linjc16/ctgov huggingface dataset:
Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.

Detailed Description
-----------------
Patients are treated with: Antithymocyte globulin (Timoglobulin SangStat) 2,5 mg/kg/day IV over 8 hours on days 1-4 Total dose: 10 mg/kg Calculated dose adjusted to ideal weight Especial considerations: Paracetamol 1 gr (oral or IV) Dexclorfeniramine 5 mg IV Methylprednisolone 1 mg/kg IV 30 minutes before Timoglobulin and repeat if necessary at 4 hours - Platelet transfusion if platelet count is < 50 x 109/L Cyclosporine (Sandimmun Neoral) -2,5 mg/kg/12 h over 3 months

Official Title
-----------------
SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: Antithymocyte globulin
* Drug: Cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) (or high risk patient not eligible to intensive chemotherapy or for bone marrow transplantation), excluding chronic myelomonocytic leukemia At less one of two following conditions: Transfusion dependence: 1)Packed red blood cell transfusions greater than 2 times; 2)Untransfused hemoglobin level no greater than 10 g/dL; 3)Platelet transfusions greater than 1 time Infection grade III or IV secondary to neutropenia ECOG < or = 2 Exclusion Criteria: Chronic myelomonocytic leukemia Creatinine greater than 2 mg/dl Bilirubin greater than 2.5 mg/dl History of heart failure History of allergy to rabbit proteins
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: Antithymocyte globulin|nan|
|Drug: Cyclosporine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myelodysplastic Syndrome, Antithymocyte Globulin, Cyclosporine
MyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management

Study Overview
=================
Brief Summary
-----------------
In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback from clinicians

Official Title
-----------------
A Study of the Management of the Patient's Disease Based on the Life Log Data of Patients With Lifestyle-related Diseases Through a Wearable Device

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

Intervention / Treatment
-----------------
* Behavioral: Daily health-related lifestyle modification prescription


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study participants must agree to support by him/herself at enroll time Patients without severe cardiopulmonary disease, cancer, or other acute diseases Patients must be over BMI > 23 kg/m2 Exclusion Criteria: Patient who did not agree with this study Patients with severe cardiopulmonary disease, cancer, or other acute diseases Patients who were pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application user group<br>In the active group, participants were educated to modify their lifestyle to lose weight by using a smart phone-based lifestyle app which was designed to collect daily activity and dietary information. The app was composed of two main modules: a diet module, and a physical activity module. | Behavioral: Daily health-related lifestyle modification prescription<br>* Daily health-related lifestyle modification prescription<br>|
| No Intervention: Control group<br>Conventional lifestyle modification | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight change | weight measurement and calculate BMI(body mass index) | baseline and after 4weeks of lifestyle intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood test result change | Blood test and its several results value measurement | baseline and after 4weeks of lifestyle intervention | 
| Mobile-app usage change | Usage log of mobile application | baseline and after 4weeks of lifestyle intervention |
Safety and Tolerability Study of the Taris Placebo System

Study Overview
=================
Brief Summary
-----------------
The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.

Official Title
-----------------
Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)

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

Intervention / Treatment
-----------------
* Device: TARIS Placebo
* Procedure: Sham Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volunteers, 18 to 55 years of age Body weight >100 lbs and BMI (body mass index) within the range 18-30 kg/m2 A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF) Exclusion Criteria: Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy) History of kidney stone formation Chronic or recurring bacterial or viral infections of the urogenital system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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 |
| --- | --- |
| Experimental: TARIS Placebo<br> | Device: TARIS Placebo<br> <br> |
| Sham Comparator: Sham Procedure<br> | Procedure: Sham Procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject reported symptoms |  | 14 days | 
| Routine and microscopic urinalysis |  | 14 days | 
| Urine culture |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder, TARIS Placebo, Interstitial Cystitis, Normal Healthy Volunteers
Analysis of Plasma Tumor DNA in Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.

Official Title
-----------------
Analysis of Mechanism of Resistance to Chemotherapy by Sequencing of Plasma DNA

Conditions
-----------------
Non Small Cell Lung Cancer Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions) Patients must have given written informed consent Exclusion Criteria: Patients who refuse the blood samplings
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 |
| --- | --- | --- |
| Detection of genetic alterations (including EGFR and ALK) in plasma samples | To evaluate the sensitivity of digital PCR to detect the genetic alterations in plasma tumor DNA | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantifying circulating tumor DNA in serially collected plasma specimens | To evaluate the change of quantity of circulating tumor DNA with digital PCR | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, plasma DNA, free DNA, EGFR, ALK
Assessment of Routine Oral Screening Programs for New Prisoners

Study Overview
=================
Brief Summary
-----------------
In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Our study aims 1) to assess the prevalence and nosology of oral diseases ; 2) to describe the care pathway of participants during their stay in the detention center where they were included ; 3) to assess the cost of care per patient, from a societal perspective, using a top-down method.

