linjc16/ctgov huggingface dataset:
Prospective Study of Minimally Invasive Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.

Official Title
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Prospective Study of Minimally Invasive Spinal Fusion Surgery for the Treatment of Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis

Conditions
-----------------
Degenerative Disk Disease, Spondylolisthesis, Spinal Stenosis, Degenerative Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Patient age 21 - 90 years. Diagnosis of Spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude). A spinal fusion is being undertaken via the minimally invasive approach. The patient agrees to follow-up for routine care for at least 2 years post-operatively. Exclusion Criteria: Inability for post-operative follow-up

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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MIS, Minimally Invasive Spine Surgery, Fusion, Spine, SMISS
Dynamic Area Telethermometry (DAT) as an Imaging Modality in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether this new method of taking pictures called Dynamic Area Telethermometry (DAT) might be a good way of looking at patients with cancer that is relatively close to the surface of the body.

Detailed Description
-----------------
The DAT system resembles a video camera which picks up changes in body temperature which may reflect disease-related changes in blood flow to some areas, particularly those involved with tumors. Patients with known tumor sites amendable to DAT evaluation will be imaged at the time of staging and at later time points. Thermal profiles will be compared to those of normal adjacent tissues and correlated with the images of the tumors on conventional images.

Official Title
-----------------
Dynamic Area Telethermometry (DAT) as an Auxiliary Imaging Modality in Assessment of Patients With Cancer

Conditions
-----------------
Malignant Tumors, Subcutaneous Tumors, Lymph Node Tumors

Intervention / Treatment
-----------------
* Procedure: Dynamic Area Telethermometry (DAT)


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Histologically confirmed malignancy Primary or secondary tumor location amendable to DAT scanning: subcutaneous tissues Older than 15 years of age Able to withhold movement for 20 seconds, hold breath for 20 seconds for chest wall lesions and clinically stable acutely Exclusion Criteria: Uncontrolled motion Tumors not verified or measurable by standard imaging

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Dynamic Area Telethermometry (DAT)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of DAT in tumors detected by conventional imaging and evaluation of therapy induced changes in DAT imaging profile over time. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DAT, imaging modality
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Official Title
-----------------
A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Conditions
-----------------
Warm Antibody Autoimmune Hemolytic Anemia

Intervention / Treatment
-----------------
* Drug: Fostamatinib 150 mg bid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have had a diagnosis of primary or secondary warm antibody AIHA. - Must have failed at least 1 prior treatment regimen for AIHA. Exclusion Criteria: Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria. Subject with a platelet count of < 30,000/μL. Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy. Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fostamatinib 150 mg<br>Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks | Drug: Fostamatinib 150 mg bid<br>* Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.<br>* Other names: Tavalisse;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin response | Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin | by Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Warm antibody autoimmune hemolytic anemia (AIHA)
Incidence Of Hepatitis In Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The aim is to investigate incidence of HBsAg, anti-HCV in serum samples and evaluation of biomarkers taken from patients who were followed the intensive care unit of Sakarya University Training and Research Hospital and The intensive care unit attracts attention by making health workers more susceptible to the risk of hepatitis.

Detailed Description
-----------------
This retrospective study included 536 cases who were followed with various diagnoses in intensive care units between 1 Ocak 2015 ile 1 Ocak 2016, covering the six months period, retrospectively. Sakarya University's Faculty of Medicine Review Board (71522473/050.01.04/113) approved the study after approval of the research ethics committee (. Medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, HBsAg, anti-HCV, AST, ALT, bilirubin, creatinine levels.

Official Title
-----------------
Incidence Of Hepatitis And Its Effect On Prognosis In Patients Who Follow In Intensive Care Unit

Conditions
-----------------
Intensive Care Unit

Intervention / Treatment
-----------------
* Other: hepatitis viruses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were followed in the intensive care unit Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: hepatitis viruses|There are 5 main hepatitis viruses, referred to as types A, B, C, D and E. These 5 types are of greatest concern because of the burden of illness and death they cause and the potential for outbreaks and epidemic spread. In particular, types B and C lead to chronic disease in hundreds of millions of people and, together, are the most common cause of liver cirrhosis and cancer.The aim is to investigate incidence of HBsAg, anti-HCV in serum samples and evaluation of biomarkers taken from patients who were followed the intensive care unit of Sakarya University Training and Research Hospital.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAg | HBsAg is the serologic hallmark of HBV infection and is the first marker to appear after acute infection. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-HCV | Anti-HCV antibody tests look for antibodies to HCV in the blood, indicating an HCV infection has occurred. | 1mounth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBsAg, Anti-HCV,, seropositivity
A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

Study Overview
=================
Brief Summary
-----------------
Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and neck) and negatively impacts survival and other outcomes, but many patients have difficulty quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far have had limited success. This is a pilot randomized controlled trial designed to determine if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates for cancer patients who smoke.

