linjc16/ctgov huggingface dataset:
Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

Detailed Description
-----------------
This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life.

Official Title
-----------------
A Phase 3 Study to Demonstrate the Safety and Efficacy of Recombinant Platelet-Activating Factor Acetylhydrolase (rPAF-AH, Pafase®) for Reducing 28 Day All Cause Mortality in Patients With Severe Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: rPAF-AH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Clinical diagnosis of severe sepsis At least 18 years old Patient or legally authorized representative able to provide informed consent Exclusion criteria Severe lung injury (acute respiratory distress syndrome) Immunocompromised Severe liver disease Inflammation of the pancreas, organ rejection, or burns to more than 30% of body Enrolled in another clinical trial Already participated in this or other rPAF-AH study There is not a commitment to aggressive treatment Has a disease with life expectancy less than 6 months

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rPAF-AH|nan|

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
-----------------
Severe sepsis, Platelet-activating factor acetylhydrolase
Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.

Official Title
-----------------
A Relative Bioequivalence Study of 600 mg Gemfibrozil Tablets Under Fasting Conditions

Conditions
-----------------
Bioavailability

Intervention / Treatment
-----------------
* Drug: Gemfibrozil Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men or women 18 years of age or older weight within +/- 20% for height and body frame willing to participate and sign a copy of the informed consent form Exclusion Criteria: recent history of drug or alcohol addiction or abuse pregnant or lactating women history of allergic response to gemfibrozil use of tobacco products evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant receipt of any drugs as part of a research study within 28 days prior to study dosing

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Drug<br> | Drug: Gemfibrozil Tablets<br> <br> |
| Active Comparator: Reference Drug<br> | Drug: Gemfibrozil Tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioavailability, Gemfibrozil
Effect of Dexamethasone Implant on Optic Disc

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of dexamethasone implant which is an intraocular corticosteroid on the optic nerve fibers. Retinal nerve fiber thicknesses and optic nerve head pitting rates were measured before and 6 months after the injection.

Detailed Description
-----------------
Diabetic macular edema is the most frequent ocular complication of diabetes resulting in irreversible loss of vision if untreated. Dexamethasone implant implant is used to treat macular edema due to diabetes. It stay in the vitreous for 6 months after intravitreal administration. Dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both increasing intraocular pressure and its direct effect on neural tissue during the effective 6-month period.

Official Title
-----------------
The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy

Conditions
-----------------
Glaucoma and Ocular Hypertension, Diabetic Macular Edema, Intravenous Drug Usage, Optic Disk Disorders

Intervention / Treatment
-----------------
* Procedure: intravitreal dexamethasone implant application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients who underwent first time intravitreal injection Exclusion Criteria Previously received any surgery Proliferative diabetic retinopathy Glaucoma or glaucoma suspicion Optic disc fatigue Optic disc edema Uveitis and media opacity Blurred of image clarity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intravitreal dexamethasone implant application|Peripapillary RNFL thickness measurements and colored fundus photographs were compared before and 6 months after intravitreal DEX implant injection. The cup-to-disc ratios of fundus photographs were calculated using the Image-J program.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripapillary RNFL thickness measurements | micrometer | six month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic maculopathy, dexamethasone implant, optic disc, vascular endothelial growth factor
Reliability of BIS Monitoring in Neurosurgical Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.

Official Title
-----------------
Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients

Conditions
-----------------
Sovra and Intra Tentorial Lesions

Intervention / Treatment
-----------------
* Device: Bispectral Index (BIS Vista, Covidien)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BIS > 90 at baseline (awake) ASA I or II Exclusion Criteria: GSC < 15 anticipated difficult ventilation and/or intubation BMI > 30 surgical site that does not allow BIS monitoring bilateral hearing loss not speaking Italian Language

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Neurosurgical<br> | Device: Bispectral Index (BIS Vista, Covidien)<br>* BIS values at LOC, PI, ROC.<br>|
| Non-neurosurgical<br> | Device: Bispectral Index (BIS Vista, Covidien)<br>* BIS values at LOC, PI, ROC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS values at LOC, PI and ROC |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of intraoperative awareness | intraoperative awareness assessed by BRICE Interview | 0, 1, 3, 30 days after surgery | 
| incidence of postoperative delirium | assessed by Nursing Delirium Scale and CAM-ICU. | 0, 1, 3, 30 days after surgery | 
| predicted site effect drugs concentration at LOC, PI and ROC | Propofol and Remifentanil site effect concentrations delivered by TCI. | 8 months | 
| total amount of anesthetic drugs delivered at the end of surgery |  | 8 months | 
| recovery time after surgery | Time needed for the patients to completely regain orientation | 8 months |
The Therapy of Large Endometrioma

Study Overview
=================
Brief Summary
-----------------
Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve. Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve. In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy. This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above. The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone

Official Title
-----------------
Evaluate the Therapy of Large Ovarian Endometrioma

Conditions
-----------------
Endometrioma, Endometriosis Ovary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometrioma size ≥ 6cm determined by MRI or ultrasonography Women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis. Cyst single or bilateral Exclusion Criteria: Cyst with radiographic or macroscopic in laparoscopy atypia Pregnancy Patient with contraindication to GnRH agonist (Enantone® 3,75 mg et Decapeptyl® 3 mg) Patient with contraindication to laparoscopy Patient with contraindication to general anesthesia Subject refusing to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US) |  | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of the ovarian reserve postoperative | Compare the dosages of anti-mullerian hormone (AMH) preoperative and postoperative at 3 months | at 3 months | 
| The number of re-operation |  | at 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriomas measuring 6 cm or more, Ovarian Endometrioma, laparoscopic drainage, recurrence, AMH, GnRH agonist therapy
Metformin for the Treatment of Diabetes in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy.

