linjc16/ctgov huggingface dataset:
Genetic Mutation in Recurrent Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy and immunotherapy.

Official Title
-----------------
Overall Perspective on the Characteristics of Genetic Mutation in Recurrent Cervical Cancer

Conditions
-----------------
Recurrent Cervical Cancer, Nucleotide Variant, Copy Number Variation, Insertion-deletion Variation, Genomic Structural Variation, Total Mutation Burden, Microsatellite Instability, PD-1, PD-L1

Intervention / Treatment
-----------------
* Diagnostic Test: Multi-gene panel testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma With available materials for analysis With detailed clinicopathological information Given consent to participate the trial Exclusion Criteria: Not meeting all of the inclusion criteria

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Multi-gene panel testing|A multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of genetic mutations | Frequency of various genetic mutations among recruited patients | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mutation burden | Total mutation burden calculated in definite patient | Two years | 
| Frequency of microsatellite Instability | Microsatellite Instability in definite patient | Two years | 
| Expression rates of PD-1 and PD-L1 antibodies | Expression rates of PD-1 and PD-L1 antibodies among recruited patients | Two years |
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial. All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.

Official Title
-----------------
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Device: permanent mesh fixation
* Device: absorbable mesh fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent from the adult patient (18 years and older, no maximum age) primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair Exclusion Criteria: no written informed consent hernia defects larger than 10cm diameter in width 'hostile' abdomen; open abdomen treatment contraindication to pneumoperitoneum emergency surgery (incarcerated hernia) lateral or parastomal hernia sites

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: absorbable fixation left side<br> | Device: permanent mesh fixation<br>* Permanent mesh fixation will be used.<br>Device: absorbable mesh fixation<br>* Absorbable mesh fixation will be used.<br>|
| Active Comparator: absorbable fixation right side<br> | Device: permanent mesh fixation<br>* Permanent mesh fixation will be used.<br>Device: absorbable mesh fixation<br>* Absorbable mesh fixation will be used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with a VAS scale more than 40 |  | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of invasive interventions (local infiltrations, reoperations) postoperatively |  | 1 year after surgery | 
| number of patients taking analgetics |  | 1 year post-surgery | 
| perioperative morbidity rate |  | 1 year after surgery | 
| quality of life |  | 1 year post-surgery | 
| recurrence rate |  | 1 year post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventral hernia
Turkish Version of the Postoperative QoR-15

Study Overview
=================
Brief Summary
-----------------
Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery after surgery. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into Turkish, and do a full psychometric evaluation of the Turkish version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, orthopedic, gynecological, urologic, eye and ENT surgery, in the University of Health Sciences, Gülhane Education and Rraining Hospital Ankara, Türkiye.

Official Title
-----------------
Translation and Validation of the Turkish Version of the Postoperative Quality of Recovery Score QoR-15

Conditions
-----------------
Surgery, Cross-Cultural Comparison, Postoperative Period, Recovery of Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged > 18 years old underwent selective or day surgery with general anesthesia (including all surgical categories except heart and vascular surgery) able to complete the QoR-15T in Turkish agreed to provide written informed consent to participate Exclusion Criteria: aged < 18 years old patients with a neuropsychiatric disturbance not agreed to provide written informed consent to participate

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 |
| --- | --- | --- |
| Quality of Recovery 15 Score | Postoperative Quality of Recovery 15 in Turkish scale (QoR-15T) | 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Questionnaire Quality-of-recovery 15 (QoR-15)
Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy

Study Overview
=================
Brief Summary
-----------------
This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

Detailed Description
-----------------
This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

Official Title
-----------------
Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy in The Region Of Madrid: A Population-Based, Cross-Sectional Study

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who picked-up Co-meds in the study period Exclusion Criteria: NONE
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of Co-meds in HIV-infected individuals on ART | number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender. | 6 months | 
| number of Co-meds between the ART-treated population and HIV-uninfected | the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender. | 6 months | 
| prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals | prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals, with description of the types of harm expected from each different potential CSDIs identified | 6 months |
Comparison of Different Video Laryngoscopes in a Manikin With Immobilized Cervical Spine

Study Overview
=================
Brief Summary
-----------------
To determine whether different video laryngoscopes facilitate intubation in an manikin with immobilized cervical spine compared with standard laryngoscopy.

