linjc16/ctgov huggingface dataset:
Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

Study Overview
=================
Brief Summary
-----------------
A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung cancer, will be randomized by the use of a computer-generated table of random numbers to receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure or a placebo pill following the same time schedule.

Official Title
-----------------
Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

Conditions
-----------------
Post-thoracotomy Pain

Intervention / Treatment
-----------------
* Drug: Oral Duloxetine 60mg
* Drug: placebo pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria ASA I, II, and III patients scheduled for thoracotomy for pleural or lung cancer resection. Age above 18 years & less than 65 years. Adequate coagulation function within 30 days of surgery, defined as platelet count 100,000/mL or more, INR≤ 1.5, and partial thromboplastin time ≤40 seconds. Exclusion criteria: Allergy to duloxetine or to local anesthetics. Patients with educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barriers that would prevent understanding of the informed consent & preclude accurate assessment of postoperative pain and/or ability to answer questions about pain. Patients with severe renal and/or liver disease. History of chronic pain, long term narcotic use and/or antidepressants. Reasons for exclusion after randomization will be protocol violations or patient request. Fever, evidence of infection, or other coexisting medical conditions that would preclude epidural placement.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: duloxetine group<br>duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure. | Drug: Oral Duloxetine 60mg<br>* duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure<br>|
| Placebo Comparator: placebo pill group<br>placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure. | Drug: placebo pill<br>* placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of morphine needed to treat postoperative pain | Total dose of morphine needed to treat postoperative pain over 48 hours of study period | 48 hours |
An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that it is feasible and safe to deliver a conservative approach to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on average,10 days).

Detailed Description
-----------------
Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average) Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days) Target an oxygen saturation between 90 and 92% Adjust FiO2 to achieve target SaO2 at all times Assess percentage of time patient is within target Assess for safety of this approach

Official Title
-----------------
A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: conservative O2 therapy
* Other: standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanical ventilation expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours) Exclusion Criteria: expected to be off mechanical ventilation today or tomorrow carbon monoxide poisoning necrotizing fasciitis

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: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard care<br>normal treatment | Other: standard care<br> <br> |
| Active Comparator: conservative O2 therapy<br>a value of 90-92% O2 saturation will be targeted | Other: conservative O2 therapy<br>* target lower O2 saturation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in PaO2/FiO2 ratio from baseline to worst value | Pao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate | blood lactate will be measured regularly and assessed during standard care and the intervention period | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen, critical illness, mechanical ventilation
Develop and Implement Asthma Controlling Strategies (2)

Study Overview
=================
Brief Summary
-----------------
To develop and implement asthma controlling strategies for inner city and high risk populations.

Detailed Description
-----------------
BACKGROUND: Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations, released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Effect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChart

Study Overview
=================
Brief Summary
-----------------
Our objective is to determine the effectiveness of varied outreach methods (e.g. standard versus tailored MyChart messaging) to children age 6-17 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling and appointment completion.

Official Title
-----------------
Effect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChart

Conditions
-----------------
Health Care Utilization

Intervention / Treatment
-----------------
* Other: No Message
* Other: Standard message
* Other: Tailored message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 6-17 years has not had a well child check in past 365 days no appointment scheduled in next 45 days parent preferred language = English or Spanish Exclusion Criteria: no active MyChart account

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No message<br>No message sent | Other: No Message<br>* No messages are sent<br>|
| Active Comparator: Standard message<br>2 MyChart reminders that child is overdue for well child check visit | Other: Standard message<br>* 2 MyChart reminders that child is overdue for well child check visit<br>|
| Active Comparator: Tailored message<br>2 MyChart reminders that child is overdue for well child check visit with date of last WCC and age | Other: Tailored message<br>* 2 MyChart reminders that child is overdue for well child check visit with date of last WCC and age<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appointment completed | Appointment completed (yes or no) based on electronic health record documentation | Within 8 weeks of receiving intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appointment scheduled | Appointment scheduled (yes or no) based on electronic health record documentation | Within 2 weeks of receiving intervention |
The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer .

Official Title
-----------------
The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients . Confirmed by Histopathology or Cytology of Lung Cancer Patients should be voluntary to the trial and provide with signed informed consent The researchers believe patients can benefit from the study. Exclusion Criteria: Patients with a known history of allergic reactions and/or hypersensitivity attributed to Albumin-binding taxol or its accessories Pregnant or lactating women Patients with Albumin-binding taxol contraindications Patients of doctors considered unsuitable for the trial

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 |
| --- | --- | --- |
| Progress free survival | Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | overall survival is defined as the length of time from random assignment to death or to last contact. | 3 year | 
| disease control rate | Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1 | 1 year | 
| Objective tumor response rate | Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Albumin-binding taxol
Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).

