linjc16/ctgov huggingface dataset:
Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine whether there is a correlation between the microcirculation measured preoperatively in patients undergoing major vascular surgery and the postoperative mortality during hospitalization period. The microcirculation will be measured sublingually with the Cytocam-IDF imaging technique.

Official Title
-----------------
Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery: a Prospective Cohort Study

Conditions
-----------------
Surgery--Complications

Intervention / Treatment
-----------------
* Other: Cytocam-IDF imaging device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Males and females ASA III classification Written informed consent obtained by the patient Elective hospital admission for major vascular surgery, both open and endovascular Exclusion Criteria: Emergency surgery Minor vascular procedures (e.g. varicose vein stripping; thromboembolectomy; vascular access formation) Pregnancy Refusal or inability to provide written informed consent (language barrier, mental retardation)

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will be split into two groups after data collection. They will receive the same treatment during the clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cytocam-IDF Imaging<br>All patients will undergo the same interventional test. | Other: Cytocam-IDF imaging device<br>* Observation of the microcirculation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative high-sensitive troponin T (hsTnT) | Indicator of acute coronary syndrome | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause of death | Causes of death | 30 days | 
| Non-cardiovascular adverse events and serious adverse events | Incidence of non-cardiovascular complications | 30 days | 
| Cardiovascular adverse events and serious adverse events | Incidence of cardiovascular complications | 30 days | 
| Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period. | In addition, demographic parameters (age, weight, height) and comorbidities will be taken into account. | 30 |
A Social Network AOD Intervention for Homeless Youth Transitioning to Housing

Study Overview
=================
Brief Summary
-----------------
This project will pilot test a computer-assisted social network intervention, using motivational interviewing techniques, that can help case managers work with formerly homeless young adults who recently transitioned to supportive housing to reduce substance use and increase permanent supportive connections during this critical transitional period.

Official Title
-----------------
A Social Network AOD Intervention for Homeless Youth Transitioning to Housing

Conditions
-----------------
Substance Use

Intervention / Treatment
-----------------
* Behavioral: Motivational Network Intervention
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-25 In a housing program for homeless transition age youth Past month substance use Screen positive for past-year harmful substance use Exclusion Criteria: • Not able to speak/understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management. | Behavioral: Motivational Network Intervention<br>* See earlier description<br>|
| Active Comparator: Usual Care<br>As part of residency, participants receive regular case management meetings. | Other: Usual Care<br>* See earlier description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days drug used |  | 30 days | 
| Proportion of supportive vs. risky network members |  | 4 weeks | 
| Number of drinks consumed on drinking days |  | 30 days | 
| Number of drinking days |  | 30 days | 
| Number of days consumed 5 (for men) or 4 (for women) drinks on a single occasion | heavy drinking | 30 days |
Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Study Overview
=================
Brief Summary
-----------------
In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.

Official Title
-----------------
Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Conditions
-----------------
Stage I-III Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥ 18 years-old at the time of consent to participate this trial Patients with stage I-III invasive breast cancer No prior anti-cancer treatment Felt to be a possible candidate for neoadjuvant therapy by their physician Exclusion Criteria: Known to have other aggressive malignant tumor in the past 5 years. Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators. There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. The investigator determines that subjects are not appropriate to participate in the study due to other factors.

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 receiving neoadjuvant therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miller-Payne grading system |  | 3 years | 
| Residual cancer burden (RCB) |  | 3 years |
The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels

Study Overview
=================
Brief Summary
-----------------
High levels of mannose-binding lectin (MBL), an activator of a part of the immune system called the complement system, have been associated with increased mortality and risk of early signs of kidney damage in patients with type 2 diabetes. The effect of weight loss and changes in insulin resistance on MBL levels have been poorly elucidated. This study includes 36 nondiabetic obese subjects, who will receive a very low- calorie diet (VLCD) of 800 kcal/day for 8 weeks. Fasting blood samples will be obtained at baseline and after 8 weeks of VLCD and concentrations of MBL, glucose and insulin will be measured. Insulin resistance is assessed using the HOMA-IR method.

Official Title
-----------------
The Effect of Weight Loss on Serum Mannose-Binding Lectin (MBL) Levels

Conditions
-----------------
Obesity, Weight Loss

Intervention / Treatment
-----------------
* Other: Weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese Exclusion Criteria: Diabetes Other severe disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Weight loss|Very low-calorie diet (VLCD) of 800 kcal/day for 8 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Weight loss, Very low-calorie diet, Mannose-binding lectin, Insulin resistance
Method for Improved Intraoperative Blood Loss Estimates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a mathematical algorithm which the investigators plan to use to more accurately estimate intraoperative blood loss.

Official Title
-----------------
Method for Improved Intraoperative Blood Loss Estimates

Conditions
-----------------
Improved Intraoperative Blood Loss Estimates

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All elective surgical patients Exclusion Criteria: Age < 18 Pregnant women Prisoners Lack of informed consent Attending Physician feels enrollment could interfere with optimal patient care Patients who did not have a preoperative hemoglobin measured as part of their preoperative work-up Patients whose preoperative hemoglobin fraction is abnormal. Patients who will likely require an intraoperative blood transfusion. Patients for whom the intraoperative use of the Cell Saver is anticipated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Minimal blood loss patients<br> | |
| Moderate to heavy blood loss patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of intraoperative blood loss |  | duration of surgery |
Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

Study Overview
=================
Brief Summary
-----------------
Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.

