linjc16/ctgov huggingface dataset:
Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how often women have problems passing their urine (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better understand normal voiding function after surgery as well as to find factors that may help us predict who will have problems after surgery.

Official Title
-----------------
Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

Conditions
-----------------
Voiding Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stress incontinence, diagnosis must be confirmed by cough stress test or multichannel urodynamics Undergoing minimally invasive sling procedure - TVT (by transvaginal or surpapubic approach) Must be competent to give informed consent Exclusion Criteria: No diagnosis of stress urinary incontinence Undergoing minimally invasive sling procedure by route other than TVT Undergoing any other pelvic organ prolapse repair procedures Pregnancy Known voiding dysfunction preoperatively

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-void residual volume |  | Pre-operative and post-operative periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-day voiding diary, uroflow, standardized questionnaires |  | Pre-operatively and post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voiding dysfunction following TVT placement
Gene Therapy for Wet AMD

Study Overview
=================
Brief Summary
-----------------
FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Official Title
-----------------
An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Neovascular Age-related Macular Degeneration

Conditions
-----------------
Neovascular Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Genetic: FT-003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects that are willing and able to follow study procedures; Female or male patients ≥45 years old at the time of signing the ICF; Clinically diagnosed with nAMD; Presence of active CNV The best corrected visual acuity (BCVA) of the studied eye is ≤ 53 letters; Exclusion Criteria: • Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 45 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
Interventional Model Description: Neovascular Age-related Macular Degeneration
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FT003 Dose 1<br>Low dose of FT-003 | Genetic: FT-003<br>* Administered via intraocular injection.<br>|
| Experimental: FT003 Dose 2<br>Mid dose of FT-003 | Genetic: FT-003<br>* Administered via intraocular injection.<br>|
| Experimental: FT003 Dose 3<br>High dose of FT-003 | Genetic: FT-003<br>* Administered via intraocular injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability after FT-003 injection | Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0) | At Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline |  | At Week 52 |
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors

Study Overview
=================
Brief Summary
-----------------
This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.

Detailed Description
-----------------
Neurofibromatosis Type 2 (NF2) is characterized by multiple tumors of the cranial and spinal nerves, and, in particular, by bilateral acoustic tumors. Surgical resection of these tumors generally results in the transection of the VIIIth nerve, destruction of the cochlea and auditory nerve, and total hearing loss. Due to the loss of the auditory nerve, these patients are not candidates for cochlear implantation. The Auditory Brainstem Implant (ABI) provides the only available intervention to restore some auditory sensation to these patients. An ABI is an implantable prosthesis that produces sound sensation by electrical stimulation of the ascending auditory pathway at the level of the cochlear nucleus. The PABI may be placed surgically during tumor resection. Efficacy will be assessed using psychophysical and standard speech reception measures.

Official Title
-----------------
Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

Conditions
-----------------
Neurofibromatosis 2

Intervention / Treatment
-----------------
* Device: Penetrating auditory brainstem implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of neurofibromatosis type 2 Speak English as a primary language Exclusion criteria: Physical, psychological, or medical conditions that contraindicate the surgical procedure

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Penetrating auditory brainstem implant|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
-----------------
Electric Stimulation, Implants, Artificial, Brainstem, Electrodes, Speech Perception
Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix

Study Overview
=================
Brief Summary
-----------------
This study tested the safety and performance of a new cell collector device and compared the results to those obtained with the current existing device that are being used routinely

Detailed Description
-----------------
This study tested the feasibility, safety and efficacy of the new e2TM Collector, and compared its performance with the standard method for obtaining cervical cells for Pap test of endocervical cytobrush and Ayer's Spatula

Official Title
-----------------
Double-Blinded Multicenter Clinical Study Assessing the Equivalence of the InPath Cervical Cell Collector to the Standard Endocervical Brush and Spatula in Patients Seeking Primary Pap Screening or Follow-up Screening

Conditions
-----------------
Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia, Uterine Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages >14 being followed for a previous abnormal Pap All patients will have signed an Informed Consent form prior to being enrolled in this study Exclusion Criteria: Patients who have had a hysterectomy

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervix, Uterus, Dysplasia, Cancer, Collector
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.

