linjc16/ctgov huggingface dataset:
Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
Post-operative cognitive dysfunction (POCD) is a common concern for aging patients undergoing elective orthopedic surgery and significantly effects health outcomes. This study aims to evaluate the incidence of and risk factors associated with post-operative cognitive dysfunction in aging patients without prior history for mild cognitive impairment or dementia.

Official Title
-----------------
Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery

Conditions
-----------------
Post Operative Cognitive Dysfunction

Intervention / Treatment
-----------------
* Procedure: Elective Orthopedic Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥50 and ≤90 Any patient undergoing elective orthopedic surgery for hip, knee, or shoulder replacement (as defined by diagnostic codes: M16.0, M16.12, M16.11, M17.0, M17.12, M17.11, M19.011, M19.012) Exclusion Criteria: History of cognitive impairment of dementia Montreal cognitive assessment (MoCA) <26 History of Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, normal pressure hydrocephalus, Huntington's disease, stroke, seizure disorder, brain tumor, or brain surgery History of surgery requiring anesthesia within the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 having surgery<br>Older adults undergoing elective orthopedic surgery. | Procedure: Elective Orthopedic Surgery<br>* Patients having knee (unilateral primary osteoarthritis or bilateral primary osteoarthritis) surgery, hip (unilateral primary osteoarthritis or bilateral primary osteoarthritis) or shoulder (primary osteoarthritis) elective surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of post operative cognitive dysfunction (POCD) | Defined as a 1.5 standard deviation decline on any one of the cognitive test performed from baseline to three-months post surgery. Score range: 0-100. A higher score indicates more cases of incident of POCD. | 3 months |
The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate.

Conditions
-----------------
Hematoma

Intervention / Treatment
-----------------
* Procedure: Central venous catheterization
* Procedure: Central venous catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who require a central venous catheter for their thoracic surgery Exclusion Criteria: Refuse to enroll Infection at insertion site Carotid artery disease Anomaly of central vasculature Hypertrophied thyroid History of recent neck surgery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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: 2 stage<br>Approach the internal jugular vein in a 2 stage fashion during central venous catheterization | Procedure: Central venous catheterization<br>* Approach the internal jugular vein in a 2 stage fashion during central venous catheterization<br>|
| Active Comparator: 1 stage<br>Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization | Procedure: Central venous catheterization<br>* Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematoma formation |  | immediately after catheterization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hematoma formation, success rate
Mutation p.Ile112Thr : Discrepancy Between Factor IX Level and Bleeding Phenotype

Study Overview
=================
Brief Summary
-----------------
It appears that the mutation p.Ile112Thr in the factor IX gene confers a discrepancy between mild factor IX level and severe bleeding phenotype. Databases and litterature analysis are poor on this matter. The goal of this study is to compile bleeding phenotype in patients with this specific mutation to prove the clinico-biological discordance in order to improve patient care and follow-up.

Official Title
-----------------
Discrepancy Between Factor IX Level and Bleeding Phenotype

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemophilia B with p.Ile112Thr mutation on factor IX gene Exclusion Criteria: None
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<br>Hemophilia B with p.Ile112Thr mutation on factor IX gene | Other: data collection<br>* data collection on the history of the disease, hemophilia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding phenotype | bleeding phenotype in patients with p.Ile112Thr in factor IX gene | Through study completion, an average of 4 months |
Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.

Official Title
-----------------
A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy Detectable metastases ECOG performance status of 0 or 1 Exclusion Criteria: Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer Significant cancer related pain Prior gene therapy, chemotherapy, or immunotherapy

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

Sexes Eligible for Study
-----------------
Male

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

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

| Intervention/Treatment |
| --- |
|Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine|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
-----------------
Prostate, Cancer, Advanced Prostate Cancer, Metastatic, Hormone-refractory, GVAX, Vaccine, Allogeneic cells
Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

Official Title
-----------------
A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Drug: Trimegestone
* Drug: 17b Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day Intact uterus Exclusion Criteria: Known or suspected breast carcinoma or estrogen-dependent neoplasm Undiagnosed abnormal genital bleeding

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 55 Years

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

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

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: Trimegestone|nan|
|Drug: 17b Estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study bleeding patterns throughout the treatment period (6 months) |  |  | 
| Evaluate changes in the Menopause-Specific Quality of Life Questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopause
Qualitative Analysis on the Experiences of Employment Among Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this search is to realize the subjective experiences of employment among schizophrenic patients by qualitative analysis. We plan to recruit 50 people diagnosed with schizophrenia and divide into two groups, employment and unemployment. Every subjects will complete the demographic data, the evaluation of severity of disease, the record of medication and an intensive interview about their employment experiences. Finally, we will analysis the thick descriptions to understand how schizophrenic patients interpret their employment experiences and which factors will affect their successful employment.

