linjc16/ctgov huggingface dataset:
Decompensation Detection Study

Study Overview
=================
Brief Summary
-----------------
To gather data and analyze decompensation events.

Official Title
-----------------
Decompensation Detection Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients implanted with an approved Guidant CRT-D HF device programmed to CRT therapy in VDD or DDD mode. Patients prescribed to the LATITUDE(R) system configured for at least weekly device interrogations and symptoms reporting. Patients willing to use the LATITUDE(R) enabled weight scale. Exclusion Criteria: Patients that require adaptive rate pacing (rate-responsive modes). Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days. Both

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 |
| --- | --- |
| 1<br>Algorithm Test Set | |
| 2<br>Algorithm Development Set | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection and analysis. |  | End of patient follow up. |
Caretaker vs. Routine Blood Pressure Sphygmomanometer

Study Overview
=================
Brief Summary
-----------------
Caretaker vs. routine blood pressure sphygmomanometer

Detailed Description
-----------------
The aim of this study is to: Compare blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Official Title
-----------------
Caretaker vs. Routine Blood Pressure Sphygmomanometer

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: Caretaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ages > 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer. Exclusion Criteria: Patients not scheduled to be monitored using blood pressure sphygmomanometer.

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 |
| --- | --- |
| Caretaker<br>Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker). | Device: Caretaker<br>* Application of Caretaker device to subjects that are scheduled for elective surgeries.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing blood pressure using routine blood pressure cuff to that recorded by the Caretaker device. | As per blood pressure monitor validation guidelines, the primary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and the reference (brachial cuff). In line with the ANSI/ISO/AAMI guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (every 5 minutes during the surgical case) and will average the difference over all pairs from all subjects. | Length of surgery |
Arterial Remodeling in Smokers

Study Overview
=================
Brief Summary
-----------------
Cigarette smoking is the most important modifiable cardiovascular risk factor leading to endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the study was to investigate the effect of smoking on vascular response to transradial coronary angiography (TCA).

Official Title
-----------------
Response-to-injury in Patients Undergoing Transradial Coronary Angiography: Arterial Remodeling in Smokers

Conditions
-----------------
FMD, IMT, Smoking

Intervention / Treatment
-----------------
* Procedure: smoke expose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all subjects underwent a TCA Exclusion Criteria: acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) CRP > 1 mg/dl malignant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Current Smoker underwent TCA<br>subjects who smokes daily | Procedure: smoke expose<br> <br> |
| Former Smokers underwent TCA<br>subjects who do not smoke since 7 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMT hyperplasia | IMT is measured by high resolution ultrasound in the radial arteries. | change in radials IMT after 6-14 month after a TCA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow mediated dilatation (FMD) | change in flow mediated dilatation after 10-14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TCA, FMD, IMT, Smoking
Use of PRP in Endometrial Reconstruction

Study Overview
=================
Brief Summary
-----------------
Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes; some causes result from issues related to the endometrium. Unfortunately, no cure exists for medical conditions resulting in the destruction of the endometrium, or for non-functional uterus. Thus, safe and effective therapies are needed to treat these diseases and to establish fertility in affected women. These novel techniques refer to the use and application of regenerative/paracrine factors to regenerate the endometrium in patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP) from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution and/or effect in the endometrial repair by functional proofs.

Detailed Description
-----------------
The objective is to know the effect of these regenerative factors obtained from Platelet-Rich Plasma in an immunodeficient murine model with AS/EA Blood from patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA) will be collected, maintained under anticoagulant solution and after several centrifugations PRP will be obtained. Demonstration of a functional endometrium will be proved determining pregnancy and implantation rates as well as the number of live pups/pregnant female in our mice model. Also, the uterus histology will be analysed in treated and untreated mice

Official Title
-----------------
Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models

Conditions
-----------------
Asherman Syndrome, Endometrial Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy. No pregnancy after hormonal treatment. Exclusion Criteria: Psychiatric diseases.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| Endometrial thickness after reconstruction in murine model | Using histological and functional technologies demonstration of regeneration ability of PRP | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet-Rich Plasma, Cell therapy, Regenerative factors, Autologous treatment, Paracrine factors
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs. tacrolimus treated LTR, thus providing the rationale for a subsequent clinical trial to utilize EPO in combination with everolimus as a more successful pathway toward tolerance.

