linjc16/ctgov huggingface dataset:
Effect of Usage of Electroencephalogram (EEG) Entropy on the Incidence of Postoperative Cognitive Dysfunction in Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly patients after general anesthesia.

Official Title
-----------------
Is the Ese of EEG Entropy as Intra-operative Monitor Improves Postoperative Cognitive Dysfunction

Conditions
-----------------
Cognitive Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-II. scheduled for retinal surgery expected to take 2-3 hours under general anesthesia. orotracheal intubation. Exclusion Criteria: history of cardiac, pulmonary, liver or renal disease. significant obesity (body mass index >30. Long-term user of central nervous system activator drugs, benzodiazepines and/or opiates. dementia, brain atrophy and other neurological disorder.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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 |
| --- | --- |
| 1<br>Entropy group | |
| 2<br>Control | |

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
-----------------
EEG entropy, Elderly, Decreases, POCD, Use of EEG entropy, Geriatric
Altered Calcium and Vitamin D in PMDD or Severe PMS

Study Overview
=================
Brief Summary
-----------------
Osteoporosis has become one of the most widely recognized disorders of our times affecting an estimated 25 million women in this country. Recent evidence has suggested that premenstrual syndrome (PMS) is associated with a calcium deficiency state and bone loss. This may place premenopausal women at greater risk for osteoporosis. An entity such as PMS may be an important physiological marker of a calcium disturbance. The purpose of this investigation is to understand more completely the extent to which calcium balance is disturbed in severe PMS or Premenstrual Dysphoric Disorder (PMDD) by utilizing new tools to assess calcium and bone turnover. The long term objective is to elucidate the pathophysiology of PMDD or severe PMS as it relates to calcium hormones and bone markers. The experimental design involves the comparison between women witn severe PMS and asymptomatic controls.

Official Title
-----------------
Altered Calcium And Vitamin D Metabolism in PMDD

Conditions
-----------------
Premenstrual Syndrome

Intervention / Treatment
-----------------
* Procedure: Measures of calcium and bone turnover


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical history of severe PMS for the PMS group No medical history of PMS for the control group Prospective 2 month documentation of moderate to severe symptoms for the PMS group Prospective 2 month documentation of absent symptoms for the control group General good health Regular menstrual cycles No history of metabolic bone disease Exclusion Criteria: Amenorrhea Anorexia nervosa Malabsorption Inflammatory bowel disease Erosive gastrointestinal disease Gastrectomy Malignancy Multiple myeloma Primary hyperparathyroidism Use of suppressive doses of thyroxine Cushing's syndrome Use of glucocorticoids or anticonvulsants Use of diuretics Metabolic bone disease Pregnancy or perimenopause or menopause Mental retardation Menstrual irregularity Significant gynecologic abnormality Use of birth control pills

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Measures of calcium and bone turnover|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
-----------------
Premenstrual Dysphoric Disorder, Severe Premenstrual Syndrome, Calcium metabolism, Vitamin D, Bone Markers, Premenopausal, Menstrual Cycle
Improvement of the Diagnosis and Medico-legal Management of Psychological Trauma in Patients Involved in the Terrorist Attack in Nice on the 14th July 2016

Study Overview
=================
Brief Summary
-----------------
Psychological trauma is a major public health concern that affects numerous patients who have experienced traumatic events. The objective of our research was to improve the diagnosis and management of persons experiencing such events. We will seek to determine factors brought into play in the construction of psychological trauma and the best way to identify them so as to implement the optimal management of patients and ensure recognition of this condition. In addition, in the context of our activity as expert witnesses, we will study the methods used to assess and quantify psychological trauma. In this respect, a medical appointment will be made by a nurse of the Forensic Medicine Department of Dijon CHU. During this consultation, a self-report questionnaire will be completed by the patient alone to evaluate the level of acute stress followed by a psychiatric consultation and completion of the IES-R questionnaire with the doctor to identify symptoms of psychological trauma.

Official Title
-----------------
DIAGNOSIS and FORENSIC MANAGEMENT OF PSYCHOLOGICAL TRAUMA IN PATIENTS INVOLVED IN THE TERRORIST ATTACK IN NICE ON THE 14TH JULY 2016

Conditions
-----------------
Registration of a Complaint Following the Terrorist Attack of 14 July 2016

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who have registered a complaint leading to the involvement of the Forensic Medicine Department of DIJON CHU to evaluate requests for temporary sick leave for psychological reasons following the event in NICE on the 14 July 2016. Exclusion Criteria: Refusal of the patient to attend the consultation proposed by the Forensic Medicine Department of DIJON CHU, Refusal of the patient to take part in a clinical study. Verbal information about the clinical study when the appointment was made by the Forensic Medicine nurse, Reiteration of the verbal information during the consultation, A letter and an official information document given to each patient by the DIJON CHU research Unit stating the objectives and methods of the clinical study, Contact details of the Forensic Medicine Department given to patients if they have any questions about the study.
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 |
| --- | --- | --- |
| PID scale |  | At baseline |
E3 Breast Cancer Taxotere Combination

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

Official Title
-----------------
A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).

