linjc16/ctgov huggingface dataset:
Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.

Study Overview
=================
Brief Summary
-----------------
Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study the investigators try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.

Official Title
-----------------
Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic

Conditions
-----------------
Peripherally Inserted Central Catheters, Centrally Inserted Central Catheter, Transpulmonary Thermodilution, Hemodynamic Monitoring

Intervention / Treatment
-----------------
* Diagnostic Test: transpolmonary thermodilution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (≥18 years) admitted to the ICU Patients requiring hemodynamic monitoring using EV1000TM Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed) Exclusion Criteria: body weight <40 kg severe aortic regurgitation or intra-cardiac shunt treatment with an intra-aortic balloon pump contraindication for placement of PICC, CICC or a femoral arterial catheter abdominal aneurism extracorporeal circulation pregnancy lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: transpolmonary thermodilution|Thermodilution was attempted via PICC and via CICC in the same patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index comparison via PICC | comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC. | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of single-lumen 5Fr PICCs to CICC | Comparison of single-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output | one hour | 
| Comparison of triple-lumen 6Fr PICCs to CICC | Comparison of triple-lumen 6 Fr PICCs to CICC in their reliability of assessing cardiac output | one hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PICC, CICC, Cardiac output, shock
ARTISS a Single-centre Randomised Control Study

Study Overview
=================
Brief Summary
-----------------
The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients.

Detailed Description
-----------------
The principle aim of the study is to investigate the effect of ARTISS on abdominal wound drainage whether this could result in earlier drain removal and earlier patient discharge from hospital. The primary outcome investigated will be post- operative abdominal drainage duration in days which is vital information during this Covid pandemic to reduce hospital stay (and therefore possible Covid exposure) which could result in earlier discharge from hospital, as well as significantly reducing cost of the procedure to the NHS and frees in-patient beds for more efficient use of resources.

Official Title
-----------------
The Influence of ARTISS on Post-operative Abdominal Drainage and Seroma Formation in DIEP/MS-TRAM Free Flap Breast Reconstruction Patients

Conditions
-----------------
Breast Neoplasms, Mammaplasty

Intervention / Treatment
-----------------
* Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
* Other: no ARTISS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female adult (age 18-80) Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction Exclusion Criteria: Patients who are unable to consent or do not consent Clotting disorder Pregnancy Individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). COVID positive Known previous allergic reactions to ARTISS

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

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
Interventional Model Description: Randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: without ARTISS<br>Surgery performed without active comparative | Other: no ARTISS<br>* Wound closed without sealant<br>|
| Active Comparator: with ARTISS<br>Surgery performed with active comparative | Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)<br>* Wound sealant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative abdominal mean drainage duration | post-operative abdominal mean drainage duration | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle-sparing transverse rectus abdominis myocutaneous flap, Deep Inferior Epigastric Artery Perforator
PrEP at a Syringe Services Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.

Official Title
-----------------
Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study

Conditions
-----------------
Hiv, Substance Use Disorders

Intervention / Treatment
-----------------
* Drug: Descovy 200Mg 25Mg Tablet
* Behavioral: PrEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over the age of 18 speak either English or Spanish ability to provide informed consent currently enrolled in the syringe services program have a negative HIV rapid test result estimated creatinine clearance > 30 ml/minute Exclusion Criteria: do not meet the above criteria of inclusion decline to participate test positive for HIV via rapid test are pregnant or plan on becoming pregnant have symptoms acute HIV. Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid PrEP group<br>Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program. | Drug: Descovy 200Mg 25Mg Tablet<br>* daily Descovy tab by mouth<br>Behavioral: PrEP<br>* PrEP will be provided in a community setting by community-based harm reduction program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracellular level of tenofovir diphosphate | assessed via dried blood spot | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to PrEP initiation post negative HIV rapid test | number of days between receiving negative test result and initiating PrEP via self-report | up to 12 months |
Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.

Detailed Description
-----------------
Patients: All consecutive patients with compensated HBV, HCV, alcohol or hemochromatosis-related cirrhosis (without any previous clinical complication including liver cancer). Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein assay (none versus 6-month). End points: rate of small tumors (first main criteria); survival (second main criteria).

Official Title
-----------------
Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month

Conditions
-----------------
Compensated Cirrhosis

Intervention / Treatment
-----------------
* Procedure: Ultrasonographic screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Compensated cirrhosis Exclusion Criteria: Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee Intra-articular injection of triamcinolone hexacetonide in three months preceding the inclusion or by a different corticoid in the month preceding the inclusion Evolutionary infectious or neoplastic pathology

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Procedure: Ultrasonographic screening<br>* Ultrasonographic screening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of small hepatocellular carcinoma (HCC) |  | 6 months versus 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | during the study | 
| Clinical value of serum alfa-fetoprotein assay |  | during the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemochromatosis, Cirrhosis, Hepatocellular carcinoma, Screening, Randomized, HBV, HCV, alcohol
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.

