linjc16/ctgov huggingface dataset:
Using Neuroimaging to Investigate Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this neuroimaging study is to investigate the brain correlates of Major Depressive Disorder with anxiety symptoms as well as potentially identify predictors of treatment outcome.

Detailed Description
-----------------
The purpose of this study is to test whether the structural and functional connectivity between the dorso-lateral prefrontal cortex (DLPFC) and amygdala will decline as symptoms of co-morbid anxiety (Anxiety Factor Score) increase in patients with MDD. This decrease in connectivity will also account for decrease in treatment response. The structural connectivity will be assessed using Diffusion Tensor Imaging (DTI) and the functional connectivity will be assessed using resting state BOLD fMRI.We propose to use the fMRI and DTI to identify biological markers that are associated with treatment response in a cohort of patients with a spectrum of Anxiety Factor Scores.

Official Title
-----------------
Using Neuroimaging to Investigate Neurobiological Correlates of Treatment Resistance Associated With Co-morbid Anxiety in Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder, Depression, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Competent to give informed consent Diagnosis of Major Depressive Disorder Males and females Ages 18-50 years old All races and ethnicities Able to read, speak, and understand English* Exclusion Criteria: History of psychiatric illness except Major Depressive Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia Alcohol or substance abuse within the last 6 months or alcohol or substance dependence within the last year Diagnosis of an organic brain disease Serious unstable medical illness History of serious head injury Unsafe or unable to have an MRI or previous inability to tolerate MRI Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| MDD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response-the Quick Inventory of Depressive Symptomatology: Clinician Rated (QIDS-SR) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of comorbid anxiety-a subset of the Hamilton Rating Scale for Depression will be used to determine the anxiety/somatization factor scores |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, Depression, Anxiety
A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension

Detailed Description
-----------------
Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization. Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy. Patients had four scheduled clinical visits during the study, following the screening visit.

Official Title
-----------------
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Mild to Moderate Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nebivolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic. Exclusion Criteria: Recent myocardial infarction or stroke Contraindications to beta-blocker therapy

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: Nebivolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to week 12 in the average sitting DBP at trough. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 2, 6, and 12 in the average sitting, supine, standing systolic and diastolic blood pressure and sitting HR. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, Beta-Blocker, Hypertension
Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus

Study Overview
=================
Brief Summary
-----------------
A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy

Official Title
-----------------
Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: Delphi questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experts in the fields of radical right colectomy Exclusion Criteria: Panelists who were not able to commit to all rounds of the modified Delphi process
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Expert surgeon on radical right colectomy<br>Expert surgeon on radical right colectomy com pricing corresponding author/senior author from paper included in a preliminary systematic review on this topic Sica GS, Vinci D, Siragusa L, Sensi B, Guida AM, Bellato V, García-Granero Á, Pellino G. Definition and reporting of lymphadenectomy and complete mesocolic excision for radical right colectomy: a systematic review. Surg Endosc. 2022 Sep 12. doi: 10.1007/s00464-022-09548-5. | Other: Delphi questionnaire<br>* An invitation email, including a link to the survey, will be sent to the panel of experts in the field of radical right colectomy. The Delphi questionnaire will be administered via www.surveymonkey.com. In the first survey, panel members will agree on surgical steps, definition of surgical steps and nomenclature for radical right colectomy In subsequent surveys, panel expert will agree on a common definition, nomenclature and reporting for right colectomy. Multiple rounds will be conducted until consensus is reached. After each round, the study team will calculate the agreement and distribution of responses. Likert responses will be dichotomized with positive values indicating agreement and neutral or negative values indicating disagreement. For the questions that do not reach a consensus of more than 70% in the first round or need further explanation, additional rounds of the survey may be performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of consensus | The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement | 3 months |
Phase II Study of the Enzyme Inhibitor NTBC for Tyrosinemia Type I

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Assess whether 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (NTBC) at 0.6 mg/kg per day prevents liver failure in at least 1 patient with tyrosinemia type I.

Detailed Description
-----------------
PROTOCOL OUTLINE: Only 2 patients with tyrosinemia type I are known to this research team; others will be treated if found and if clinical conditions permit. The enzyme inhibitor 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (NTBC) is administered orally, in 2 divided doses daily with meals. Patients will be followed closely for side effects attributable to NTBC.

Conditions
-----------------
Tyrosinemia, Type I

Intervention / Treatment
-----------------
* Drug: NTBC


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Tyrosinemia type I No cirrhosis No hepatocellular carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 0 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: NTBC|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
-----------------
rare disease, inborn errors of metabolism, tyrosinemia I
A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

Detailed Description
-----------------
Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

Official Title
-----------------
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Conditions
-----------------
Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Device: iStent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open-angle glaucoma (POAG) Subject on at least one glaucoma medication Patient requiring cataract surgery and an intraocular lens implantation Exclusion Criteria: Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) Angle closure glaucoma

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: A<br> | Device: iStent<br>* Glaucoma Surgery<br>* Other names: Glaukos iStent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle, Glaucoma, Cataract, Surgery
Levetiracetam Treatment of Tardive Dyskinesia

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.

