linjc16/ctgov huggingface dataset:
Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology

Study Overview
=================
Brief Summary
-----------------
Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer will be received an examination oncogériatric

Official Title
-----------------
Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology

Conditions
-----------------
Geriatrics, Cancer

Intervention / Treatment
-----------------
* Other: cognitive evaluation by MMS (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient old over 70 years Patient with cancer (solid tumor or hematological) for which a 1st line treatment is planned Patient candidate an oncogeriatric assessment Patient agreeing to participate in the study French language Lack of subsequent neurological sequelae with cognitive impact stroke, dementia or progressive psychiatric disorder Patient having a life expectancy ≥ 6 months Exclusion Criteria: Primitive cancer of the central nervous system or brain metastasis Patients unable to meet the cognitive tests Refusal to participate Realization of a MMSE or MoCA test in the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 71 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cognitive evaluation by MMS (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) tests|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with cognitive disorders identified by the MoCA or the MMSE prior to treatment |  | before their first treatment for the cancer, at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
geriatrics, cancer, MMS test, MoCA test, cognitive evaluation
Nutritional Aspects of Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in healthy controls. II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining, sitting, and standing, by whole-room indirect calorimetry and isotope dilution. III. Quantify activity patterns by time-motion studies using 24-hour activity records and 12-hour videotaping. IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term oxygen consumption. V. Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by clinical anthropometry, whole-body potassium counting, and total-body electrical conductance. VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.

Detailed Description
-----------------
PROTOCOL OUTLINE: All participants undergo extensive nutritional and metabolic assessment with body composition evaluation. Studies include macronutrient intake, body fat, lean muscle mass, metabolic rate, and time-action studies; and 24-hour cardiac telemetry. Rett syndrome girls also receive a hemogram and hand x-ray.

Conditions
-----------------
Rett Syndrome

Intervention / Treatment
-----------------
* Procedure: Metabolic assessment with body composition evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Patients aged 5 to 18 with Rett syndrome Able to sleep and awaken alone

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Metabolic assessment with body composition evaluation|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
-----------------
Rett syndrome, neurologic and psychiatric disorders, rare disease
Ultrasonographic Fetal Soft Markers and Aneuploidy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the prevalence of soft markers which will be identified during a second trimester ultrasound. Secondary aims were to estimate the association between the soft markers and trisomies 13, 18 and 21 as well as the effect on the number of invasive tests will be performed.

Official Title
-----------------
Correlation Between Ultrasonographic Fetal Soft Markers and Aneuploidy

Conditions
-----------------
Soft Markers

Intervention / Treatment
-----------------
* Device: Midtrimester anomaly scan
* Genetic: Fetal Karyotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant woman between (16-24) weeks of gestation. singelton pregnancy. Exclusion Criteria: Multiple pregnancies. Mental condition rendering the patients unable to understand the nature and scope of the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 16-24 weeks Pregnant womes<br>Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more. | Device: Midtrimester anomaly scan<br>* A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy<br>* Other names: 2nd trimester anomaly scan;Genetic: Fetal Karyotyping<br>* Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the association between soft markers identified at second trimester ultrasound and aneuploidy. | fetal soft markers detection which include the following: choroid plexus cyst. Mild ventriculomegaly. Enlarged cistern magna. Nasal bone hypoplasia. Increased nuchal fold. Echogenic cardiac focus. Single umbilical artery. Pyelectasis. Echogenic bowl. Short femur. Short humerus. All data will be collected and statistics will be done for the correlation between one or more soft markers with structural anomalies and its relation with aneuploidy. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anomaly scan, Anuploidy
Ultrasonic Wound Debridement vs. Standard Sharp Debridement

Study Overview
=================
Brief Summary
-----------------
A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.

Official Title
-----------------
Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial

Conditions
-----------------
Chronic Skin Ulcers

Intervention / Treatment
-----------------
* Device: Contact ultrasonic debridement device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic wound needing debridement >3 cm2 Ulcer history >4mo Adequate arterial blood flow (ABI>0.7) Venous, Inflammatory, Pressure, Diabetic Exclusion Criteria: Bleeding disorder ABI<0.7 Uncontrolled diabetes Taking systemic corticosteroids Chemotherapy Participating in another study Treatment with Apligraft, Dermagraft, or Regranex within 90 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contact Ultrasonic Debridement Device<br> | Device: Contact ultrasonic debridement device<br>* Cavitational ultrasound wound debridement device<br>* Other names: SonicOne, Misonix Inc, Farmingdale NY;|
| Active Comparator: Standard Sharp Debridement<br> | Device: Contact ultrasonic debridement device<br>* Cavitational ultrasound wound debridement device<br>* Other names: SonicOne, Misonix Inc, Farmingdale NY;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete wound closure |  | 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative rate of wound healing |  | 8, 12 and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound debridement, requiring debridement
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

