linjc16/ctgov huggingface dataset:
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.

Official Title
-----------------
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers

Conditions
-----------------
Ocular Infection

Intervention / Treatment
-----------------
* Drug: DCN01
* Drug: Unisol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given a written, informed consent Be willing and able to follow all instructions A negative urine pregnancy test if female of childbearing potential Exclusion Criteria: Known sensitivities to study medication or its components Any signs of an active infection Use of disallowed products during the period indicated prior to the enrollment or during the study Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCN01<br> | Drug: DCN01<br>* Three serial applications per periocular region.<br>|
| Placebo Comparator: Unisol<br> | Drug: Unisol<br>* Three serial applications per periocular region.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in periocular region bacterial load |  | Baseline to 10 min post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of periocular regions with a reduction from baseline in bacterial load. |  | Baseline to 10 min post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DCN01, Ocular Surgical Preparation, Prophylaxis against infection, Pre-operative prep
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma

Study Overview
=================
Brief Summary
-----------------
In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.

Official Title
-----------------
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma

Conditions
-----------------
Colorectal Carcinoma, Hepatic Metastasis

Intervention / Treatment
-----------------
* Drug: Dendritic cells vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment. Capacity of understanding and signing the informed consent and to undergo the study procedures Availability of tumor tissue, for maturing dendritic cells Adequate renal, hepatic and bone marrow function Exclusion Criteria: Clinically relevant diseases or infections. Concurrent participation in other clinical trial or administration or other antitumoral treatment Concurrent cancer, with the exceptions allowed by the principal investigator (PI). Pregnant or breast feeding women Immunosuppressant treatment

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 |
| --- | --- |
| No Intervention: Observation<br>Observation after standard treatment | |
| Experimental: Dendritic cells vaccine<br>Adjuvant treatment with dendritic cells vaccine after standard treatment | Drug: Dendritic cells vaccine<br>* Vaccination with autologous dendritic cells loaded with autologous tumor antigens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free survival |  | Progression free survival at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal carcinoma, resectable hepatic metastasis, adjuvant treatment, dendritic cells
Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents

Study Overview
=================
Brief Summary
-----------------
To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids, benzodiazepines, and antidepressants before versus after starting each of the following biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims database.

Official Title
-----------------
Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD 9 diagnosis RA 714.0 Documented first biologic prescription (index prescription) for abatacept, infliximab, etanercept, or adalimumab Continuous therapy (gap between scripts no greater than 150% days supply) for minimum 6 months from index Prescription claims data available for 6 months before and 12 months after index biologic prescription Continuous eligibility for 6 months before and 12 months after index biologic prescription Exclusion Criteria: Prescription claims for another biologic during the observation period (including rituximab and anakinra) Prescriptions not continuous for at least 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with RA and new to abatacept<br> | |
| Patients with RA and new to infliximab<br> | |
| Patients with RA and new to etanercept<br> | |
| Patients with RA and new to adalimumab<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants |  | 0-6 months after index biologic prescription | 
| Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants |  | 7-12 months after index biologic prescription | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of depression and/or anxiety (ICD-9 diagnosis code) |  | Between 0-6 months after index biologic prescription | 
| Prevalence of depression and/or anxiety (ICD-9 diagnosis code) |  | 7-12 months after index biologic prescription |
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.

Official Title
-----------------
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

Conditions
-----------------
Foot Ulcer, Diabetic

Intervention / Treatment
-----------------
* Device: PriMatrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Type 1 or 2 diabetic patients that present with foot ulcers. Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension. Ulcer depth: Full thickness (absence of all epithelial layers or deeper) Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft) All ulcer durations will be eligible Patients currently receiving NPWT for a diabetic foot ulcer Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place. Exclusion Criteria: Active foot infections Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study Patients who are pregnant Allergies to any material contained within the NPWT or bioscaffold Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm (Internal Control)<br>One-half of ulcer receives negative pressure wound therapy One-half of ulcer receives a fetal bovine collagen bioscaffold (PriMatrix, TEI Biosciences, Boston, MA) in addition to the same negative pressure wound therapy | Device: PriMatrix<br>* Dermal Repair Scaffold<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing |  | 12 weeks |
Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease

Study Overview
=================
Brief Summary
-----------------
Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1) short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.

