linjc16/ctgov huggingface dataset:
Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
In Post-Herpetic Neuralgia(PHN) patients: To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study To measure the plasma concentration of TRK-700 and its metabolites

Official Title
-----------------
TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-

Conditions
-----------------
Post-Herpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: TRK-700
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pain persisting for at least 3 months after the onset of herpes zoster Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4 Exclusion Criteria: Patients with another skin disease that may affect the evaluation of the pain at the site of PHN Patients with pain other than PHN that may affect the evaluation of pain Patients with pain that is suspected to be mainly psychogenic Patients who have received neurolytic or neurosurgical therapy for PHN

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 84 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: 1:TRK-700<br>high dose | Drug: TRK-700<br> <br> |
| Experimental: 2:TRK-700<br>low dose | Drug: TRK-700<br> <br> |
| Placebo Comparator: 3:Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average Numerical Rating Scale (NRS) | Change in average NRS collected by Pain Diary from baseline to week 8 in subjects receiving TRK-700 versus Placebo | baseline to week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRK-700, Post-Herpetic Neuralgia
The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy

Study Overview
=================
Brief Summary
-----------------
In varicocele the venous pressure in the prostatic bed is increased .This may result in raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy. Restoring normal venous drainage is expected to lower hydrostatic pressure followed by inhibition of prostatic growth and possibly leading regression in prostatic dimensions.

Detailed Description
-----------------
35 male patients, aged 45 years or older, with documented benign prostatic hypertrophy (BPH)and varicocele as visualized by ultrasound and/or termography examination will be enrolled. Each patient will undergo a full urologic examination to exclude possible malignancy as well as a thorough medical examination to establish eligibility for treatment. In all selected patients the varicocele will be obliterated by means of embolization of the spermatic veins. The patients will be followed every three months by abdominal ultrasound as well as by serial PSA for a period of 6-12 months.

Official Title
-----------------
Selective Retrograde Venography and Sclerotherapy of Internal Spermatic Veins and Associated Venous Bypasses and Retro-Peritoneal Collateral in Patients With Varicocele and Hypertrophy of Prostate

Conditions
-----------------
Varicocele

Intervention / Treatment
-----------------
* Procedure: Sclerotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age > 45 < 80 years BPH Bilateral varicocele. Exclusion Criteria: Coagulation disturbance CHF Malignancy Renal failure.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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 |
| --- |
|Procedure: Sclerotherapy|Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of above 20% in nocturia |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Varicocele
Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To describe the incidence of clinical features in adults with internal ventriculoperitoneal (VP) shunt infections, To determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and To evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

Detailed Description
-----------------
Information from medical records of patients seen by the PI will be collected and analyzed to describe the incidence of clinical features in adults with internal ventriculoperitoneal shunt infections, to determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and to evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

Official Title
-----------------
Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infections and Time to Re-Implantation in Adults

Conditions
-----------------
Ventriculoperitoneal Shunt, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age >= 18 yrs) with VP shunts (ventriculoatrial [VA], and other cerebrospinal fluid [CSF] catheters will not be included). Cases will include patients with a diagnosis of VP shunt infection. Controls will be patients with a clinical suspicion of shunt infections with negative CSF cultures. Exclusion Criteria: Patients with meningitis from community acquired organisms (e.g. Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Haemophilus Influenzae).

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shunt, internal ventriculoperitoneal
Smart Bra for Diagnosing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.

Official Title
-----------------
Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA

Conditions
-----------------
Breast Cancer, Medical Device

Intervention / Treatment
-----------------
* Device: BRA CONNECT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-specific invasive carcinoma diagnosed by biopsy X-ray images available Tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically Patient with a breast size compatible with the study bra size Exclusion Criteria: Contralateral breast cancer Inflammatory breast cancer History of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling) History of breast cancer or mastectomy Presence of dermatological pathology or breast skin ulceration Hematoma post biopsy History of thoraco-abdominal radiotherapy Known allergy to one of the materials of the device Fever (body temperature > 37.8°C) Pacemaker port

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient group<br> | Device: BRA CONNECT device<br>* skin thermal analysis for the detection of breast abnormalities<br>|
| Other: Control group<br> | Device: BRA CONNECT device<br>* skin thermal analysis for the detection of breast abnormalities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed. | Sensitivity and specificity of the device to detect a breast abnormality | 20 minutes of recording |
Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis

Study Overview
=================
Brief Summary
-----------------
This study is aimed at determining if office based surgery is an effective way of cutting health care cost while maintaining patient safety and satisfaction.

