linjc16/ctgov huggingface dataset:
Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects

Study Overview
=================
Brief Summary
-----------------
Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.

Conditions
-----------------
Digestive Cancers

Intervention / Treatment
-----------------
* Drug: Glutamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with GI neoplasm Patient that must start a (new) line of chemotherapy with at least 2 cycles Age > 18 ans Exclusively orally fed Life expectancy more than 3 months Intravenous 5FU-based chemotherapy with 2 or 3-week cycles Hematological toxicities from previous chemotherapies terminated or <= 2 Exclusion Criteria: Positive HIV status Pregnant or lactating woman Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study Patient having diarrhoea of grade > 1 for more than 2 weeks before the inclusion State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy Sepsis Concomitant radiotherapy, except analgesic radiotherapy

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glutamine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Perioperative Epidural Trial (POET) Pilot Study

Study Overview
=================
Brief Summary
-----------------
To investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia AND postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial

Official Title
-----------------
Perioperative Epidural Trial (POET) Pilot Study

Conditions
-----------------
Post Operative Pain Control

Intervention / Treatment
-----------------
* Procedure: anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects at high risk of cardio-respiratory complications post operatively. Exclusion Criteria: Contraindication to epidural anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 45 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

| Intervention/Treatment |
| --- |
|Procedure: anesthesia|Intraoperative general anesthesia AND postoperative IV narcotic analgesia.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia, anesthesia
Trafficking of Indium-III-Labeled Cultured Immune Cells in Patients Undergoing Immunotherapy for Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are to receive immune cells in adoptive transfer, will have less than or equal to 50% of those cells labeled with In-111-oxine and administered along with the remainder of their unlabeled cells. They will then undergo gamma-camera imaging over the next 0-7 days and blood samples and tumor sites which are accessible with minimal surgery (low-risk biopsy) may be sampled in some patients for enumeration of radiolabeled cells. End-points will be tumor and normal organ imaging and the amount of In-111 per gram of tissue in biopsies or per ml. of blood.

Detailed Description
-----------------
Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are to receive immune cells in adoptive transfer, will have less than or equal to 50% of those cells labeled with In-111-oxine and administered along with the remainder of their unlabeled cells. They will then undergo gamma-camera imaging over the next 0-7 days and blood samples and tumor sites which are accessible with minimal surgery (low-risk biopsy) may be sampled in some patients for enumeration of radiolabeled cells. End-points will be tumor and normal organ imaging and the amount of In-111 per gram of tissue in biopsies or per ml. of blood.

Official Title
-----------------
Trafficking of Indium-111-Labeled Cultured Immune Cells in Patients Undergoing Immunotherapy for Advanced Cancer

Conditions
-----------------
Neoplasm

Intervention / Treatment
-----------------
* Procedure: Gamma-camera imaging
* Procedure: Low-risk biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA All patients will be 18 years of age or older. All patients will be enrolled in NCI-approved intramural immunotherapy protocol in which immune cells are adoptively administered to treat advanced cancer. EXCLUSION CRITERIA Patients who are receiving less than 3x10(9) cells in transfer will be excluded. Impaired patients who are unable to give valid informed consent will also be excluded. Patients who are pregnant will be excluded. All other exclusion criteria stated in the parent immunotherapy protocol. Patients who are HIV-infected.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Gamma-camera imaging|nan|
|Procedure: Low-risk biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adoptive Immunotherapy, Cellular Therapy, Lymphocyte Migration, Tumor Imaging
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass machine to deliver blood and oxygen to all of the organs and tissues.

Official Title
-----------------
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Conditions
-----------------
Open-heart Surgery, Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: Phenoxybenzamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0-18 years of age weight of less than or equal to 20 kilograms Exclusion Criteria: Parental refusal to give informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery | Drug: Phenoxybenzamine<br>* 0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU<br>* Other names: Dibenzyline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively | Number of subjects who required Norepinephrine >0.1mcq/kg/min | 72 hours postoperatively |
Effects of US-guided SAPB During Breast Surgery

Study Overview
=================
Brief Summary
-----------------
The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients. We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.

Official Title
-----------------
The Effects of Ultrasound-guided Serratus Anterior Plane Block on Intraoperative Opioid Consumption and Hemodynamic Stability During Breast Surgery: A Randomized Controlled Study

Conditions
-----------------
Hemodynamic Instability, Opioid Use, Block, Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Serratus anterior plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18-75, ASA I-II-III risk group Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods Patients whose informed consent was read and whose consent was obtained Exclusion Criteria: who do not want to participate in the study, ASA IV-V patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Serratus anterior plane block<br> | Procedure: Serratus anterior plane block<br>* local anesthetic application between serratus anterior muscle and 5th rib<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic stability | effect of serratus anterior plane block on hemodynamic stability during breast surgery | during surgery | 
| opioid consumption | effect of serratus anterior plane block on opioid consumption during breast surgery | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence time | the time period between surgical incision closure and extubation. | end of the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodynamics, serratus anterior plane block, opioid consumption, breast surgery
Questionnaire for Obstetricians and Anesthesiologist

Study Overview
=================
Brief Summary
-----------------
The research was planned as a face-to-face survey evaluation. The questionnaire will be applied to obstetricians and anesthesiologists working in public and private hospitals. The universe of the research will be selected by simple random sampling method, and the total number of people who will participate is planned to be 200, approximately 100 from each of the two branches. Our survey consists of 5 parts structurally. Demographic data, rate of cesarean section and postpartum hemorrhage, uterotonic agent preferences in low/high risk cesarean section surgeries, the preference for second-line uterotonic agents, and the dose preferences of uterotonic agents.

