linjc16/ctgov huggingface dataset:
Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an operative hemodynamic optimization using the plethysmographic variability index during orthopedic surgery could decrease the length of hospital stay and the postoperative morbidity.

Official Title
-----------------
Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study

Conditions
-----------------
Hip Arthroplasty, Knee Arthroplasty, General Anesthesia

Intervention / Treatment
-----------------
* Device: Plethysmographic variability index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Indication to a knee or hip arthroplasty under general anesthesia Sinusal rhythm Non Inclusion Criteria: Pregnant women Black skin Dialysis Cardiac arrythmia Sepsis Use of another hemodynamic monitoring during surgery

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PVI group<br>Fluid optimisation using PVI | Device: Plethysmographic variability index<br> <br> |
| No Intervention: Control group<br>Standard care using a hemodynamic protocol during general anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay after knee or hip arthroplasty | Surgeons, blinded to the group allocation, are the postoperative care providers who decide the length of hospital stay. | Real length of hospital stay expressed as number of day (maximum 60 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin value |  | Postoperative Day 1 and Day 3 | 
| Creatinine value |  | Postoperative Day 1 and Day 3 | 
| Arterial Lactate |  | 1 hour after end of surgery | 
| Postoperative cardiac complications |  | Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60 | 
| Theorical length of hospital stay after knee or hip arthroplasty | Evaluation twice per day starting day 3 until up day 60. A check list was used by an independant investigator to define the theorical date of end hospitalisation, from day 3 until day 60 | Theorical length of hospital stay expressed as number of day (maximum 60 days) |
A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects With Social Anxiety Disorder

Conditions
-----------------
Social Phobia

Intervention / Treatment
-----------------
* Drug: Placebo treatment during 8 weeks
* Drug: Paroxetine treatment during 8 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Outpatient with Social Anxiety Disorder The subject is healthy Willing to restrict alcohol intake Capable of giving informed consent Exclusion criteria: Subjects with depression or any other psychiatric condition Subjects positive for HIV or hepatitis Subjects taking drugs or other medication Pregnant or becoming pregnant during the study Subjects who have donated blood Subjects who are left-handed Subjects with claustrophobia Subjects with an electronic device or ferromagnetic metal foreign body

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arm 1<br>Paroxetine treatment during 8 weeks | Drug: Paroxetine treatment during 8 weeks<br>* treatment drug<br>* Other names: Placebo treatment during 8 weeks;|
| Placebo Comparator: arm 2<br>Placebo treatment during 8 weeks | Drug: Placebo treatment during 8 weeks<br>* comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients). |  | baseline and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients). |  | baseline and after 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, Social Anxiety Disorder, fRMI
A Safety and Efficacy Study of Xolair in Peanut Allergy

Study Overview
=================
Brief Summary
-----------------
This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.

Official Title
-----------------
A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Xolair (omalizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has a diagnosis of acute peanut allergy The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms The patient is six to 75 years of age The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC) The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level The patient is able to swallow capsules Exclusion Criteria: Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions Have a history of allergy to wheat protein Have previously been exposed to monoclonal antibody treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 75 Years

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 |
| --- |
|Drug: Xolair (omalizumab)|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
-----------------
Peanut
Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records

Study Overview
=================
Brief Summary
-----------------
To document the clinical outcomes of cancer patients who received the Guardant360® test and agree to share their records with Guardant Health.

Detailed Description
-----------------
This is an observational study of clinical outcomes to be conducted in the United States. Patients with a diagnosis of Stage 3-4 advanced cancer who possess specific pathway mutations identified by the Guardant360® test will be eligible to enroll in the study. Patients will be recruited by telephone or email and/or through the Guardant Health Patient Portal to determine interest in the study. Should patients be interested in contributing to this registry study, they will be prompted to consent via a commercial service for patients to request, manage, and view their medical records. Enrolled participants will be requested to release copies of their medical records for review by the principal investigator. Study adminsitrators will abstract participant demographics, cancer-related therapies, and clinical outcomes for analysis.

Official Title
-----------------
Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records (GRECO)

Conditions
-----------------
Non-Hematologic Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria: Adults (≥ 18 years old) with a diagnosis of Stage 3 or Stage 4 cancer (non-hematologic malignancy). Patients with advanced cancers not typically staged 1-4 (such as extensive stage small lung cancer) may be enrolled. Results from Guardant360® test Patient has previously provided contact information (either email or phone) to Guardant Health. Able and wiling to complete the informed consent process. Willingness to consent to the release of medical records. Willingness to provide Medical Records Release General Exclusion Criteria: Unwilling or unable to provide written informed consent. Unable to understand English. Diagnosis of NSCLC Guardant 360® test results released to the patient's physician no less than 14 days and no greater than 60 days prior to initial patient contact.

