linjc16/ctgov huggingface dataset:
On-pump Intraoperative Echocardiography

Study Overview
=================
Brief Summary
-----------------
This pilot study uses an ultrasound probe that is currently clinically used to assess pituitary anatomy, the Hitachi-Aloka high resolution pituitary transducer to measure left ventricular (LV) septal thickness during cardiopulmonary bypass in the performance of surgical septal myectomy. Septal thickness will be assessed and can be visualized during the procedure and if it is likely to improve the efficacy and safety of the procedure. The probe has FDA clearance for a variety of intra-operative surgical procedures but will be off-label for this cardiac surgical protocol.

Official Title
-----------------
On-pump Intraoperative Echocardiography (OPIE)

Conditions
-----------------
Septal Myectomy

Intervention / Treatment
-----------------
* Device: Pre Operative On-pump intraoperative echocardiography
* Device: Pre Operative Transesophageal echocardiography (TEE) imaging
* Device: Post Operative On-pump intraoperative echocardiography
* Device: Post Operative Transesophageal echocardiography (TEE) imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled to receive a septal myectomy. Exclusion Criteria: Less than 18 years of age

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septal myectomy<br> | Device: Pre Operative On-pump intraoperative echocardiography<br>* Center tendency parameters(mean, standard deviation) will be reported for each outcome.<br>* Other names: OPIE;Device: Pre Operative Transesophageal echocardiography (TEE) imaging<br>* Center tendency parameters(mean, standard deviation) will be reported for each outcome.<br>* Other names: TEE;Device: Post Operative On-pump intraoperative echocardiography<br>* Center tendency parameters(mean, standard deviation) will be reported for each outcome.<br>Device: Post Operative Transesophageal echocardiography (TEE) imaging<br>* Center tendency parameters(mean, standard deviation) will be reported for each outcome.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Septal Thickness Measured Before Cardiopulmonary Bypass | Center tendency parameters(mean, standard deviation) | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Septal Myectomy
Knowledge Attitudes Behaviours and Practices Regarding HIV of Sex Workers in the French Antilles

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to determine the knowledge attitudes, behaviours and practices of sex workers regarding HIV in Martinique, guadeloupe and Saint martin.

Official Title
-----------------
Knowledge Attitudes Behaviours and Practices Regarding HIV of Sex Workers in the French Antilles

Conditions
-----------------
Hiv

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sex worker living in the french antilles Exclusion Criteria: refusal to participate

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| martinique<br> | Other: no intervention survey<br>* there was no intervention this was a survey<br>|
| guadeloupe<br> | Other: no intervention survey<br>* there was no intervention this was a survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey |  | one year | 
| Attitudes regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey |  | one year | 
| Behaviours regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey |  | one year | 
| Practices regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey |  | one year |
Expanded Access to NanoPac

Study Overview
=================
Brief Summary
-----------------
NanOlogy may consider offering expanded access to NanoPac for patients who do not meet the enrollment criteria of clinical trials in progress.

Official Title
-----------------
Expanded Access to NanoPac

Intervention / Treatment
-----------------
* Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment Decision Making Between Oncologists and Women With Newly Diagnosed Breast Cancer and Their Healthy Companions

Study Overview
=================
Brief Summary
-----------------
RATIONALE: A study that looks at communication between patients and doctors may help oncologists improve patient satisfaction with their treatment plan. PURPOSE: This phase I trial is studying treatment decision making between oncologists and women with newly diagnosed breast cancer and their healthy companions.

Detailed Description
-----------------
OBJECTIVES: Primary To determine the association between women's and physicians' participatory communication behaviors (e.g., patients asking questions, physicians soliciting questions) on treatment decision-making process and health outcomes. Secondary To capture the language used in the treatment-decision interactions. To assess the degree of variation in the language used among physicians and patients who are active participants and those who are less inclined to participate in the treatment decision-making interaction. OUTLINE: Patients and their companions undergo consultation with the physician for treatment decision making. The treatment discussion is audio/videotaped for approximately 45 minutes. Patients complete one short survey prior to physician consultation. After the treatment discussion, patients complete two short surveys, one immediately after the visit in the waiting room before leaving for the day, and the second one a week after the visit by a web-based survey or by mail. PROJECTED ACCRUAL: A total of 300 women with breast cancer and 600 companions of these women will be accrued for this study.

Official Title
-----------------
The Process and Outcomes of Treatment Decision-Making Communication Between Oncologists and Newly Diagnosed Female Breast-Cancer Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets one of the following criteria: Woman with newly diagnosed early-stage breast cancer Caregiver or companion willing to participate in study PATIENT CHARACTERISTICS: Speaks native English or has learned to speak English fluently Patient's companion ≥ 18 years old (if applicable) Able to complete questionnaires without assistance Not pregnant PRIOR CONCURRENT THERAPY: Not specified

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| The association between patients' and physicians' participatory communication and psychosocial outcomes. |  | Pre- and post-Initial treatment decision making visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Understanding Non-Response in Spine Fusion Surgery

Study Overview
=================
Brief Summary
-----------------
To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).

