linjc16/ctgov huggingface dataset:
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Detailed Description
-----------------
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.

Official Title
-----------------
Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: Chlorhexidine Gluconate
* Other: Vehicle
* Drug: DynaHex-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or Females 16 years of age or older Signed informed consent Good Health Six inches of abdomen and groin areas without tattoos, or skin disorders Exclusion Criteria: Dermatological Conditions Sensitivity to latex Sensitivity to CHG

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine Gluconate Cloth<br>2% CHG, single application | Drug: Chlorhexidine Gluconate<br>* 2% CHG solution on cloth<br>* Other names: CHG;|
| Placebo Comparator: Vehicle Cloth<br>Excipients on cloth | Other: Vehicle<br>* Excipients of CHG product only<br>* Other names: Control;|
| Active Comparator: Active Chlorhexidine gluconate solution<br>Dynahex 2% CHG | Drug: DynaHex-2<br>* 2% CHG solution<br>* Other names: CHG 2%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin | Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline. Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels. | 10 minutes, 6 hours, 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preoperative surgical skin preparation
Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)

Study Overview
=================
Brief Summary
-----------------
The principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision. Secondary objective will be to test the glare and contrast sensitivity.

Detailed Description
-----------------
This study is a pilot study. As such it will recruit a limited number of patients : 20. Patients recruited will suffer from cataract, have no comorbidity, expressed the desire for spectacle independence and have realistic expectations. Descriptive statistics will be used to determine the visual acuities at any distance. The occurence of glare and the determination of the contrast sensitivity will also be determined.

Official Title
-----------------
Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)

Conditions
-----------------
Bilateral Cataract

Intervention / Treatment
-----------------
* Device: trifocal intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age-related cataract Preoperative Corneal astigmatism < 0.75 D Age 21 and older Visual Acuity > 0.05 Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant. Patient willing multifocal implantation and with realistic expectations. Exclusion Criteria: Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...) Previous ocular surgery or trauma.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: trifocal intraocular lens|Standard cataract surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | At far, near and intermediate distance. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast sensitivity | Assessment of the contrast sensitivity: determination of the visual acuity with low-contrast chart (Pelli Robson standard sight-chart ). | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOL, cataract, trifocal, FineVision
Neurocognitive Features of Patients With Treatment-Resistant Depression

Study Overview
=================
Brief Summary
-----------------
There is an urgent need for novel and effective interventions for treatment-resistant depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some preliminary findings to suggest that ketamine may exert its antidepressant effects through promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a pattern separation task) and a battery of other well-established cognitive measures. This is an assessment-only study, as we will be recruiting subjects to complete an assessment battery at two time points, before and after receiving ongoing ketamine administrations for at least four weeks.

Conditions
-----------------
Treatment Resistant Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be 18-80 years old be able to read, understand, and provide written informed consent in English, meet criteria for a current moderate/severe (> 14 on QIDS-SR) depressive episode (unipolar or bipolar mood disorder), have a history of > 3 failed antidepressant trials, and be be seeking ketamine ongoing treatment through the ketamine clinic at Massachusetts General Hospital and be deemed appropriate for the clinic. Exclusion Criteria: Subjects who will not provide consent to neuropsychological testing Subjects who are not deemed appropriate for the ketamine clinic will not be enrolled

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Treatment-resistant depression patients<br>Subjects with TRD who have been deemed appropriate for (and have decided to receive) clinical, non-research ketamine treatment at the ketamine clinic at Massachusetts General Hospital. As this is an assessment-only observational study, no treatment assignment or randomization procedures will be used. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pattern separation task results | The pattern separation task is a computer-based behavioral task that captures characteristic of pattern separation processes. Pattern separation is thought to be involved in the process of you finding your car everyday despite being in a different space; this may be dysfunctional in people with depression. The task itself is not an intervention; it is a rapid assessment of putative changes in pattern separation. | Baseline - post at least 2 weeks on a stable dose of intranasal ketamine |
Cardiovascular Vulnerability to Particulate Exposure

Study Overview
=================
Brief Summary
-----------------
This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. To investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.

Detailed Description
-----------------
Approximately 60 subjects have participated fully in Boston and Steubenville in the repeated 40 minute measurement of continuous EKG (Holter), blood pressure, and oximetry. In Steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary inflammation. The exposure monitoring has included outdoor particle mass of PM2.5, outdoor gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor contribution of pollution to health effects.

