linjc16/ctgov huggingface dataset:
Acupuncture and Nausea/Vomiting in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia Control Group: Standard anti-emetic therapy only This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.

Official Title
-----------------
Is Intra-operative Acupuncture at P6 Plus IV Antiemetics More Effective Than IV Antiemetic Therapy Alone in Preventing Postoperative Vomiting in Pediatric Patients Following Tonsillectomy With or Without Adenoidectomy?

Conditions
-----------------
Postoperative Vomiting and Nausea

Intervention / Treatment
-----------------
* Device: Acupuncture Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 to 3 physical status Undergoing Tonsillectomy and/or adenoidectomy Consent obtained from Parent/Guardian Exclusion Criteria: Taking preoperative steroids, including inhalers Taking baseline anti-emetics History of motion sickness BMI > 35 (morbid obesity) Severe OSA (Apnea/hypopnea Index > 10) Have genetic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 9 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Therapy Only<br>Patients will not receive acupuncture. Standard anti-emetic therapy will be given. | |
| Experimental: Acupuncture Plus Standard Therapy<br>Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. | Device: Acupuncture Needle<br>* A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist<br>* Other names: Seirin Pyonex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Nausea and Vomiting | Post operative Nausea and vomiting in phase 1 and 11 recovery (Measured as a percentage of participants who experienced this outcome) Post op Nausea and vomiting on post op day one ( measured as a percentage of participants who experienced this outcome) as reported on a telephone survey | 24 hours |
A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine in patients with pancreatic cancer.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of Gemcitabine Plus LY293111 Compared to Gemcitabine Plus Placebo in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: LY293111
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent Tumor that can be measured by x-ray or scan Adequate organ function Exclusion Criteria: Inability to swallow capsules Documented brain metastases Prior chemotherapy or biological therapy for this disease

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: LY293111|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| tumor response |  |  | 
| PK |  |  |
Targeted-sequencing of PTC in Different Stages

Study Overview
=================
Brief Summary
-----------------
The prevalence of papillary thyroid micro-carcinoma (PTMC) increased rapidly in recent years but the design of treatment is controversial because a majority of them are indolent. Therefore, to recognize which PTMC is of strong progressive potential which should be operated is very crucial. Fine needle aspiration (FNA) pre-surgery could obtain tumor cells which could be used in genetic analysis. To date, there is no specific way to evaluate the aggressive potential of a PTMC pre-surgery. So, the purpose of this proposal is to screen genetic mutations of the aggressive type of PTMC. The candidate did a whole exome sequencing on 3-3 pairs of PTCs and found some SNPs and Indels in TP53、TTN、PDF. To further investigate those mutations, a target region sequencing will be done in 40 pairs tumor samples. And ultimately to find out which genetic event could contribute to strong aggressive potential of PTC. The mutations details would be design to test the FNA and tissue sample to validate if the genetic testing based on FNA is reliable. The gene test results would be evaluated with sonographic features to predict the potential of small thyroid carcinoma before surgery. This project won't aim to study the function and mechanism of specific genes but just screen them out. So, the fund would cover the fee of the whole study and this study is very likely to achieve the goal.

Official Title
-----------------
Targeted-sequencing of PTC in Different Stages

Conditions
-----------------
Exploratory Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who will receive thyroid resection Exclusion Criteria: patients who has been radiologically treated
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 |
| --- | --- | --- |
| types of mutation of targets genes in papillary thyroid carcinomas in different stages | types of mutation of targets genes in papillary thyroid carcinomas in different stages | 2018-1-1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid
Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)

Study Overview
=================
Brief Summary
-----------------
Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management. The investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer. Indeed, these criteria were previously defined on a smaller cohort, in the context of 3D radiotherapy (mainly T3, T4 tumors). In addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the CTV margins used.

Official Title
-----------------
Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)

Conditions
-----------------
Bronchial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject operated on at HUS for T1/T2a N0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019 CT scan available on the HUS imaging server or on CD Subject who has not expressed opposition to the use of his or her data for research purposes Exclusion Criteria: Subject who has expressed opposition to participating in the study Impossibility to give the subject informed information (difficulties in understanding the subject, ...) Subject under legal protection Subject under guardianship or curatorship

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

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 |
| --- | --- | --- |
| Retrospective histological study of tumor cell dissemination around the tumor |  | Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchial cancer, Bronchopulmonary cancer, Stereotactic radiotherapy, Stereotactic CTV margins, Cell lung cancer, 3D radiotherapy
Incretin Effect on the Immunological Phenotype

Study Overview
=================
Brief Summary
-----------------
Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

Detailed Description
-----------------
Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.

