linjc16/ctgov huggingface dataset:
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

Study Overview
=================
Brief Summary
-----------------
The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.

Official Title
-----------------
Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation

Conditions
-----------------
Aortoiliac Aneurysms, Iliac Aneurysms

Intervention / Treatment
-----------------
* Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An aortoiliac or iliac aneurysm of appropriate size Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Unsuitable arterial anatomy

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

| Intervention/Treatment |
| --- |
|Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,|Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.|

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
-----------------
Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Prevalence of Female Circumcision Among Young Women in Beni-Suef, Egypt

Study Overview
=================
Brief Summary
-----------------
Female circumcision (FC) is a deeply-rooted practice in Egypt with deblitating physical and psychological consequences, however the previous two decades witnessed sincere efforts to counterfight this practice. The objective of this study is to investigate the prevalence of circumcision among young women (12-25 years) in Beni-Suef , Egypt.

Detailed Description
-----------------
This cross-sectional study was conducted on a total of 3353young women residing urban and rural quraters in Beni-Suef City. Data was collected usinga questionnaire that included information about the socio-demographic charcteristics of the women, their gynecological data, exposure to FC, and complaints associated with menses during the previous year.

Official Title
-----------------
Prevalence of Female Circumcision Among Young Women in Beni-Suef, Egypt. A Cross-sectional Study

Conditions
-----------------
Woman Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young women aged 12 to 25 years living in Beni-Suef city of Egypt. the urban Metropolitan of Beni-Suef City was classified according to the socioeconomic level of its quarters to low, middle, and high levels. Out of each level, one quarter was selected randomly, by a card withdrawal, where households residing these quarters were chosen using a random start. For the rural villages surrounding the urban Metropolitan, three villages were selected randomly; one on the road to the North, one on the road to the West, and the last one on the road tothe South. Each village was clustered roughly into two sites; one to the East of the water channel and one to the West of the same water channel Exclusion Criteria: Women from other places in Egypt.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

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

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 |
| --- | --- | --- |
| Gynecological manifestations measured by a questionnaire. | A questionnaire included questions about the manifestations associated with menses and average duration of dysmenorrhea during the previous year. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| social status measured by a questionnaire | A questionnaire included questions about age at menarche, social, educational and work status. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female circumcision, Young Women, Dysmenorrhea,Dysuria
Return to Play Checklist

Study Overview
=================
Brief Summary
-----------------
This study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair.

Official Title
-----------------
Safe Return to Play Following Surgery for Labral Repair: Development and Validation of a Return to Play Checklist

Conditions
-----------------
Labral Tear, Glenoid

Intervention / Treatment
-----------------
* Other: Safe return to play checklist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Males and non-pregnant females aged 15 years or older with a capsulolabral tear undergoing arthroscopic capsulolabral repair surgery at the Rothman Institute with one of the investigators Exclusion Criteria: Patients with an labral repair Patients only undergoing debridements with no repair Patients undergoing revision shoulder surgery or those with a history of multiple shoulder surgeries Concomitant severe glenohumeral arthritis or adhesive capsulitis Patients with a worker's compensation claim Patients diagnosed with psychological disorders Patients with a history of alcohol or drug abuse -Patients on preoperative narcotic therapy -

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Utilization of a safe return to play checklist<br>Athletes who were treated for a capsulolabral tear who have undergone arthroscopic capsulolabral repair surgery will be evaluated using an objective checklist prior to being allowed to return to their sport. The utilization and outcome of using this checklist will be evaluated | Other: Safe return to play checklist<br>* this objective checklist will be utilized by the physical therapy staff and surgeon to determine whether an athlete is safe to return to their sport<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful completion of the return to play checklist | This outcome measure will count the number of patients who meet all the criteria in the return to play checklist prior to returning to their sport | 1 year post-surgery |
Fistula Laser Closure

Study Overview
=================
Brief Summary
-----------------
The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function. For several years,differents techniques were developed said sphincter sparing techniques to handle fistulas at risk on the anal continence. Recently there is one of them , named FiLAC using a clip system not yet evaluated. The purpose is to assess the success rate of his new surgery technique.

Official Title
-----------------
Fistula Laser Closure

Conditions
-----------------
Fistula;Rectal

Intervention / Treatment
-----------------
* Procedure: FiLAC laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with anal fistula drained at least 3 months before inclusion. Exclusion Criteria: Fistula not well drained

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

| Intervention/Treatment |
| --- |
|Procedure: FiLAC laser|The technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery success rate |  | 6 months |
What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.

Detailed Description
-----------------
in this study, 15 skeletal class 2 orthognathic patients will be selected. CBCT and proface will be done preoperatively. after the surgery and 6 months later the imaging investigations will be repeated to investigate the soft tissue changes that have resulted due to the bone movement.