Official Title
-----------------
Understanding Non-Response in Spine Fusion Surgery

Conditions
-----------------
Spine Fusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has diagnosis of degenerative disc disease Subject is undergoing lumbar spine fusion surgery Exclusion Criteria: Subject is less than 18 years of age Subject is not fluent in English Subject requires a caretaker for medical decision making

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 |
| --- | --- | --- |
| Oswestry Disability Index | Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100. The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option 0 indicating the least amount of disability and 5 indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes. | Baseline, 60 day, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient reported outcomes
Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula

Study Overview
=================
Brief Summary
-----------------
The investigators recently proposed a new hypothesis on the pathogenesis of mammillary fistulae (MF) suggesting that occlusion of hair follicles by keratinous plugging may relevantly contribute to the development of MF. The investigators believe that the pathogenesis of MF mimics the behaviour of hidradenitis suppurative, as both clinical entities manifest themselves as a chronic, suppurative and recurrent inflammatory process. This new proposal has led to the present suggestion of a therapeutic alternative for MF.

Detailed Description
-----------------
To compare the results from a prospective observational database with two groups of patients: patients with MF treated by percutaneous drainage and saline solution. patients with MF treated by percutaneous drainage and saline solution plus percutaneous triamcinolone. These patients are treated following usual clinical practice in our Department. All the procedures are made through an ultrasound-guided way. During the follow-up of these cases (clinical and with ultrasound) resolution rate will be registered by the same investigator. The follow-up will be at least 6 months.

Official Title
-----------------
Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula

Conditions
-----------------
Mammillary Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mammillary fistula older than 18 years patient acceptation to the recruitment Exclusion Criteria: diabetes mellitus arterial hypertension immunodepression peptic ulcer chronic bowel inflammatory diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Saline<br>Percutaneous drainage and saline solution irrigation | |
| Triamcinolone<br>Percutaneous drainage and saline solution irrigation plus percutaneous triamcinolone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of mammillary fistula |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mammillary fistula, triamcinolone, ultrasound management, percutaneous treatment
Evaluation of Colonic Diminutive Polyps With Electronic Filters

Study Overview
=================
Brief Summary
-----------------
Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a remove and discard technique has been proposed. The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.

Detailed Description
-----------------
Any diminutive polyps encountered during a colonoscopy will be examined with the use of electronic filters and magnification and assigned by the endoscopist to a adenoma/non adenoma category, resected and retrieved: a follow up surveillance period will be assigned on the basis of the endoscopic appearance of the polyps. Each polyp will then be sent separately to Pathology for the histologic evaluation, and a surveillance interval period will be determined accordingly.

Official Title
-----------------
Remove and Discard Policy in Colonic Diminutive Polyps: is it Always Safe?

Conditions
-----------------
Colonic Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects undergoing colonoscopy Exclusion Criteria: Patients assuming oral anticoagulant therapy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category | All the retrieved polyps will be examined and the percentage of accordance between the endoscopic and histologic diagnosis will be determined | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost savings expressed in dollars between the remove and discard technique and histologic examination of samples | The cost of histologic examination for any polyp retrieved will be determined according to the current italian tariff of the procedure and the savings will be calculate | 1 year | 
| Percentage of concordance between the surveillance periods, determined on the basis of the endoscopic and histologic evaluation of the polyps | For any patient, there will be an analysis of the surveillance period assigned both by the endoscopist and the pathologist in order to determine the percentage of accordance between the two. | 1 year |
Buprenorphine Detox With Two Types of Treatment. BBD II - 11

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare overall treatment outcome between behavioral versus enhanced behavioral treatment types.

Official Title
-----------------
Buprenorphine Detox With Two Types of Treatment. BBD II

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Weeks abstinent |  |  | 
| Weeks continuous abstinence |  |  | 
| Overall treatment outcome |  |  |
Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics

Study Overview
=================
Brief Summary
-----------------
Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.

Detailed Description
-----------------
Study will be blinded and randomized 1:1 to either Vancomycin Powder at closure or no vancomycin powder at closure.

Official Title
-----------------
Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics

Conditions
-----------------
Lumbar Pain

Intervention / Treatment
-----------------
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult, 18 years or greater undergoing posterior approach spinal surgery Exclusion Criteria: Prisoner, pregnant women, patient under the age of 18, those of diminished decision making capacity. patients with known reaction to Vancomycin. patients having surgery specifically for spine infection patients having ADCF or ALIF

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancomycin<br>Patient will receive Vancomycin powder to the incision just before skin closure | Drug: Vancomycin<br>* Patient will be randomized to either vancomycin or no vancomycin. This treatment will take place prior to the closure of the incision from back surgery.<br>|
| No Intervention: no vancomycin<br>Patient will be randomized to either vancomycin powder or no vancomycin powder. This arm the patient will not have the powder placed in the incision before skin closure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical wound infection rate, both deep and superficial infections |  | 12 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative rate of MRSA infections. |  | 12 weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Posterior spine surgery, infection, vancomycin, surgical wound infection
Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.

Official Title
-----------------
A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors

Conditions
-----------------
Advanced/Metastatic Solid Tumors

Intervention / Treatment
-----------------
* Drug: NMS-1116354


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available Maximum of 4 regimens of prior cancer therapy allowed Prior radiotherapy allowed if no more than 25% of BM reserve irradiated Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy ECOG performance status (PS) 0 or 1 Adult (age >/= 18 and </= 80 years) patients Adequate renal, liver and BM reserve Capability to swallow capsules intact Exclusion Criteria: Current enrollment in another therapeutic clinical trial Known brain metastases Currently active second malignancy Major surgery within 4 weeks prior to treatment Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis Pregnancy or breast-feeding women Known active infections Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption Adrenal insufficiency Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: 1<br> | Drug: NMS-1116354<br>* Oral daily administration for 14 consecutive days followed by 7 days of rest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD) |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½) |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I study, Advanced/Metastatic Solid Tumors, Cdc7 kinase inhibitor