linjc16/ctgov huggingface dataset:
Hemodynamic Changes in Altitude Adaptation

Study Overview
=================
Brief Summary
-----------------
We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount Aconcagua.

Detailed Description
-----------------
Several parameters will be recorded to analyze their influence on the adaptation to high altitude. Such as, food composition, dietary supplements, water intake and output.

Official Title
-----------------
Hemodynamic Changes in Altitude Adaptation

Conditions
-----------------
Acute Mountain Sickness, High Altitude Pulmonary Edema, High Altitude Cerebral Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No acute or chronic disease Body mass index : 20 - 30 Exclusion Criteria: Any preexisting disease that has a potential impact on physical performance such as: pulmonary cerebral muscular cardiac vascular - diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Climbers on Mount Aconcagua<br>The Cohort consists of volunteers climbing Mount Aconcagua. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Oxygen Delivery | Unit: ml/min baseline measure will be obtained at sea level | daily, up to 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Hemoglobin Concentration | Unit: mg/dl baseline measure will be obtained at sea level | daily, up to 18 days |
Chlorhexidine & Pneumonia in Nursing Home Residents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is determine if topical oral application of a chlorhexidine antimicrobial spray will significantly reduce pneumonia and respiratory infections, and improve oral health compared to a placebo solution in nursing home residents.

Official Title
-----------------
Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents

Conditions
-----------------
Pneumonia, Respiratory Infection

Intervention / Treatment
-----------------
* Drug: chlorhexidine
* Drug: Placebo mouthwash


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be at least 65 years old. Be dependent in 2 or more Activities of Daily Living as noted on the nursing home resident's Minimum Data Set - One must be ADL J- Personal Hygiene. Have natural teeth and/or wear complete or partial dentures. Expected to be a resident in a nursing home for two years. Exclusion Criteria: Existing pneumonia. History of chlorhexidine reaction or allergy and/or multiple medication or substance allergies. Receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Peridex mouthwash | Drug: chlorhexidine<br>* 0.12% chlorhexidine mouthwash spray,  1.3 ml, twice a day.<br>* Other names: Peridex;|
| Placebo Comparator: 2<br>Placebo mouthwash | Drug: Placebo mouthwash<br>* Placebo mouthwash spray application of  1.3 ml twice a day.<br>* Other names: Peridex mouthwash without chlorhexidine.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory pathogens |  | 12 months | 
| Plaque and Gingival Indices |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, Elderly, Chlorhexidine, Respiratory pathogens
Monitor Patients With Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, non-randomized study to evaluate performance of an external monitor for heart failure patients

Detailed Description
-----------------
External monitoring of heart failure patients with the AVIVO System.

Official Title
-----------------
Adherent Monitoring of Congestive Heart Failure During Therapy for Excess Fluid Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Avivo System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is female or male, 18 years of age or older Has an ejection fraction of 40% reported within 12 months of enrollment Having acute decompensated heart failure and receiving treatment for fluid overload Exclusion Criteria: Is participating in another clinical study that may confound the results of this study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Avivo System|Non invasive external monitoring device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Patient Performance and Acceptance of Virtual Reality Visual Field Devices

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.

Official Title
-----------------
Patient Performance and Acceptance of Virtual Reality Visual Field Devices

Conditions
-----------------
Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step, Visual Field Defect, Paracentral Scotoma of Both Eyes

Intervention / Treatment
-----------------
* Other: VIrtual Reality Visual Field Exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient >13 years old at Bascom Palmer Eye Institute Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma Exclusion Criteria: Adults unable to consent, pregnant women, prisoners Patients under the age of 13

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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: Virtual Reality Visual Field Group<br>Participants in this group will have virtual reality visual field testing during standard of care follow-up visit. | Other: VIrtual Reality Visual Field Exam<br>* Virtual reality visual field exam will be administered using the virtual reality headset. Exams can take up to 20 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operational Effectiveness | Operational effectiveness will be reported as the length of the visit and virtual reality visual field exam testing times. Both will be measured in minutes. | Day 1 | 
| Medical Effectiveness as Measured by Visual Field Indexes | Medical effectiveness will be evaluated by visual field indexes, such as mean deviation, pattern standard deviation, and foveal threshold, which are all measured in decibels. These values are generated based on the participants' performance in the visual field exam. | Day 1 | 
| Medical Effectiveness as Measured by Glaucoma Hemifield Test | Medical effectiveness will be evaluated by the glaucoma hemifield test. This value is generated based on the participants' performance in the visual field exam. | Day 1 | 
| Reliability Indices | Reliability index is generated based on the participants' performance in the visual field exam. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal Sensitivity
The Interaction Between Severe Acute Respiratory Distress Syndrome Viral Proteins and Monocytes

