linjc16/ctgov huggingface dataset:
Accuracy of Pulse Oximeters With Profound Hypoxia During Motion

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients during controlled motion.

Detailed Description
-----------------
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients during controlled motion.

Official Title
-----------------
Determination of SpO2 and PR Accuracy Specifications During Motion Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Device: Pulse oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both male and female subjects who can give written informed consent Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile Meeting the demographic requirements Exclusion Criteria: Age below 18 or over 50 Pregnant women Significant arrhythmia Blood pressure above 150 systolic or 90 diastolic Subjects whom the investigator consider ineligible for the study

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pulse oximeter|OLV-4202 pulse oximeter (SW version: 01-11)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor Oxygen Saturation by Arms Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n) | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor Pulse Rate by Arms Calculation | Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n) | 30 seconds |
Laparoscopy and COVID-19 Contamination

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to search the presence of the SARS-COV-2 virus (COVID19) in the pneumoperitoneum of patients with a positive (or suspected) COVID19 status during a routine laparoscopy.

Official Title
-----------------
Laparoscopy and COVID-19 Contamination

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

Intervention / Treatment
-----------------
* Other: Additional and minimal collection of products of the human body carried out during a sample for standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of legal age Indication for laparoscopy Positive (past or current) or suspected Covid19 status (cough, fever, suggestive radiological images, etc.) Lack of opposition to participating in the study Exclusion Criteria: Patient under legal protection Covid19 status negative, (former or current) and not suspected Patient unable to object Patient with no social security care

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

| Intervention/Treatment |
| --- |
|Other: Additional and minimal collection of products of the human body carried out during a sample for standard of care|Swab of the peritoneal fluid for traces of COVID19. The collection of peritoneal fluid is a standard care practice. Swab from the laparoscopy filter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective of the study is to demonstrate the presence of SARS-COV-2 in the exsufflated gas at the end of laparoscopy. | The SARS-COV-2 will be looked for in the gas before its elimination at the end of the intervention. To this end, the PCR search will be carried out on the filter used | Day 1 , at the end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of the study is to demonstrate the presence of SARS-COV-2 in the peritoneal fluid during laparoscopy | SARS-COV-2 will be tested for by PCR in the peritoneal fluid collected during laparoscopy | Day 1 , at the end of the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LAPAROSCOPY, pneumoperitoneum
Evaluation of Predictive Visual Analog Scale (VAS) for Determining the Ingesta of Patients Carrying a Digestive Cancer

Study Overview
=================
Brief Summary
-----------------
The main objective of our study is to determine if the evaluation of ingesta of cancer patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of patients during hospitalization (for patients malnourished, at risk of malnutrition or risk free).

Conditions
-----------------
Digestive System Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 18 years Admitted to hospital for systemic therapy of gastrointestinal cancer Signature of the non-opposition. Exclusion Criteria: Patients who because of their affection will fasted more than 12:00 during the three days preceding hospitalization. Artificial nutrition Patients

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 |
| --- | --- | --- |
| Evaluation of ingesta | Evaluation of ingesta will be done using SAV scale. | 3 days |
Internet Weight Control for Bingeing Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.

Detailed Description
-----------------
The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.

Official Title
-----------------
Internet Weight Control for Bingeing Adolescents

Conditions
-----------------
Obesity, Eating Disorders

Intervention / Treatment
-----------------
* Behavioral: Internet-based intervention designed to reduce binge eating and improve healthy weight regulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male high school students in Hayward Unified School District or Meridian School District 85th or greater percentile for age-adjusted weight Objective binge eating one or more times weekly for a duration of ≥ 3 months Access to a computer with internet access English literacy at a sixth grade reading level Exclusion Criteria: Current (or history of) diagnosis of anorexia or bulimia nervosa Active suicidal ideation Current enrollment in a formal weight loss or binge eating program (e.g., Weight Watchers) Any medical condition in which the actual condition or treatment affects weight and/or appetite (i.e., cancer, diabetes)

Ages Eligible for Study
-----------------
Minimum Age: 14 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Internet-based intervention designed to reduce binge eating and improve healthy weight regulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of binge eating; weight |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
binge eating, weight loss, obesity
Ultrasound Detection and Characterization of Subclinical Hypertrophy in Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as detected with ultrasound and its impact on glycemic variability.

Detailed Description
-----------------
Lipohypertrophy is a well documented phenomenon in patients with diabetes in which hypertrophy and differentiation of adipocytes occurs in the dermal reticular layer at the sites of subcutaneous insulin injection. Currently, lipohypertrophy is assessed by palpating insulin injection sites. The detection on early, non palpable (subclinical) lipohypertrophy remains difficult in the clinical setting. Recent studies have identified distinct ultrasonographic features of hyperechogenicity in areas of adipose tissue consistent with clinical evidence of lipohypertrophy at insulin injection sites, and have detected changes int he thickness of subcutaneous tissue where not clinically evident in population of patients with type 1 diabetes. Lipohypertrophy can adversely affect glycemic control. Injecting into lipohypertrophic areas leads to poor absorption and the need for increasing doses of insulin. In this study study participants will undergo an assessment for lipohypertrophy during a scheduled visit at the VGH Diabetes Centre. A Diabetes Nurse will assess lipohypertrophy by palpation according to the FIT Protocol. A second diabetes nurse who was not present at the palpation will assess insulin injection sites for lipohypertrophy by ultrasound using a linear probe.

