linjc16/ctgov huggingface dataset:
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor

Study Overview
=================
Brief Summary
-----------------
In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.

Conditions
-----------------
Surgery, Healthy

Intervention / Treatment
-----------------
* Device: DCI pulse oximeter sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has physical status between ASA 1 or 2 Able to communicate in English Exclusion Criteria: Pregnant or sexually active without birth control. Hemoglobin less than 11g/dL Known alcohol or drug abuse Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection Nail polish Head injury with loss of consciousness within the last year Known neurological and psychiatric conditions. Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Reynods syndrome Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg Baseline heart rate <50 beats per minute

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor. | Device: DCI pulse oximeter sensor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor | Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. | Up to 24 hours |
Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets

Study Overview
=================
Brief Summary
-----------------
Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted to ACV and L-valine after oral administration. In subjects with normal renal function, ACV is predominantly eliminated unchanged in the urine, with a small proportion metabolized to 9-carboxymethoxymethylguanine (CMMG). The metabolism of ACV to CMMG is thought to involve aldehyde dehydrogenase (ALDH). On the basis of a high proportion of the Japanese population having low-activity ALDH, it can be hypothesized that the conversion of ACV to CMMG is decreased, thereby leading, in patients with renal impairment, to higher plasma concentrations of ACV. This pilot study was conducted to investigate potential relationships between genetic polymorphisms of ALDH2, an isozyme of ALDH, and the plasma pharmacokinetics (PK) of VACV, ACV and CMMG in subjects with end-stage renal disease on hemodialysis.

Official Title
-----------------
Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets -Single Oral Dose Study in Hemodialysis Patients-

Conditions
-----------------
Virus Diseases

Intervention / Treatment
-----------------
* Drug: Valaciclovir Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Japanese subjects with chronic renal failure undergoing hemodialysis regularly three times a week for at least 12 weeks prior to the start of the study. Exclusion criteria: Subjects with current alcohol dependence. Subjects with gastrointestinal dysfunction that may affect drug absorption. Subjects who have received an organ transplant (However, subjects with a corneal transplant or any other organ transplant that may not affect the objectives of the study will be eligible for inclusion in this study).

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valaciclovir Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The pharmacokinetic parameters for VACV, ACV and CMMG - Relationship between ALDH2 genotypes and the pharmacokinetics of VACV, ACV and CMMG in blood |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Change in blood ACV and CMMG concentrations after a 4-hour hemodialysis session - Safety (adverse events occurring during the study, clinical laboratory tests) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valaciclovir Hydrochloride, hemodialysis patient, ALDH, pharmacokinetics, Japanese
Can Calorie Labels Increase Caloric Intake

Study Overview
=================
Brief Summary
-----------------
This study is a test of possible mechanisms by which calorie labels might lead people to increase calorie intake. The investigators hypothesize that calorie labels might increase calorie intake because 1) people infer that higher calorie foods are tastier, 2) calorie labels invoke thoughts of dieting, leading people to overconsume as a reaction, 3) people try to maximize calories consumed per dollar spent, and 4) calorie labels change one's goal motivation toward food, causing people to eat more.

Official Title
-----------------
Can Calorie Labels Increase Caloric Intake? A Test of Possible Perverse Effects of Calorie Labels

Conditions
-----------------
Food Consumption

Intervention / Treatment
-----------------
* Other: Calorie information
* Other: No calorie information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to taste items used in study Exclusion Criteria: Food allergies to items used in study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calorie label<br> | Other: Calorie information<br>* Nutrition label featuring calorie information will be provided.<br>|
| Active Comparator: No calorie label<br> | Other: No calorie information<br>* No nutrition label will be provided in this condition.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calories consumed | The investigators will assess how many calories are consumed by participants by weighing the cereal provided before and after participants complete the taste test portion of the study. This will happen within 30 minutes of the intervention, which is an experimental manipulation of whether or not calorie labels are present. | At time of intervention (30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes toward food | Using survey measures, the investigators will assess how people feel toward the food item they just tasted, rating it in terms of perceived tastiness, healthiness, overall quality, and value. These ratings will be on a Likert scale from 1-5. | At time of intervention (30 minutes) |
Beta Blocker Effects in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.

Detailed Description
-----------------
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups. Parameters assessment: Length of ICU stay Length of total hospital stay CT scan to exclude another intracranial hemorrhage or increase in hemorrhage Functional status will be assessed using the GCS Hemodynamic data ( bl.p / hr ) Crystalloid volume that patient need in 24h Mortality rate

Official Title
-----------------
Beta Blocker Effects on Patients With Traumatic Brain Injury

Conditions
-----------------
Trauma, Brain

Intervention / Treatment
-----------------
* Drug: Propranolol
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GCS preoperative >10 Abbreviated Injury Scale (AIS) >3 Length stay in ICU >48 h Exclusion Criteria: Hypersensitivity to propranolol Asthmatic patient COPD History of smoking Any cardiac problems eg: ( heart failure or HB ) pheochromocytoma Pregnant patient Length stay <48h Death within 48 h of admission Patient who previously received any beta blocker at home. Symptomatic Bradycardia <60 b/m (sick sinus syndrome) Hemodynamic unstable patients

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: beta blocker<br>Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours | Drug: Propranolol<br>* intravenous propranolol for case patients<br>|
| Placebo Comparator: placebo<br>Will be given normal saline 10 ml every 6 hours for 48 hours | Drug: Saline<br>* intravenous saline for placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | number of surviving in patients receiving propranolol and patients who did not receive any beta blocker | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | number of patient showing effect of beta blocker on TBI related to HR | 7 days | 
| icu stay | number of patients were beta blocker in TBI affected on ICU and total hospital stay | 7 days |
Influence of Oxygen on Non-invasive Measurement of Hemoglobin

Study Overview
=================
Brief Summary
-----------------
This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.

