linjc16/ctgov huggingface dataset:
Use of HRV Measuring Hearing-aid Device to Detect Acute Stress

Study Overview
=================
Brief Summary
-----------------
Validation of in-ear device to measure acute mental stress in comparison with a Polar H10 chest band. Stress is measured on the basis of heart rate variability.

Official Title
-----------------
Use of HRV Measuring Hearing-aid Device to Detect Acute Stress

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Device: BIORICS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dutch speaking and understanding Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally recognized representative) has been informed of all pertinent aspects of the study Age ≥ 50 years No contra-indications for the use of the receiver in-the-ear device (BiometRIC SR 26UAA01GF), and smartwatch and chest strap heartrate monitor Exclusion Criteria: • Smokers Obese patients (BMI >30 kg/m2) Presence of a pacemaker Supraventricular tachycardias: atrial fibrillation, atrial flutter, frequent supraventricular extrasystole or frequent ventricular extrasystole Otologic contraindications determined by licensed otolaryngologist

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Device: BIORICS<br>* Wearing BIORICS in their ear and perform mental arrhythmic test, relaxation exercises and Stroop test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability measured BIOMETRIC in-ear device | RMSSD | 1 day |
A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.

Official Title
-----------------
A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

Conditions
-----------------
Macular Edema, Cystoid

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217) Intravitreal Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have persistent post cataract extraction macular edema whose condition is stable Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization Have at least one eligible eye to be treated in the study Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye Have macular edema confirmed by fluorescein angiography Exclusion Criteria: Have proliferative vitreoretinopathy greater than grade B in either eye Have ocular disorders in the study eye that may confound interpretation of study results Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months Have had any ocular implant device for the delivery of therapeutic agents Be taking any excluded medications that could obscure or confound study results

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: denufosol tetrasodium (INS37217) Intravitreal Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 
| tolerability |  |  | 
| retinal thickness |  |  | 
| visual acuity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular edema, post cataract extraction, cystoid macular edema, post cataract extraction macular edema
Immune Function of Infants With HIV

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate data from infants born to HIV infected mothers in order to better characterize disease progression in early HIV infection.

Detailed Description
-----------------
The role of HIV-specific cytotoxic T-lymphocytes (CTL) in controlling viremia and protecting against disease progression following vertical infection may be dependent upon CTL functional responses as well as on the timing of detection, magnitude, and breadth of the responses. Novel and sensitive assay systems (MHC-peptide tetramers, ELISPOT assays, intracellular cytokine assays) have enhanced the detection and characterization of virus-specific CTL responses in the peripheral blood. This study will use these novel methods to examine the timing of detection, magnitude, specificity, and in vitro functional properties of HIV-specific CTL in infants; to evaluate the effects of potent combination antiretroviral therapy on HIV-specific CTL in infants; and to evaluate the immunogenicity of recombinant pox-based vaccines in HIV infected infants with prolonged viral suppression following early potent combination antiretroviral therapy. Blood samples from infants born to HIV infected women will be obtained from infants enrolled in other HIV trials. Generally, samples will be obtained at birth, Week 1, and Months 1, 2, 4, 6, 9, and 12.

Official Title
-----------------
Killer Cells and Viral Load in Vertical HIV Infection

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants and children born to HIV infected women

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

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
-----------------
AIDS, Vertical Transmission, Acute Infection
Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).

Official Title
-----------------
Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy

Conditions
-----------------
Hyperopia

Intervention / Treatment
-----------------
* Procedure: Photorefractive keratectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D; Uncorrected Visual Acuity of 20/40 or worse; Best-Corrected Visual Acuity of 20/60 or better. Exclusion Criteria: Systemic or ocular conditions that could bias results Previous photorefractive surgery

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Procedure: Photorefractive keratectomy|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
-----------------
photorefractive keratectomy, hyperopia, radial keratotomy, refractive surgery
Podocyturia as Predictive Factor for Pre-eclampsia

Study Overview
=================
Brief Summary
-----------------
Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive treatment using aspirin could be administrated in early pregnancy. We hypothesized that podocyturia could be an early indicator of preeclampsia. This is a prospective, non-interventional, monocentric study.