Official Title
-----------------
Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: Liraglutide
* Drug: Saxagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -healthy subjects or patients with type 1 diabetes Exclusion Criteria: pregnancy treatment with GLP-1-Analoga (Liraglutide, Exenatide) treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin) chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg. | Drug: Liraglutide<br>* once daily subcutaneous injection<br>* Other names: Victoza;|
| Active Comparator: Saxagliptin<br>Saxagliptin 5mg tablet by mouth every day for 4 weeks | Drug: Saxagliptin<br>* once daily tablet<br>* Other names: Onglyza;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of regulatory FOXP3+ T cells | the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunophenotyping | The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autoimmune disease, diabetes type 1, incretin effect
Effect of Cervical Collar in Cervical Radicular Pain.

Study Overview
=================
Brief Summary
-----------------
Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. We will compare short term (six weeks and three months) and long term ( one year) effect of six weeks use of neck collar (stiff or soft)together with neck school information with neck school information alone.

Official Title
-----------------
Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study

Conditions
-----------------
Cervical Radicular Pain

Intervention / Treatment
-----------------
* Device: Soft or stiff cervical collar(device), neck school(behavior)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical radicular pain caused by herniated disc og spondolytic spurs written consent from patient Exclusion Criteria: previous necksurgery whiplash or other necktrauma serious diseases somatic or psychiatric patients not able to speak and read Norwegian well insufficient correlation between clinical and radiological findings

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Soft or stiff cervical collar(device), neck school(behavior)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| painscore on visual analog scale 0-100mm after 6weeks treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| painscore visual analog scale 0-100mm after 3weeks,3months,1year |  |  | 
| Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year |  |  | 
| Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical intervertebral disc displacement, cervical spondylosis, radiculopathy, neck collar, brace, physiotherapy, treatment, rehabilitation
Understanding immunE-related toXicities by multifACeT Profiling

Study Overview
=================
Brief Summary
-----------------
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.

Detailed Description
-----------------
The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs. Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT. IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.

Official Title
-----------------
EXACT - Understanding immunE-related toXicities by multifACeT Profiling

Conditions
-----------------
Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age 18 years or older Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy Exclusion Criteria: Medical or psychological condition that would preclude informed consent Planned participation in a drug trial receiving investigational agents Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry. Subjects unable to comply with the study or sample schedule.

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 |
| --- | --- | --- |
| Patients who experience irAEs | To determine the proportion of patients who experience irAEs during treatment with CPI. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological and clinical characteristics | To profile biological and clinical characteristics at baseline and during treatment with CPI to detect indicators predictive of the development of immunotherapy-related adverse events (irAEs). | 60 months | 
| Time to development of irAEs | To determine time to clinical development of irAEs during treatment with CPI. | 36 months | 
| Proportion of patients experiencing irAEs | • To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment. | 60 months |
Catheterization During Second Elective Caesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Use versus non use of urinary catheterization during Second Elective caesarean delivery:

Detailed Description
-----------------
Evaluation OF use versus non use of urinary catheterization during Second Elective caesarean delivery:by urine analysis 24 hours postoperative to exclude urinary tract infection.

Official Title
-----------------
Evaluation OF Use Versus Non Use of Urinary Catheterization During Second Elective Caesarean Delivery

Conditions
-----------------
Wound Infection

Intervention / Treatment
-----------------
* Device: Foley's Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria pregnant females who will undergo second elective caesarean section at full term pregnancy (38:41 weeks gestational age). Exclusion Criteria: Women with history of more than one previous caesarean Section. Women with history of a tonic postpartum hemorrhage. Women with Urinary tract infection in present pregnancy. Women with diabetes mellitus in present pregnancy. Women with medical disorder in present pregnancy that obligate monitoring of urine output during and after caesarean section, such as severe pre-eclampsia or renal disease with pregnancy. Emergency caesarean section

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 38 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Use of urinary catheterization in Cesarean section | Device: Foley's Catheter<br>* Urinary tract infection inpatient catheterized versus non catheterized<br>|
| No Intervention: Group 2<br>NO urinary catheterization during Cesarean section | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field |  | participants will be followed for the duration of urinary tract infection,an expected average 2 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CCSWI
Maternal Problem-Solving in Childhood Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.

Detailed Description
-----------------
The purpose of this study is: to develop a time-and-attention control condition to better assess the direct and mediational effect of PSST independent of social support (placebo); to develop a personal digital assistant hand-held supplement to standard PSST to provide real-time training, reinforcement, and on-the-spot documentation of PSST usage; to develop independent measures of the application of problem-solving strategies in everyday life; and to measure utilization of and satisfaction with other resources accessed by mothers as independent indicators of the usefulness and cost-effectiveness of PSST.

Official Title
-----------------
Maternal Problem-Solving in Childhood Cancer

Conditions
-----------------
Stress, Cancer

Intervention / Treatment
-----------------
* Behavioral: Problem-Solving Skills Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact. Exclusion Criteria: Mothers of children with cancer if they do not read or speak English or Spanish, if their child is in severe medical crisis, or if they live a prohibitive distance to complete the intervention.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Problem-Solving Skills Training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity |  |  | 
| e.g. depression, anxiety, and increasing satisfaction with resource utilization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood cancer, intervention, maternal coping, problem solving skills, anxiety, cope, problem solving