Official Title
-----------------
Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma

Conditions
-----------------
Carcinoma, Renal Cell, Urogenital Neoplasms, Urologic Neoplasms, Kidney Neoplasms

Intervention / Treatment
-----------------
* Drug: motexafin gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments Measurable disease Hemoglobin ≥ 9 mg/dL ECOG performance status of 0, 1, or 2 Willing and able to provide written informed consent Exclusion Criteria: Inadequate bone marrow, renal and liver function by laboratory criteria Absolute neutrophil count < 1500/µL; Platelet count < 100,000/µL; AST or ALT > 2 x upper limit of normal (ULN); Alkaline phosphatase > 5 x ULN; Total bilirubin > 2 x ULN; Creatinine > 2.0 mg/dL. Evidence of central nervous system metastases within past year Uncontrolled hypertension Known history of porphyria, G6PD deficiency or HIV

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

| Intervention/Treatment |
| --- |
|Drug: motexafin gadolinium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD]) |  |  | 
| Time to progression |  |  | 
| Progression-free survival |  |  | 
| Overall survival and survival at 6 and 12 months |  |  | 
| Duration of clinical response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney cancer, Renal cell carcinoma, Motexafin gadolinium
Registry for Patients With Erdheim-Chester Disease and Other Histiocytoses

Study Overview
=================
Brief Summary
-----------------
The investigators want to understand more about what kinds of health problems are caused by histiocytosis, what happens as a result of different treatments, and how ECD affects people's lives, their feelings and their attitudes. The investigators also want to learn how these things change over time for people with these conditions. To try to figure this out, doctors would like to collect information about people who have histiocytosis and how they are treated for this disease. Some participants will be asked to complete a brief interview over the telephone. Only a limited number of interviews will take place, and not everyone will be asked to participate in the interview. It is okay if the participant does not want to participate in the interview portion. If this is the case, the participant should let the study team member know when contacted.

Official Title
-----------------
Registry for Patients With Erdheim-Chester Disease and Other Histiocytoses

Conditions
-----------------
Erdheim-Chester Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Erdheim-Chester Disease, Langerhans cell histiocytosis, Rosai Dorfman disease, or another histiocytic neoplasm by either 1) documented histopathologic establishing ECD or HN or 2) documented histopathologic findings compatible with Erdheim-Chester disease or HN in the context of corroborating clinical and/or radiologic findings or 3) documented radiologic findings, in the absence of a biopsy having been performed or yielding evaluable tissue, that are felt by the Principal Investigator to unequivocally represent an ECD/HN diagnosis given the clinical context or 4) self reported with supporting documentation upon medical record collection. Proficiency in English, in the determination of the Investigator or by self report. Willing to have historical and future HN-related health records sent to Registry review. Exclusion Criteria: Patients unwilling to sign consent. Participants under the age of 18.

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 |
| --- | --- |
| Patients with Erdheim-Chester Disease and Other Histiocytoses<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create registry for Erdheim-Chester Disease and Other Histiocytoses | This ECD and Other Histiocytoses registry is motivated to capture comprehensive clinical information as well as patient-centered data about ECD and Other Histiocytoses patients. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
registry, Other Histiocytoses, Langerhans cell histiocytosis, Rosai Dorfman disease, 17-516
ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

Study Overview
=================
Brief Summary
-----------------
This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.

Detailed Description
-----------------
The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing transaortic transcatheter procedure with the commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ System.

Official Title
-----------------
Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

Conditions
-----------------
Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intended transaortic (Tao) TAVI using Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System Compliance with the indications according to the Instructions for Use Written informed consent Exclusion Criteria: Presence of contraindications as to the Instructions for Use TAo with concomitant procedure (e.g. Tao + CABG) Participation in the SOURCE XT registry

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 |
| --- | --- |
| TAVI<br>All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | to determine Overall mortality within 30 days after TAVI | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAVI-related in-Hospital and 30 d mortality | see title | 30 days after TAVI | 
| complication rates | Complication rates as to VARC2 | 30 days after TAVI | 
| Number of Patients with adverse Events in Relation to Baseline Parameters | Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI | 30 days after TAVI |
Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.

Official Title
-----------------
Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients

Conditions
-----------------
Type 2 Diabetes Mellitus, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 35-70 type 2 diabetes mellitus impotence with and without hypertension, hypercholesteremia Exclusion Criteria: patients with history of cardiovascular and malignant disease, advanced nephropathy (creatinine≥2.2mg/dl) hepatopathy (liver enzymes higher than the double of normal values) patients taking nitrates CHF: NYHA > II Stable angina: CCS > II

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sildenafil|Orally administered, Sildenafil 100mg, unique administration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil. |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil. |  | 60 minutes |