linjc16/ctgov huggingface dataset:
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity

Study Overview
=================
Brief Summary
-----------------
Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.

Detailed Description
-----------------
Prospective study design among subjects with MGD and qualifying for IPL therapy. Study testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4). Subjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements. No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months

Official Title
-----------------
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Device: Intense Pulse Light Energy delivery (IPL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry eye MGD Exclusion Criteria: No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery No change in ocular medications in the last 2 months
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: Single arm<br>Intense pulse light therapy (E-Schwin) | Device: Intense Pulse Light Energy delivery (IPL)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film osmolarity change |  | Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4). |
Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery

Study Overview
=================
Brief Summary
-----------------
Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.

Detailed Description
-----------------
The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.

Official Title
-----------------
Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure

Conditions
-----------------
Carpal Tunnel Syndrome, Trigger Finger

Intervention / Treatment
-----------------
* Procedure: Wound closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient greater than or equal to 18 years of age. Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release Exclusion Criteria: Any patient identified outside of the proposed study time period. Any patient receiving revision surgery Patients who have had prior ipsilateral palmar or finger surgery Patients with Dupuytren's disease

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorbable suture<br>Wound closure with absorbable suture. | Procedure: Wound closure<br>* Comparison of two wound closures<br>|
| Active Comparator: Non-absorbable suture<br>Wound closure with non-absorbable suture. | Procedure: Wound closure<br>* Comparison of two wound closures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar formation with the Patient and Observer Scare Assessment Scale | Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS). The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. | 1 year |
Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

Study Overview
=================
Brief Summary
-----------------
Congenital heart disease is the most common congenital malformation in the world with high morbidity and mortality. However, there is no data to assess the perioperative outcome of congenital heart disease surgery among Chinese cross-regional population. This study aims to investigate the perioperative outcome of congenital heart disease surgery in childhood from a chinese cross-regional cohort.

Official Title
-----------------
Perioperative Outcome of Congenital Heart Disease Surgery in Childhood: Results From a Chinese Cross-regional Cohort Study

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Procedure: Congenital Heart Disease Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was aged 1 week-18 years Subjects underwent congenital heart disease surgery; Available data to investigate perioperative outcome. Exclusion Criteria: Cardiac reoperation; Emergency surgery; Interventional procedure within prior 30 days prior to surgery; Missing outcome data.

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Congenital Heart Disease Surgery|Patients with congenital heart disease will undergo congenital heart disease surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of systemic inflammatory response syndrome | Systemic inflammatory response syndrome was determined mainly on (i) Core temperature of >38.5°C or <36°C measured by rectal, oral, or central catheter probe; (ii) Tachycardia, defined as a mean heart rate >2 SD above normal for age in the absence of external stimulus, chronic drugs, or painful stimuli; or otherwise unexplained persistent elevation over a 0.5- to 4-hr time period, or for children <1 yr old: bradycardia, defined as a mean heart rate <10th percentile for age in the absence of external vagal stimulus; or otherwise unexplained persistent depression over a 0.5-hr time period; (iii) Mean respiratory rate >2 SD above normal for age, the prolonged mechanical ventilation defined as ventilation duration > 48 hrs, or unplanned re-intubation for an acute process not related to underlying neuromuscular disease or the receipt of general anesthesia; (iv) Leukocyte count elevated or depressed for age or >10% immature neutrophils. | postoperative day 7 or hospital discharge, whichever occurred first. |
The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.

Detailed Description
-----------------
The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.

Official Title
-----------------
A Multicenter, Open-Label Study Assessing the Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Hypertension Not Controlled by Monotherapy

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

Intervention / Treatment
-----------------
* Drug: IRBESARTAN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have hypertension and uncontrolled SBP on monotherapy. Patients who have read, signed and received a copy of the informed consent prior to any study procedures Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study. Exclusion Criteria: Any history of secondary hypertension History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months

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

| Intervention/Treatment |
| --- |
|Drug: IRBESARTAN|150/12.5 mg tablets one or two tablets orally per day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean SBP |  | from baseline to week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean DBP |  | from baseline to week 18. | 
| Changes in mean SBP and DBP |  | from baseline to week 10 | 
| SBP and DBP response and control rates |  | at weeks 10 and 18 |
Methylene Blue for the Prevention of Hypotension During Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients. This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.