Official Title
-----------------
Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Procedure: Short spot stenting
* Procedure: Long lesion stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAOD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4 Multiple (>1) short (focal; >1 and < 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines Unilateral occlusive disease Age ≥ 18 Exclusion Criteria: Patients with PAOD Rutherford category 5 and 6 Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat Bilateral lesions with treatment indication Contra-indication for anticoagulant therapy Renal insufficiency (MDRD < 50 ml/min) Life expectancy < 6 months Known contrast allergy Pregnancy Unable to complete a questionnaire in the home language

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: Short spot stenting<br>Short spot stenting | Procedure: Short spot stenting<br> <br> |
| Experimental: Long lesion stenting<br>Long lesion stenting | Procedure: Long lesion stenting<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention |  | 1 year |
Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study is conducted in order to evaluate the effect of remote ischemic preconditioning on children undergoing cardiac surgery, especially focusing on possible differences according to preoperative cyanosis.

Official Title
-----------------
Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery: Implication of Preoperative Cyanosis

Conditions
-----------------
Cyanosis

Intervention / Treatment
-----------------
* Other: RIPC (remote ischemic preconditioning)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: open heart surgery under cardiopulmonary bypass: ventricular septal defect, tetralogy of Fallot Exclusion Criteria: chromosomal defect airway and parenchymal lung disease blood disorder isolated atrail septal defect immunodeficiency

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 10 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remote ischemic preconditioning<br> | Other: RIPC (remote ischemic preconditioning)<br>* RIPC will be performed by four 5-min cycles of lower limb ischemia and 5 in reperfusion using blood-pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure measured via arterial line.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| troponin level | troponin level will be checked 1, 6, 12 and 24 hours after operation. Ater making a graph (troponin-time), area under the curve will bw calculated. | within the 1 day after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
troponin, open heart surgery, children
Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. This study aims to develop and validate a predictive nomogram for postoperative acute kidney injury in older patients undergoing noncardiac surgery.

Detailed Description
-----------------
Postoperative acute kidney injury (AKI) affects approximately 2% to 40% of patients undergoing cardiac and major noncardiac surgeries. Older patients are more susceptible to renal impairment than younger patients. However, the incidence and associations of AKI in older patients are rarely understood. Generally, in-depth knowledge of risk factors and thus able to identify patients at high risk to develop postoperative AKI is essential to optimize perioperative prevention and protection strategies. In this retrospective study, the investigators intend to develop and validate a predictive model for postoperative using the identified risk factors. The primary outcome is postoperative AKI, which according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion, is defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery.

Official Title
-----------------
Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery

Conditions
-----------------
Postoperative Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 65 years and older Exclusion Criteria: Emergency operation Cardiac surgery Incomplete data Incomplete data Local anesthesia Preoperative renal failure or requirement for dialysis

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 120 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 |
| --- | --- |
| older patients undergoing noncardiac surgery<br>older patients (aged ≥65 years) scheduled for noncardiac surgery | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery | 7 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prediction model, nomogram, older, noncardiac surgery
Ocriplasmin Research to Better Inform Treatment (ORBIT)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, prospective, observational, Phase 4 study that will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites.

Detailed Description
-----------------
The sites will prospectively enroll consecutive patients eligible for participation in the study. Informed consent will be obtained prior to any data being collected. This study is observational; therefore, all treatment decisions and assessments are at the discretion of the patient's treating physician and are not mandated by the study design or protocol. Patients will be enrolled at a routinely scheduled visit, on the day of JETREA® administration after the JETREA® injection. No specific visits, examinations, laboratory tests or procedures are mandated as part of this study. There is no pre-set visit schedule, and the frequency and timing of actual patient visits is at the discretion of the treating physician following standard of care. All available and relevant data will be collected prospectively.

Official Title
-----------------
Ocriplasmin Research to Better Inform Treatment (ORBIT)

Conditions
-----------------
Symptomatic Vitreomacular Adhesion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years or older diagnosed with symptomatic VMA treated with JETREA ® at the physician's discretion in a manner consistent with the product label. Willing and able to provide written informed consent Exclusion Criteria: Patients who are treated with JETREA® for medical conditions outside of the US product label. Concurrent participation in a research study that prescribes ocular treatment, imaging and/or interventions

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ocriplasmin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician. |  | 12 Months | 
| Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician |  | 12 months | 
| Mean change in visual acuity (VA) from baseline across time |  | 12 months | 
| Occurrence and time to vitrectomy |  | 12 months |