linjc16/ctgov huggingface dataset:
Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh

Study Overview
=================
Brief Summary
-----------------
Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcome. This advanced procedure is offered at Morristown Memorial. This protocol will review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.

Conditions
-----------------
Pelvic Organ Prolapse, Urinary Incontinence, Mesh Erosion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient receiving Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh Exclusion Criteria: Other graft material than polypropylene mesh Enrollment in another study

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

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

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
-----------------
uterine prolapse, vaginal prolapse, mesh erosion, urinary incontinence, bowel symptoms
Evaluation Study for a Non-Contact Biometer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard.

Detailed Description
-----------------
The features of a not yet commercial available new biometer will be compared to available contact and non contact biometers in different patient groups.

Official Title
-----------------
Neuartige Kontaktlose Biometrische Messungen

Conditions
-----------------
Cataract, Pseudophakia, Myopia, Hyperopia, Aphakia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 year or older Normal eye Cataract Corneal abnormality (scar, opacity, transplant) refractive corneal surgery Pseudophakia Aphakia Silicon oil refractive IOL 2.-9. (at least one yes)

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?
-----------------
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
-----------------
Biometry, corneal opacity, astigmatism, refraction
Study to Evaluate Effectiveness of Aranesp®

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).

Official Title
-----------------
Aranesp® Monthly Preference Study

Conditions
-----------------
Kidney Disease

Intervention / Treatment
-----------------
* Drug: Aranesp®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20% Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aranesp®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject preference |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney disease, Renal, CKD (Chronic Kidney Disease), CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen, Aranesp®, Darbepoetin alfa, QW dosing, Q2W dosing, Q4W dosing, Patient preference, Subject preference
A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT in Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
The leading cause of primary hyperparathyroidism (pHPT) is a solitary adenoma (89%). The treatment of pHPT is generally surgical removal of the overactive parathyroid gland(s). Since a solitary adenoma is the predominant cause, parathyroid surgery is preferably performed through a minimally invasive parathyroidectomy (MIP) in which only the suspected adenoma causing the pHPT is resected in a focused manner. To facilitate the performance of a MIP, accurate preoperative imaging is pivotal. This study aimed to analyze the diagnostic performance of 11C-choline PET/CT after prior negative or discordant first-line imaging in patients with pHPT undergoing parathyroid surgery with an optimized imaging protocol.

Official Title
-----------------
A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT for Detection of Hyperfunctioning Parathyroid Glands After Prior Negative or Discordant Imaging in Primary Hyperparathyroidism

Conditions
-----------------
Primary Hyperparathyroidism, Primary Hyperparathyroidism Due to Adenoma

Intervention / Treatment
-----------------
* Diagnostic Test: 11C-choline PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for inclusion were ≥18 years old, diagnosed with biochemically confirmed pHPT, underwent a MIBI-SPECT/CT and/or cUS with negative or discordant results, and underwent a 11C-choline PET/CT followed by parathyroidectomy. Exclusion Criteria: Patients were excluded if they were known to have a germline mutation predisposing for familial hypocalciuric hypercalcemia (FHH).

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 |
| --- | --- |
| All enrolled subjects received an 11C-choline PET/CT prior to enrollment.<br>Patients with biochemically proven primary hyperparathyroidism who underwent parathyroid surgery after localization by means of 11C-choline PET/CT and negative or discordant first-line imaging | Diagnostic Test: 11C-choline PET/CT<br>* 11C-choline PET/CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 11C-choline PET/CT | Per-lesion sensitivity of 11C-choline PET/CT for the detection of overactive parathyroid glands | Until 6 months after parathyroid surgery | 
| Positive predictive value of 11C-choline PET/CT | Per-lesion positive predictive value of 11C-choline PET/CT for the detection of overactive parathyroid glands | Until 6 months after parathyroid surgery | 
| Accuracy of 11C-choline PET/CT | Per-lesion accuracy of 11C-choline PET/CT for the detection of overactive parathyroid glands | Until 6 months after parathyroid surgery |
Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective randomized controlled clinical trial will evaluate the sensitivity, precision and effectiveness of photoelectrochemical immunosensor for early diagosis of acute myocardial infarction.

Official Title
-----------------
Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Symptoms of chest pain Exclusion Criteria: Patients who will undergo immediate PCI Pregnant Lactating women Patients with mental disorders Patients are using other experimental drugs; Refusal to provide informed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Automatic chemiluminescence analyzer will be used for dectecting the concentration of cardiac troponin I as control group. | |
| Experimental: Photoelectrochemical immunosensor<br>Photoelectrochemical immunosensor will be used for dectecting the concentration of cardiac troponin I as test group. | Device: Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor<br>* Graphene quantum dots combined with Si nanowire is a new method of photoelectrochemical immunosensor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of photoelectrochemical immunosensor | Sensitivity，precision and cost of the photoeletrochemical immunosensor | 28 days |
Biologically Focused Therapy of Treatment-Refractory MDS Patients

Study Overview
=================
Brief Summary
-----------------
This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.