Official Title
-----------------
Methylene Blue for the Prevention of Hypotension During Hemodialysis: a Randomized Open Label Trial

Conditions
-----------------
Acute Kidney Injury, Shock

Intervention / Treatment
-----------------
* Drug: Methylene Blue
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or legal representative accepted trial enrollment Age above 18 years Chronic or acute kidney injury in need for renal replacement therapy Blood pressure lower than 100 mmHg or in use of any vasopressor Exclusion Criteria: Pregnancy Death considered imminent in the next 24 hours Patients not on full code status Hypertensive patients where dialysis was indicated to remove fluids Known allergy to methylene blue Known glucose-6-phosphate deficiency Previously enrolled in the trial Acute coronary Syndrome Domiciliary nitrate use

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 |
| --- | --- |
| Active Comparator: Methylene Blue<br>Methylene blue will be infused during renal replacement therapy | Drug: Methylene Blue<br>* 1 mg per kilogram bolus, followed by 0.1 milligram per kilogram during renal replacement therapy<br>|
| Other: Control<br> | Other: Control<br>* Usual care during renal replacement therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint | Composite endpoint of: Increase in vasopressor dose in at least 15% of initial dose or interruption of dialysis or reduction in ultrafiltration rate | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy | 6 hours | 
| Maximum vasopressor dose | Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours | 24 hours | 
| Mortality in the intensive care unit | Death in the intensive care unit | 60 days | 
| Mortality in the hospital | Death during hospital stay | 60 days |
Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. In addition, the surgical refinements that were introduced over the years are reported.

Official Title
-----------------
The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps

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

Intervention / Treatment
-----------------
* Procedure: LTP flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lateral thigh region suitable as a donor site Abdomen not suitable as donor site Informed consent Exclusion Criteria: Pre-operative imaging showing no suitable perforators
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LTP flap breast reconstruction<br>All consecutive patients who underwent LTP flap breast reconstructions (unilateral, bilateral or stacked unilateral) between September 2012 and November 2016 at three centers in Maastricht, the Netherlands, and New York and New Orleans, the United States, were included. Autologous breast reconstruction was performed by using the upper lateral thigh region as a donor site. | Procedure: LTP flap<br>* A flap is harvested from the upper lateral thigh region based on septocutaneous perforators located in the posterior septum between the tensor fascia latae and gluteus medius muscles.<br>* Other names: Septocutaneous tensor fasciae latae (sc-TFL) flap;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recipient- and donor-site complications | Recipient site: Total flap loss, partial flap loss, venous congestion, infection, hematoma, seroma, fat necrosis and wound complications. Donor site: Infection, hematoma, seroma, fat necrosis, wound complications. | Through study completion up to an average of 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flap re-explorations | Total number of flaps that required a re-exploration because of arterial or venous insufficiency, hematoma or kinking of the pedicle. | Through study completion up to an average of 12 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast reconstruction, Perforator flap, Microsurgery
Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine eligibility for one of three treatment studies of the CCR5 antagonist GW873140 or an observational study without GW873140. No investigational treatment will be administered through this study.

Official Title
-----------------
A Screening Protocol to Determine Eligibility for One of Three Phase III Treatment Studies Evaluating the Efficacy and Safety of GW873140 in R5-tropic and R5/X4-tropic HIV-1 Infected, Treatment-experienced Subjects With Drug-resistant Virus or an Observational Study.

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: GW873140


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected. Screening viral load at least 5000copies/mL. Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening. Able to receive a ritonavir-boosted protease inhibitor during treatment studies. Women of childbearing potential must use specific forms of contraception. Exclusion criteria: Acute laboratory abnormalities. History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility. Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment or observational studies. Pregnancy or breastfeeding women. Recent participation in an experimental drug trial. Prior use of a CCR5 or CXCR4 antagonist. Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness. Current use of certain medications may exclude participation in this study. Additional qualifying criteria and laboratory test requirements to be assessed by study physician.

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: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW873140|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1 GW873140 CCR5 antagonist experienced
Solid Organ Transplant Recipients With SARS-CoV-2 French Registry

Study Overview
=================
Brief Summary
-----------------
Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. For this purpose, The investigators conducted a nationwide multicentric and multiorgan Registry to collect data about all French SOT recipients who develop a SARS-CoV-2 infection. The aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population

Official Title
-----------------
Clinical Presentation and Incidence of SARS-CoV-2 Infection in Different Cohorts of Solid Organ Transplant Patients and Follow-up in France

Conditions
-----------------
SARS-CoV-2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection Adult and pediatric Exclusion Criteria: - There are no exclusion criteria, except for the patient's explicit refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Clinical Presentation and Incidence of Covid-19 Infection in Different Cohorts of Solid Organ Transplant Patients |  | From 1st March 2020 to 1st March 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Covid-19, Solid Organ transplantation, Incidence, Prognosis, Cellular response, Humoral Response