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 |
| --- | --- | --- |
| Objective response rate (ORR) | Portion of patients with tumors that are found to have complete or partial response | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Guardant Health, GRECO
A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

Study Overview
=================
Brief Summary
-----------------
This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

Official Title
-----------------
A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

Conditions
-----------------
Hepatitis C, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol Provide written, informed consent Be willing and able to comply with the visit schedule Key Exclusion Criteria: Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry History of clinically significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 |
| --- | --- | --- |
| Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen |  | Up to 3 years | 
| Average number of DRM loss by treatment regimen |  | Up to 3 years | 
| Liver disease progression | Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms. | Up to 3 years | 
| Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen |  | Up to 144 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Registry, HCV RNA, Treatment experienced, Treatment naive, GS 9451, GS 5885, Sequence, GS 5816, GS 7977, Sofosbuvir, Sovaldi™, SOF, Ledipasvir, LDV
Uroflow Measurements in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The goal of this study to determine normal values for certain urinary measurements in order to better understand voiding dysfunction in women.

Detailed Description
-----------------
see above

Official Title
-----------------
Uroflow Measurements in Healthy Volunteers

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers/employees Normal voiding function. Willing to participate. Exclusion Criteria: Subjects currently receiving treatment for any lower urinary tract condition or having any voiding difficulty.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voided Volume | Volume of spontaneous void | March 2008 | 
| Maximal Flow Rate | Maximal uroflow of spontaneous subject voids | March 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urogynecology
Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

Study Overview
=================
Brief Summary
-----------------
This study will address the following questions: Does the use of oestrogen inserted vaginally with an applicator, help with the symptoms of faecal (bowel) incontinence in women who are past the age of menopause? Do women find it easy to use? Is the treatment safe for the womb lining? Is there any systemic absorption of the treatment?

Detailed Description
-----------------
Faecal incontinence affects about 5% of women, the most common cause is often cited by women as obstetric trauma. However in clinical practice many women report that their symptoms of faecal incontinence begin around the same time as menopause. A community survey examining the prevalence of faecal incontinence in menopausal women is in progress. If a correlation is found between the onset of menopause and the development of faecal incontinence, further investigation of effective treatment will be indicated. The investigators want to investigate whether vaginally administered oestradiol can alleviate or improve symptoms in women who have faecal incontinence after the menopause. This is a pilot study.

Official Title
-----------------
A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Drug: oestradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post menopausal women with faecal incontinence Exclusion Criteria: No hormone replacement therapy (HRT) for at least 8 weeks prior to screening Diabetes mellitus Neurological disorder Terminal illness Current treatment for breast cancer Unable to give informed consent

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

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

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: oestradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of treatment mode delivery, through questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oestradiol, faecal incontinence, post menopausal, post menopausal women with faecal incontinence
Diagnostic Value of C-reactive Protein and White Blood Cell Counts for Early Detection of Inflammatory Complications After Open Resection of Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory complications after open resection of colorectal cancer.

Conditions
-----------------
Given Indication for Open Resection of Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with resection of colorectal cancer Exclusion Criteria: lack of measurement of C-reactive protein lack of measurement of white blood cell counts

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 |
| --- | --- |
| Patients after open resection of colorectal cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative inflammatory complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leakage |  | 60 days |
Clinicopathological Characteristics of Colon Cancer in Young Age

Study Overview
=================
Brief Summary
-----------------
A Study on the Characteristics of Colorectal Cancer by Age and sex.

Detailed Description
-----------------
The investigators aimed to investigate the prognosis according to sex and age by analyzing the clinical, pathophysiological, and molecular characteristics of colorectal cancer (CRC), and to find the factors influencing the prognosis of CRC.

Official Title
-----------------
Clinicopathological Characteristics of Colon Cancer in Young Age

Conditions
-----------------
Colo-rectal Cancer, Molecular Pathway Deregulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated after being diagnosed with colorectal cancer Exclusion Criteria: Patients under age of 18 years, or patients who cannot choose whether to participate or not Patients who refuse to participate in the 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 |
| --- | --- |
| Colorectal cancer group<br>Patients treated after being diagnosed with colorectal cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival (overall/disease-specific) according to sex, molecular profiles and sex hormone receptors | Time from diagnosis to death | From date of enrollment until the date of death from colorectal cancer or from any cause, assessed up to 120 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival according to sex, molecular profiles and sex hormone receptors | Time from diagnosis to recurrence | From date of enrollment until the date of first documented recurrence of colorectal cancer, assessed up to 120 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, prognosis, sex difference