linjc16/ctgov huggingface dataset:
PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
The prognostic value of programmed death-ligand 1 (PD-L1) and BRAF expression in nasopharyngeal carcinoma (NPC) is not well-defined. In this study the investigators investigated alterations in PD-L1, BRAF and EGFR by using immunohistochemistry analysis in a cohort of consecutively enrolled NPC patients.

Detailed Description
-----------------
NPC is a common type cancer in Macau and Southern China. The role of PD-L1 in NPC remains controversial. There many reasons behind these inconsistent findings. We used the SP263 antibody with the standard cut off value of 1% and 5%, which is frequently used for lung cancer and other cancer types. We also plan to include over 150 patients, which will be the largest study in NPC. This will help us to gain insights in NPC.

Official Title
-----------------
Expression and Clinical Significance of PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Radiation: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years of age Locally advanced (stage IIIB) or metastatic (stage IV) NPC Fresh-frozen tissue samples were available were included After treatment with curative surgery or radiotherapy in Macau With follow up data were available Exclusion Criteria: • Enrolment in studies that prohibit any participation in this observational study

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 |
| --- | --- |
| NPC patients<br>Consecutive patients who were pathologically diagnosed with NPC and for whom fresh-frozen tissue samples were available were included. | Radiation: Radiation<br>* Consecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Efficacy after radiation | Followed up with 12 months after last patient in | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival in PD-L1 positive and negative group | Followed up with 12 months after last patient in | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasopharyngeal carcinoma, programmed death-ligand 1, prognosis
Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients

Official Title
-----------------
A Prospective Evaluation of the VIPUN Balloon Catheter 0.2: an Investigational Medical Device for the Monitoring of Gastric Motility in Adult Critically Ill Patients

Conditions
-----------------
Critical Illness, Intolerance; Nutritional, Delayed Gastric Emptying, Gastric Motor Dysfunction

Intervention / Treatment
-----------------
* Device: VIPUN Balloon Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Of adult age (18 years or older) ICU patients in which enteral nutrition is planned to be initiated and are expected to stay at least 1 day in ICU on enteral feeding. Patients should be mechanically ventilated or have an endotracheal tube or tracheostomy in place. Exclusion Criteria: Contra-indication for (re-) placement of nasogastric feeding catheters. History of gastric or esophageal surgery Any gastrointestinal surgery or trauma that could significantly increase the risk related to the investigational medical device in the opinion of the investigator Fed by mouth or enterally prior to inclusion Patient is moribund Known pregnancy or breastfeeding women Receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIPUN Balloon Catheter<br>Recording of gastric motility with the investigational medical device. Gastric emptying rate of a liquid meal is assessed with the 13C-octanoate breath test. | Device: VIPUN Balloon Catheter<br>* Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric motility | Assessed with the VIPUN Balloon Catheter | 10 hours | 
| gastric emptying rate | Assessed with 13C-octanoate breath test | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate placement and removal balloon catheter | Success rate completing the procedures to place and remove the balloon catheter | Day 0 until day 1 (<24 h) | 
| Safety parameters potentially related to the use of the investigational medical device | Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded. | Day 0 until day 30 |
Assessment of Bioavailability of Phenolics From an Orange Peel Extract

Study Overview
=================
Brief Summary
-----------------
In this study, the bioavailability of a specific orange peel extract is tested. The composition and morphology of the test product is altered compared to the generic product, which is used as a control. Due to intellectual property issues, more information cannot be given at this moment. Also the difference in bioavailability between a capsule and a lozenge is tested. The hypothesis is that the bioavailability of the altered extract will be improved compared to the control.

Official Title
-----------------
Assessment of Bioavailability of Phenolics From an Orange Peel Extract

Conditions
-----------------
Improving Bioavailability

Intervention / Treatment
-----------------
* Dietary Supplement: phenolics form orange peel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults BMI 18.5 to 25 Exclusion Criteria: pregnancy smoking alcohol or drug abuse use of medication use of nutritional supplements abnormal liver or kidney function

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: phenolics form orange peel, type 1<br>1 dose of 500 mg of phenolics from orange peel, orally ingested | Dietary Supplement: phenolics form orange peel<br> <br> |
| Active Comparator: phenolics from orange peel, type 2<br>1 dose of 500 mg of phenolics from orange peel, orally ingested | Dietary Supplement: phenolics form orange peel<br> <br> |
| Experimental: phenolics from orange peel, type 3<br>1 dose of 500 mg of phenolics from orange peel, orally ingested | Dietary Supplement: phenolics form orange peel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentrations of specific phenolics and their metabolites |  | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine concentrations of specific phenolics and their metabolites |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phenolics, orange peel, bioavailability
Modified HFNC Oxygen in Patients Undergoing Bronchoscopy.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the Modified High-flow nasal cannula is effective in the oxygen of the patients undergoing bronchoscopy.

Official Title
-----------------
Modified High-flow Nasal Cannula Oxygen in Patients Undergoing Bronchoscopy.

Conditions
-----------------
Bronchoscopy,Oxygen

Intervention / Treatment
-----------------
* Device: Modified High-flow nasal cannula
* Device: nasal cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria age more than 18 years old; need for bronchoscopy for diagnosis purpose. Exclusion criteria peripheral arterial pulse oximetry was < 90% platelet count < 60 × 109/L; nasopharyngeal obstruction or blockage.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified High-flow nasal cannula therapy<br>Patients undergoing bronchoscopy are given Modified High-flow nasal cannula oxygen therapy all the time. | Device: Modified High-flow nasal cannula<br>* Modified High-flow nasal cannula<br>|
| Active Comparator: Nasal cnnnula therapy<br>Patients undergoing bronchoscopy are given nasal cannula oxygen therapy all the time. | Device: nasal cannula<br>* Conventional oxygen therap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients SpO2 < 90% during bronchoscopy |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the operation time |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Modified High-flow nasal cannula, Bronchoscopy, Oxygen therapy
The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant

Study Overview
=================
Brief Summary
-----------------
Hopefully this research can help to provide the optimal nutrition management from pregnancy so that the babies wiil born with better quality of health and reduce the morbidity and mortality. Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of probiotics supplementation on pregnant women to the baby especially from inflammation pathways. The investigators hope the result of this research can help reducing infant morbidity and mortality rate in Indonesia, also has a benefit for future research.