Official Title
-----------------
Ultrasound Guided Detection and Characterization of Subclinical Lipohypertrophy in Type 1 and Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Lipohypertrophy

Intervention / Treatment
-----------------
* Other: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years of age or older Type 1 or Type 2 diabetes Using insulin to manage diabetes for at least 2 years Exclusion Criteria: Using insulin pumps, insulin secretagogues, Glucagon-Like Peptide-1 (GLP-1) agonists to manage diabetes Use of immunosuppressant agents Women who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ultrasound|Abdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Subclinical Lipohypertrophy | Lipohypertrophy seen on ultrasound but not felt by palpation | Assessed one time only at the time of clinic visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Lipohypertrophy, Ultrasound
The Association of G9a Protein and Clinical Outcome of Patients With Vulvar Cancer

Study Overview
=================
Brief Summary
-----------------
To assess the G9a expression in vulvar cancer

Detailed Description
-----------------
Vulvar cancer can be treated with surgery, radiotherapy or chemoradiotherapy. Recurrence of vulvar cancer generally can be detected by imaging study. Currently, there is a paucity of sensitive marker to detect the recurrence of vulvar cancer. G9a is a recently identified protein with histone lysine methyltransferase activity. The role of histone methyltransferases in promoting tumorigenesis and progression of human cancers has been noted in some cancers, such as ovarian cancer, endometrial cancer and cervical cancer. The role of G9a protein in vulvar cancer remains obscure. All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 will be included. All patients' clinical characteristerics including age, stage, pathologic finding, and follow-up data will be recorded from chart review. The archived specimens will be used for immunohistochemical staining of G9a protein. Tumor size, local invasion, lymph node metastasis, and final disease stage will be determined. Correlation will be performed between G9a and clinical outcome of vulvar cancer.

Official Title
-----------------
Far Eastern Memorial Hospital

Conditions
-----------------
Vulvar Cancer, G9a Protein

Intervention / Treatment
-----------------
* Biological: G9a protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 were included. Exclusion Criteria: N/A

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: G9a protein|To assess G9a protein expression on vulvar cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between clinical outcome of vulvar cancer and G9a | The association of G9a protein and clinical outcome (such as overall survival and progression-free survival) of patients with vulvar cancer | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between histopathologic features of vulvar cancer and G9a | Correlation between histopathologic features (such as tumor grade, lymphovascular space invasion, lymph node metastasis and tumor size) of vulvar cancer and G9a | 1 year |
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: gaboxadol
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with a diagnosis of primary insomnia and in good physical and mental health Exclusion Criteria: Adult patients with other medical , neurological and sleep disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: gaboxadol|Duration of Treatment - 6 weeks|
|Drug: Comparator: placebo (unspecified)|Duration of Treatment - 6 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time spent awake and time to fall asleep at night after 2 days |  | After 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time spent awake and time to fall asleep at night after 30 days |  | After 30 days | 
| Amount of deep sleep after 2 days |  | After 2 days |
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

Study Overview
=================
Brief Summary
-----------------
To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients

Official Title
-----------------
A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.

Conditions
-----------------
Ovarian Neoplasms, BRCA1 Protein, BRCA2 Protein

Intervention / Treatment
-----------------
* Drug: KU-0059436 (AZD2281)(PARP inhibitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists. Exclusion Criteria: Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KU-0059436<br>KU-0059436 administered orally twice daily | Drug: KU-0059436 (AZD2281)(PARP inhibitor)<br>* oral<br>* Other names: Olaparib;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 |  | assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumour response |  | assessed every 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced ovarian cancer, BRCA 1 protein, BRCA 2 protein, Poly(ADP ribose)polymerases
Therapeutic Schools: Affect Management and HIV Prevention

Study Overview
=================
Brief Summary
-----------------
Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.

Official Title
-----------------
Therapeutic Schools: Affect Management and HIV Prevention

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Affect Management
* Behavioral: HIV Prevention Skills
* Behavioral: General Health Promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent attending therapeutic school Exclusion Criteria: Adolescent is HIV positive Adolescent is developmentally delayed Adolescent is pregnant Adolescent has a history of sexual crime

Ages Eligible for Study
-----------------
Minimum Age: 13 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Affect Management<br>* 12-session group intervention including affect management training as well as sexual health skills training.<br>|
| Active Comparator: 2<br> | Behavioral: HIV Prevention Skills<br>* 12-session group intervention including sexual health skills training.<br>|
| Active Comparator: 3<br> | Behavioral: General Health Promotion<br>* 12-session group intervention including health information on a variety of health topics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent-reported condom use |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention, HIV seronegativity