linjc16/ctgov huggingface dataset:
Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients

Detailed Description
-----------------
The investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ASCVD risk score

Official Title
-----------------
Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Simvastatin 40mg
* Drug: Fenofibrate 200mg
* Drug: Omega 3 fatty acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2diabetes Non proliferative diabetic retinopathy Exclusion Criteria: Uncontrolled glycemic level proliferative diabetic retinopathy
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 |
| --- | --- |
| Active Comparator: Receive oral hypoglycemic +omega 3<br>Eicosapentanoic acid + standard treatment | Drug: Omega 3 fatty acid<br>* Drugs that lower lipid levels<br>* Other names: n3 FA;|
| Active Comparator: Receive oral hypoglycemic +statin<br>Simvastatin + standard treatment | Drug: Simvastatin 40mg<br>* Drugs that lower lipid level<br>* Other names: Statin;|
| Active Comparator: Receive oral hypoglycemic +fibrate<br>Fenofibrate +standard treatment | Drug: Fenofibrate 200mg<br>* Drugs that lower lipid levels<br>* Other names: Fibrate;|
| No Intervention: Receive oral hypoglycemic only<br>Standard treatment only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 80 participants will be evaluated through reduction of macular edema | assessed by ocular coherence tomography | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 80 participants will be evaluated through reduction of cardiovascular risk | assessed by ASCVD risk score | 18 weeks |
Impact on Quality of Life 3 Years After Diagnosis of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To study the quality of life of patients with prostate cancer at a distance from their care at a time when they are supposed to have taken a normal life and compared to subjects without cancer prostate of the same age.

Official Title
-----------------
Impact on Quality of Life 3 Years After Diagnosis of Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms, Quality of Life

Intervention / Treatment
-----------------
* Procedure: therapeutic management of the prostate Cancer as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
- exposed group Inclusion Criteria: prostate cancer diagnosed from 1 December 2011 to 31 December 2014 under 75 and residing in the Hérault department at diagnosis recruited in the EPICAP study Exclusion criteria: having relapsed in the range non-exposed group: Inclusion Criteria: controls (without prostate cancer) recruited in the EPICAP study matched to cases on age (5 years) residing in the Hérault department Exclusion criteria: diagnosis of prostate cancer set in the range

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate Cancer<br>Group drawn of the case group of the case control study, entitled EPICAP | Procedure: therapeutic management of the prostate Cancer as usual<br> <br> |
| No Prostate Cancer<br>Group drawn of the control group of the case control study, entitled EPICAP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC Quality of Life Questionnaire - Core 30 Score (EORTC QLQ-C30 Score) |  | 3 years from diagnosis for cases of prostate cancer and from recruitment for controls |
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under fasting conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Balsalazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two Period, 7 day washout |
Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

Study Overview
=================
Brief Summary
-----------------
A group of engineers at Michigan State developed a novel waveform analysis technique (Long Time Interval Analysis [LTIA]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.

Official Title
-----------------
Comparison of Retia Medical (Long Time Interval Analysis) to Deltex Esophageal Doppler for Cardiac Output Measurement

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: Retia Medical Long Time Interval Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18 years or older) Undergoing hepatobiliary surgery (open or laparoscopic) requiring general anesthesia as part of the patient's clinical care Attending anesthesiologist plans to place an intra-arterial catheter for routine care Attending anesthesiologist believes that non-invasive cardiac output monitoring would benefit the patient Exclusion Criteria: Minors (17 years or younger) Parturient (pregnant women) Cognitively impaired Unable to sign informed consent form Prisoner Prior esophageal surgery Moderate to severe aortic regurgitation Mechanical cardiac support (e.g., intra-aortic balloon pump) Severe, persistent arrhythmias

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LTIA Group<br>Patients in the LTIA Group (all patients) will have blood pressure recorded continuously. LTIA will be used to measure stroke volume and cardiac output after the completion of data collection | Device: Retia Medical Long Time Interval Analysis<br>* Retia Medical Long Time Interval Analysis will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearson Correlation Coefficient | Correlation between change in CO from LTIA vs. change in CO from esophageal Doppler | Data collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolled |
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

Study Overview
=================
Brief Summary
-----------------
To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Official Title
-----------------
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Drug: Premarin/MPA 0.45 mg/1.5 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, postmenopausal women, aged 35 to 70 years Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55 BMI in the range of 18 to 35 kg/m2 Exclusion Criteria: History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic) History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs) Use of prescription or investigatioanl drugs within 30 days before test article administration

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Premarin/MPA 0.45 mg/1.5 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components) |  |  |
Plasma Rich in Growth Factors in Post-extraction Sockets

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical success, radiographical volume maintenance and histological bone regeneration after using either a bovine bone xenograft or an autogenous platelet rich plasma enrich in growth factors, known as Endoret®-PRGF®.

