linjc16/ctgov huggingface dataset:
Wear Experience With Daily Contact Lenses Over a Long Day

Study Overview
=================
Brief Summary
-----------------
This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.

Official Title
-----------------
Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days

Conditions
-----------------
Contact Lens

Intervention / Treatment
-----------------
* Device: Precision1® Daily Disposable Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a current spherical contact lens wearer with longs days of lens wear. Distance visual acuity of 20/25 or better with current contact lenses. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI). Recent eye exam within the past year. Must have a working smart phone and be willing to download an app and/or receive and respond to texts. Ability to give informed consent. Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3. Exclusion Criteria: No current ocular inflammation or infection as assessed by the study investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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: Daily Disposable Contact Lens<br>All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks. | Device: Precision1® Daily Disposable Contact Lens<br>* Soft, spherical contact lens used to correct distance vision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS) | Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent. | Up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Daily Disposable Contact Lens, Spherical Contact Lens, Soft Contact Lens
the Effect of Gut Microbiota on the Prognosis of Sepsis

Study Overview
=================
Brief Summary
-----------------
Sepsis is a life-threatening condition that arises when the body's response to infection injures its own tissues and organs. Common signs and symptoms include fever, increased heart rate, increased breathing rate, and confusion. Clinically, sepsis patients with diarrhea often result in a bad prognosis. Gut microbiota consists of a complex community of microorganisms that live in the digestive tracts of animals. The gut microbiota comprises the largest and most diverse reservoir of mutualistic microorganisms associated with animals. The aims of this study is to determin the effect of gut microbiota on the prognosis of Sepsis, by using 16s pyrosequencing, comparing the blood culture result.

Official Title
-----------------
the Effect of Gut Microbiota on the Prognosis of Sepsis

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with sepsis 18 years to 65 years of age Exclusion Criteria: patients had complications such as acute cerebral infarction or acute myocardial infarction The use of antibiotics, pro-prebiotics within 3 months <18 years or >65 years History of intestinal surgery patients withdraw from this study

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sepsis with diarrhea<br> | |
| sepsis without diarrhea<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharged from ICU |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, Gastrointestinal Microbiome, Gut microbiota, Gut Flora, Intestinal Flora
Evaluation of Emergency Department Visits and Activity : Study

Study Overview
=================
Brief Summary
-----------------
The main objective will be to evaluate the type of care performed and the main reasons for consulting patients for an odontological emergency in order to better adapt to the flow and expectations of patients.

Official Title
-----------------
Analysis of Emergency Department Visits and Activity in Montpellier Dental University Hospital : Study Protocol

Conditions
-----------------
Dental

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - All adults (>18years) consulting in the emergency department (Montpellier University Hospital) Exclusion criteria: person under 18 years old patients who does not speak French

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 |
| --- | --- | --- |
| Rate of The result for each item of the questionnaire according to the reason for the emergency | The result for each item of the questionnaire according to the reason for the emergency | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Know the type of population received | Know the type of population received, the areas of Montpellier most likely to consult the CSERD, the demand for care | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental emergencies, Emergency department, Patients coming to the CHU ADV Montpellier for consultation
Registry and Biorepository for IBD in Central Texas

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. The biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, IV catheter placement, and/or endoscopy). Participants may choose to provide any or all of the aforementioned information and/or samples.

Official Title
-----------------
Registry and Biorepository for the Study of Inflammatory Bowel Diseases in Central Texas

Conditions
-----------------
Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Other: NO INTERVENTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 18 years or older Willing and able to provide written consent for participation in the registry and biorepository Patients with known or suspected inflammatory bowel disease Exclusion Criteria: Patient is unable to comprehend and/or cooperate with study activities Patient is too ill to provide consent Coagulopathy that precludes safe biopsy of the bowel Comorbidity that precludes safe participation in endoscopic procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory Bowel Disease<br>any patient with IBD will be included in the registry | Other: NO INTERVENTION<br>* THERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with inflammatory bowel disease | Number of patients with Crohns, ulcerative colitis, and IBD undetermined | 10 YEARS |
Effects of Axle Positions on Wheelchair Skills in Manual Wheelchair Users

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of altering the wheelchair set-up on mobility and safety by changing the rear-axle position on a manual wheelchair.

Official Title
-----------------
Effects of Axle Positions on Wheelchair Skills in Manual Wheelchair Users

Conditions
-----------------
Physical Disability

Intervention / Treatment
-----------------
* Other: rear axle position
* Other: forward axle position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: manual wheelchair users minimum of 17 years of age at least one week experience in a manual wheelchair, for at least an hour a day alert able to answer questions able to fit in the testing wheelchairs permission to participate from the attending physician Exclusion Criteria: significant visual impairments unstable medical conditions (e.g., angina) emotional/psychological problems that may make testing unpleasant

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: forward position<br> | Other: forward axle position<br>* Wheelchair will have the axle at least 5cm farther forward than the most rear axle position.<br>|
| Experimental: rear position<br> | Other: rear axle position<br>* Wheelchair axle position located as far towards the rear of the wheelchair as possible.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheelchair skills test |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wheelchair user
ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS

Study Overview
=================
Brief Summary
-----------------
Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support. Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS

Official Title
-----------------
Extracorporeal Membrane Oxygenation for COVID-19 and Influenza H1N1 Associated Acute Respiratory Distress Syndrome: a Multi-centre Retrospective Cohort Study

Conditions
-----------------
ARDS, COVID-19, H1N1 Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis Severe ARDS (according to Berlin Definition) VV ECMO Invasive mechanical ventilation through endotracheal tube or tracheostomy Exclusion Criteria: • Age<18 years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br> | |
| H1N1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality on day 60 after ECMO initiation |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | 90 days | 
| ICU length of stay |  | 90 days | 
| Hospital mortality on day 90 after ECMO initiation |  | 90 days | 
| ECMO duration |  | 90 days | 
| ECMO associated hemorrhagic complications |  | 60 days | 
| ECMO associated mechanical complications |  | 60 days | 
| Invasive mechanical ventilation duration |  | 90 days | 
| ECMO related haemorrhagic complications |  | 90 days | 
| ECMO related mechanical complications |  | 90 days |
A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced cancer.

Official Title
-----------------
A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: ZIO-201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic and /or unresectable disease state after previous standard chemotherapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>ZIO-201 | Drug: ZIO-201<br>* ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicities |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | 6 months |
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

Official Title
-----------------
Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months HbA1c (glycosylated haemoglobin) equal to or below 12% Willing and able to perform self blood glucose monitoring (SMBG) Exclusion Criteria: History of drug or alcohol dependence Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation Previous participation in this trial Receipt of any investigational drug within the last month prior to this trial Known or suspected allergy to trial products or related products

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIAsp<br> | Drug: biphasic insulin aspart 30<br>* Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals<br>|
| Experimental: Insulin aspart<br> | Drug: biphasic insulin aspart 30<br>* Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals<br>Drug: insulin aspart<br>* Administrated subcutaneously (s.c., under the skin) before lunch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-point blood glucose profile |  |  | 
| Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification |  |  | 
| Incidence of adverse events |  |  | 
| Hypoglycaemic episodes (minor, major or nocturnal) |  |  |
Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of obscure gastrointestinal bleeding, and frequently require an extensive diagnostic work-up. For these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT enterography (CTE) for evaluation of suspected small bowel pathology. This is an observational study enrolling patients referred to the Brigham and Women's Hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation of obscure gastrointestinal bleeding.

Official Title
-----------------
Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Conditions
-----------------
Obscure Gastrointestinal Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anemia, hematochezia, melena, Hematemesis, heme positive stool with negative EGD+/-colonoscopy Exclusion Criteria: Under the age of 18 Unable to give consent IV Contrast Allergy (excluded from CT) Renal insufficiency (excluded from CT) Unable to swallow (excluded from capsule) Small bowel obstruction or stricturing disease (excluded from capsule)

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 |
| --- | --- | --- |
| Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding |  | Continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital course, clinical improvement |  | 120 days from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obscure Gastrointestinal Bleeding, Occult Gastrointestinal Bleeding, Overt Gastrointestinal Bleeding, Capsule Endoscopy, CT Enterography
Effect of Advertisements on Treatment Compliance in Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer may help doctors plan the best treatment. PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in women with breast cancer.

Detailed Description
-----------------
OBJECTIVES: Primary Evaluate the consequences of advertisement on treatment compliance in women with breast cancer. Secondary Determine the factors favoring or not favoring adherence to the medical recommendations. OUTLINE: Patients and their medical and nonmedical caregivers are interviewed by a sociologist or anthropologist twice over 1 year. The first interview is at the consultation visit and the second interview is at the patient's home. The impact of advertisement on treatment compliance is measured. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Official Title
-----------------
Socio-anthropological Study Evaluating the Impact of Observance or Treatment in Patients With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: counseling intervention
* Procedure: psychosocial assessment and care


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of breast cancer Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: counseling intervention|nan|
|Procedure: psychosocial assessment and care|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment compliance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting adherence to the medical plan |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer