linjc16/ctgov huggingface dataset:
Phase II Study of ABI-007 for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.

Official Title
-----------------
Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: ABI-007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed gastric adenocarcinoma Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence Age: 20 - 74 At least one measurable lesion by RECIST criteria Exclusion Criteria: History of Taxans use Patients with another active malignancy Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE) Chronic treatment with steroids

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: 1<br>ABI-007 | Drug: ABI-007<br>* ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | During chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | During chemotherapy | 
| Progression-free survival |  | Until progression | 
| Overall survival |  | Over a year form randomaization | 
| Disease control rate |  | Duration chemoterapy |
Dietary Intervention With Shop Model - SHOPUS

Study Overview
=================
Brief Summary
-----------------
The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and cardiovascular diseases.

Official Title
-----------------
A Six Month Randomized Controlled Dietary Intervention Study of the New Nordic Diet vs Average Danish Diet in Adults (18-65y) Using the Shop Model for Optimal Dietary Adherence

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abdominal obesity Exclusion Criteria: BMI > 45, previous weight change

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Nordic Diet<br>New Nordic Diet | Behavioral: Dietary intervention<br>* Instruction to diet for 6 month<br>|
| Experimental: Average Danish Diet<br>Average Danish Diet | Behavioral: Dietary intervention<br>* Instruction to diet for 6 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight (kg) | Change in body weight from randomization to end of intervention | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fat percentage | Change in body fat percentage (DEXA-scanning) | 26 weeks | 
| Dietary compliance | Level of dietary compliance | 26 weeks | 
| Changes in components of the metabolic syndrome | Changes in the number of components of the metabolic syndrome | 26 weeks | 
| Achievement of 5% weight loss | Achievement of 5% weight loss from randomization to end of intervention | 26 weeks |
Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling

Study Overview
=================
Brief Summary
-----------------
This study evaluates patients willingness to participate in a trial comparing standard genetic counseling versus personalized genetic counseling. Collecting information from patients may help researchers learn why patients may or may not take part in the future study that compares standard genetic counseling to personalized genetic counseling.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To evaluate patients' willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on Li-Fraumeni syndrome patient reported outcome (LFSPRO) ShinyApp data. OUTLINE: Patients complete a questionnaire over 15-20 minutes. Patients positive for a TP53 mutation complete an additional questionnaire over 15-20 minutes within 1 month after test results.

Official Title
-----------------
Evaluate Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling Based on LFSPRO-ShinyApp Data

Conditions
-----------------
Li-Fraumeni Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals age 15 or older OR parent/guardian of a patient younger than 15 years (if age 15-17, the patient will provide assent and parent/guardian will provide consent) English fluency Receive genetic counseling specifically for TP53 genetic testing and who consent to undergo TP53 genetic testing OR individuals whose genetic testing indicates a TP53 germline mutation Exclusion Criteria: Individuals who are non-English speaking Individuals having low suspicion for a TP53 germline mutation during pretest counseling and test negative for a TP53 mutation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire)<br>Patients complete a questionnaire over 15-20 minutes. Patients positive for a TP53 mutation complete an additional questionnaire over 15-20 minutes within 1 month after test results. | Other: Questionnaire Administration<br>* Complete questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on LFSPRO ShinyApp data |  | Through study completion, an average of 1 year |
Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children

Study Overview
=================
Brief Summary
-----------------
Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)

Detailed Description
-----------------
Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days. Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed) Analysis: sequential Bayesian study

Official Title
-----------------
Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State

Conditions
-----------------
Solid Malignancies

Intervention / Treatment
-----------------
* Drug: Pegfilgrastim (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0 to 18 years solid malignancy Lansky score >70% more than 17 days since the beginning of the last chemotherapy cycle absolute neutrophil count (ANC) greater than 1×109/l no administration of any hematopoietic growth factor in the previous 8 days Exclusion Criteria: clinical or biological conditions precluding the mobilization or collection procedure

Ages Eligible for Study
-----------------
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
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegfilgrastim (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, Children, Bone marrow transplantation, Mobilization, G-CSF, Children with solid malignancies
Quality of Recovery After Quadratus Lumborum Block for Cesarean Section.

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block (QLB) as a part of multimodal analgesia using Postoperative quality of recovery scale.

Detailed Description
-----------------
Several researchers had evaluated the effectiveness of QLB in controlling postoperative pain in different patient populations. In these studies, the effectiveness of the QLB was mainly assessed by postoperative pain scores and analgesia consumption, rather than adapting any of the more comprehensive recovery scales . Postoperative quality of recovery scale (PostopQRS) is a relatively new recovery score, which was first published on 2010, and was designed to be a tool for assessment of multiple domains in recovery. In this assessment tool, recovery was defined as return to the pre-surgery base line scores or better. The aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block QLB as a part of multimodal analgesia using Postoperative quality of recovery scale.