Official Title
-----------------
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Conditions
-----------------
Liver Transplant Rejection

Intervention / Treatment
-----------------
* Drug: Erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age 18-74 years History of liver transplantation > 2 years prior for non-immune causes Use of immunosuppressive monotherapy (either tacrolimus or everolimus) for treatment of liver transplantation Stable immunosuppression regimen at least 3 months prior to enrollment. Ability to provide verbal and written informed consent Exclusion Criteria: • Hgb above average normal value (15.7 g/dL in men, 13.8 g/dL in women); ALT > 2 times upper limit of normal; uncontrolled hypertension with SBP>160 or DBP>100; end-stage renal disease on hemodialysis; history of venous thromboembolism including deep vein thromboses or pulmonary emboli, stroke, heart failure, seizure disorder, significant cardiovascular disease including a history of myocardial infarction, pure red cell aplasia, intolerance or allergy to erythropoietin; Active malignancy (untreated or undergoing therapy); known hypersensitivity to mammalian cell-derived products; known hypersensitivity to human albumin; presence of vascular access; prior recipient of erythropoietin within 12 weeks of the study; and pregnancy Patient unable to provide consent including infants, children, teenagers, prisoners, cognitively impaired adults. Prisoners and other vulnerable populations will also be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EPO Arm<br> | Drug: Erythropoietin<br>* Erythropoietin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPO effects on Treg induction | We will use flow cytometry to analyze the phenotype of peripheral blood mononuclear cells (PBMC) collected before and 4 and 12 weeks after EPO administration. Data will be analyzed to extract changes in lymphocyte subset frequencies, including Tregs | 12 weeks |
Assessment of Caries Diagnosis and Caries Treatment in Dental PBRN Japan

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for diagnosis, treatment, and prevention of dental caries.

Detailed Description
-----------------
We conducted a cross-sectional study consisting of a questionnaire survey in Japan. We used the same questionnaire as used in the DPBRN Study, Assessment of Caries Diagnosis and Caries Treatment.

Official Title
-----------------
Assessment of Caries Diagnosis and Caries Treatment in Dental PBRN Japan

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study queried dentists working in outpatient dental practices who have affiliated with JDPBRN to investigate research questions and to share experiences and expertise (n = 282). Exclusion Criteria: Dentist who doesn't perform some measure of restorative dentistry at their practice.

Ages Eligible for Study
-----------------
Minimum Age: 24 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Indicate Surgical Intervention |  | Up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental caries,, Caries diagnosis,, Caries treatment,, Caries risk,, Practice pattern,, Clinical epidemiology,, Dental Practice-Based Research Network
Macular Thickness Measurements Using Retinal-thickness OCT

Study Overview
=================
Brief Summary
-----------------
Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a commercial OCT (Optical Coherence Tomography)

Official Title
-----------------
Macular Thickness Measurements Using RTOCT

Conditions
-----------------
Age-Related Macular Degeneration, Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability and agreement to give informed consent (IC) Diagnosis of AMD or DR in SE by OCT Ability to undergo OCT scans Exclusion Criteria: AMD and DR in the same SE Evidence of macular disease other than AMD or DME in SE

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 |
| --- | --- |
| Intermediate AMD<br> | |
| Advanced AMD<br> | |
| DR without macular edema<br> | |
| DR with macular edema<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between retinal measurements, done by the RTOCT device and a commercial OCT |  | 1 year |
Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy

Study Overview
=================
Brief Summary
-----------------
Some antiepileptic drugs are found to have hormonal side effects. We want to study possible hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a questionnaire and we will collect blood samples from them, to analyse hormones.