Detailed Description
-----------------
This study utilizes the Notable Labs personalized testing service using an ex vivo assay, but does not involve actual treatment or treatment determinations. The results of these screenings will be made available to patients and their physicians for their use off study. The primary objective of the study is: • To determine the feasibility of selecting patient specific treatment regimens based on ex vivo within 30 days The exploratory objectives of the study are: • To identify biomarkers that explain ex vivo drug sensitivity results

Official Title
-----------------
Biologically Focused Therapy of Treatment Refractory MDS Patients

Conditions
-----------------
Myelodysplastic Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide informed consent; Myelodysplastic syndrome as defined by WHO classification (see Appendix 2), or MDS/MPN with >= 5% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) 1 and 2 by WHO classification Relapsed/refractory disease, defined as failed or are ineligible for hypomethylating agent therapy Cytogenetics reported Exclusion Criteria: Hypoplastic MDS Patients without adequate marrow samples for ex vivo analysis

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Feasibility testing<br>During the screening visit, blood and/or a bone marrow sample will be obtained for the patient's standard clinical evaluation. An aliquot of the blood and/or marrow sample will be obtained for ex vivo drug sensitivity assay | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with successful ex vivo results | Proportion of patients with successful ex vivo results within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing | 30 days | 
| Proportion of patients with successful treatment decisions | Proportion of patients with successful treatment decisions made by the molecular oncology board within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDS
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.

Detailed Description
-----------------
This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.

Official Title
-----------------
A Phase III Study of the Conversion Efficacy and Safety of Repeated Intravenous Doses of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter Following Valvular and/or Coronary Artery Bypass Graft Surgery

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
-----------------
* Drug: RSD1235


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery Exclusion Criteria: Unstable Class IV heart failure

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: RSD1235|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of RSD1235 |  | 90 minutes post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in sinus rhythm at 90 minutes |  | Time from first exposure to conversion to sinus rhythm | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment
Etude génétique Des Arméniens

Study Overview
=================
Brief Summary
-----------------
This study aims at better understanding the genetic structure of the Armenians, an old population whose genetics has not been the subject of many studies. We will study 500 individuals whom grandparents originate from different regions of Armenia. Each individual will be genotyped using a large panel of genetic markers. Principal component analysis will be used to analyze the genetic structure of this population.

Official Title
-----------------
Etude génétique Des Arméniens

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Four grand-parents originating from Armenia Exclusion Criteria: One or more grand-parents not originating from Armenia

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| Genome wide genotyping of individuals |  | 3 months following inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Principal component analysis of genotypes |  | Three months after completion of individual genotypes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
population genetics
Depakote ER in Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
This study examines the effect of Depakote ER versus placebo in a randomized trial of borderline personality disorder. Patients all participate in DBT therapy and those who are not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline Personality Symtoms are measured and side-effects are assessed.

Official Title
-----------------
A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Drug: Depakote ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Male or female patients with the diagnosis of borderline personality disorder between the ages of 21 adn 55 years old. Must be in good physical health - Exclusion Criteria:Major psychiatric illness on Axis I - schizophrenia or bipolar disorder. May not have current MDD. May not be dependent on illicit substances or alcohol. -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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: Depakote ER|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Checklist 90 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barratt Impulsivity Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Borderline Personality Disorder
Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

Study Overview
=================
Brief Summary
-----------------
Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor specimens that would normally be discarded after surgery.

Detailed Description
-----------------
The purpose of this non-treatment, non-interventional protocol is to collect, preserve, and store excess tumor specimens, which would otherwise be discarded, following routine nephrectomy for subjects with advanced renal cell carcinoma (RCC). The collected tumor specimen will be preserved under current Good Manufacturing Practice conditions and will not be used for any other research or therapeutic purpose without a separate consent from the subject, specific to the intended use on a separate Institutional Review Board or Institutional Ethics Committee approved Argos sponsored study. Following routine nephrectomy (partial or cytoreductive) as indicated for subjects with advanced RCC, small samples of the excised tumor will be sectioned and placed into an RNA preservative solution as supplied by the sponsor. After collection, this preserved tumor specimen will be shipped to a repository operating under current Good Manufacturing Practice conditions. The tumor specimen will be stored for no longer than five years unless subsequent consent is obtained for extended storage or other use.

Official Title
-----------------
Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

Conditions
-----------------
Kidney Cancer, Renal Cell Carcinoma, Advanced Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age ≥ 18 years 2. Diagnosis or clinical signs of advanced RCC (Stage III or IV RCC; Refer to Appendix A) 3. Scheduled for cytoreductive or partial (unilateral or bilateral) nephrectomy 4. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of tumor specimen collection prior to enrollment Exclusion Criteria: 1. Evidence of brain metastases prior to nephrectomy 2. Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids, for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.) 3. History of HIV infection, or history of chronic infection with Hepatitis B or Hepatitis C

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 |
| --- | --- | --- |
| Tumor Specimen | Tumor specimen collection | 5 years |