Official Title
-----------------
Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: hemoglobin measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients scheduled for a potentially hemorrhagic surgical procedure Exclusion Criteria: anomaly (malformation, infection, swelling, irritation, ulceration, degenerative changes or significant edema) of the fingers, tremors.

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: surgical patients<br>patients studied just before induction of anesthesia | Device: hemoglobin measurement<br>* Non invasive hemoglobin measurements (Pronto 7 device and NBM-200 device)will be made with : at baseline (simultaneous blood sample for a laboratory measurement of hemoglobin), with the patient breathing oxygen via a face-mask (FiO2 50 ± 5%), with the patient breathing oxygen via a face-mask (FiO2 90 ± 5%) (simultaneous blood sample for a laboratory measurement of hemoglobin).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices) | Statistical comparison of the 3 measurements (baseline, FiO2 50%, FiO295%) for each device | one year (end of the recrutement period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis | Statistical comparison of the 2 devices | one year (end of the recrutement period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemoglobin determination, oxygen
Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

Study Overview
=================
Brief Summary
-----------------
Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice

Official Title
-----------------
Special Investigation for Vizimpro Tablets

Conditions
-----------------
EGFR Mutation-positive Inoperable or Reccrent NSCLC

Intervention / Treatment
-----------------
* Drug: dacomitinib hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate) Exclusion Criteria: Exclusion criteria is not provided in this study

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| VIZIMPRO(dacomitinib hydrate)<br>Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate) | Drug: dacomitinib hydrate<br>* The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition.<br>* Other names: VIZIMPRO;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and proportion of patients with ILD (interstitial lung disease) | The number and proportion of patients with ILD (interstitial lung disease) will be tabulated by subgroup by risk factor | 52 weeks form the start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate will be calculated. The response rate is defined as the propotion of patients with a best ovarall response of CR ro PR in the effectiveness analysis set. | 52 weeks from the start date | 
| The number and population of patients with adverse reactions | The number and population of patients with adverse reactions will be tabulated. | 52 weeks from the start date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VIZIMPRO, EGFR mutation-positive inoperable or recurrent NSCLC, non-small cell lung cancer
Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. Caspase-8 is a key enzyme involved in controlling cell death. This study examines the importance of caspase-8 in oral cancer.

Detailed Description
-----------------
Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. The caspase family of enzymes are the key performers of controlled cell death and caspase-8 is frequently mutated in oral cancer. This study will perform DNA sequencing to determine if the gene is wild-type (not mutated). The abundance of inactive (uncleaved) and active (cleaved) caspase-8 will be determined. The levels of the proteins that caspase-8 interacts with (including caspase-3) will be determined. Results will be correlated with tumour stage, patient outcome and the presence of immune cells and other microscopic features. This will improve the understanding of the importance of caspase-8 in oral cancer.

Official Title
-----------------
Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma

Conditions
-----------------
Oral Cancer

Intervention / Treatment
-----------------
* Other: There is no intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oral cancer Sufficient follow up data Exclusion Criteria: Patient has indicated that they do not wish their tissue to be used for research. . The quantity or quality of tissue is too little or poor to provide adequate material without significant reserve. The material contains bone.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: There is no intervention.|There is no intervention. This is a retrospective study analysing archived tumour samples.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caspase-8 activity in oral cancer and its impact on disease progression | Molecular analysis of caspase-8 activity will be undertaken and correlated with tumour features and outcome. | Up to 3 years |
Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.

Study Overview
=================
Brief Summary
-----------------
To determine the levels of zidovudine triphosphate ( AZT-TP ) in maternal and fetal cord blood mononuclear cells. To determine the ratio of AZT-TP to endogenous nucleoside triphosphate levels in maternal and fetal cells. To determine the extent of drug transfer through the feto/placental unit.

Official Title
-----------------
Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.

Conditions
-----------------
HIV Infections, Pregnancy

Participation Criteria
=================

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard

Detailed Description
-----------------
All consecutive subjects with type 2 diabetes referred from June 2012 to December 2019 were eligible. They were excluded if data on ongoing therapy, anthropometric or laboratory parameters, or measured REE was not available or if presenting with conditions known to affect indirect calorimetry.

Official Title
-----------------
Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes Available resting energy expenditure assessed by indirect calorimetry Exclusion Criteria: data on ongoing therapy (e.g. lifestyle measures with or without approved drugs), anthropometric or laboratory parameters (including white blood count, estimated glomerular filtration rate, TSH), or REE assessed by the means of indirect calorimetry could not be retrieved presenting with conditions known to affect indirect calorimetry (e.g. patients with strenuous exercise on the day before, asymptomatic patients with severe chronic kidney disease (eGFR < 30 ml/min/ 1.73 m2), increased white blood count, or subnormal TSH)
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational|Observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight in Kilograms | Baseline | 
| Neck circumference | Neck circumference in cm | Baseline | 
| Waist circumference | Waist circumference in cm | At baseline | 
| Hip circumference | Hip circumference in cm | Baseline | 
| Body mass index (BMI) | Body mass index (BMI) (expressed in kg/m^2) | At baseline | 
| Resting Energy Expenditure (REE) | Resting Energy Expenditure (REE) in kcal | At baseline |