Official Title
-----------------
Clinical Behavior and Molecular Pathways of PRGF in Post-extraction Sockets

Conditions
-----------------
Tooth Extraction, Dental Implants

Intervention / Treatment
-----------------
* Device: PRGF
* Device: ABB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper or lower premolar or molar tooth in need of extraction and later restoration by dental implant. Adjacent and opposing natural teeth present and healthy. At least 3 mm from the tip of the dental root to the maxillary sinus or the inferior alveolar canal. Exclusion Criteria: Active local infection. Uncontrolled diabetes mellitus. Long term (>10 years) use of oral bisphosphonates. Use of intravenous bisphosphonates. Recent use (<3 months) of antibiotics, antiinflammatories or analgesics drugs. Pregnancy. Smokers of more than 10 cigarettes per day. Any oral pathology that needs to be treated before tooth extraction, particularly the presence of more than 25% of sites with bleeding on probing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRGF<br>Post-extraction socket grafted with PRGF-Endoret | Device: PRGF<br>* After tooth extraction, the socket will be grafted with PRGF-Endoret<br>* Other names: PRGF-Endoret;|
| Active Comparator: ABB<br>Post-extraction socket grafted with anorganic bovine bone (ABB) | Device: ABB<br>* After tooth extraction, the socket will be grafted with Geistlich Bio-Oss® Collagen<br>* Other names: Geistlich Bio-Oss® Collagen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar bone change in Cone Beam Computerized Tomography | Volumetric change in the alveolar bone from immediately after tooth extraction to immediately before implant placement (4 months after the extraction and grafting of the socket) | Baseline and 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tooth extraction, Socket regeneration, Dental Implants
Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair

Study Overview
=================
Brief Summary
-----------------
The induction of anaesthesia is one of the most critical situations for high-risk-patients undergoing interventions surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase. This retrospective cohort study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of catecholamines during the induction and the interventional procedure in patients undergoing interventional mitral valve repair.

Official Title
-----------------
Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair

Conditions
-----------------
Blood Pressure, Hypotension Drug-Induced

Intervention / Treatment
-----------------
* Drug: Etomidate
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective interventional mitral valve repair Sevoflurane or etomidate have been used for induction of anesthesia Exclusion Criteria: Pregnancy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Etomidate group<br>Patients who received etomidate for induction of anaesthesia during interventional mitral valve repair (Mitraclip) | Drug: Etomidate<br>* Use of etomidate<br>|
| Sevoflurane group<br>Patients who received sevoflurane for induction of anaesthesia during interventional mitral valve repair (Mitraclip) | Drug: Sevoflurane<br>* Use of sevoflurane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-induction hypotension | Hypotension in the first 20 minutes after induction of anesthesia | First 20 minutes after induction of anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of catecholamines after induction during the first 20 minutes after inductionafter induction | Use of catecholamines during the first 20 minutes after induction of anaesthesia | First 20 minutes after induction | 
| Use of catecholamines | Use of catecholamines during the procedure | Length of procedure (Approximately 60 to 90 minutes in average) |
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.

Official Title
-----------------
Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study

Conditions
-----------------
Sensorineural Hearing Loss, Bilateral

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects, 18 years or older Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations. Subjects who have been implanted between January 2016 and December 2021. Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types. Subjects who are fluent in French (language used in the questionnaire and speech tests) Subjects who are not opposed to participating in the study Subjects for who the medical record data is available throughout the defined data search period. Exclusion Criteria: Subjects with single-sided deafness (SSD). Subjects who are not affiliated to the French Social Security. Subjects who are under legal protection.

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 |
| --- | --- | --- |
| Score of the French MBAA2 sentence recognition test in quiet | Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of <90/100 correct sentence. | 1 month post activation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cochlear implant, Sentence recognition, Cognitive processing, Electrophysiology
A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women

Study Overview
=================
Brief Summary
-----------------
The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women

Official Title
-----------------
A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration, Pharmacology And Pharmacokinetics, Of Multiple Doses Of PF-02413873 In Healthy Female Subjects.

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: PF-02413873 100 mg QD
* Drug: PF-02413873 1500 mg QD
* Drug: PF-02413873 20 mg QD
* Drug: PF-02413873 500 mg QD
* Drug: PF-02413873 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women of childbearing potential with a regular menstrual cycle Exclusion Criteria: Evidence or history of any major disease Pregnant or nursing women Requirement for chronic medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-02413873<br>PF-2413873 active treatment | Drug: PF-02413873 100 mg QD<br>* 100 mg of PF-02413873 oral suspension once daily for 14 days<br>Drug: PF-02413873 1500 mg QD<br>* 1500 mg of PF-02413873 oral suspension once daily for 14 days<br>Drug: PF-02413873 20 mg QD<br>* 20 mg of PF-02413873 oral suspension once daily for 14 days<br>Drug: PF-02413873 500 mg QD<br>* 500 mg of PF-02413873 oral suspension once daily for 14 days<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: PF-02413873 Placebo<br>* PF-0241383 Placebo once daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests. |  | 1 month | 
| PF-02413873 pharmacokinetics |  | 1 month | 
| Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion. |  | 14 days |