abdominal wall endometriosis<br>All the surgically excised endometrioma cases during the same time period | Other: Microscopic examination using H&E stained slides<br>* Reexamination of the stained slides of the patients from the hospital archive and adding a CD10 stain when required<br>* Other names: CD10 immunohistochemistry;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive for endometrioma | Presence of endometrial glands and stroma along with hemosidren pigment under microscopic examination, confirms the diagnosis and the case will be calculated and the related clinical data | 1 day |
Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol

Study Overview
=================
Brief Summary
-----------------
This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Detailed Description
-----------------
Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but also stable at room temperature and easily available worldwide. It is indicated for the treatment of gastritis, but is widely used off-label for a variety of indications in the practice of obstetrics and gynecology, including medication abortion, induction of labor, and the treatment of postpartum hemorrhage. The optimal dosage and route of administration have not been well defined and vary with physicians. The potency of misoprostol's effect varies with dosage, route of administration and dosing interval; both maternal and fetal factors may, to certain extent, affect the abortion interval. This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Conditions
-----------------
Labor Induction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.All female patients who were admitted for medical termination of second-trimester pregnancy Exclusion Criteria: 1. Patients who are allergy to Cytotec.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancy<br>Women who underwent termination of pregnancy at second trimester due to a variety of causes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful termination rate by Cytotec. |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting abortion interval by cytotec. | To identify the factors affecting termination interval Cox regression model. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
termination of pregnancy, abortion
Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil

Study Overview
=================
Brief Summary
-----------------
Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.

Official Title
-----------------
Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years; Newly diagnosed advanced stage IIIB-IV NSCLC (AJCC 8th edition) or locally advance/distant relapse in the period of January 2015 to December 2020. NSCLC with pathological confirmation of ALK rearrangement by immunohistochemistry, fluorescent in situ hybridization (FISH) or next generation sequencing (NGS); ECOG 0-4; Patients with CNS metastases are also considered eligible, regardless of the initial treatment instituted. Exclusion Criteria: - Incomplete medical chart in terms of date of diagnosis, ALK test results and outcomes

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 |
| --- | --- | --- |
| - Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting. |  | December of 2020 | 
| - Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment. |  | December of 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Estimate the progression-free survival of first-line treatment, and other subsequent lines; |  | December of 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Non-Small-Cell Lung
Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization in Total Hip Arthroplasty (THA) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients.

Official Title
-----------------
Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization After Primary Total Hip Arthroplasty

Conditions
-----------------
Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Primary THA Exclusion Criteria: Alcoholism Known orthostatic hypotension Daily use of anxiolytic medication

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 |
| --- | --- | --- |
| Orthostatic intolerance |  | 6 and 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic hypotension |  | 6 and 24 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobilization, Hip arthroplasty, cardiovascular
Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

Study Overview
=================
Brief Summary
-----------------
A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal infection.

Official Title
-----------------
Randomized, Open-label, Comparative Study of Zosyn (Pip/Tazo [12g/1.5g]) Administered by Daily 24hr Continuous Infusion vs Zosyn (Pip/Tazo) [3g/0.375g]) q6h for the Treatment of Hospitalized Patients With Complicated Intra-abdominal Infection

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Piperacillin/Tazobactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Written informed consent will be obtained prior to enrollment into the study. If any patient is unable to give consent, it may be obtained from next of-kin or a legal representative if in accordance with local laws and regulations Hospitalized, ≥18 years of age Male or non-pregnant, non-lactating female who is post-menopausal, surgically sterilized or is using birth control pills, contraceptive implant or injection (ex: NORPLANT®; DEPO-PROVERA®), intra-uterine device, barrier methods with spermicide, or abstinence. (Effective contraception should have been in place for at least two months prior to study entry and must continue for at least 30 days after treatment discontinuation) Exclusion Criteria Patients with underlying immunodeficiency disease or patients requiring chronic treatment with known immunosuppressant medications including >5mg/day prednisone Active or treated leukemia, or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the past year or which is anticipated to begin prior to the Test-of-Cure visit; or any known or suspected malignancy to the abdomen Concurrent hemodialysis, peritoneal dialysis or patients with indwelling peritoneal catheters or shunts, plasmapheresis or hemoperfusion

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Piperacillin/Tazobactam|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
-----------------
Abdominal Infections
Distal Femur Fracture Nonunion - Statistical Analysis Plan

Study Overview
=================
Brief Summary
-----------------
Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

Detailed Description
-----------------
See attached PDF.