Study Overview
=================
Brief Summary
-----------------
Severe acute respiratory syndrome (SARS) is a new threat to public health since November, 2002. The SARS is highly contagious and is believed to be transmitted by person-to-person through droplet and direct contact. The patients present with fever, chills, cough, myalgia, dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the patients develop respiratory failure that requires assisted ventilation. The mortality rate is reported as 6.5%-7%. After several months, the world scientists found the etiology to be a new coronavirus not belonging to the previous coronavirus group I, II and III. The new virus is called SARS associated coronavirus (SARS-CoV). Although the high morbidity and mortality of SARS occurred in adults, there was rare mortality reported in the children. The report from Hong Kong pointed out that the symptoms of SARS in younger children were milder and the clinical course was not as aggressive as in adults. Therefore, the aim of the project is to design the experiment to see the differences of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and adults. The investigators hope that the result could explain the reason for milder disease in younger children and the immunological pathogenesis of SARS.

Conditions
-----------------
Severe Acute Respiratory Syndrome

Intervention / Treatment
-----------------
* Procedure: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults, children and cord blood
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood sampling|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
-----------------
Immunology
MK0767 in Type 2 Diabetes (0767-012)

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This study will also see how effective MK0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-HDL cholesterol when compared with placebo and pioglitazone.

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

Intervention / Treatment
-----------------
* Drug: MK0767


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus patients between the ages of 21 and 75 inclusive Patient is willing to discontinue current therapy for the duration of the study Patient is not a heavy drinker Exclusion Criteria: Patient has a history of Type 1 diabetes and/or ketoacidosis Patient has severe diabetic retinopathy, or nephropathy, or neuropath Patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1 Patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0767|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Study Overview
=================
Brief Summary
-----------------
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation. This clinical study is aimed at : evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions; evaluating the pharmacokinetic (PK) profile of cidofovir after local application.

Official Title
-----------------
A Phase I Clinical Study to Evaluate the Tolerance and Safety of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesion(s) (CIN 2 and 3)

Conditions
-----------------
Uterine Cervical Neoplasms, Cervix Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Drug: Cidofovir gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged between 18 and 50 years old volunteers informed consent signed cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring) Exclusion Criteria: pregnancy or breast feeding subtotal hysterectomy current or ancient renal impairment current immune disorder current use of drugs interfering with renal function current treatment for any cancer current use of treatment interfering with immunity current use of anti-viral treatment current or recent participation to another experimental study during the last 3 months before the screening visit current vaginal application of drugs or cosmetics local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: Cidofovir<br> | Drug: Cidofovir gel<br>* topical gel applied once a week for 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | weeks 1, 2, 3 and 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervix Intraepithelial Neoplasia grades 2 and 3
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis

Study Overview
=================
Brief Summary
-----------------
This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.

Detailed Description
-----------------
Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.

Official Title
-----------------
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis

Conditions
-----------------
Cholelithiasis, Inflammatory Response

Intervention / Treatment
-----------------
* Other: Single incision laparoscopic cholecystectomy
* Other: Laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncomplicated cholelithiasis American Society of Anesthesiologists (ASA) I or II No previous operations in upper abdomen Body mass index (BMI) <30 Exclusion Criteria: Cholecystitis ASA > II BMI>30 Previous operations in upper abdomen Previous operations in intestine
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lap Group<br>Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy | Other: Laparoscopic cholecystectomy<br>* Standard 4 port laparoscopic cholecystectomy<br>|
| Active Comparator: SILS group<br>Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy | Other: Single incision laparoscopic cholecystectomy<br>* One port placed through the umbilicus<br>|

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
-----------------
SILS, Inflammatory reaction, a-defensins, SILS vs standard laparoscopic cholecystectomy
Evaluation of an Incontinence Product

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad.

Conditions
-----------------
Incontinence

Intervention / Treatment
-----------------
* Other: Incontinence Detection System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking/reading adults, age ≥ 18 years Incontinent (fecal, urine, or dual incontinence) Patients with dual incontinence who require use of a fecal management system (but no urinary catheter) Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent Exclusion Criteria: Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy Is considered to be near death or requires hospice care

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 |
| --- | --- |
| Phase 1<br>Subjects will use the incontinence pad with incontinence detection notifications turned on | Other: Incontinence Detection System<br> <br> |
| Phase 2<br>Subjects will use the incontinence pad with incontinence notification turned off | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient exposure time following an incontinence event |  | Through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction surveys |  | Through study completion, an average of 6 months | 
| Staff satisfaction surveys |  | Through study completion, an average of 6 months | 
| Family/patient support member surveys |  | Through study completion, an average of 6 months | 
| Incidence of incontinence associated skin irritation and breakdown issues |  | Through study completion, an average of 6 months | 
| Incidence of pressure injuries |  | Through study completion, an average of 6 months |