Detailed Description
-----------------
Randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen to treatment with either insulin glargine or BID NPH human insulin, with baseline diabetic retinopathy of severity 53/<53 on the ETDRS scale, for 5 years of followup. Outcomes measured by seven-field fundus photography at baseline, 1.5, 3,6,and 9 months, and annually.

Official Title
-----------------
Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

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

Intervention / Treatment
-----------------
* Drug: Insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus for at least 1 year treated with oral antidiabetic agents or insulin at stable doses for at least 3 months HbA1c between 6 and 12% inclusive baseline retinopathy severity not to exceed 53/<53 on the ETDRS scale unlikely to require laser surgery or vitrectomy within upcoming year Exclusion Criteria: prior treatment with insulin glargine treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with a 3-step or greater progression in the patient |  |  | 
| level recoded integer ETDRS retinopathy scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who:develop proliferative retinopathy or develop clinically significant macular edema |  |  | 
| the distribution of patients on the patient level recoded integer ETDRS retiopathy scale |  |  | 
| the change from baseline in HbA1c and fasting plasma glucose |  |  | 
| the incidence of hypoglycemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Retinopathy, Diabetes
Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.

Official Title
-----------------
A Multicenter, Open-Label, Single-Arm, Free Tablet Combination, Long-Term Study to Evaluate the Safety of Nebivolol in Combination With Valsartan in Patients With Stage 1 or Stage 2 Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nebivolol, Valsartan and Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients of age 18 years or above Patients diagnosed with stage 1 or stage 2 essential hypertension Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant Exclusion Criteria: Secondary hypertension or severe hypertension Clinically significant cardiovascular disease or heart failure A medical contraindication to discontinuing a current antihypertensive therapy History of Type 1 diabetes mellitus

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Nebivolol and Valsartan free tablet combination | Drug: Nebivolol, Valsartan and Hydrochlorothiazide<br>* Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Recording |  | From Baseline to Week 53 (Visit 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure (DBP). |  | From Baseline to Week 52 (Visit 15) | 
| Systolic Blood Pressure (SBP) |  | From Baseline to Week 52 (Visit 15) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage 1, Stage 2, Hypertension, 1 year open label safety study
Comparison Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy

Study Overview
=================
Brief Summary
-----------------
comparison of early and long term results of open lichtenstein repair and totally extraperitoneal herniorrhaphy for primary inguinal hernias.

Detailed Description
-----------------
Early results such as postoperative pain, operation time and long term results such as chronic pain and recurrence will be compared.

Official Title
-----------------
Comparison of Early and Long Term Outcomes of Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy for Primary Inguinal Hernias

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inguinal hernia Exclusion Criteria: recurrent hernia

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: lichtenstein<br>hernia repair | Procedure: hernia repair<br>* inguinal hernia repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | hernia recurrence | 3 years |
Human Phototoxicity Test

Study Overview
=================
Brief Summary
-----------------
To determine the phototoxic potential of a topically applied article in human subjects.

Official Title
-----------------
Human Phototoxicity Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Other: Sunscreen Spray- Liquid (BAY987516)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a HIPAA (Health Insurance Portability and Accountability Act) Authorization Form in conformance with 45CFR (Code of Federal Regulations ) Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator. Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunscreen Spray-Liquid<br>All subjects are patched with the same product | Other: Sunscreen Spray- Liquid (BAY987516)<br>* 50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions will be evaluated using the 5 point grading scale |  | Up to 48 hours |
Study of Sc-FOS for Pouchitis Prevention

Study Overview
=================
Brief Summary
-----------------
The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.

Official Title
-----------------
Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial

Conditions
-----------------
Pouchitis

Intervention / Treatment
-----------------
* Drug: Short-Chain Fructooligosaccharide
* Drug: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 18-65 years. History of ulcerative colitis Ileostomy closure after IPAA Ability to give appropriate consent Exclusion Criteria: Crohn's disease. Perianal disease (including abscess, fissure, or stricture) Pregnancy Lactation Concurrent treatment for IBD or pouchitis

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short-Chain Fructooligosaccharide<br>4 chews (8.0 g scFOS) orally per day for 12 months | Drug: Short-Chain Fructooligosaccharide<br>* 4 chews (8.0 g scFOS) orally for 12 months<br>|
| Placebo Comparator: Maltodextrin<br>4 chews (maltodextrin) daily for 12 months | Drug: Maltodextrin<br>* 4 chews (maltodextrin) daily for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year | In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (<7 points). | baseline, 1 year |