Official Title
-----------------
Quality of Recovery After Quadratus Lumborum Block for Cesarean Section: A Prospective Pilot Study

Conditions
-----------------
Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status II, normal singleton pregnancy, 37 weeks gestation or more Scheduled for elective cesarean section Exclusion Criteria: Patients refusing spinal Patients with BMI >35 kg/m2). Expected difficult surgery (> 3 previous sections, abnormal placentation, prolonged surgery more than 2 hours from skin to end) and Estimated Blood Loss more than 1500). Expected difficult spinal anesthesia. Abnormal coagulation and other contraindications for spinal anesthesia and/or QLB Patient with chronic pain. Patient treated from psychosis. Patients with communication, language barriers .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline postoperative quality of recovery score | Domains of postoperative recovery score are : The physiologic domain . The nociceptive domain The emotive domain . Activities of daily living Cognitive domain Over all patients perspective domain | 72 hours |
Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content

Study Overview
=================
Brief Summary
-----------------
This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in patient position on the measurement of respiratory heat loss (enthalpy). This study would be carried out on patients whose operation requires the use of the steep Trendelenburg position independent of this study.

Official Title
-----------------
Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content

Conditions
-----------------
Effect of Patient Position on Airway Heat Content

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age greater than 18 years scheduled for an elective surgical procedure requiring general anesthesia, positive pressure ventilation using an endotracheal tube and the steep Trendelenburg position Exclusion Criteria: Adults unable to give primary consent age less than 18 years pregnancy prisoners infusion of inotropic drugs positive end expiratory pressure (PEEP) requirements >8 cm H2O Women, minorities or non-English speaking subjects will not be excluded.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respired gas heat content | (6 months for protocol and 2 hours per patient) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enthalpy, Trendelenberg position, Mechanical ventilation
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.

Official Title
-----------------
CARE: A Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400

Conditions
-----------------
Intracranial Aneurysms

Intervention / Treatment
-----------------
* Device: PC 400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms. Patients treated with conventional coils should be treated per their IFU. Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed. Exclusion Criteria: Pre-planned use of multiple coil systems and/or flow diverters.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PC 400<br>Patients treated with the PC 400 according to the IFU | Device: PC 400<br> <br> |
| Conventional Embolic Coils<br>These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms. | Device: PC 400<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time]. | Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time. | At immediate post-procedure | 
| 2. Procedural serious adverse events |  | Procedural serious adverse events up until 3 days or discharge, whichever occurs first. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IC aneurysms, coil embolization, PC 400, radiation exposure,
The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.

Conditions
-----------------
NSAIDs-induced Small-intestinal Injuries

Intervention / Treatment
-----------------
* Drug: Rebamipide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent 20 to 85 years of age RA, OA, or low back pain No change of drugs before 3 months Under 5 mg of corticosteroid use CRP < 1mg/dl Small-intestinal mucosal injuries more than one Hemoglobin level is below normal range Exclusion Criteria: Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis Prostaglandins, metronidazole or salazosulfapyridine Can not swallow Eith pacemaker After gastrointestinal operation Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease. Taking rebamipide before one week Any other conditions that the investigator feels would interfere with data interpretation or create under risk.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebamipide<br> | Drug: Rebamipide<br>* 100mg tid, 4 or 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of mucosal breaks |  | 4 and 8 weeks after treatment |
Etoricoxib for Postoperative Pain After Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is evaluate the analgesic efficacy and safety profile of the Cox-2 specific analgesic Etoricoxib (arcoxia®) when administrated pre and postoperatively for controlling pain in adult patients undergoing thyroid surgery. Patients will be followed up in the immediate postoperative period, during the first postoperative (POD) day and in POD 2, 3 and 7. It is expected that with the addition of Etoricoxib, patients will experience less pain during the overall postoperative period and also a better quality of recovery when compared with the traditional analgesic regimen.

Official Title
-----------------
Effect of the Administration of Etoricoxib on Postoperative Pain and Quality of Recovery in Patients Undergoing Thyroid Surgery

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: etoricoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 and <70 years body weight within normal ranges ability to understand the use of pain assessment scales and the PCA device Exclusion Criteria: known allergy to any of the drugs utilized contraindication to opioid and non-opioid analgesic drugs a history of bleeding disorders, peptic ulceration or anticoagulant use within the last month pregnant or breast-feeding patients history of known or suspected drug abuse or patients who had taken NSAIDs within 24 h prior to surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: etoricoxib<br>G1 (CONTROL): Oral NSAID (diclofenac, three times a day) administrated pre-operatively and for 3 days after surgery. G2: Etoricoxib 120 mg, pre and post-operatively for 3 days after surgery | Drug: etoricoxib<br>* G1 (CONTROL): Oral NSAID (diclofenac, three times a day) administrated pre-operatively and for 3 days after surgery. G2: Etoricoxib 120 mg, pre and post-operatively for 3 days after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain scores during postoperative period |  | every 6 hours, 24hours,48hours,72hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of rescue analgesics |  | 24hours, 48hours, 72hours. |