linjc16/ctgov huggingface dataset:
Quality of Life and Symptom Management in Patients With Bladder Cancer

Study Overview
=================
Brief Summary
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RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment. PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.

Detailed Description
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OBJECTIVES: Primary To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer. To obtain feedback on data collection methods to enhance acceptability in these patients. OUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.

Official Title
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A Qualitative Study of Patients With Non-Invasive Bladder Cancer

Conditions
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Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of bladder cancer within the past 4 years Non-invasive disease Low- or high-risk disease Recruited from patients at the Baylor College of Medicine Scott Department of Urology clinics, the Michael E. DeBakey Veteran Affairs Medical Center, and the Urology Clinic at MD Anderson Cancer Center OR from participants at a community event PATIENT CHARACTERISTICS: Not pregnant Able to read, speak, and understand English PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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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 |
| --- | --- | --- |
| Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer | Study is a retrospective qualitative study of nonmuscle-invasive bladder cancer patients using a semi-structured interview protocol. | One timepoint | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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stage 0 bladder cancer
Automated EDSS Score Calculation by Smartphone Application

Study Overview
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Brief Summary
-----------------
The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies. Its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature. The application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.

Official Title
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Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients

Conditions
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MS CHRONIC PROGRESSIVE

Intervention / Treatment
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* Other: neurological exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with multiple sclerosis seen at the Central Nervous System Day Hospital as part of their follow-up and requiring neurological examination. Age ≥ 18 years No opposition to the use of their data Exclusion Criteria: - Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring

Ages Eligible for Study
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Minimum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Multiple Sclerosis<br> | Other: neurological exam<br>* Patients participating in the study are recruited from the investigator's tertiary multiple sclerosis management centre. They are systematically examined neurologically as part of their routine follow-up. the patient will be exceptionally examined by two distinct persons, a senior doctor and a junior doctor (internal or external) independently. At the end of the neurological examination, each examiner will evaluate the EDSS score in a classical way (using paper definitions) then using the smartphone application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDSS score apllication VS paper version | comparison of the overall EDSS score obtained with the application and its paper version at the end of the neurological examination | 6 months |
Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. We propose a study comparing three acrylic single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the investigated IOLs will be performed. Since PCO develops slowly within years, a long-term follow-up of three years will be necessary. As those IOLs are currently often implanted IOLs, their performance on PCO development and their optical quality is of high interest for the ophthalmologic community.

Official Title
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Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses

Conditions
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Posterior Capsule Opacification

Intervention / Treatment
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* Device: Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned Age 40 and older Visual potential in both eyes of 20/30 or better as determined by investigators estimation Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Preceding ocular surgery or trauma Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations, etc.) Uncontrolled systemic or ocular disease

Ages Eligible for Study
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Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior capsule opacification | Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software | 3 years |
Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)

Study Overview
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Brief Summary
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The purpose of the study is to find out if the plasma concentration of galantamine extended release is changed when BMS-708163 is administered at the same time.

Official Title
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A Study of the Effect of Concomitant Administration of Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: galantamine
* Drug: galantamine
* Drug: BMS-708163


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and postmenopausal women Exclusion Criteria: Gastrointestinal disorders Bleeding disorders Peptic ulcer disease Cholecystectomy Seizure disorder Asthma Chronic obstructive pulmonary disease Urinary tract obstruction Cardiac conduction abnormalities, including but not limited to sick sinus syndrome and those with unexplained syncopal episodes Inability to tolerate oral medication Inability to be venipunctured and/or tolerate venous access

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: galantamine 8 mg (ER)<br> | Drug: galantamine<br>* Capsule, Oral, 8 mg (ER), once daily, Days 1-7<br>* Other names: Razadyne ER ™;|
| Active Comparator: galantamine 16 mg (ER)<br> | Drug: galantamine<br>* Capsule, Oral, 16 mg (ER), once daily, Days 8-24<br>* Other names: Razadyne ER ™;|
| Active Comparator: BMS-708163<br> | Drug: BMS-708163<br>* Capsule, Oral, 125 mg, once daily, Days 15-24<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24) |  | Study Days 14 & 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs) |  | Study Days 7, 14, 18, 25 and study discharge |
Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging

Study Overview
=================
Brief Summary
-----------------
The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography angiography (CTA). The endpoint was major adverse cardiac events (MACE).The investigator aim to evaluate the prognostic value of CTA, risk factors and bio-markers for MACE.

Detailed Description
-----------------
The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography (CT). Cardiac CT was assessed for coronary artery calcification score (CACS) and the extent, the location, the stenosis severity, and the composition of the plaque in CTA. The base line information was recorded, including risk factors, drugs, bio-markers, and psychological. The endpoint was MACE, defined as composite cardiac death, nonfatal myocardial infarction (MI).we aim to evaluate the prognostic value of CTA, risk factors and bio-markers for major adverse cardiac events (MACE).