Conditions
-----------------
Tardive Dyskinesia

Intervention / Treatment
-----------------
* Drug: levetiracetam
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: meet Glazer Morgenstern criteria for TD - Exclusion Criteria: none -

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetram Administration<br> | Drug: levetiracetam<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal Involuntary Movement Scale (AIMS) Total Score |  | 12 weeks |
Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Study Overview
=================
Brief Summary
-----------------
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

Official Title
-----------------
A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Conditions
-----------------
Kidney Transplant Rejection

Intervention / Treatment
-----------------
* Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation. Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels) Kidney transplant patients who >90 days (+/- 2 weeks) post-transplant will be included in this study Exclusion Criteria: Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant. Recipients of previous non-renal solid organ and/or islet cell transplantation. Infection with HIV. Infection with BK nephropathy. Patients that have nephrotic proteinuria (urine protein >3 gm/day).

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 |
| --- | --- |
| All Subjects Enrolled<br>Renal transplant recipients who are undergoing routine management | Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling<br>* 5 mL collection PAXgene blood sample<br>* Other names: Standard of care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility of TruGraf Results | Percent of total number of TruGraf results that the PI identified as having clinical utility | through study completion, an average of 6 months | 
| Correlation of TruGraf Results | Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care. | through study completion, an average of 6 months | 
| Feasibility of TruGraf Testing | Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow | through study completion, an average of 6 months |
Attentional Bias Retraining in Veterans

Study Overview
=================
Brief Summary
-----------------
The study has two goals. First to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability.

Detailed Description
-----------------
Aim 1: Develop Attentional Bias Retraining protocol (Phase 1) 1.1 Computerized assessment & retraining programs 1.2 Procedures and measures Aim 2: Implement in pilot sample (Phase 2) 2.1: Assess feasibility and tolerability 2.2: Collect pilot data to plan future studies 2.3: Efficacy estimates based on changes in response time to dot probe task

Official Title
-----------------
Attentional Bias Retraining in Veterans

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Attentional bias retraining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in ground combat operations in Vietnam Scored 40 - 80 on PTSD Checklist - Military version Availability and willingness to attend 2x weekly computer sessions for 6 weeks Exclusion Criteria: Active substance dependence Significant cognitive impairment Current and active suicidal or homicidal ideation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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 |
| --- | --- |
| Other: Attentional Bias Retraining<br>Each participant receives 12 sessions. The first three sessions are baseline (assessment only) sessions. The last four sessions must be treatment sessions. The attentional bias intervention starts randomly on sessions 4 - 8, and continues until the end of the 12 sessions. | Behavioral: Attentional bias retraining<br>* Participants complete a computer-based intervention, which is designed to correct cognitive biases associated with PTSD by training to attend to neutral information rather than the trauma-related cue words.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-traumatic Checklist - Military version (PCL-M) | PCL-M assess the 17-cardinal symptoms of PTSD. | Change from Baseline and Post-treatment (1 month after last training session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attentional bias scores | Attentional bias scores represent participants cognitive bias to orient towards trauma-relevant information more quickly than neutral information. | Change from Baseline and Post-treatment (1 month after last training session) |
Intracavitary Fluid and Position of C-section-scar

Study Overview
=================
Brief Summary
-----------------
Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the position of C-section-scar ?

Detailed Description
-----------------
To evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the uterine fundus and the inner cervical os. To this end, we will compare measured variables, in patients with intracavitary fluid and without intracavitary fluid.

Official Title
-----------------
Does the Presence of Intracavitary Fluid During Hormonal Stimulation for IVF Depends on the Position of C-section-scar?

Conditions
-----------------
Fluid Uterus

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound,transvaginal scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above an age of 18 years. Patients performing IVF treatment. One or multiple C-sections. C-scar region visible during trans-vaginal scan. Exclusion Criteria: Patients who were IUD carriers in the last 3 months.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with intracavitary fluid<br>to evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, this group patients will have intracavitary fluid. | Diagnostic Test: ultrasound,transvaginal scan<br>* The presence of fluid in the uterine cavity during hormonal stimulation.<br>|
| Patients without intracavitary fluid<br>to evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, in this group patients will not have intracavitary fluid. | Diagnostic Test: ultrasound,transvaginal scan<br>* The presence of fluid in the uterine cavity during hormonal stimulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/Absence of ICF | to evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the inner cervical os, during hormonal stimulation for IVF. | 1 year and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of fluid accumulation in the cavity | Presence or Absence of ICF | 1 year and 6 months |