Conditions
-----------------
Advanced Breast Cancer

Intervention / Treatment
-----------------
* Drug: Vandetanib (ZD6474)
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females with histological/cytological confirmation of breast cancer. Subjects with a measurable lesion or bone lesions Exclusion Criteria: Previous radiotherapy within 6 weeks Significant cardiac events, arrhythmias or other cardiac conditions

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Docetaxel + placebo vandetanib | Drug: Docetaxel<br>* intravenous infusion<br>* Other names: Taxotere®;|
| Experimental: 2<br>Vandetanib + Docetaxel | Drug: Vandetanib (ZD6474)<br>* once daily oral dose<br>* Other names: ZACTIMA™;Drug: Docetaxel<br>* intravenous infusion<br>* Other names: Taxotere®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With a Disease Progression Event | Number of patients with objective disease progression or death (by any cause in the absence of objective progression) | RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zactima
Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics

Study Overview
=================
Brief Summary
-----------------
A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.

Official Title
-----------------
A Repeat Dose, Randomised, Double Blind, 2-way Crossover Study to Assess the Safety and Systemic Exposure of an Investigational Formulation Compared to Concurrent Administration of Individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS Inhalers in Subjects Aged 18 - 55 Years With Mild Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: fluticasone propionate/salmeterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Documented history of mild or intermittent asthma Have PEF and FEV1>80% predicted Not a smoker BMI of 19 - 29 Exclusion criteria: Have had a life threatening episode of asthma Have had a respiratory tract infection in the last four weeks Have other respiratory disease Have taken certain medications within restricted time periods

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>investigational drug | Drug: fluticasone propionate/salmeterol<br>* investigational drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective was to look at the safety and tolerability of a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol |  | Administration occurred over 14 days and tolerability | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol |  | Administration occurred over 14 days and tolerability | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma
Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

Study Overview
=================
Brief Summary
-----------------
The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity. The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.

Detailed Description
-----------------
This is a phase 3 prospective randomized trial.

Official Title
-----------------
Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Laparoscopic restrictive procedure
* Procedure: Sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI>40) Age > 18 Exclusion Criteria: Pregnancy Uncontrolled medical or psychiatric conditions Previous bariatric procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Sleeve gastrectomy with omentectomy<br> | Procedure: Laparoscopic restrictive procedure<br>* Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy<br>|
| Active Comparator: 2 Sleeve gastrectomy<br> | Procedure: Sleeve gastrectomy<br>* Sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic outcomes |  | 5 years | 
| Diabetes resolution |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, Bariatric Surgery, Obesity Surgery, Omentectomy, Sleeve gastrectomy
Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Study Overview
=================
Brief Summary
-----------------
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants

Detailed Description
-----------------
The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type. All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.

Official Title
-----------------
Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled for a standard total knee replacement Patient who are scheduled for patient-specific total knee replacement (iTotal) Patient age > 18 years Exclusion Criteria: Patients who do not receive a total knee replacement Unwilling or unable to comply with study requirements

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 |
| --- | --- |
| Phase I<br>A series of 50 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements | |
| Phase II<br>The Phase I (50 consecutive primary iTotal patients) will also have implant fit data assessed for the femur. After final implantation is complete measurement will be assessed and recorded. A series of 25 primary knees that are scheduled for Standard TKR implants will then undergo the same measurements of the femur. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater | Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia. | Intraoperatively, up to 120 minutes | 
| Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater | Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia. | Intraoperatively, up to 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee replacement, total knee arthroplasty, patient-specific
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.

Official Title
-----------------
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

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

Intervention / Treatment
-----------------
* Drug: GS-5816


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic (> 6 months), hepatic impairment. In the opinion of the Investigator, be in good health. Exclusion Criteria: Severe hepatic encephalopathy. Prior placement of a portosystemic shunt. Hepatorenal or hepatopulmonary syndrome. Suspicion of hepatocellular carcinoma.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. | Drug: GS-5816<br> <br> |
| Experimental: Cohort 2<br>(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816. | Drug: GS-5816<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of GS-5816 | The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax. | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of adverse events and laboratory abnormalities | The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities. | Up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C (HCV) Infection, Moderate Hepatic Impairment, Severe Hepatic Impairment
The Study of CM326 in Adult Subjects With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.

Detailed Description
-----------------
The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Official Title
-----------------
An Open, Multineutral Study Evaluating the Safety and Efficacy of CM326 in the Long-term Treatment of Adult Subjects With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Biological: CM326


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With confirmed Atopic Dermatitis (AD) at the screening. Have the ability to understand the nature of the study and voluntarily sign the informed consent. Be able to communicate well with investigators and follow up protocol requirements. The subjects agreed to use highly effective contraceptive measures during the study. Exclusion Criteria: Not enough washing-out period for previous therapy. Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline. Major surgery is planned during the study period. Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM326<br>CM326 injection, subcutaneous (SC) | Biological: CM326<br>* CM326 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent Adverse events related to CM326 | at week 52 |