linjc16/ctgov huggingface dataset:
Optimizing Antibiotic Use in Long Term Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if a multi-faceted intervention to implement diagnostic and therapeutic algorithms for management of suspected urinary infection in nursing home residents could reduce antibiotic prescribing for urinary indications in this population.

Detailed Description
-----------------
Antibiotic use is intense in nursing homes and frequently inappropriate when prescribed for urinary indications. Evidence from randomized controlled trials suggests that treatment of asymptomatic bacteriuria, the presence of bacteria in the urine in the absence of urinary symptoms, is not beneficial. Despite this, one in three prescriptions for urinary indications are for asymptomatic bacteriuria. To improve antibiotic prescribing in this setting we conducted a cluster randomized trial of a strategy to implement diagnostic and treatment algorithms for urinary infection. 24 nursing homes were randomized to either the intervention (implemented at the nursing home level using a multi-faceted approach: small group interactive sessions for nurses, one-on-one interviews for physicians, videotapes, written material, and outreach visits) or to usual care.

Official Title
-----------------
Optimizing Antibiotic Use in Long Term Care

Conditions
-----------------
Urinary Tract Infection, Antibiotic Use

Intervention / Treatment
-----------------
* Behavioral: diagnostic and treatment clinical algorithms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals- all residents eligible Nursing homes Free standing long term care facilities with >100 beds No stated policy for diagnosis or treatment of urinary tract infections The facility agrees to refrain from introducing new strategies for antibiotic utilization or clinical pathways during study Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diagnostic and treatment clinical algorithms|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial prescriptions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary cultures, |  |  | 
| hospitalizations, deaths |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary tract infections,, antibiotic use,, long term care facilities
Gastric Insufflation and Laryngeal Mask Airway

Study Overview
=================
Brief Summary
-----------------
Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM

Conditions
-----------------
Gastric Insufflation

Intervention / Treatment
-----------------
* Device: LMA SupremeTM
* Device: AuraOnceTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 or 2 Age > 18 yrs Use of laryngeal mask airway required Exclusion Criteria: risk of pulmonary aspiration of gastric contents Contraindication for the use of laryngeal mask airway Tracheal intubation required Patient's refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Design Details

Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LMA SupremeTM<br> | Device: LMA SupremeTM<br> <br> |
| Sham Comparator: Ambu AuraOnce<br> | Device: AuraOnceTM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of gastric insufflation |  | during pulmonary ventilation through the laryngeal mask airway | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngeal mask airway ventilation
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.

Official Title
-----------------
Restoration of First Phase Insulin Release in Subjects With Type 2 Diabetes Mellitus With Subcutaneous Injection of 20 µg AVE0010 in a Double-blind, Randomized, Placebo-controlled, Two-way Cross Over Intravenous Glucose Challenge Study.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Lixisenatide (AVE0010)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin HbA1c>=6,0 % and <=8,5 % at screening BMI 25 to 35 kg/m² 155>=BP systolic >=90 mmHg 100>=BP diastolic>=45 mmHg 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: 65 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1: AVE0010/Placebo<br>Period 1: lixisenatide 20 µg in 200 µL, one single dose Period 2: placebo 200 µL, one single dose | Drug: Lixisenatide (AVE0010)<br>* Solution for subcutaneous injection 100 µg/mL<br>Drug: Placebo<br>* Subcutaneous injection<br>|
| Experimental: Sequence 2: Placebo/AVE0010<br>Period 1: placebo 200 µL, one single dose Period 2: lixisenatide 20 µg in 200 µL, one single dose | Drug: Lixisenatide (AVE0010)<br>* Solution for subcutaneous injection 100 µg/mL<br>Drug: Placebo<br>* Subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin secretion curve |  | within 10 minutes after I.V. glucose challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin secretion curve |  | within 10 to 120 minutes after I.V. glucose challenge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin release, Diabetes mellitus type 2, GLP-1 agonist
The Effects of Probiotic Supplementation on the Results of Gastric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.

Official Title
-----------------
The Effects of Probiotic Supplementation on Anthropocentric, Nutrients Status, Inflammation, GI Hormones, Quality of Life, and Microflora in Patients Undergoing Gastric Bypass Surgery

Conditions
-----------------
Gastric Bypass Surgery

Intervention / Treatment
-----------------
* Dietary Supplement: probiotic
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI> 40 or >35 plus other morbidities Undergoing the gastric bypass surgery Willing to participate in the study Exclusion Criteria: History of any chronic GI or kidney disorders, malignancies, or immune deficiencies Taking any immunomodulatory or immunosuppressor medications Taking Antibiotics from 4 weeks before and during the intervention Being on special diet such as vegetarian diet Doing as a professional Athlete Pregnancy and Lactation

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: probiotic<br>the probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, and Lactobacillus bulgaricus) and prebiotic (fructooligosaccharide). | Dietary Supplement: probiotic<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules have identical appearance to probiotic capsules and contain Maltodextrin. | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weigh of the participants will be measured in Kg. |  | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of vitamin B12 (mg/dl) |  | 3 months after surgery | 
| serum level of vitamin B12 (mg/dl) |  | 12 months after surgery | 
| serum level of vitamin D(ng/ml) |  | 3 months after surgery | 
| serum level of vitamin D (ng/ml) |  | 12 months after surgery |
Colonization of the Female Urethra With Mycoplasma Hominis, Ureaplasma Urealyticum, Chlamydia Trachomatis, or Neisseria Gonorrhea in Patients With Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder symptoms, and to correlate these findings with cystoscopic and urodynamic findings.