Detailed Description
-----------------
The study is a retrospective chart review with prospective patient satisfaction and functional outcome surveys. Patients that have had office based procedures that otherwise could be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015 will be contacted for study enrollment. Patient satisfaction and functional outcome surveys will be administered to those patients that consent to the research study. The data to be collected will include but is not limited to: age gender limb dominance, complications and co-morbidities.

Official Title
-----------------
Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis

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

Intervention / Treatment
-----------------
* Procedure: Wide Awake Local Anesthesia No Tourniquet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015 Exclusion Criteria: K-wire hardware removal Closed reductions Patients receiving antibiotics at the time of the procedure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Wide Awake Local Anesthesia No Tourniquet|Wide Awake Local Anesthesia No Tourniquet for office based hand surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rates | Collect the incidence of complications. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost savings | Compare the costs of the WALANT procedure with similar procedures done at an ASC or as an outpatient. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand
Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

Study Overview
=================
Brief Summary
-----------------
The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing. Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).

Conditions
-----------------
Neurodegenerative Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with neurodegenerative conditions Healthy subjects Subjects diagnosed with ADHD
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 |
| --- | --- |
| Nerodegenerative diseases<br>Patients with parkinsonism and patients with dementia | |
| Controls<br> | |
| ADHD<br>Subjects diagnosed with ADHD | |

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
-----------------
Detecting volatile biomarkers using breath sample
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

Study Overview
=================
Brief Summary
-----------------
This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.

Official Title
-----------------
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

Conditions
-----------------
COVID-19 Vaccine, Breastmilk

Intervention / Treatment
-----------------
* Other: Vaccinated Pregnant or Lactating persons


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lactating birthing persons from the general public or Sinai Health System Exclusion Criteria: None
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 |
| --- | --- |
| Lactating birthing persons delivering at Sinai Health System or from the general population<br> | Other: Vaccinated Pregnant or Lactating persons<br>* vaccinated lactating persons from Sinai Health System or the general public<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with and timing of SARS-CoV-2 specific antibodies in breastmilk post-vaccination |  | Week prior to first dose of vaccination and until 4 weeks following the second dose of vaccination. |
A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

Official Title
-----------------
A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

Conditions
-----------------
Hypertension, High Blood Pressure

Intervention / Treatment
-----------------
* Device: ROX Coupler
* Other: Sham procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening. Exclusion Criteria: Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: Treatment Group A<br>ROX Coupler implantation and continuing antihypertensive medications. | Device: ROX Coupler<br>* ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).<br>|
| Sham Comparator: Control Group B<br>Sham procedure and continuing current antihypertensive medications. | Other: Sham procedure<br>* Sham procedure + continuing current antihypertensive medications.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure | Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean office systolic blood pressure | Change in mean office systolic blood pressure at six months as compared to Baseline | Baseline, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, High Blood Pressure, Systolic Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Vascular Disease
Treatment With UX007 for a Single Patient With GLUT1 Deficiency Syndrome

Study Overview
=================
Brief Summary
-----------------
This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome.

Detailed Description
-----------------
This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome. Patient has already tried the other acceptable treatments for GLUT1 with either side effects that caused treatment to be discontinued (Ketogenic Diet) or a current treatment that is not showing any efficacy and is difficult to sustain for a long duration given this patient's age (modified Atkins diet). Due to the patient's ongoing neuroregression and lack of other viable treatments, the use of UX007 (triheptanoin) is warranted. There is no comparable or satisfactory alternative therapy to treat this patient's severely debilitating condition and the potential benefits to the patient justify the potential risks of the treatment. The potential risks from UX007 (triheptanoin) are not unreasonable given the context of this patient's condition.

Official Title
-----------------
Treatment With UX007 (Triheptanoin) for a Single Patient (ERS) With Glucose Transporter 1 (GLUT1) Deficiency Syndrome

Conditions
-----------------
Glucose Transporter 1 Deficiency Syndrome

Intervention / Treatment
-----------------
* Drug: Triheptanoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome. Exclusion Criteria: Not applicable as study only includes one patient.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triheptanoin|A single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome will receive tripheptanoin (UX007).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |