linjc16/ctgov huggingface dataset:
Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.

Study Overview
=================
Brief Summary
-----------------
The acute and subchronic effects of amitriptyline were compared to placebo in a double-blind crossover randomized study on driving ability and driving-related skills in chronic neuropathic pain patients.It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

Detailed Description
-----------------
The present study was designed to determine the effects of nocturnally administered 25 mg amitriptyline, compared to placebo, after single (Day 1, acute effects) and repeated (Day 15, subchronic effects) administration on driving performance in neuropathic pain patients. In addition to the on-the-road driving test, laboratory tests measuring driving-related skills were administered. Moreover, effects of amitriptlyine on an attentional capacity task were tested using Event-Related Potentials (ERPs). It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

Official Title
-----------------
Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients

Conditions
-----------------
Chronic Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: amitriptyline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age, amitriptyline responder, adequately treated with amitriptyline in studied dose before study participation, pain intensity score (VAS) of at least 4 cm on a 10 cm scale, driving licence, driving experience, speak fluently Dutch, normal vision, right-handed Exclusion Criteria: psychological or physical disorder other than pain(-related), other psychotropic medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal drug use

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amitriptyline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| driving parameters |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory task parameters |  |  | 
| ERPs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erp, neuropathic pain, driving, attention, amitriptyline
Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.

Detailed Description
-----------------
The most important area for research on the pterygium are the recurrence occurred after operation. Now the best way to prevent the recurrence is autologous conjunctival stem cell transplantation, but this way of operation can cause lack of conjunctiva and conjunctival scar, even may effect the later glaucoma surgery. For the atretoblepharia patients, amniotic membrane transplantation and autologous oral mucosa transplantation can not make effect to alleviate it. In this pilot project, investigators would like to study the effect of tissue engineering conjunctiva transplantation in the treatment of pterygium and tissue engineering conjunctiva transplantation combined with conjunctiva sac formation for the treatment of atretoblepharia. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various conjunctiva loss caused by trauma, infections, and so on.

Official Title
-----------------
Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Procedure: Tissue engineering conjunctiva transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary and recurrent pterygium patients,atretoblepharia patients Voluntarily signed informed consent No surgery and anesthesia contraindications. Exclusion Criteria: The patients combined systemic diseases Reject study and follow visit Patients don't accept the tissue engineering conjunctiva Cannot tolerate surgery or anesthesia

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical Coherence tomography<br> | Procedure: Tissue engineering conjunctiva transplantation<br>* During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The epithelial defect size of the transplanted tissue engineering conjunctiva |  | the 7 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pterygium, tissue engineering, atretoblepharia
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.

Study Overview
=================
Brief Summary
-----------------
Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Detailed Description
-----------------
In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Official Title
-----------------
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.

Conditions
-----------------
Laparoscopic Surgery, Surgical Wound, Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Coated Vicryl plus
* Drug: Coated vicryl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-75 candidate for laparoscopic surgical intervention during the period of the study were included. Exclusion Criteria: Patient has immunodeficiency disorder. Patient receiving anti-cancer / immunosuppressive therapy. Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coated Polyglactin 910 with Triclosan<br>Coated Polyglactin 910 with Triclosan | Drug: Coated Vicryl plus<br>* Vicryl plus (Coated Polyglactin 910 with Triclosan)<br>* Other names: Coated Polyglactin 910 with Triclosan;|
| Active Comparator: Coated Polyglactin 910 without Triclosan<br>Coated Polyglactin 910 without Triclosan | Drug: Coated vicryl<br>* Vicryl (Coated Polyglactin 910 without Triclosan)<br>* Other names: Coated Polyglactin 910 without Triclosan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| port site infection (PSI) | the incidence of port site infection (PSI) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | Post-operative hospital stay in days | 30 days |
Transcranial Direct-Current Stimulation in Childhood Dystonia

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that transcranial direct current stimulation over the motor cortex will reduce muscle overflow and improve hand function in children with primary or secondary dystonia.

Official Title
-----------------
Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia

Conditions
-----------------
Childhood Onset Dystonias

Intervention / Treatment
-----------------
* Device: TDCS (Transcranial Direct-current Stimulation)
* Device: sham TDCS (Transcranial Direct-current Stimulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dystonia affecting one or both hands age 4 to 21 years Exclusion Criteria: metal implants in the head inability to cooperate with instructions

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 21 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current | Device: TDCS (Transcranial Direct-current Stimulation)<br>* active TDCS<br>* Other names: eldith DC-stimulator (neuroconn, Ilmenau, Germany);|
| Sham Comparator: sham<br>inactive Transcranial Direct current stimulation (TDCS) at 0mA | Device: sham TDCS (Transcranial Direct-current Stimulation)<br>* TDCS at 0mA<br>* Other names: eldith DC-stimulator (neuroconn, Ilmenau, Germany);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand muscle overflow | surface EMG measure of overflow into muscles during attempted relaxation. | 10 minutes post- transcranial Direct-current Stimulation (TDCS) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood dystonia
Clinical and Biological Characteristics of Hidradenitis Suppurativa

Study Overview
=================
Brief Summary
-----------------
Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.

Official Title
-----------------
Clinical and Biological Characteristics of Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Participation Criteria
=================
Eligibility Criteria
-----------------
Hidradenitis Suppurativa Patients Inclusion Criteria: Age 13 years or older Diagnosis of HS clinically-confirmed by a physician Exclusion Criteria: 1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent. Healthy Volunteer Inclusion Criteria: No history of chronic skin conditions No recent history of antibiotic use Exclusion Criteria: 1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Hidradenitis Suppurativa Patients<br>Patients with physician diagnosed Hidradenitis Suppurativa | |
| Healthy Volunteers<br>Healthy volunteers without any skin conditions or recent history of antibiotic use. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa. |  | 2016-2026 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary aims include correlating alterations in clinical and biological characteristics with disease status, and identifying genetic variants that predict disease progression or response to therapy. |  | 2016-2026 |
ARTUS MONO Artificial Urinary Sphincter

Study Overview
=================
Brief Summary
-----------------
The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff placed around the bladder neck. The purpose of this clinical investigation is to evaluate the feasibility of implantation of the device, its safety and its efficacy, when temporarily implanted in female patients scheduled for anterior pelvic exenteration for bladder cancer.

Official Title
-----------------
Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women

Conditions
-----------------
Urinary Incontinence,Stress

Intervention / Treatment
-----------------
* Device: ARTUS MONO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients aged ≥ 18 yo BMI > 18,5 and < 35 Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion Signed informed consent Exclusion Criteria: Advanced bladder cancer with bladder neck and/or urethral extension Past pelvic radiation therapy Patient previously treated with an artificial urinary sphincter or other urogenital implant Positive urine culture during the past 2 weeks Indwelling bladder catheter during the past 2 weeks Documented history of sensitivity to silicone History of connectivitis disease Immunosuppressive therapy in the last 3 months Vulnerable subjects Participation in any other clinical investigation

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>ARTUS MONO | Device: ARTUS MONO<br>* Temporarily implant and activation of the medical device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder catheterization in presence of ARTUS MONO cuff | Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARTUS MONO cuff implant | Visual analogic scale (from worst to best imaginable easiness and safety) | Day 0 | 
| ARTUS MONO cuff activation | Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AUS, Artificial Urinary Sphincter
Safety and Efficacy of Different Antiviral Regimens for Hepatitis C Virus Relapse

Study Overview
=================
Brief Summary
-----------------
The primary goal of hepatitis C virus (HCV) Direct Acting Antivirals (DAAs) is to achieve undetectable HCV RNA in the blood. A response that should be maintained for at least 12 weeks from completion of therapy. This is called sustained virological response (SVR) which corresponds to cure of HCV infection as risk of later relapse is very small. SVR is important to achieve improvement in liver necroinflammation and fibrosis and to decrease complications of cirrhosis. Failing to achieve SVR after treatment requires another regimen for these experienced patients. Real-world data are always needed to evaluate and improve our practices. Here investigators aim to assess tolerability and efficacy of different regimens used for management of genotype 4 HCV relapse.

Official Title
-----------------
Safety and Efficacy of Directly Acting Antiviral Agents in Genotype 4 Hepatitis C Virus Relapse Among Egyptian Patients

Conditions
-----------------
Hepatitis C, Relapse, Antivirals

Intervention / Treatment
-----------------
* Drug: directly acting antivirals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with HCV relapse after sofosbuvir plus either Non-structural protein 5 A (NS5A) or protease inhibitor. Exclusion Criteria: No exclusion criteria

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

| Intervention/Treatment |
| --- |
|Drug: directly acting antivirals|Different regimens given for genotype 4 relapse: Sofosbuvir/velpatasvir/voxilaprevir ±ribavirin; sofosbuvir/velpatasvir ±ribavirin; ombitasvir/paritaprevir/ritonavir+ ribavirin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response |  | 12 weeks after completion of treatment |
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Study Overview
=================
Brief Summary
-----------------
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.

Official Title
-----------------
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: HiRes 90K Bionic Ear System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No previous implant experience. Age 18 years or older. Postlingual onset of hearing loss. Sensorineural hearing loss of a severe or greater degree in both ears. Normal/patent cochlear anatomy in each ear. English language proficiency. Willingness and ability to participate in all scheduled procedures. Exclusion Criteria: No exclusion criteria specified, except for the opposite of inclusion criteria listed above.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bilaterally Implanted with HiRes 90K device. | Device: HiRes 90K Bionic Ear System<br>* Cochlear implant system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. | Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported. | 8 months of bilateral cochlear implant use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HINT Sentences in Noise | 20 sentences presented in noise at fixed levels | 8 months of bilateral cochlear implant use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HiResolution Bionic Ear, severe to profound hearing loss, bilateral implantation