Official Title
-----------------
Questionnaire for Evaluation of Uterotonic Usage Habits of Obstetricians and Anesthesiologist

Conditions
-----------------
Atony, Uterine, Uterine Bleeding, Cesarean Section Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstetricians and anesthesiologists who want to participate in the survey Exclusion Criteria: the ones who do not want to participate -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anesthesiologist<br> | |
| Obstetricians<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterotonic usage habits in postpartum hemorrhage | to learn the uterotonic use preferences of both obstetricians and anesthesiologists in postpartum | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterotonic usage habits in elective cesearean section | to learn the uterotonic use preferences of both obstetricians and anesthesiologists in elective cesarean section | 3 months |
Virtual Reality Colonoscopy : a Study From Nancy

Study Overview
=================
Brief Summary
-----------------
Colonoscopy is an exam which can be responsible for pain and discomfort for the patient. Therefore colonoscopy is performed most of the time under general anaesthesia. Moreover, drug-induced sedation comes with adverse effects especially among fragile patients. Besides, monitoring patients during and after sedation is both logistically demanding and costly. Virtual reality offers immersive and three dimensional experiences that distract the attention and might improve patients comfort. The aim of the study is to investigate the use of virtual reality during colonoscopy versus general anaesthesia.

Detailed Description
-----------------
The study is based on a home made questionnaires completed by the operator and the patient before and after the colonoscopy.

Official Title
-----------------
Virtual Reality Colonoscopy : a Study From Nancy

Conditions
-----------------
Colorectal Neoplasms, Colorectal Polyp

Intervention / Treatment
-----------------
* Procedure: colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient needed planned colonoscopy able to fill in questionnaires in French Exclusion Criteria: visual or auditor impairments dementia patient limited French language skills diagnosis of balance disorders or epilepsy

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 |
| --- | --- |
| Virtual reality colonoscopy<br>using virtual reality with glasses and sound no anaesthesia | Procedure: colonoscopy<br>* Colonoscopy<br>|
| General anaesthesia colonoscopy<br>gold standard | Procedure: colonoscopy<br>* Colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete colonoscopy defined by caecum intubation (binary criterion : yes or no) | found of the report | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain) | asked on the questionnaire | baseline | 
| Anxiety evaluated by the validated score State Trait Anxiety Inventory ranging from 20 (absence of anxiety) to 80 (highest anxiety) | asked on the questionnaire | baseline | 
| Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort | asked on the questionnaire | baseline | 
| Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing) | asked on the questionnaire | baseline | 
| Polyp removal (binary criterion : yes or no) | found on the report | baseline |
Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity

Study Overview
=================
Brief Summary
-----------------
Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.

Official Title
-----------------
Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Device: GT3X Actigraph accelerometer.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10-18 years old adolescent normal clinical examination, normal nutritional status at baseline defined by a weight / height ratio between - 2 and + 2 DS DS Exclusion Criteria: abnormal ECG known chronic disease acute infection dating back at least a week.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: non-blinded group<br>The non-blinded subjects will be informed that the accelerometer device (GT3X Actigraph accelerometer) is an accelerometer that assessed physical activity levels and patterns | Device: GT3X Actigraph accelerometer.<br> <br> |
| Other: blinded group<br>The blinded subjects will be informed that they will test the reliability of a new device for body posture assessment and these youngsters will not receive any information with regards to physical activity. | Device: GT3X Actigraph accelerometer.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity by GT3X Actigraph accelerometer. | The physical activity measured in counts/day using an GT3X Actigraph accelerometer. Participants were instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. | during 4 days |
Institutional Registry on Outpatient and Hospitalized COVID-19 Infected Patients

Study Overview
=================
Brief Summary
-----------------
Creation of an Institutional Registry system for patients with confirmed COVID-19 infection with the collection of epidemiological data, risk factors, diagnosis, prognoses, treatment, follow-up and survival.

Detailed Description
-----------------
Ambispective observational cohort with administrative admission date corresponding to the day of positivity of the PCR test for COVID-19, and discharge date of the cohort to the date corresponding to the epidemiological discharge, last contact with the health system and / or date of death. Due to its institutional nature, the registry will collect data from the different patients who are assisted at different levels of the institution: emergency department, hospitalization in the general ward, critical areas, outpatient monitoring (including telemedicine) and home hospitalization.

Official Title
-----------------
Institutional COVID-19 Patient Registry

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient assisted by HIBA adult services Patient diagnosed with COVID-19

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 |
| --- | --- | --- |
| Mortality rate | Proportion of deceased persons from PCR positivity to epidemiological status out of the total number of infected persons followed in the same period | From the date of the positivization of the PCR to the date of death or epidemiological discharge, whichever occurs first, assessed up to 30 days. | 
| Readmission rate | Requirements for re-admission during the post-discharge period for a COVID hospitalization | Within a month of discharge |