Official Title
-----------------
What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study

Conditions
-----------------
Orthognathic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with class II skeletal deformity Patients must be over 18 years of age to allow for growth cessation Patients must not have any systemic condition which contraindicates general anaesthesia Exclusion Criteria: o patients with cleft palate patients with syndromes affecting their craniofacial structure patients with facial scars patients with severe facial asymmetry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| 3D soft-tissue changes (linear) | the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of soft tissue change to hard tissue change | the distance that the soft tissue has moved compared to the underlying bone, as a percentage. | 6 months | 
| Is the esthetic outcome as expected/imagined? | using a 100mm visual analogue scale the patient will be asked to score how the aesthetic outcome measured against his expectations. 0mm is the worst score where the changes havent met the expectations at all and 100mm is where the outcome has perfectly met the expectation. | 6 months | 
| 3D soft-tissue changes (angular) | the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery | 6 months | 
| 3D soft-tissue changes (volumetric) | the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
class II,, soft tissue changes, CBCT
Hemostasis During Hypospadias Surgery

Study Overview
=================
Brief Summary
-----------------
A comparison between the two hemostatic methods of hypospadias repairing operation, in terms of early and mid-term (up to 6 months) failure rate (wound dehiscence and urethral stricture needing reoperation) between the two groups: Group A) diluted Epinephrine injection, Group B) tourniquet application in children

Official Title
-----------------
A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome

Conditions
-----------------
Hypospadias Repair

Intervention / Treatment
-----------------
* Procedure: tourniquet application
* Drug: epinephrine injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - age under 15 Hypospadiasis ( Distal, Midshaft, Proximal) Exclusion Criteria: - Bleeding tendency Penoscrotal Hypospadiasis Other method

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

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

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: Hypospadiasis repair<br> | Procedure: tourniquet application<br> <br> Drug: epinephrine injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding |  | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fistula |  | after surgery for 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypospadias, dehiscence, urethral stricture, side effects
Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

Detailed Description
-----------------
The investigators select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

Official Title
-----------------
A Study to Assess the Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in the Treatment of Operable Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Abraxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Karnofsky ≥ 70 Provision of informed consent Pathological confirmation of breast cancer Tumor stage (TNM):T2-4bN0-3M0 Measurable disease as per RECIST criteria Not previously treated with radiotherapy, chemotherapy or biological therapy. Laboratory criteria: PLT ≥ 100*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2*ULN TBIL,DBIL,CCr ≤ 1.5*ULN Exclusion Criteria: Pregnant woman History of organ transplantation With mental disease With severe infection or active gastrointestinal ulcers With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ) With heart disease Experimental drug allergy
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: Abraxane<br>Abraxane for neoadjuvant chemotherapy | Drug: Abraxane<br>* Abraxane for neoadjuvant chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic assessment | therapeutic assessment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions and disease-free survival | Adverse reactions during the treatment and disease-free survival | 2 year |
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

Official Title
-----------------
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: VX-121/TEZ/D-IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study Key Exclusion Criteria: History of drug intolerance in a parent study Pregnant or breast-feeding females Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: VX-121/TEZ/D-IVA<br>Participants will receive VX-121/TEZ/D-IVA once daily. | Drug: VX-121/TEZ/D-IVA<br>* Fixed-dose combination tablets for oral administration.<br>* Other names: VX-121/tezacaftor/deutivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | From Day 1 up to Week 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) |  | From Baseline up to Week 96 | 
| Absolute Change From Baseline in Sweat Chloride (SwCl) |  | From Baseline up to Week 96 | 
| Number of Pulmonary Exacerbations (PEx) |  | From Baseline up to Week 96 |
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.

Official Title
-----------------
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis

Conditions
-----------------
Squamous Cell Carcinoma of the Oral Cavity, Oropharynx Metastases, Lymph Metastases

Intervention / Treatment
-----------------
* Procedure: endoscopic examination
* Procedure: FDG-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (CUP) Stage T1-4; Tx N+ for the CUP Multidisciplinary Group of Head and Neck Tumors at Ghent University Hospital decision of radical radiotherapy (±concurrent chemotherapy) Informed consent obtained, signed and dated before specific protocol procedures. Exclusion Criteria: Age < 18 years Pregnant or lactating women Active infection or fistula in the oral/oropharyngeal mucosa Previous cancer of the oral cavity and the oropharynx Prior head-and-neck radiotherapy Expectation of non-compliance with the study protocol Known allergy for topical anesthetics (Xylocaïne)

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

| Intervention/Treatment |
| --- |
|Procedure: endoscopic examination|on a weekly basis during 7 weeks|
|Procedure: FDG-PET|once pre-radiotherapy and once 2 weeks after initiation of radiotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of optical imaging in the evaluation of radiation-induced mucositis. |  | weekly assessment during 7 weeks | 
| Feasibility of FDG-PET in the evaluation of radiation-induced mucositis. |  | 2 weeks after radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oropharynx and lymph node metastases from an unknown primary tumor