Official Title
-----------------
A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Inhaled insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Currently treated and on a stable doses of drugs for the preceding two (2) months Exclusion Criteria: Type 1 Diabetes Smoking

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inhaled insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose. Other secondary efficacy |  |  | 
| endpoints include, body weight, patient reported outcomes, incidence and severity |  |  | 
| of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to |  |  | 
| insufficient clinical response. |  |  |
Placenta Development Study

Study Overview
=================
Brief Summary
-----------------
This study will help us learn more about how the placenta develops.

Detailed Description
-----------------
The primary purpose of this study is to understand the epigenetic signaling events in placental trophoblast development.

Official Title
-----------------
Epigenetic Mechanisms Underlying Trophoblast Syncytialization

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI - 18-25 kg/m2 at least 18 years of age singleton pregnancy less than 36 weeks and plan to deliver in the Little Rock/North Little Rock Area Exclusion Criteria: Women with pre-existing medical conditions (e.g. diabetes, hypertension, pre-eclampsia, STD, gestational diabetes) Women who are using recreational drugs, tobacco, or alcohol during their pregnancy. Women who plan on keeping their placenta following delivery for non-medical reasons.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BMI 18-25 Pregnant Women<br>BMI 18-25 less than 36 weeks pregnant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that placental syncytial fusion involves epigenetic changes in histone modifications | Number of participants that histone acetyltransferases eszymes, CBP and p300 affect syncytial fusion | 40 weeks |
Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

Study Overview
=================
Brief Summary
-----------------
High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules

Official Title
-----------------
Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

Conditions
-----------------
Glioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children under 5 years old High grade glioma (WHO status III or IV) No previous treatment with chemotherapy or radiotherapy No contraindication to chemotherapy Consent of legal representative for participation in the study Exclusion Criteria: Low grade glioma Any other histological pattern Parent's denial to access data concerning their child in the frame of medical research

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient survival associated with relapse rate after surgery |  | 10 years | 
| Assessment of patient survival associated with relapse rate after chemotherapy |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma, Children, Chemotherapy, treatment toxicitT, Survival
Hereditary Hepatorenal Tyrosinemia Natural History in Egypt and the Arab World (Multicenter Clinical Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry/repository is to understand the natural history of tyrosinemia in our region and to provide a mechanism to store data and specimens to support the conduct of future research about hereditary tyrosinemia among the Arabs.

Detailed Description
-----------------
The purpose of this study is to create an electronic registry of phenotypic, laboratory information, treatment and outcomes options for tyrosinemia type I. The registry is longitudinal in nature including retrospective clinical data from birth to the most recent encounter with all data entered in chronological fashion. The goals of this registry are the better understanding of the natural history and treatment outcomes of these patients and to determine/evaluate biochemical and clinical parameters for monitoring and prognosis of tyrosinemia type I.

Official Title
-----------------
Hereditary Hepatorenal Tyrosinemia Natural History (Multicenter Clinical Study): Registry for Patients With Tyrosinemia Type I in Egypt and the Arab World

Conditions
-----------------
Hereditary Tyrosinemia, Type I

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biochemical or molecular diagnosis of Tyrosinemia Type I. Examined/followed by one of the participating sites. Parental/guardian permission (informed consent) for participation. Exclusion Criteria: Diagnosis of tyrosinemia has been excluded. Not examined/followed by one of the participating sites. Unwilling to provide informed consent for participation.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Create a registry for tyrosinemia type I. | This outcome is a binary 'yes/no' outcome as to whether or not this study can successfully create a repository with the intent to store data and specimens to support the conduct of future research on tyrosinemia type I. | 5 Years |
Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement

Study Overview
=================
Brief Summary
-----------------
Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained when using of the titanium mesh to close the lateral window of the maxillary sinus as a new option for tenting compared to collagen membrane.

Detailed Description
-----------------
this study is aimed to review the bone height, quality and closure of lateral osteotomy used for maxillary sinus floor lifting comparing titanium mesh to collagen membrane.

Official Title
-----------------
Titanium Mesh Versus Collagen Membrane for Closure of Lateral Window Approach in Maxillary Sinus Floor Elevation With Simultaneous Implant Placement. Randomized Controlled Clinical Trial

Conditions
-----------------
Edentulous; Alveolar Process, Atrophy

Intervention / Treatment
-----------------
* Procedure: titanium mesh
* Procedure: collagen membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site Exclusion Criteria: Sinus pathology. Heavy smokers more than 20 cigarettes per day Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: collagen membrane group<br>Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with collagen membrane | Procedure: collagen membrane<br>* closing the lateral window for maxillary sinus floor elevaion with collagen membrane<br>|
| Experimental: titanium mesh group<br>Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with titanium mesh | Procedure: titanium mesh<br>* closing the lateral window for maxillary sinus floor elevation with titanium mesh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone height | Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane . | 6 months |