linjc16/ctgov huggingface dataset:
Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital

Study Overview
=================
Brief Summary
-----------------
During the past two decades, the frequency of invasive fungal infections has increased dramatically in hospitalised patients throughout the world, and Candida has now emerged as one of the leading causes of bloodstream infections (BSIs). Risk-factors for invasive candidiasis include improvements in intensive care strategies (i.e., central venous catheters, mechanical ventilation, hyper-alimentation), prolonged stays in intensive care units (ICUs), the development of more aggressive surgical techniques, and the prolongation of survival of critically-ill patients. Two other important factors, observed mainly in cancer patients, are colonization of mucous membranes by yeasts, and neutropenia, resulting from increased use of antibiotics and anti-neoplastic agents, respectively. The crude mortality rate of candidaemia is high (38-75%), and the attributable mortality has been estimated at 25-38%. During the past 15 years, the prevalence of infections caused by non-albicans Candida spp. has increased exponentially, so that these organisms now account for > 50% of episodes of fungaemia in various surveys. The increase in invasive fungal infections, the associated high mortality rate, and the emergence of antifungal resistance, have all driven the search for more potent antifungal drugs. The aims of the present study are to investigate the prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility patterns of Candida spp. isolates from a tertiary-care hospital in Italy.

Official Title
-----------------
Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital

Conditions
-----------------
Candidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| candidemia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aims of the present study are to investigate the prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility patterns of Candida spp. isolates from a tertiary-care hospital in Italy. |  | 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fungal susceptibility
The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent in a Private Practice

Study Overview
=================
Brief Summary
-----------------
The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Model
* Behavioral: Knee Anatomy Video
* Behavioral: Verbal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection. Exclusion Criteria: Patients without the capacity to provide consent Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verbal<br>This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group. | Behavioral: Verbal<br>* Each participant will receive a verbal informed consent discussion without a visual aid.<br>|
| Active Comparator: Verbal + Model<br>This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion. | Behavioral: Model<br>* Each participant will receive an informed consent discussion with the aid of an anatomic knee model.<br>|
| Active Comparator: Verbal + Video<br>This group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer. | Behavioral: Knee Anatomy Video<br>* Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Nkem Test | This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as The Nkem Score. | baseline |
Agreement of the Nexfin™ Monitor With Non-invasive Blood Pressure Measurement

Study Overview
=================
Brief Summary
-----------------
Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm. This can be set to inflate every minute, but measurement may fail due to patient movement or shivering. Failed measurement occurs in up to 38% of patients. This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

Detailed Description
-----------------
This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

Official Title
-----------------
Agreement of the Nexfin™ Non-invasive Cardiac Output Monitor With Non-invasive Blood Pressure Measurement in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: a Pilot Observational Study

Conditions
-----------------
Blood Pressure Measurement

Intervention / Treatment
-----------------
* Device: Nexfin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female pregnant patients ≥19 years old Undergoing elective Cesarean section under spinal or combined spinal-epidural anesthesia Exclusion Criteria: Contraindication to wearing Nexfin cuff (upper limb vascular disease, amputated digits) Obesity (BMI > 38 kg/m2) Use of arterial line for BP measurement Inability to read and understand English

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| study group<br>all participants | Device: Nexfin<br>* Nexfin cuff placed on finger to measure blood pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nexfin bp vs NIBP |  | During cesarean delivery |
Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With GERD

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional study of symptom burden and clinical management. A subset of patients who have attended the Primary Care (PC) office with reflux symptoms during a retrospective period of 4 months (Index Visit) are invited to complete health survey questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order to assess the type, intensity and frequency of GERD symptoms at both visits and describe the treatment provided. Additionally, the impact of GERD on subjects' life, productivity and willingness to pay for GERD symptom relief will be explored. This design will give a real-life clinical practice picture in a representative population of PC doctors and subjects.

Official Title
-----------------
A Cross-Sectional, Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With Gastroesophageal Reflux Disease (GERD) RANGE: Retrospective ANalysis of GErd

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Ability to complete PRO instruments (non-applicable to non-attendees) Subject with GERD symptom(s). At least presence of troublesome heartburn and/or regurgitation even if not specifically recorded at the Index Visit. At least one visit during the Retrospective Visit Period (-6 to -2 months prior to study start). In the reasons for the Index Visit section of the medical record mention of acid regurgitation and/or heartburn symptom(s) or GERD diagnosis or GERD complications has to be explicit or a treatment decision (prescription) in a previously diagnosed subject although no mention of symptoms is made. Exclusion Criteria: Prophylactic PPI use to reduce the risk of ulcers in subjects being treated with NSAIDs PPI treatment to heal an ulcer induced by NSAID treatment PPI treatment for H-pylori eradication Participation in any other clinical study in the time window between the Index Visit and Visit 1