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia > high school

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

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

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 |
| --- | --- | --- |
Patient Education in Preventing Nausea and Vomiting in Cancer Patients Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Patient education may improve the effectiveness of ondansetron in preventing nausea and vomiting in patients receiving chemotherapy. PURPOSE: This randomized clinical trial is studying how well patient education works in preventing nausea and vomiting in cancer patients receiving chemotherapy.

Detailed Description
-----------------
OBJECTIVES: I. Determine whether an educational intervention to enhance the effectiveness of ondansetron can prevent acute postchemotherapy nausea and emesis in cancer patients. II. Assess any potential effectiveness of the intervention on delayed postchemotherapy nausea and emesis in these patients. III. Examine the effect of the intervention on patient expectations. OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by center and chemotherapy agent (cisplatin vs carboplatin vs doxorubicin). Patients are randomized to one of two treatment arms. Arm I: Patients receive standard educational materials. Arm II: Patients receive specific intervention material in addition to standard educational materials. Patients then complete a patient information questionnaire. Patients receive ondansetron orally or IV over 10-15 minutes in addition to the first 2 courses of chemotherapy. Patients complete a nausea and emesis questionnaire after each of their first 2 chemotherapy treatments. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

Official Title
-----------------
Patient Information and Antiemetic Drug Efficacy

Conditions
-----------------
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Chemotherapy naive with diagnosis of any cancer scheduled to receive chemotherapy containing cisplatin, carboplatin, or doxorubicin PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ondansetron|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
-----------------
nausea and vomiting, unspecified adult solid tumor, protocol specific
Coronary Artery Disease and Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and myocardial infarction among 408 patients with coronary artery disease referred for evaluation of coronary intervention who were examined with overnight cardio respiratory monitoring between March 1992 and June 1995.

Official Title
-----------------
Long Term Effects of Sleep Apnea in Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women younger than 70 with disabling angina pectoris and coronary disease according to coronary angiography.

Ages Eligible for Study
-----------------
Maximum Age: 70 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 |
| --- | --- |
| 2 groups<br>The cohort is grouped according to one group with sleep apnea and one group without sleep apnea | Other: There is no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke, death, acute myocardial infarction |  | 10 years from date of inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with coronary artery disease
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines

Study Overview
=================
Brief Summary
-----------------
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines

Official Title
-----------------
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines

Conditions
-----------------
Crow's Feet Lines

Intervention / Treatment
-----------------
* Biological: HU-014
* Biological: Botox Inj


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator Exclusion Criteria: Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.) From screening, Subject who get a plastic Surgery within 48 Weeks Subject who has skin disorder including infection and scar on injection site Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc. Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day) Any condition that, in the view of the investigator, would interfere with study participation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HU-014 Inj<br> | Biological: HU-014<br>* Hutox Inj(Clostridium botulinum type A)<br>|
| Active Comparator: Botox Inj<br> | Biological: Botox Inj<br>* Botox Inj(Clostridium botulinum type A)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4] |  | 4 weeks |
Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

Study Overview
=================
Brief Summary
-----------------
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system

Detailed Description
-----------------
The purpose of this study is to evaluate the cardiac events (MACE) and adverse extra cardiac events at 6 month follow up and up to 24 months for the patients treated with Galileo system

Official Title
-----------------
Vision II: Non Randomized French Evaluation of GALILEO Intravascular Radiotherapy System in Patients With de Novo Coronary Arteries Lesions by Restenosis on Angioplasty or Restenosis on Endoprosthesis

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Guidant GALILEO Intravascular Radiotherapy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with angor, patients with only one de novo lesion. Target zone must be < 52 mm, artery section must be < 3,7mm and > 2,25 mm Exclusion Criteria: Vessel with extremely tortuous proximal segment, lesion with angulous segments (>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc…

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System | Device: Guidant GALILEO Intravascular Radiotherapy System<br>* Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse cardiac or extra cardiac events |  | 24-month |
Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.

Official Title
-----------------
Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Femina Pocket BR (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd Femina Pocket BR (Lactic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral skin test in the region; To use products of the same category; Exclusion criteria: Lactation or gestation; Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs; Cutaneous disease (local or spread) in the evaluation area; Pathology which may cause immunity depression, such as HIV, diabetes; Endocrine pathology Solar exposure 15 days before evaluation; Treatment until four months before the selection. Allergic or atopic history to cosmetics products The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd Femina Pocket BR (Lactic Acid) | Drug: Dermacyd Femina Pocket BR (Lactic Acid)<br>* Dermacyd Femina Pocket BR (Lactic Acid) during 21 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of irritation |  | From the start to the end of the study | 
| Good acceptability |  | From the start to the end of the study |