Detailed Description
-----------------
We have previously performed long-term studies of rats treated with levetiracetam and compared them with a control group. Here we have found that levetiracetam has a probable effect on the ovaries, since the treated animals had larger ovaries, fewer cysts, more corpora lutea and more secondary follicles than the untreated animals (Taubøll et al 2004). Blood tests on the animals showed that those treated with levetiracetam had higher testosterone levels and lower levels of estrogen and FSH, whilst LH and progesterone levels were unaffected by the treatment (Svalheim et al, 2005a, b). Studies on cell cultures from pig ovaries, as carried out by our group in collaboration with Jagiellonian University, Krakow, Poland, appeared to support these findings (Taubøll et al. 2006, submitted). Our wish therefore now is to study fertile men and women in order to look for any changes in the balance of sex hormones during use of levetiracetam in order to establish whether the findings in animal trials are clinically relevant to humans.

Official Title
-----------------
Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females.

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having epilepsy Age 18- 45 Using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months Exclusion Criteria: Hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease) Use of hormonal anticonception drugs or other hormonal drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors

Study Overview
=================
Brief Summary
-----------------
Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.

Official Title
-----------------
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors

Conditions
-----------------
Empagliflozin in Post AKI Stage 2-3

Intervention / Treatment
-----------------
* Drug: Empagliflozin 10 MG
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post AKI stage 2-3 CrCl > 20 Exclusion Criteria: pregnancy post kidney transplant previous use of SGLT2 Inhibitors history of ketoacidosis

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin<br> | Drug: Empagliflozin 10 MG<br>* SGLT2 inhibitors<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAKE365 | Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Empagliflozin, AKI
Buprenorphine Pharmacology Related to Addiction Treatment - 18

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the interactions between buprenorphine and naltrexone, and to assess how they may directly impact the clinical issues involving: transferring patients from buprenorphine to naltrexone, developing a non-abusable form of buprenorphine, and enhancing patient acceptability of naltrexone.

Official Title
-----------------
Buprenorphine Pharmacology Related to Addiction Treatment

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

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


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/naloxone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid agonist effects |  |  | 
| Opiate withdrawal |  |  | 
| Psychological changes in: pupil diameter, blood pressure, heart rate, respiration |  |  |
A Study of Gene Polymorphisms Associated With Specific Presentations of Sexual Addiction

Study Overview
=================
Brief Summary
-----------------
The study is intended to identify gene polymorphisms significantly associated with specific behavioral- and preoccupation-typologies of sexual addiction, and to identify additional potential genetic markers of sexual addiction. Research subjects with sexual addiction will be identified from the out-patient and in-patient populations of the investigative sites. Research subjects in the Control Group will be identified from the general population and from the student body of selected colleges. Approximately 1100 subjects will be enrolled in the study. Anticipating 10% drop-out, this is intended to generate a population of approximately 500 men and women clinically diagnosed with sexual addiction, and approximately 500 healthy men and women who do not meet diagnostic criteria for sexual addiction nor have psychopathology who will serve as the control population.

Official Title
-----------------
Genetic Markers in Sexual Addiction

Conditions
-----------------
Sexual Addiction

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sexual Addict Group Age >= 18 years Participating in sexual addiction treatment program Sexual Addiction Screening Test--Revised (SAST-R) score >= 11 Meets at least 3 diagnostic criteria for sexual addiction Control Group Age >= 18 years SAST-R score < 6 Exclusion Criteria: Sexual Addiction Group Serious mental illness Significant cognitive impairment Control Group History of addiction Current or previous Diagnostic and Statistical Manual (DSM-5) diagnosis Serious mental illness Significant cognitive impairment

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 |
| --- | --- |
| Addict Group<br>In-patient and out-patient adult men and women who meet diagnostic criteria for sexual addiction. | Other: No Intervention<br> <br> |
| Control Group<br>Individuals from the general community and college student populations who have no history of identifiable psychopathology. | Other: No Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene polymorphisms identified through polymerase chain reaction using fluorescent primers and restriction fragment length polymorphism analysis |  | Assessed at Enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexual Addiction, Genomics, Personality, Polymorphism