linjc16/ctgov huggingface dataset:
Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

Study Overview
=================
Brief Summary
-----------------
This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety & efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.

Official Title
-----------------
The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4

Conditions
-----------------
Hepatitis C Genotype 4

Intervention / Treatment
-----------------
* Drug: Combined therapy LDV and SOF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV chronic infection Treatment naive and treatment experienced (previous interferon treatment) No cirrhosis or compensated cirrhosis Exclusion Criteria: Co-infection with Hepatitis B (HBV) Other associated chronic liver illness Patients with history of hematemesis (non-cirrhotic portal hypertension) Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan) Patients on drugs known to interact unfavorably (Amioidarone, ..)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- |
| Experimental: Combined Therapy LDV and SOF<br> | Drug: Combined therapy LDV and SOF<br>* All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).<br>* Other names: ledipasvir and sofosbuvir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events | The presence of any adverse effects will be used to characterize this outcome measure. | During the 12 weeks of treatment. | 
| Sustained Viral Clearance | HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml. | At Week 12 after end of treatment. |
An Observational Study on The Correlation Between Time of Initiation of Avastin (Bevacizumab) Treatment And Progression-Free Survival in Patients With Colorectal Cancer (CRONOS 1)

Study Overview
=================
Brief Summary
-----------------
This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic colorectal cancer. Patients will be followed for up to 12 months after progressive disease occurs.

Official Title
-----------------
The Correlation Between the Moment of Bevacizumab theRapy initiatiOn and the Efficacy in patieNt With cOlorectal Cancer Treated With AvaStin Based First Line Regimens (CRONOS 1)

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= the 18 years of age Previously untreated metastatic colorectal cancer Scheduled to start 1st line chemotherapeutic treatment ECOG performance status 0-1 Exclusion Criteria: Any conditions included in contraindication list for Avastin Prior chemotherapy for metastatic colorectal cancer Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic colorectal cancer completed <6 months prior to treatment 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 the time from the start of chemotherapy to the start of Avastin treatment with progression-free survival |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 60 months | 
| Safety: Incidence of adverse events |  | 60 months |
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever

Official Title
-----------------
A Proof of Concept Study of the Effects of QAX576 (an Interleukin-13 Monoclonal Antibody) on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: QAX576
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of allergic rhinitis. Exclusion Criteria: Respiratory disease other than mild intermittent asthma. Received immunotherapy in past 3 years. History of clinically significant drug allergy. History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis. History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products. Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: QAX576<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of allergic inflammation in the nose measured over 5-8 days post-dose. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose. |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic rhinitis, adults, monoclonal antibody, interleukin-13.
Uretal Flow Assessment During Gynecological Procedures

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the feasibility of using color Doppler ultrasound in ureteral flow assessment after uterine artery occlusion during a conservative gynecological procedure.

Official Title
-----------------
An Evaluation of Ureteral Flow After Temporary Bilateral Uterine Artery Occlusion During Conservative Gynecological Procedures

Conditions
-----------------
Conservative Gynecological Procedures

Intervention / Treatment
-----------------
* Device: flostat (TM) System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for conservative gynecological procedure At least 25 years of age Cervix suitable for tenaculum placement Provides written informed consent. Exclusion Criteria: Pregnancy One or more lower uterine segment fibroids Hydronephrosis as determined by renal ultrasound pre-procedurally Clinical diagnosis of urinary tract infection (UTI) In the medical judgment of the physician, such a procedure may compromise the patient's condition Inability to achieve bilateral occlusion with the clamp placement during the procedure.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: flostat (TM) System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to evaluate ureteric jets |  |  | 
| Adverse events |  |  |
The Glycocalyx in COVID-19 Patients. A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.

Detailed Description
-----------------
The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.Circulating plasma syndecan-1 is measured as surrogat parameter for the extent of the glycocalyx damage.

Official Title
-----------------
The Glycocalyx in COVID-19 Patients. A Pilot Study

Conditions
-----------------
COVID-19, Endothelial Dysfunction, Coagulation Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 detected by PCR measures going along with clinical symptoms age > 18 years Exclusion Criteria: refusal of study participation

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with COVID 19 disease<br>Patients diagnosed with and hospitalized due to COVID-19. Subgroups: ICU admitted COVID-19 + patients vs COVID 19 pts. at normal ward- | |
| Healthy volunteers<br>healthy volnuteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extent of endothelial damage | circulating plasma syndecan-1 as surrogat parameter for endothelial damage is measures | up to 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycocalyx, covid-19, ards, icu, coagulation,
Carpal Tunnel Syndrome and Amyloidosis

Study Overview
=================
Brief Summary
-----------------
Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.