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Procedure: retrospective data analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: women with urogynecologic and urodynamic examination at our institution between 1.1.2009 and 31.12.2011 Exclusion criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: retrospective data analysis|retrospective data analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of ureaplasma urealyticum |  | time of urogynecologic assessment | 
| prevalence of mycoplasma hominis |  | time of urogynecologic assessment | 
| prevalence of neisseria gonorrhea |  | time of urogynecologic assessment | 
| prevalence of chlamydia trachomatis |  | time of urogynecologic assessment |
Does Low-Dose Aspirin Improve Outcome in In Vitro Fertilisation/Intra Cytoplasmatic Sperm Injection (IVF/ICSI)?

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of daily administration of low-dose aspirin, compared to placebo, on IVF and ICSI outcome.

Official Title
-----------------
Does Low-Dose Aspirin Improve Outcome in IVF/ICSI? A Prospective, Randomized, Double Blind Placebo Controlled Trial

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: aspirin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dutch-speaking women Starting a first or second IVF/ICSI cycle Exclusion Criteria: Women suffering from platelet dysfunction thrombopenia gastro-intestinal ulcers recurrent gastritis aspirin hypersensitivity Women on treatment with anticoagulants or aspirin
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>oral administration of aspirin 100 mg | Drug: aspirin<br>* oral administration of aspirin 100 mg<br>|
| Placebo Comparator: 2<br>oral administration of placebo | Drug: placebo<br>* oral administration of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  |  | 
| Clinical pregnancy rate per embryo transfer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate per cycle |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF and ICSI
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

Study Overview
=================
Brief Summary
-----------------
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.

Official Title
-----------------
A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Device: Powered Suction Pump (VAC Freedom)
* Device: Powered Suction Pump
* Device: MWT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes Subject has a diabetic foot ulcer 5cm squared or greater Subject's diabetic foot ulcer is chronic Exclusion Criteria: HgbA1c of 12% or greater Presence of cellulitis Presence of osteomyelitis

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VAC NPWT<br> | Device: Powered Suction Pump (VAC Freedom)<br>* continuous foam based negative pressure wound therapy<br>* Other names: VAC Freedom;|
| Active Comparator: Gauze-Based NPWT<br> | Device: Powered Suction Pump<br>* continuous gauze based negative pressure wound therapy<br>* Other names: Gauze-Based Negative Pressure Wound Therapy Device;|
| Active Comparator: Moist Wound Therapy<br> | Device: MWT<br>* moist wound therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Energy Charge Between Wound Treatment Therapies | Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate | Day 0, Day 2, Day 7 |
Validation of an Early Warning Score Based Triage System in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
At Bispebjerg Hospital we have introduced an Early Warning Score based triage system , called Bispebjerg Early Warning Score (BEWS), in order to identify critically ill patient on arrival at the emergency department. The purpose of this study is to validate our triage system.

Official Title
-----------------
Nurse Administered Early Warning Score System Can be Used for Emergency Department Triage

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Red patient Seen in our emergency department between 1. april 2009 and 30. september 2009 Exclusion Criteria: None
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 |
| --- | --- | --- |
| Critical illness | The investigators have defined a critically ill patient as a patient who dies within 48 hours of arrival at the emergency department or who is admitted to ICU within 48 hours of arrival at the emergency department | 48 hours |
Affect Management Intervention for Early Adolescents Wtih Mental Health Problems

Study Overview
=================
Brief Summary
-----------------
Adolescents are at risk for HIV because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.

Official Title
-----------------
Affect Management Intervention for Early Adolescents With Mental Health Problems

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Affect Management
* Behavioral: General Health Promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seventh graders identified by counselors at participating public school Exclusion Criteria: Adolescent is HIV positive Adolescent is developmentally delayed Adolescent in pregnant Adolescent has a history of sexual crime

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

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

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

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: 1<br>Affect Management | Behavioral: Affect Management<br>* 12-session group intervention including affect management training as well as sexual health skills training<br>|
| Active Comparator: 2<br>General Health Promotion | Behavioral: General Health Promotion<br>* 12-session group intervention including health information on a variety of developmentally relevant health topics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent-reported sexual activity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent-reported condom use |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention
AUGMENTIN 1gm In Skin And Soft Tissue Infection

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Official Title
-----------------
An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan

Conditions
-----------------
Skin Diseases, Infectious, Infection, Soft Tissue

Intervention / Treatment
-----------------
* Drug: amoxicillin/clavulanate potassium 1gm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis) has given freely documented consent. Exclusion Criteria: antibiotics have renal or hepatic insufficiency systemic toxicity pregnancy lactation hypersensitivity to penicillin or Beta-lactam antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 12 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: ARM 1<br> | Drug: amoxicillin/clavulanate potassium 1gm<br>* amoxicillin/clavulanate potassium 1gm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response at 10 - 14 days post therapy |  | 10 - 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response at on-therapy evaluation visit (2 - 4 days following initiation of therapy and 48 - 96 hours post therapy) Bacteriological response at (2 - 4 days following initiation of therapy, 48 - 96 hours post therapy, 10 - 14 days post therapy) |  | 2 - 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin, AUGMENTIN, 1gm, Soft, tissue, Infections