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 |
| --- | --- | --- |
| To describe the impact of reflux symptoms on subjects' daily life |  | Assessed by means of the patient reported outcomes (PROs) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the impact of reflux symptoms on work productivity |  | Assessed by means of the patient reported outcomes (PROs) |
Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Study Overview
=================
Brief Summary
-----------------
the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Detailed Description
-----------------
due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Official Title
-----------------
Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Drug: Nitazoxanide
* Drug: Norfloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis. Exclusion Criteria: Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Double-Blind Placebo-Controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>They will receive standard therapy plus placebo | Drug: Norfloxacin<br>* Standard therapy<br>|
| Active Comparator: Nitazoxanide Group<br>They will receive standard therapy plus nitazoxanide | Drug: Nitazoxanide<br>* nitazoxanide adjuvant to standard therapy<br>* Other names: NTZ;Drug: Norfloxacin<br>* Standard therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Secondary Spontaneous Bacterial Peritonitis | Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Biological Biomarkers | Measurement of Tumor necrosis factor alfa , Procalcitonin(PCT), C-Reactive protein(CRP) and Erythrocyte sedimentation rate(ESR) with further calculation of PEC index [PEC index = PCT × (ESR + CRP)] before and after trial period | 3 months |
Semen Analysis After Proton Therapy for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate semen for changes following treatment with proton radiation therapy.

Official Title
-----------------
Semen Analysis Following Definitive Treatment of Prostate Cancer With Proton Radiation Therapy Alone

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

Intervention / Treatment
-----------------
* Other: Semen analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of low to intermediate risk prostate cancer and elected to have proton radiation therapy at University of Florida Proton Therapy Institute (UFPTI). Exclusion Criteria: Current use of Flomax, Hytrin, Cardura, Uroxatral, or Rapaflo. History of vasectomy. Current use of Lupron, Zoladex, Trelstar, Casodex, Eulexin. Current use of Avodart or Proscar.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Semen analysis<br>Analysis of semen before and after proton radiation therapy. | Other: Semen analysis<br>* Semen analysis before and after proton radiation therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post treatment sperm count |  | 12 months after radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare changes in sperm motility, sperm morphology and semen PH. | This is composite measure | 12 months after radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Semen Analysis, Prostate Cancer, Proton Radiation
Open-Label Study of ARD-0403 in Testosterone Deficient Men

Study Overview
=================
Brief Summary
-----------------
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

Official Title
-----------------
A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: ARD-0403


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Testosterone deficiency Exclusion Criteria: Previous treatment with testosterone replacement therapy within 4 weeks Moderate-severe benign prostatic hypertrophy, or prostatic cancer Haematocrit >50%

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARD-0403|ARD-0403|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  |
Hematotoxic Effects of Particulate Exposure

Study Overview
=================
Brief Summary
-----------------
Hematotoxicity is caused by a number of agents such as a benzene by-product called hydroquinone and the antitumor agent doxorubicin. This is a basic research study, conducted using normal human donors, of mechanisms involved in hematotoxicity and of the protective response of human hematopoietic progenitor cells to hematotoxic agents. Tumor necrosis factor exposure protects these cells from a subsequent exposure to hematotoxic agents. The alteration of gene expression in these cells caused by tumor necrosis factor is being studied. Additionally, the tumor necrosis factor-induced biochemical pathways involved in protection of human hematopoietic progenitor cells will be studied.

Official Title
-----------------
Hematotoxic Effects of Benzene and Doxorubicin

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

Participation Criteria
=================
Eligibility Criteria
-----------------
healthy nonsmoking no history of hematologic disorder not pregnant no medications which suppress hematopoiesis

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematotoxicity, Benzene, Bone Marrow
Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation medication.

Official Title
-----------------
Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode - An Observational Study

Conditions
-----------------
Benign Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with obstructive symptoms due to benign prostatic hyperplasia who are also on anticoagulant regimen. Anticoagulant regiments include: Aspirin 81mg, Aspirin 325mg, Adenosine diphosphate (ADP) receptor inhibitors, Cilostazol, Dabigatran, Dipyridamole, or Warfarin. The patient will be stable on their dosage regimen for at least 3 months. Maximum flow rate <15ml/s by uroflowmetry. International Prostate Symptom Score (IPSS)≥10. Exclusion Criteria: Patients with coagulopathy, INR exceeding 3. Anti-coagulation dose changes within 3 months of surgery. Patients not medically cleared to undergo surgery for medical reasons. Patients with neurogenic bladder (bladder affected due to a neurologic cause). Urethral stricture, obstruction due to stricture. Suspected bladder or prostate cancer. Prostate size greater than 80 cc.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BPH on anticoagulation<br>Patients with Benign Prostatic Hyperplasia (BPH) undergoing Transurethral Vaporization of Prostate and are on anticoagulant medication | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants |  | Introperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire |  | Before surgery and 1, 3, 6 month follow up visits | 
| Assessment of subjective patient improvement on the Sexual Health Inventory for Men (SHIM) score |  | Before surgery and 1, 3, 6 month follow-up | 
| Measurement of maximum urine flow rate as measured by urine flowmetry |  | Before surgery and 1, 3, 6 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign prostatic hyperplasia, Transurethral vaporization of prostate