Official Title
-----------------
Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Conditions
-----------------
Type II Diabetes Mellitus, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Pitavastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes mellitus Combined dyslipidemia Completed NK-104-305 (NCT00309751) Exclusion Criteria: Withdrawal from NK-104-305 (NCT00309751)
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin<br>Pitavastatin 4 mg QD | Drug: Pitavastatin<br>* Pitavastatin 4 mg QD<br>* Other names: Livalo;|
| Active Comparator: Atorvastatin<br>Atorvastatin 40 mg | Drug: Atorvastatin<br>* Atorvastatin 40 mg<br>* Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCEP LDL-C Target Attainment | Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study. | 44 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in LDL-C | Percent change from baseline in LDL-C at 44 weeks | Basseline to 44 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pitavastatin, Type II Diabetes Mellitus, Combined Dyslipidemia
A Study of ARQ 171 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly. Patients with advanced solid tumors, who are refractory to available therapy or for whom no standard systemic therapy exists, will be enrolled.

Official Title
-----------------
A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: ARQ 171


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent must be obtained and documented prior to study-specific screening procedures. A histologically or cytologically confirmed advanced solid tumor ≥ 18 years of age Measurable disease as defined by Response Evaluation Criteria in Solid Tumors Karnofsky performance status ≥ 70% Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after participation. Females of childbearing potential must have a negative serum pregnancy test. Laboratory results must meet study criteria. Exclusion Criteria: Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first infusion Surgery within 4 weeks prior to first infusion Known untreated brain metastases Pregnant or breastfeeding Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARQ 171|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetic profile of ARQ 171 |  |  | 
| To assess the preliminary anti-tumor activity of ARQ 171 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Solid Tumors, advanced solid tumors
Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to prospectively evaluate the value of pelvic MRI including diffusion- and perfusion-weighted sequences in the selected group of patients that have an undetermined ovarian mass at ultrasound.

Official Title
-----------------
Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging

Conditions
-----------------
Undetermined Ovarian Mass

Intervention / Treatment
-----------------
* Device: Pelvic MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: *Any woman with an adnexal mass undetermined by gynecological ultrasound Exclusion Criteria: Any lesion with definite diagnosis by gynecological ultrasound Denial or withdrawal of oral informed consent. Contra-indication for MRI
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with unclassified ovarian mass<br> | Device: Pelvic MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of MRI findings with histopathology or 2-years follow-up |  | 03/2015 to 03/2017 (up to 2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic MRI
Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage

Study Overview
=================
Brief Summary
-----------------
Endoscopic sphincterotomy and temporary stenting is a routine treatment for post cholecystectomy cystic duct leakage. The draw back is that the plastic stent need to be removed later in a second intervention. Our studies with animal models have demonstrated that biodegradable biliary stent is at least as good as conventional plastic stent to heal that kind of leakage. In this pilot study the biodegradable biliary stent is inserted endoscopically to patients with confirmed cystic duct leakage to demonstrate the efficacy in human setting.

Official Title
-----------------
Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study

Conditions
-----------------
Cyst

Intervention / Treatment
-----------------
* Procedure: endoscopic bile duct stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: endoscopic bile duct stenting|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical healing of bile leakage |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic duct leakage
Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs)

Study Overview
=================
Brief Summary
-----------------
An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ).Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is copidogrel loading dose administration before procedure.(8,9 ) The investigators hypothesized that a high (40mg) loading dose of Rosuvastatin administered within 24h before the procedure may be effective in reducing the rate of periprocedural MI.Therefore, the investigators will conduct a single center,prospective randomized study to assess whether a single,high (40mg) loading (within24h)dose of Rosuvastatin is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation.

Official Title
-----------------
ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis

Conditions
-----------------
Periprocedural Myocardial Necrosis

Intervention / Treatment
-----------------
* Drug: ROSUVASTATIN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable angina Exclusion Criteria: Baseline myocardial enzyme rise

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CLOPIDOGREL<br> | Drug: ROSUVASTATIN<br>* 40 mg before procedure<br>|
| Experimental: ROSUVASTATIN<br> | Drug: ROSUVASTATIN<br>* 40 mg before procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial enzymes arise |  | 6-12-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE |  | 1-6-9 MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous angioplasty, Myocardial Infarction