Detailed Description
-----------------
Carpal tunnel syndrome (CTS) can be caused by the deposition and accumulation of misfolded proteins called amyloid and is often an early manifestation of systemic amyloidosis. Patients with cardiac amyloidosis often have carpal tunnel syndrome that precedes cardiac manifestations by several years, and many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand. The investigators sought to identify the prevalence and type of amyloid deposits in patients undergoing carpal tunnel surgery and evaluate for cardiac involvement

Official Title
-----------------
Carpal Tunnel Syndrome and Amyloidosis

Conditions
-----------------
Amyloidosis, Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: Carpal tunnel syndrome surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing carpal tunnel syndrome surgery Exclusion Criteria: None
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: Amyloid<br>Biopsy | Procedure: Carpal tunnel syndrome surgery<br>* Biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery | Prevalence of amyloid deposits in biopsy in patients undergoing carpal tunnel syndrome surgery | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with cardiac involvement in echocardiogram | Cardiac involment in echocardiography | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carpal tunnel syndrome, amyloidosis
Transobturator Approach for Paravaginal Repair

Study Overview
=================
Brief Summary
-----------------
A new technique for Applying sutures to the white line in paravaginal repair.

Detailed Description
-----------------
A new trial for transobturator repair of the paravaginal defect.

Official Title
-----------------
Transobturator Approach for Paravaginal Repair a New Approach

Conditions
-----------------
Cystocele

Intervention / Treatment
-----------------
* Procedure: transobturator approach for paravaginal repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paravaginal defect cystocele midline and paravaginal defect cystocele Exclusion Criteria: uterine descent previous cystocele surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cystocele<br>Arm: Patients with paravaginal defect cystocele Intervention: transobturator approach for paravaginal repair | Procedure: transobturator approach for paravaginal repair<br>* using TOT needle to apply suturs to white line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lateral vaginal fornices elevation | test is negative means success | 3 month | 
| Operative time | Operative time | 1 day | 
| Intraoperative blood loss | Blood loss during the operative procedure | 1 day | 
| Complications rate | Intraoperative and postoperative complications | 1 week |
Turkish Version of Telehealth Usability Questionnaire (TUQ)

Study Overview
=================
Brief Summary
-----------------
The Telehealth Usability Questionnaire (TUQ) was developed to evaluate the usability of telehealth applications and services. The Turkish validity and reliability study of the scale, originally in English, has not been conducted before. The aim of this study is to develop the Turkish version of the Telehealth Usability Questionnaire (TUQ), which is a new stability tool, and to report its reliability assessment.

Detailed Description
-----------------
The Telehealth Usability Questionnaire (TUQ) turkish version will be asked by using google forms to participants whom use telehealth.

Official Title
-----------------
Investigation of the Turkish Validity and Reliability of the Telehealth Usability Questionnaire (TUQ)

Conditions
-----------------
Health Care Acceptor, Health Knowledge, Attitudes, Practice, Patient Participation

Intervention / Treatment
-----------------
* Procedure: validity and reability study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will undergo screening to confirm eligibility, completion of initial screening form, and MMSE evaluation. Study subjects were enrolled with MMSE scores between 29-30, inclusive (healthy/control), 25-28, inclusive (mild cognitive impairment), and 10-24 (dementia). - Exclusion Criteria: Unable to complete computerized and standard pencil-and-paper based assessments
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>patients who were used telehealth | Procedure: validity and reability study<br>* validity and reliability assessment of the Turkish version of the Telehealth Usability Questionnaire (TUQ)<br>|
| health professional<br>health professional who were used telehealth. | Procedure: validity and reability study<br>* validity and reliability assessment of the Turkish version of the Telehealth Usability Questionnaire (TUQ)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and Validity of TUQ by Correlation Analysis. | with telehealth will be researched | 12 month |
What Women Want: Real Time Results During Screening Mammography in the Era of Patient-Experience Driven Care

Study Overview
=================
Brief Summary
-----------------
This study explores why patients may want to receive real-time imaging results during a screening mammogram appointment at an MD Anderson breast imaging center. Real-time imaging results means women receive the results of the mammogram right away during the same clinic visit. Information from this study may help researchers better understand patient preferences to enhance patient-experience driven care.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To identify factors that may influence a patient's desire to receive real-time imaging results during their screening mammogram appointment at a breast center. OUTLINE: Participants complete an online questionnaire over 5 minutes regarding information on patient demographics and preferences for receiving real-time appointment imaging results.

Official Title
-----------------
What Women Want: Real Time Results for Screening Mammography in the Era of Patient-Experience Driven Care

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All female patients scheduled for a screening mammogram at one of our three MD Anderson Cancer Center (MDACC) Breast Imaging Houston Area Location centers Patient >= 30 years of age Able to complete an electronic informed consent for the study Exclusion Criteria: Patients not scheduled for a screening mammogram at one of the three imaging facilities

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire administration)<br>Participants complete an online questionnaire over 5 minutes regarding information on patient demographics and preferences for receiving real-time appointment imaging results. | Other: Questionnaire Administration<br>* Complete questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors that may influence a patient's desire to receive real-time imaging results during their screening mammogram appointment at a breast center | Descriptive analyses will include the characterization of patients and preferences by age, location, patient education level, ethnicity, and patient cancer history. | Up to study completion (estimated 2 years) |