Official Title
-----------------
Comparison of Different Video Laryngoscopes in a Manikin With Immobilized Cervical Spine

Conditions
-----------------
Tracheal Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anaesthesiologist experienced in tracheal intubation Exclusion Criteria: missing experience in tracheal intubation missing informed consent

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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 |
| --- | --- |
| Macintosh #3 Laryngoscope<br> | |
| Glidescope<br> | |
| Ambu Pentax AWS<br> | |
| McGrath<br> | |
| Airtraq<br> | |
| Storz C-MAC<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful tracheal intubation |  | max 5 minutes |
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Study Overview
=================
Brief Summary
-----------------
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.

Official Title
-----------------
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Conditions
-----------------
Urinary Tract Infection, Vesicoureteral Reflux

Intervention / Treatment
-----------------
* Drug: Sulfur hexafluoride type-a lipid microspheres


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Age more than or equal to 8 years Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast Includes healthy volunteers Exclusion Criteria: Age less than 8years Allergy to contrast or related products Cardiac shunt/ congenital heart anomalies Abnormal baseline ECG Open heart surgery Evidence of retinopathy Patient in intensive care Unable to comply with study requirement History of emphysema Unable to maintain oxygen saturation of 92% on at room air Pregnancy and lactation

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 50 Years

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

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

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 |
| --- | --- |
| Other: Contrast<br>All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. | Drug: Sulfur hexafluoride type-a lipid microspheres<br>* Used as a contrast to enhance renal ultrasound<br>* Other names: Lumason®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization of Renal Scars Compared to Previous Imaging | The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events Related to the Study Drug. | The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study. | 1 week |
Dose Response and Efficacy of GW842166 in Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.

Official Title
-----------------
A Phase I, Placebo Controlled, Randomised, Double Blind Two-way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: GW842166X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects aged 18 to 50 years inclusive Body Weight >50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive. Women who are not of child bearing potential Exclusion Criteria: The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test. A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study. Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine. Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW842166X|Administer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Heat pain threshold at 5 hours post dose |  | 5 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose. |  | 5 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical pain,, heat pain,, dose,, efficacy, dose response,, GW842166,, Single,, pharmacodynamics,, repeat dose,
CART-19 Cells for R/R B-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.

Official Title
-----------------
CART-19 Cells For Patients With Relapsed or Refractory B-cell Lymphoma

Conditions
-----------------
Relapsed or Refractory B-cell Lymphoma

Intervention / Treatment
-----------------
* Other: CART-19 cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged between 1-65 years Patients with relapse/refractory B-cell lymphoma Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females. Any co-morbidity precluding the administration of CART-19 cells.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 65 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: Arm 1<br>CART-19 cells treat | Other: CART-19 cells<br>* CART-19 cells treat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events that are related to treatment |  | 1 year |
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

Study Overview
=================
Brief Summary
-----------------
The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.

Official Title
-----------------
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

Conditions
-----------------
Lower Back Pain

Intervention / Treatment
-----------------
* Device: TOPS™ System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis Patients with degenerative spondylolisthesis Patients with at least 3 months failed conservative treatment Narrowing of the lumbar spinal canal Patients with lower back pain or sciatica Exclusion Criteria: Discogenic back pain at TOPS System level Back or non-radicular leg pain of unknown etiology at TOPS System level Lytic spondylolisthesis at TOPS System level More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure Known allergy to titanium and/or polyurethane

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Lower Back and Leg Pain Patients<br>Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System | Device: TOPS™ System<br>* The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Improvement | Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score | 24 months | 
| Function Improvement | Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score | 24 months | 
| Fusion Prevention | The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol | 24 months |