Official Title
-----------------
A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: TD-4208
* Drug: Tiotropium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male or female subject 40 years of age or older Exclusion Criteria: Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-4208-1<br>88 mcg | Drug: TD-4208<br>* Subjects receiving TD-4208 are blinded to one of two doses of 4208.<br>* Other names: revefenacin;|
| Experimental: TD-4208-2<br>175 mcg | Drug: TD-4208<br>* Subjects receiving TD-4208 are blinded to one of two doses of 4208.<br>* Other names: revefenacin;|
| Active Comparator: Tiotropium<br>18 mcg | Drug: Tiotropium<br>* There is not a placebo, there is an active comparator (Tiotropium) arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events: Frequency and Severity | To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE) | Baseline to Day 365 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD
Studying Dexamethasone and Prednisone Sensitivity in Samples From Younger Patients With High-Risk B-Cell Precursor Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.

Detailed Description
-----------------
OBJECTIVES: Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9. Identify differences in gene expression and GR occupancy of response elements in HR BCP-ALL patients > 10 years old in response to both Dex and Pred. OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene expression and ChiPseq data sets are compared by luciferase reporter assay.

Official Title
-----------------
B-precursor Acute Lymphoblastic Leukemia (ALL): Studying the Mechanisms Behind Dexamethasone and Prednisone Sensitivity in High-Risk Patients

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: DNA analysis
* Genetic: RNA analysis
* Genetic: gene expression analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia Samples from patients treated and not treated with Dex and Pred PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA analysis|nan|
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old |  |  | 
| Genes that are required for efficient apoptosis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B-cell childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
Impact of Neuropathic Post-Zosterian Pain on the Cognition

Study Overview
=================
Brief Summary
-----------------
Pain is defined as a sensorial and emotional phenomenon and lead consequences on the cognition. These consequences could be increased with usual treatment. So the aim of this study is to explore these cognitive consequences.

Detailed Description
-----------------
Pilot prospective study with parallel groups

Official Title
-----------------
Impact of Neuropathic Post-zosterian Pain on the Cognition (NPZ and Cognition)

Conditions
-----------------
Neuropathic Post-zosterian Pain, Cognition

Intervention / Treatment
-----------------
* Drug: usual treatment: Versatis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering of NPZ pain Over 55 years old Healthy volunteers

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: usual treatment: Versatis|To explore if the cognition is failed in treated patients suffering of neuropathic postzosteria pain. To see if treated patients with patch (Versatis®) have better cognition than treated patients without patch.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The principal outcome is to explore if the cognition is failed in treated patients suffering of neuropathic post-zosteria pain. |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study if treated patients with patch (Versatis®) have better cognition than treated patients without patch. |  | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPZ, Pain
Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor

Study Overview
=================
Brief Summary
-----------------
This study assess the accuracy of a blood pressure monitor designed to detect atrial fibrillation. Subjects use the blood pressure monitor on a daily basis for 30 days and compare the readings to an ECG done at the same time.

Official Title
-----------------
Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor: Trial of Regular vs Irregualr Pulse for the Prevention of Stroke (TRIPPS 2.0)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any of the following age 65 or older hypertension diabetes mellitus congestive heart failure previous stroke Exclusion Criteria: permanent pacemaker impalantable defibrillator

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)|Monitoring heart rhythm daily for 30 days using the blood pressure monitor and the ECG recorder.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the blood pressure monitor used for detecting atrial fibrillation compared to the electrocardiogram. |  | After final subject data is available. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess subjects understanding of the use of the device for atrial fibrillation. |  | After final subject data is available. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, home blood pressure monitoring
Tibial Nerve Versus Sciatic Nerve Block

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.

Official Title
-----------------
Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty

Conditions
-----------------
Post Operative Analgesia

Intervention / Treatment
-----------------
* Procedure: Selective Tibial Nerve block
* Procedure: Sciatic Nerve Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: total knee replacement Exclusion Criteria: History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Experimental: Selective Tibial Nerve Block<br> | Procedure: Selective Tibial Nerve block<br>* Use of selective pain block.<br>|
| Active Comparator: Control: Sciatic Nerve Block<br> | Procedure: Sciatic Nerve Block<br>* Use of Sciatic Nerve Block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop. | Measure frequency of foot drop in two groups and compare results. | Upon emergence from general anesthesia and up to 48 hours in the recovery room. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess if levels of pain and analgesic requirements are similar between the two groups. | Administer pain scale and monitor use of analgesics to compare levels two groups. | 24 hours after total knee replacement surgery. |