linjc16/ctgov huggingface dataset:
Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.

Detailed Description
-----------------
Over all 500 patients admitted for various intraocular surgeries will be included in the study. The study will be prospective, double blind, placebo controlled, and randomized. Patients will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. For patients treated with povidone iodine alone a placebo will also be given. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery. All patients will be followed for 6 weeks for symptoms and signs of infection. Bacterial and fungal culture results will be compared between the 2 groups.

Conditions
-----------------
Eye Infections

Intervention / Treatment
-----------------
* Drug: Moxifloxacin and Povidone Iodine vs Povidone Iodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 years. Various intraocular surgeries Exclusion Criteria: Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Moxifloxacin and Povidone Iodine vs Povidone Iodine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and amount of bacterial growth |  |  | 
| Post surgery infections |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis,, Intraocular surgery, Lacrimal sac, Eye lid, No conditions
Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units

Study Overview
=================
Brief Summary
-----------------
To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units

Official Title
-----------------
Effects of Piperacillin-Tazobactam Use on the Prevalence Rate of Extended-Spectrum Beta-Lactamase (ESBL) Producing Escherichia Coli and Klebsiella Pneumoniae in Hematology and Oncology Units.

Conditions
-----------------
Gram-Positive Bacterial Infections, Escherichia Coli Infections, Klebsiella Infections

Intervention / Treatment
-----------------
* Drug: piperacillin-tazobactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients of either sex, 15 years of age or older Patients who are admitted to the department of hematology and oncology Provide written informed consent Exclusion Criteria: Patients who have hypersensitivity to β-lactam antibiotics Female who are pregnant or breast-feeding Any underlying conditions or non-infectious diseases that will be ultimately fatal within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: piperacillin-tazobactam|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
-----------------
Bacterial Infections
Post Marketing Surveillance for Contac Bien Z in Japan

Study Overview
=================
Brief Summary
-----------------
This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.

Official Title
-----------------
Contac Bien Z Adverse Effect Survey

Conditions
-----------------
Allergic Rhinitis, Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: Cetrizine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation Exclusion Criteria: Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine) Those who have been under 15en diagnosed with kidney disease Children under 15 years of age

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cetrizine hydrochloride|As provided on the patient information leaflet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events after having cetrizine hydrochloride | Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the marketed cetrizine hydrochloride formulation | Participants will answer a questionnaire which consists of questions on their satisfaction after taking the marketed cetrizine hydrochloride formulation. The efficacy will be measured on a 4 point scale (1 Efficacious; 2 Somewhat efficacious; 3 Not efficacious; 4 Not known) | At baseline |
Manuka Honey in Second- and Grafted Third-degree Burns

Study Overview
=================
Brief Summary
-----------------
Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds aim at reducing infection and improving reepithelialization. The aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

Detailed Description
-----------------
In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from wound dressings containing manuka honey, only a few studies can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

Official Title
-----------------
Clinical Application Observation of Manuka Honey in Second- and Grafted Third-degree Burns

Conditions
-----------------
Second-degree Burn, Third-Degree Burn

Intervention / Treatment
-----------------
* Other: wound dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent-capable male and female patients (or guardian) ≥18 years of age ability to asses pain Exclusion Criteria: Immunosuppressive Therapy Clinical wound infection Allergy against honey Relationship to someone who is involved in the study design or assessment Participation in other clinical trials

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Burn with or without split-skin graft<br>Second degree burns and third degree burns with split-skin graft that need wound dressings | Other: wound dressing<br>* Manuka honey wound dressing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelialization | Rate of Epithelialization in percent | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual analog scale (VAS) | Up to 1 year | 
| Microbiology | Microbiological smear is assessed by gram+, gram- or no bacterium | Up to 1 year | 
| Handling | Scale (0-4) | Up to 1 year |
Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.

Conditions
-----------------
Glycemic Control, Gastrointestinal Hormone Response, Healthy Young Men

Intervention / Treatment
-----------------
* Dietary Supplement: Milk Fat
* Dietary Supplement: Milk Protein
* Dietary Supplement: Lactose
* Other: Whole milk (3.25% M.F.(
* Dietary Supplement: Simulated Milk Beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young men 20-30 years of age BMI: 20-24.9 kg/m2 Exclusion Criteria: Smoking Dieting Skipping breakfast Lactose intolerance or allergies to milk Taking medications that may affect glucose metabolism or appetite Diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Milk Fat|nan|
|Dietary Supplement: Milk Protein|nan|
|Dietary Supplement: Lactose|nan|
|Other: Whole milk (3.25% M.F.(|Commercially available milk from the grocery store|
|Dietary Supplement: Simulated Milk Beverage|Added lactose + fat + protein together to form a mixture|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose |  | 0-180 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin |  | 0-180 min |
Effects of Natural Sounds on Attention Restoration in Virtual Reality

Study Overview
=================
Brief Summary
-----------------
This study aims to examine whether listening to natural sounds in a noisy virtual reality environment compared to no natural sounds influences physiological markers.