Official Title
-----------------
Active Elderly Study

Conditions
-----------------
Heart Disease, Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Participants are 50 to 90 years of age, but almost all are 60 and older. They have been enrolled as volunteers from communities in Mission Park, Boston, and Steubenville. Inclusion criteria includes the ability to walk on level ground. Exclusion criteria includes unstable anginal, and baseline EKG patterns such as left bundle branch block that would make difficult the detection of repolarization abnormalities. Participants live at or near the study center which was located in an office or apartment in the apartment building of the majority of the participants.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECG, Holter monitoring, Cardiac, particulate exposure
Study of VX-770 on Desipramine

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effects of VX-770 on Desipramine

Official Title
-----------------
An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects

Conditions
-----------------
In Development for Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: VX-770
* Drug: VX-770


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be male or female and between 18 and 55 years of age Subject must have a body mass index (BMI) from 18 to 30 kg/m2 Subject must be judged to be in good health Exclusion Criteria: History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject Subjects who have human immunodeficiency virus, hepatitis C, or active hepatitis B Female subjects and male subjects with female partner(s) who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-770<br> | Drug: VX-770<br>* In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.<br>|
| Experimental: desipramine<br> | Drug: VX-770<br>* In period 1, subjects will receive a single oral dose of desipramine on Day 1.<br>Drug: VX-770<br>* In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VX-770 and Desipramine pharmacokinetic parameters |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments |  | 3 weeks | 
| Metabolites pharmacokinetic parameters in plasma |  | 3 weeks |
Gabapentin's Effects on Insomnia in Patients With Recent Concussion

Study Overview
=================
Brief Summary
-----------------
In this open-label, pilot study the investigators will be assessing gabapentin's effects on insomnia and other concussion-related symptoms in patients with a recent concussion experiencing insomnia.

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: Gabapentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head trauma causing concussion with either no loss of consciousness (LOC) or LOC < 30 minutes within previous 2 weeks. ISS score at Baseline of > 14. PCSS score at Baseline > 5. If brain imaging has been checked, there was no intracerebral hemorrhage noted. Glasgow Coma Scale score of 15 at Baseline. Age of at least 14 years old. Has not taken gabapentin or pregabalin any time since concussion and has no history of intolerance to gabapentin or pregabalin. Has not taken any sleeping pills for previous 2 nights and agrees not to take any for the next 2 weeks. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br> | Drug: Gabapentin<br>* 300mg capsules by mouth<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index from Baseline to 1 week |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post Concussion Symptom Scale score from Baseline to 1 week |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
concussion, gabapentin, neurontin, insomnia
Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage

Study Overview
=================
Brief Summary
-----------------
Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.

Detailed Description
-----------------
To search for a biomarker, which might be able to predict rectal anastomotic leakage before its clinical presentation. Serum procalcitonin, C-reactive protein, and drain fluid culture, IL-6 and TNF-α levels were evaluated in 50 consecutive patients with rectal cancer who underwent low anterior resection with colorectal anastomosis.

Official Title
-----------------
Predicting Value of Serum Procalcitonin, C-reactive Protein, and Drain Fluid Culture, Fluid Il-6 and Tnf-α Levels in Anastomotic Leakage Following Rectal Resection

Conditions
-----------------
Anastomotic Leakage in Colon Surgery

Intervention / Treatment
-----------------
* Procedure: Colon surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient underwent to colonic resection and had drain Exclusion Criteria: other patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anastomotic leakage<br>Patient had anastomotic leakage | Procedure: Colon surgery<br> <br> |
| No anastomotic leakage<br>Patient had no anastomotic leakage | Procedure: Colon surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage. |  | 5 day |
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

Official Title
-----------------
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies

Conditions
-----------------
Relapsed or Refractory Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: Trichostatin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years at the time of signing informed consent; Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies; Presence of measurable or evaluable disease; Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; Contraceptives or other approved avoidance of pregnancy measures Exclusion Criteria: Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression; Concomitantly taking anti-cancer therapy (bisphosphonates are permitted); Undergone major surgery ≤ 2 weeks prior to starting study drug; Evidence of mucosal or internal bleeding; Impaired cardiac function or conduction defect; Concurrent severe and/or uncontrolled medical conditions

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trichostatin A<br> | Drug: Trichostatin A<br>* Intravenous Infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs) | Measured by spontaneous reporting of adverse events (AEs) | Up to 24 months | 
| Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A |  | Up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Hematologic, Malignancies, Blood
The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems and lead to the developement of heart failure Clinical significance Correlation with biomarkers and genetic markers

Detailed Description
-----------------
Patients will undergo cardiovascular magnetic resonance (CMR) to include measurement of left ventricular volumes, ejection fraction, detection of inflammation (via STIR sequences) where appropriate, early gadolinium enhancement, late gadolinium enhancement, first pass perfusion using pharmacological stress imaging (contraindications to include comorbidities that do not permit pharmacological stress agents e.g. severe asthma, severe or symptomatic aortic stenosis)

Official Title
-----------------
The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy

Conditions
-----------------
Cardiomyopathy, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of an ischaemic or non-ischaemic cardiomyopathic process no contraindication to contrast enhanced CMR GFR >30 Exclusion Criteria: ESRF Contraindication to CM R

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Myocardial fibrosis, outcomes<br>Groups with none and variable amounts of myocardial fibrosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 3 years | 
| Ventricular arrhythmias |  | 3 years | 
| Unplanned heart failure admissions |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction |  | 3 | 
| NYHA status |  | 3 |