Official Title
-----------------
Metformin for the Treatment of Diabetes in Pregnancy

Conditions
-----------------
Gestational Diabetes, Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women GDM A2 diabetes mellitus type 2 singleton pregnancy Exclusion Criteria: diabetic nephropathy or proliferative retinopathy cannot swallow tablets

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control |  |  | 
| pregnancy complications |  |  |
Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

Study Overview
=================
Brief Summary
-----------------
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.

Official Title
-----------------
Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

Conditions
-----------------
Prostate Cancer, Immune Profile, Circulating Cancer Cells, Clinical Corelation

Intervention / Treatment
-----------------
* Procedure: Prostate cryotherapy
* Procedure: Radical prostatectomy
* Procedure: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>20 years Histopathology-proven prostate adenocarcinoma Non-metastatic localized disease Subjects have chosen their curative, definitive treatments for prostate cancer prior to enrolling for the study Subjects are willing to sign the informed consent and agree to comply with the study procedures Exclusion Criteria: Chronic use (> 2 weeks) of > 10 mg/day of prednisone or prednisolone within 2 months of the screening (topical or inhalational corticosteroids are permitted) Concurrent use of immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry Other conditions the investigators think may affect subjects' compliance

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cryoablation<br>Subjects receiving cryotherapy for prostate cancer | Procedure: Prostate cryotherapy<br>* cryoablate the prostate<br>|
| Radical prostatectomy<br>Subjects receiving radical prostatectomy | Procedure: Radical prostatectomy<br>* Remove prostate<br>|
| Radiation<br>Subjects receiving radiation for prostate cancer | Procedure: Radiation<br>* Radiate prostate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer recurrence | Includes: Biochemical (PSA) recurrence according to the ASTRO or Phoenix criteria for patients undergoing cryotherapy (Cryo) or radiotherapy (RT) Prostate biopsy positivity Radiographic evidence of recurrence (CT/MRI, Bone scan, radiographs, etc.) Time to recurrence defined by the either of the above 3 outcome parameters | 3, 6, 12, 24 months after treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | according to the QLQ C30 and PR25 questionnaire interview | 3, 6, 12, 24months after treatments |
Characterizing the Association Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery

Study Overview
=================
Brief Summary
-----------------
This observational study aims to characterize the relationship between preoperative depressive symptoms and opioid use/ misuse after surgery using a perioperative learning health care system. We will follow a prospective cohort of patients undergoing elective surgery.

Official Title
-----------------
Observational Study to Characterize the Relationship Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery

Conditions
-----------------
Opioid Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18+ Planning to undergo surgery English speaking Ability and willingness to complete questionnaires and assessments Exclusion Criteria: Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status) Known Pregnancy Elevated Suicidality Enrollment in a conflicting perioperative trial

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 |
| --- | --- |
| Patients undergoing elective operations<br>We will follow a prospective cohort of 558 patients, undergoing any elective surgery at Stanford Hospital. Subjects will undergo baseline and longitudinal testing via a (including NIH Patient-Reported Outcomes Measurement Information System- PROMIS measures of emotional distress). After surgery, participants will report weekly changes in opioid use, pain, and adverse events; and monthly changes in opioid misuse for 1 year. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Opioid Cessation |  | Assessed after surgery up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Misuse | Participant score on the Current Opioid Misuse Measure will be used to assess opioid misuse | Assessed after surgery up to 1 year |
Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate. II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is an randomized, unblinded, multicenter study. Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin. Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. Heme arginate is administered daily for 4 days. Patients are followed at 3 and 6 days after treatment.

Conditions
-----------------
Porphyria

Intervention / Treatment
-----------------
* Drug: heme arginate
* Drug: tin mesoporphyrin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria No chronic or subacute symptoms (present for longer than 2 weeks) --Prior/Concurrent Therapy-- At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin --Patient Characteristics-- Renal: Urinary porphobilinogen at least 40 mg/24 hr Other: Not pregnant Fertile female patients must use effective contraception during and 6 months before study No evidence that symptoms are due to another acute illness No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known sensitivity to heme preparation or tin mesoporphyrin No other medical condition that might increase risk to patient

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: heme arginate|nan|
|Drug: tin mesoporphyrin|nan|

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
-----------------
inborn errors of metabolism, porphyria, rare disease