Official Title
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Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging :A Cohort Study of China

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

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: suspected of coronary heart disease, coronary CTA has been completed. age > 18 years old. have biochemical test results. signed informed consent. Exclusion Criteria: malignant tumor, severe liver and kidney diseases. combination of cardiomyopathy, valvular disease, congenital heart disease, a variety of reasons the left cardiac insufficiency.

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 |
| --- | --- | --- |
| Major Adverse Cardiac Events | cardiac death, myocardial infarction (Cardiac death was defined as death due to acute myocardial infarction, ventricular arrhythmias, refractory heart failure or cardiogenic shock. The investigator reviewed all available data to determine whether a cardiac etiology was the immediate cause of death and categorized cardiac deaths into sudden cardiac death and nonsudden cardiac death. Sudden cardiac death was defined by published criteria . myocardial infarction was defined based on the criteria of typical chest pain, elevated cardiac enzyme levels and typical alterations of the electrocardiogram. ) | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, CT, MACE
Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment

Study Overview
=================
Brief Summary
-----------------
Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and involvement. In this study the investigators aimed to determine the effect of an educational video displayed on a tablet-device. The investigators hypothesized that an educational video would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.

Official Title
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Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment - a Randomized, Controlled Trial

Conditions
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Osteoporosis

Intervention / Treatment
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* Behavioral: Educational video


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Scheduled for at DXA scan at the osteoporosis clinic Currently on once-weekly alendronate treatment Informed consent Exclusion Criteria: Patients that do not understand Danish Patients having hearing impairments (unable to hear the video) Patients having visual impairments (unable to watch the video) Patients diagnosed with dementia Patients unable to give written informed consent.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video intervention<br>A tablet-administered educational video (10 minutes duration). | Behavioral: Educational video<br>* Video: Information on osteoporosis and alendronate treatment.<br>|
| No Intervention: Control<br>No intervention (no video) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge score |  | Baseline and 2-week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in confidence to treatment score, as indicated by participant response to questionnaire. | Measured on a scale from 1-10 | Baseline and 2-week follow up | 
| Change in satisfaction with the amount of information score, as indicated by participant response to questionnaire. | Measured on a scale from 1-10 | Baseline and 2-week follow up | 
| Change in understandability of the information score, as indicated by participants response to questionnaire. | Measured on a scale from 1-10 | Baseline and 2-week follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient education, Video intervention
Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction

Study Overview
=================
Brief Summary
-----------------
This study is perfored to investigate the efficacy of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for acute postoperative pain after nasal closed reduction surgery.

Detailed Description
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To investigate the treatment of postoperative pain after nasal closed reduction surgery, we plan to investigate the effect of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for the patinets undergoing nasal closed reduction under general aensthesia, compaing to the control group (normal saline spray and normal saline-soaked nasal packing).

Official Title
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Efficacy of Preoperative Lidocaine Spray and Local Aensthetics-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction

Conditions
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Nasal Fracture

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: patients scheduled to receive nasal reduction surgery under general aensthesia Exclusion Criteria: concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local anesthetic group<br>local aensthetic group receive preopetaive lidocaine spray and lidocaine-bupivacine mixture-soaked nasal pacing after nasal reduction surgery | Drug: Lidocaine<br>* for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing<br>* Other names: bupivacaine;|
| Placebo Comparator: control group<br>control group receive preoperative normal saline spray and normal saline-soaked nasal packing after nasal reduction surgery | Drug: Lidocaine<br>* for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing<br>* Other names: bupivacaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain in recovery room | Using VAS, postoperative pain is measured. | immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rescue analgesics in recovery room | Fentanyl iv injection for pain control is checked. | 1 hr after surgery |
Acute and Chronic Pulmonary and Renal Complications Following Contracting Severe Respiratory Distress Syndrome Coronavirus-19

Study Overview
=================
Brief Summary
-----------------
Tracking post- corona virus infection pulmonary and renal complications

Detailed Description
-----------------
Mortality from pulmonary and renal system is highly noticable with COVID-19 pandemic . We trying to monitor compliction

Official Title
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Acute and Chronic Pulmonary and Renal Complications Following Contractiong Coronavirus Severe Respiratory Distress Syndrome.

Conditions
-----------------
Pulmonary and Renal State

Intervention / Treatment
-----------------
* Other: follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All COVID 19 patients admitted to ICU Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: follow up|follow up population|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function | serum creatinine | 12 weeks |
Simvastatin Reduces Adiponectin Levels and Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients.

Official Title
-----------------
Phase 4 Study of Simvastatin That Affects Insulin Sensitivity

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Low-density lipoprotein cholesterol levels more than 100 and body mass index more than 23.0 Exclusion Criteria: Patients with overt liver disease Chronic renal failure Hypothyroidism, myopathy Uncontrolled diabetes Severe hypertension, stroke Acute coronary events Coronary revascularization within the preceding 3 months, or Alcohol abuse.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipophilic statins, Insulin resistance, hypercholesterolemic patients