Official Title
-----------------
Assessment of Routine Oral Screening Programs for New Prisoners in France

Conditions
-----------------
Oral Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: new prisoners fluent French language Exclusion criteria: adult guardianship

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 |
| --- | --- | --- |
| Description of the oral problems of people entering detention | Description of the oral problems of people entering detention : Any oral disease at inclusion (prevalence study) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attending to consultations | attending to consultations : The rate of attended visits is defined as the number of visits attended by the patient, divided by the number of scheduled visits, during the prison stay of the participant. | The collection of data will end at the discharge of the participant, or at 6 months after inclusion. |
Incorporating Flow Limitation Into the Diagnosis and Quantification of Sleep Disordered Breathing

Study Overview
=================
Brief Summary
-----------------
The diagnosis and treatment of sleep disordered breathing have come to the forefront of clinical medicine following recognition of the high prevalence and associated morbidity of sleep apnea. The effects on quality of life as well as societal costs have been well documented. The NYU Sleep Research Laboratory has spent the last several years working on the problem of improving the diagnosis of mild sleep disordered breathing which manifests as the upper airway resistance syndrome. Our approach has been to develop a non-invasive technique to detect increased upper airway resistance directly from analysis of the airflow signal. A characteristic intermittent change of the inspiratory flow contour, which is indicative of the occurrence of flow limitation, correlates well with increased airway resistance. Currently all respiratory events are identified manually and totaled. This is time consuming and subject to variability. The objective of the present project is to improve upon the manual approach by implementing an artificially intelligent system for the identification and quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary signals collected during a routine sleep study. The utility of other reported indices of sleep disordered breathing obtained during a sleep study will be evaluated. Successful development of an automated system that can identify and classify upper airway resistance events will simplify, standardize and improve the diagnosis of sleep disordered breathing, and greatly facilitate research and clinical work in this area. Using a physiological based determination of disease should allow better assessment of treatment responses in mild disease.

Conditions
-----------------
Sleep-Disordered Breathing

Intervention / Treatment
-----------------
* Procedure: Non-invasive technique to diagnose and quantitate sleep-disordered breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sleep disordered breathing

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Non-invasive technique to diagnose and quantitate sleep-disordered breathing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Contrast Enhanced EUS in the Evaluation of Pancreatic Cancer and Pancreatic Masses

Study Overview
=================
Brief Summary
-----------------
Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. All these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers.

Official Title
-----------------
Contrast Enhanced EUS Using Definity in the Evaluation of Pancreatic Cancer and Pancreatic Masses

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled. Age 21 years and above. Ability to provide informed consent Exclusion Criteria: Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are: Right-to-left, bi-directional, or transient right-to-left cardiac shunts; Worsening or clinically unstable congestive heart failure; Acute myocardial infarction or acute coronary syndromes; Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval; Respiratory failure; Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature; Hypersensitivity to DEFINITY™ or its components.

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

Study Overview
=================
Brief Summary
-----------------
This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico .

Detailed Description
-----------------
This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico in two different time periods (time period #1 is from January 1 2012-December 31 2012 and time period #2 is from May 1 2014-April 30 2015. Our exposure is a state in which a woman lives in (New Mexico or Texas). Our intervention is the change in Texan laws occurring from July 2013-January 2014.

Official Title
-----------------
Travelling for Rights

Conditions
-----------------
Pregnancy Termination

Intervention / Treatment
-----------------
* Other: Change in Texas Law


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women obtaining an induced abortion at one of the following clinics: University of New Mexico's Center for Reproductive Health (UNM CRH), Planned Parenthood - Albuquerque Surgical Center or Southwestern Women's Options. Women residing in Texas or New Mexico. -Women obtaining an induced abortion between January 1 2012- Exclusion Criteria: No chart available for data extraction Gestational age at time of abortion initiation ≥ 24 weeks gestation as determined by ultrasound imaging.
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Time Period 1<br>Women who obtained an abortion from January 1 2012-December 31 2012 | |
| Time Period 2<br>Women who obtained an abortion from May 1 2014-April 30 2015. | Other: Change in Texas Law<br>* The change in Texan laws occurring from July 2013-January 2014<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women from Texas travelling to NM, to obtain an abortion. | The primary objective of this study is to determine whether the proportion of Texan women obtaining an induced abortion in New Mexico increased between time period #1 and time period #2. | 2012-2015 |
Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the anesthetic considerations and outcomes during repeated caesarean section and to compare such considerations in low-order vs high-order repeated caesarean sections.

Detailed Description
-----------------
Data concerning anesthetic considerations and outcomes will be gathered from the electronic medical records of all parturients undergoing repeated caesarean sections in our medical center. the collected data will be stored anonymously. Different aspects of anesthetic considerations and outcomes will be compared and subjected to analysis.

Official Title
-----------------
Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study

Conditions
-----------------
Anesthesia, Pregnancy, High Risk, Pregnancy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parturients undergoing repeated caesarean section. Exclusion Criteria: -
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 |
| --- | --- |
| Parturients undergoing repeated caesarean sectiona<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of sections performed under general anesthesia |  | 1 day | 
| Percentage of in-surgery conversion from regional to general anesthesia |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caesarian Section, Repeated Caesarian Section, Anesthesia
Prognosis of Acute Kidney Injury:China Collaborative Study on AKI（CCS-AKI）Study

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) is a common clinical syndrome, especially in the hospital patients. AKI is recognized as an important risk factor for incident chronic kidney disease, accelerated progression to end-stage renal disease,and increased risk of short-term and long-term mortality.This study is to observe the prognosis of hospitalized patients with AKI in China.

Official Title
-----------------
Prognosis of Acute Kidney Injury:China Collaborative Study on AKI（CCS-AKI）Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed with acute kidney injury, according to KDIGO criteria Exclusion Criteria: Nephrectomy Kidney transplantation Peak serum creatinine of less than 53µ mol/L Serum creatinine decrease after amputation Patients died during hospitalization End-stage kidney disease(chronic kidney disease stage 5) malnutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AKI<br> | |
| non-AKI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated glomerular filtration rate decline | >50% baseline | 2 years | 
| Chronic kidney disease classification upgrade |  | 5 years | 
| New cardiovascular events |  | 5 years | 
| All-cause mortality |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI recovery |  | 5 years | 
| Rehospitalization |  | 5 years |