Detailed Description
-----------------
The investigators hypothesize that listening to natural sounds has restorative effects on attention by supporting greater use of involuntary attention. This generates the prediction that exposure to natural sounds in the context of a noisy environment will have greater restorative effects on attention (i.e., physiological) as compared to the control group (exposed to noise only). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, noise sensitivity, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

Official Title
-----------------
Effects of Natural Sounds on Attention Restoration in Virtual Reality

Conditions
-----------------
Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Working Memory

Intervention / Treatment
-----------------
* Other: Masking Sound
* Other: No masking sound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singapore-based Non-clinical 18-35years Exclusion Criteria: Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing Individuals with a history of ear, developmental, neurological, or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VR Simulated Outdoor Environment<br>Exposure to recorded outdoor environmental sounds | Other: No masking sound<br>* Prerecorded environmental noise but no masking sounds played from headphones<br>|
| Experimental: VR Simulated Outdoor Environment with Masking Sounds<br>Exposure to recorded outdoor environmental sounds augmented with masking sounds | Other: Masking Sound<br>* Prerecorded environmental noise and masking sounds played from headphones<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart Rate Variability | Electrocardiograph (Change) | 1 day (during fatiguing task and sound intervention) | 
| Change in Fatigue State Questionnaire | Change in Fatigue State Questionnaire Score | baseline, up to 2 mins after fatiguing task and up to 2 mins after sound intervention |
Obtaining and Storing Wound Debridment Samples For Immediate or Future Wound-Related Scientific Study

Study Overview
=================
Brief Summary
-----------------
Debridement Samples being collected for future or immediate research purposes.

Detailed Description
-----------------
Inclusion Criteria The subject must have a full thickness wound. The subject must be a candidate for sharp debridement. The subject must be 18 years of age or older The subject must be mentally competent as determined by the Principal Investigator. Exclusion Criteria 1. The subject may not be currently incarcerated or pregnant. Nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.

Official Title
-----------------
Obtaining and Storing Wound Debridment Samples for Immediate or Future Wound-Related Scientific Study

Conditions
-----------------
Wound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must have a full thickness wound. The subject must be a candidate for sharp debridement. The subject must be 18 years of age or older The subject must be mentally competent as determined by the Principal Investigator Exclusion Criteria: The subject may not be currently incarcerated or pregnant. Nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Debridement<br>The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies. This clinical wound material can be studied in order to better understand the molecular, cellular, or ecological components of the wound system. These studies may be able to provide important insights into the keys of wound healing, wound persistence, or wound deterioration. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
study of debridement tissue for research purposes., open wound
PET Imaging in ALS Patients

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of ALS, based on a well established basic science pathway, published human autopsy data, preliminary data in ALS mutant mice, and our recently published data using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy human volunteers.

Official Title
-----------------
Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers

Conditions
-----------------
Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
-----------------
* Other: PET Scanning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ALS patients, ranging in age from 18-80. Must meet El Escorial Criteria for Probable or Definite ALS. Disease duration >1 year, but <3 years. Weakness in at least two extremities. Forced vital capacity less than 80% and greater than 50%. Exclusion Criteria: Documented orthopnea or otherwise unable to lie flat in a PET scanner for 90 minutes. Presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices that would preclude an MRI scan. Absence of sufficient collateral arterial circulation for radial arterial line placement in both wrists. Significant abnormalities of hepatic or renal function, or illicit substance use. Positive drug screen. (Subjects currently taking prescribed narcotic medication who have a positive drug screen for this medication will not be excluded. Medication history will be obtained during screening). Weighs > 350 lbs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET Scanning<br>Imaging of mGluR5 using PET scanning | Other: PET Scanning<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glutamate Receptor Distribution | The two primary outcome variables (VT and BPND) are quantitative estimates of mGluR5 distribution in the defined central nervous system regions. We will employ plasma reference graphical analysis (PRGA) which yielded the most accurate estimates of BPND and VT in a test-retest scheme. We will perform various analyses to determine if BPND or VT measurements in the volumes of interest differ between the ALS and control subject groups. | 1 year |
The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Study Overview
=================
Brief Summary
-----------------
Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).

Detailed Description
-----------------
The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH). This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.

Official Title
-----------------
Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices

Conditions
-----------------
Portal Hypertension, Cirrhosis, Hematemesis, Melena

Intervention / Treatment
-----------------
* Drug: Terlipressin
* Drug: Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age Exclusion Criteria: Ulcerative esophagitis, Mallory Weiss tear, Bleeding gastric or duodenal ulcers, Bleeding from gastric varices or portal hypertensive gastropathy and Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Terlipressin<br>* 2 mg stat & then 1 mg q6h iv and Placebo of Octreotide<br>* Other names: Novapresin;|
| Active Comparator: B<br> | Drug: Octreotide<br>* Octreotide 50mcg/hr infusion & a placebo of Terlipressin<br>* Other names: sandostatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & Efficacy |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Variceal bleed, Cirrhosis, Vasoactive agents, Terlipressin, Octreotide, Safety & Efficacy