Official Title
-----------------
Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan

Conditions
-----------------
Femur Distal Fracture, Nonunion of Fracture

Intervention / Treatment
-----------------
* Procedure: Lateral locking plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 16 years AO/OTA type A or C distal femur fracture Fracture located on the metaphyseal area of the distal femur (square method) Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate Operative treatment within 1 month after trauma Operative treatment between years 2009 and 2018 Exclusion Criteria: Stress fracture Pathological fracture An epicondylar or subchondral fracture A ligament sprain in distal femur Treatment with a double-plating method or with both plate and nail Non-surgical treatment and patients who died before the treatment Treatment with an unconventional plate (other than distal femur plate) Patients whose follow-up criteria not fulfilled

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 110 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Lateral locking plate|Plating of the distal femur fracture with lateral locking plate.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | Reoperation due to fracture nonunion | Within 36 months after the initial trauma | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prediction, Distal femur fracture, Nonunion, Statistical analysis plan
Adherence Evaluation in COPD

Study Overview
=================
Brief Summary
-----------------
The rationale of this study is to have a better understanding of the perception of the pulmonologists, general practitioners and patients of adherence (causes, main consequences, supportive tools,..) and the use of TAI-questionnaire (appreciation, usability,…) by interviewing pulmonologists & general practitioners and a survey with patients. Based on the outcome, projects and tools can be developed to help health care professionals to motivate patients to improve adherence and to help patients to increase their adherence to inhalation therapy.

Official Title
-----------------
Evaluation of Perception and Knowledge of Adherence to COPD Inhalation Therapy at Patient, GP and Pulmonologist Level

Conditions
-----------------
Adherence, Treatment, COPD

Intervention / Treatment
-----------------
* Other: No intervention (survey)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonologists or general practitioners or COPD patient (suffering from COPD treated with inhalation therapy) Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonologists<br>Interviews with pulmonologists | Other: No intervention (survey)<br>* No intervention -> survey at 1 timepoint<br>|
| General practitioners<br>Interviews with general practitioners | Other: No intervention (survey)<br>* No intervention -> survey at 1 timepoint<br>|
| Patients<br>Survey with COPD patients | Other: No intervention (survey)<br>* No intervention -> survey at 1 timepoint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge and perception of adherence | Gathering knowledge based on semi-structured interview (definition, causes, consequences of bad adherence,...) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of the adherence to inhalers-questionnaire (TAI) | Evaluate the usability of 'Test of the adherence to inhalers'-questionnaire (TAI) based on semi-structured interview | Baseline |
Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence

Study Overview
=================
Brief Summary
-----------------
.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .

Detailed Description
-----------------
Lay open is the classic surgical management for Peri Anal fistula,however division of significant portion of anal sphincter may be divided with postoperative fecal incontinence,Many surgical techniques have been described for sphincter preservation ,But unfortunately associated high recurrence rate.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .The operation is done in tow stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane thus converting it to intersphincteric fistula which is then laid open , with division of internal sphincter with preserving external sphincter.

Conditions
-----------------
High Transsphincteric Perianal Fistula

Intervention / Treatment
-----------------
* Procedure: Rerouting technique for transsphincteric perianal fistula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High arching transsphincteric fistula Transsphincteric fistula with high internal opening Transsphincteric fistula with short anal canal. Horseshoe perianal fistula fulfilling above criteria. Exclusion Criteria: Transsphincteric fistula. Low perianal fistula.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: transsphincteric perianal fistula<br>Rerouting technique done in patients with high transsphincteric fistula or with high internal opening. | Procedure: Rerouting technique for transsphincteric perianal fistula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery . |  | one year |