Official Title
-----------------
The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant

Conditions
-----------------
Bifidobacterium

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women ,gestation age 32-34 weeks, normal pregnancy, plan to deliver spontaneously, no antibiotic tend to give exclusive breastfeeding want to join the research well doing baby Exclusion Criteria: pregnant women with pre-eclampsia,bleeding,infection,premature rupture of the membrane or other chronic disease plan to deliver by caesarean section
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saccharum lactis | Other: Placebo<br> <br> |
| Experimental: Probiotic<br>Bifidobacterium animalis lactis | Dietary Supplement: Probiotic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal microbiota examination by DNA extraction and real time PCR |  | 3 months | 
| Examination of IL-8 in breast milk |  | 3 months | 
| Examination of urine IFABP |  | 3 months | 
| Calprotectin examination in stool of infants aged 3 months |  | 3 months | 
| Alpha 1 antitrypsin |  | 3 months |
Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum Chitotriosidase Level in Psoriasis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum Chitotriosidase level in psoriatic patients.

Official Title
-----------------
Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum Chitotriosidase Level in Psoriasis.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Radiation: Narrowband ultraviolet B
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to severe plaque psoriasis of any age and gender. Exclusion Criteria: History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months. Pregnancy and lactation. Infections. Patients with chronic diseases: hepatic disorders, hematologic diseases, chronic renal failure or cancer.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narrowband ultraviolet B<br>Patients will receive 8 sessions of NB-UVB per month for 3 successive months | Radiation: Narrowband ultraviolet B<br>* Patients will receive 8 sessions of NB-UVB per month for 3 successive months<br>* Other names: NB-UVB;|
| Active Comparator: Methotrexate<br>Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months | Drug: Methotrexate<br>* Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months<br>* Other names: MTX;|
| No Intervention: healthy individuals as control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Chitotriosidase in psoriasis | Measurement of serum Chitotriosidase in psoriatic patients before and after treatment with NB-UVB versus MTX in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of psoriasis | Clinical evaluation: Assessment of disease severity will be performed by using psoriasis area severity index (PASI score) before and after treatment with NB-UVB in comparison with MTX. | 3 months |
Perioperative Risk Calculator

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to develop a machine-learning model for calculating the risk of postoperative complications. In addition to the data collected during the premedication, the model will include all intraoperative values recorded in the Patient Data Management System (PDMS), which include not only vital and respiratory parameters, but also medication and doses, intraoperative events and times. Postoperative complications are defined according to their severity according to the Clavien-Dindo score (Dindo, Demartines et al., 2004) and are collected from the data available in the health information system (HIS). The machine-learning model is created using an extreme-gradient boosting algorithm which has been updated with new data from the year 2021 to ensure accuracy of the model.

Official Title
-----------------
Machine-learning Model for Perioperative Risk Calculation

Conditions
-----------------
Perioperative/Postoperative Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who underwent surgery with anesthesia Exclusion Criteria: none
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 |
| --- | --- | --- |
| postoperative complications | Postoperative complications are classified by means of the Clavien-Dindo-Score. The Clavien-Dindo-Score describes classes of severity of postoperative complications: Grade I: any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II: requiring pharmacological treatment Grade IIIa: requiring surgical, endoscopic or radiological intervention not under general anesthesia Grade IIIb: requiring surgical, endoscopic or radiological intervention under general anesthesia Grade IVa: single organ dysfunction Grade IVb: multiorgandysfunction Grade V: death of a patient | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital mortality | mortality within hospital stay | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine learning, decision support, risk calculator, anesthesia
Comparison of Glycemic Control Achieved With 2 Different Needles

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.

Official Title
-----------------
Comparison of Glycemic Control Achieved With a 31 Gauge x 6 mm NovoFine® Needle vs. a BD 29 Gauge x 12.7 mm Ultra-Fine® Needle in Subjects With Diabetes Mellitus and a BMI Exceeding 30 kg/m2: An Open Label, Randomized, Two-Period Crossover Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: NovoFine® needle 6 mm
* Device: Ultra-Fine needle 12.7 mm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus Current treatment with insulin or insulin analogues for the last 6 months BMI greater than or equal to 30.0 kg/m2 Currently injecting in the thigh or abdomen HbA1c below 10% Exclusion Criteria: Severe, uncontrolled hypertension Self-mixing insulin Unwillingness to monitor blood glucose Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NovoFine® needle 6 mm|nan|
|Device: Ultra-Fine needle 12.7 mm|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject preference and handling |  |  | 
| Frequency of hypoglycaemic episodes |  |  | 
| Quality of Life |  |  |
Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®

Study Overview
=================
Brief Summary
-----------------
To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.

Official Title
-----------------
A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: LBEC0101
* Drug: Enbrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, 20 to 45 years of age the moment of screening Body mass index is between 18.0 and 30.0 kg/m Exclusion Criteria: The tuberculosis patient or latent tuberculosis patient Hypersensitivity response to the test and comparator drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Drug: LBEC0101<br>* Etanercept 25mg, single dose<br>|
| Experimental: Group 2<br> | Drug: Enbrel<br>* Etanercept 25mg, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etanercept levels in blood |  | 22 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Etanercept, Enbrel, healthy volunteers