Official Title
-----------------
Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers

Conditions
-----------------
Tobacco Use Disorder, Head and Neck Neoplasms, Thoracic Neoplasms, Radiation

Intervention / Treatment
-----------------
* Other: Comprehensive smoking cessation intervention
* Behavioral: Enhanced usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosis of head and neck or thoracic (including lung) cancer Undergoing radiation at Johns Hopkins Radiation Oncology for 5 or more weeks English-speaking and able to provide informed consent Smoked any cigarettes in previous 14 days Exclusion Criteria: Palliative radiation Undergoing stereotactic radiosurgery Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 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: Comprehensive intervention<br>New evidence-based comprehensive smoking cessation intervention including several elements that have proven successful in non-cancer patients but not used for cancer patients before. | Other: Comprehensive smoking cessation intervention<br> <br> |
| Active Comparator: Enhanced usual care<br>Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment. | Behavioral: Enhanced usual care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation | Smoking cessation will be defined as BOTH (1) self-reported 7-day abstinence from smoking and (2) exhaled carbon monoxide level of 8 or lower as biochemical confirmation of abstinence. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking cessation, Head and neck neoplasms, Lung neoplasms, Thoracic neoplasms, Radiation
Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring

Study Overview
=================
Brief Summary
-----------------
Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.

Detailed Description
-----------------
Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported such as bleeding, infection rate, cardiac complications, prolonged wound healing and patient discomfort. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring. Measurements are performed with the SpotOn® sensor by Arizant Healthcare, Inc..

Official Title
-----------------
Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement

Conditions
-----------------
Hypothermia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery in gynecology or trauma surgery planned surgery time > 60 min patients older than 16 years Exclusion Criteria: emergency surgery need for post-surgery ventilation patient's denial to take part in the study

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- | --- |
| body core temperature (°C) |  | body core temperature taken at 15 min after induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body core temperature (°C) |  | body core temperature taken at 45 min after induction of anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perioperative hypothermia, zero heat flux, non-invasive measurement of body core temperature
Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the ability of a multidisciplinary group, the Evolutionary Tumor Board (ETB), to develop therapeutic strategies in patients without curative options.

Official Title
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Feasibility of Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board in Cancer Patients

Conditions
-----------------
Incurable Disease

Intervention / Treatment
-----------------
* Other: Evolutionary Tumor Board (ETB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be considered likely incurable given a standard of care. This is inclusive of participants in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but not curative options for care. Participant must have a life expectancy greater than 3 months Participant must have an ECOG performance status 0-2 Participant and primary Oncologist are willing to consider the therapeutic strategies recommended by the ETB Willingness to be followed over time and allowing collection of clinical data including scans and serial blood sampling. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Reviewed by ETB<br>Participants clinical history, available therapeutic options, and outcome expectations will be presented to the Evolutionary Tumor Board (ETB) along with images and pathology. Strategies and models will be presented regarding additional evolutionary ideas that can be applied. | Other: Evolutionary Tumor Board (ETB)<br>* The ETB consists of evolutionary biologists, mathematicians, research scientists, statisticians,data scientists, radiologists, pathologists, oncologists (surgical, radiation, medical, and pediatric), and clinical trial coordinators.The ETB will generate hypotheses, mathematical models, and experiments from the discussion towards further integration of evolutionary ideas towards therapeutic strategies for participants. The ETB will collect data through a chart review regarding adherence and results of ETB recommendation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETB developing therapeutic strategies | The investigators want to demonstrate the ability of a multidisciplinary group, the ETB, to develop therapeutic strategies in participants without curative options. They plan to enroll 35 patients to this study over 3 years. The primary objective will be successfully met if they can develop an evolutionary based plan that differs from the participants options prior to presentation for at least 80%, or 28 of these participants. | Baseline to up to 60 months from end of therapy |
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).

Study Overview
=================
Brief Summary
-----------------
In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?

Official Title
-----------------
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).

Conditions
-----------------
Clinical Performance

Intervention / Treatment
-----------------
* Procedure: endocrown


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with good oral hygiene Patients having one or more endodontically treated molars that need prosthetic restoration. Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival Fully erupted molars Molars free of developmental defect Healthy periodontium Absence of periapical pathosis Acceptable endodontic treatment and proper bone support Exclusion Criteria: Patients with bad oral hygiene Patients with active periodontal disease Patients with missing teeth opposing to the area intended for restoration Patients with parafunctional habits or psychiatric problems or unrealistic expectation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lithium disilicate<br>The intervention will be: Prosthetic endocrown | Procedure: endocrown<br>* endocrown<br>|
| Active Comparator: Fiber reinforced composite<br>The intervention will be: Prosthetic endocrown | Procedure: endocrown<br>* endocrown<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical performance | Using the modified United States Public Health Service criteria (Modified USPHS)- categorical | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lithium dislocate, fiber reinforced composite