Official Title
-----------------
Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Other: Podocyturia quantification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged 18 years or more single pregnancy first planned prenatal visit before 16 weeks of gestation planned delivery at Hôpital Femme Mère Enfant in Lyon, France patient receiving information and non opposition to participate Exclusion Criteria: multiple pregnancy pregnancy stopped antecedent of nephropathy inability to understand information provided prisoner or under administrative supervision fetal malformation, chromosomal anomalies preterm delivery for other reason that any hypertensive disorder of pregnancy or Intrauterine growth restriction

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients coming before 16 weeks of gestation at their first planned prenatal visit at the Hôpital Femme Mère Enfant, who planned to deliver at the Hôpital Femme Mère Enfant | Other: Podocyturia quantification<br>* Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of pre-eclampsia | Occurrence of pre-eclampsia during pregnancy | At childbirth (around 8 months) |
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Study Overview
=================
Brief Summary
-----------------
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

Official Title
-----------------
Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study of the Safety of an Endovascular Motor Neuroprosthesis in Participants With Severe Upper Limb Impairment.

Conditions
-----------------
Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Spinal Cord Injury, Stroke, Lacunar, Stroke, Brainstem, Upper Limb Injury, Spinal Muscular Atrophy

Intervention / Treatment
-----------------
* Device: Motor Neuroprosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe motor impairment Able to give consent Appropriate candidate for neurointerventional procedure Able and willing to access all clinical testing and not impeded by geographical location Proficient in English Have a study partner Exclusion Criteria: Active condition resulting in immunosuppression Unsuitable for general anaesthetic Anaphylactic allergy to contrast media Allergy to nickel History of pulmonary embolism History of recent deep vein thrombosis Psychiatric or psychological disorder No study partner or caregiver Unable to provide evidence of COVID vaccination

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single<br>Implantation of motor neuroprosthesis medical device. | Device: Motor Neuroprosthesis<br>* Type of implantable brain computer interface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related adverse events |  | 12 months post implant |
Efficacy, Safety of T2769 in Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
Efficacy of T2769 in Dry Eye Desease

Detailed Description
-----------------
Multicenter and open study

Official Title
-----------------
Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Other: T2769


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent Male or female aged from ≥ 18 years old Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening Exclusion Criteria: Best far corrected visual acuity ≤ 2/10 Severe blepharitis Severe dry eye

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2769<br>T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily | Other: T2769<br>* At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days<br>* Other names: Ophthalmic solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Symptomatology | Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42. | Baseline and Day 42 |
Effect of Shock Waves Therapy on Chronic Anal Fissure

Study Overview
=================
Brief Summary
-----------------
the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure

Detailed Description
-----------------
Design of the study: A prospective, randomized, blind, paired (right/left) comparison. Materials: Measurement tool: healing of anal fissure, Wexner Constipation Scoring System anal pain intensity by means of a 10-point visual analogue scale (VAS) Therapeutic instruments: •. shock waves • topical application of 0.4% glyceryl trinitrate (GTN) ointment Methods: • Testing procedures: The assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment. • Treatment procedures: Patients will be assigned randomly into two groups equal in number: shock waves Group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control Group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (GTN) ointment only..

Official Title
-----------------
Effect of Shock Waves Therapy on Anal Fissure

Conditions
-----------------
Chronic Anal Fissure

Intervention / Treatment
-----------------
* Device: shock master (shock waves device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with chronic anal fissure symptomatic for at least 6 months failed conservative measures Exclusion Criteria: Pregnant women, cardiac patients, patients with a pacemaker, low molecular heparin or warfarin treatment, neurological disease,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- |
| Experimental: shock waves<br>group of patients with anal fissure will be treated with shock waves | Device: shock master (shock waves device)<br>* device produces shock waves<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | assessment of pain | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wexener scale | assess the constipation | up to 3 months |
High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients.

Official Title
-----------------
The Effect of High-Flow Needleless Valve and DualCap Disinfection Devices on Incidence of Catheter-related Bloodstream Infection in Hemodialysis Patients: a Single Center Randomized Controlled Trial

Conditions
-----------------
Catheter-related Bloodstream Infection

Intervention / Treatment
-----------------
* Device: High-Flow Needleless Valve
* Device: DualCap Disinfection Devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre Have signed information consent form Exclusion Criteria: Have got bacteremia before catheter implantation Catheter changing in situ

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management | |
| Experimental: Only High-Flow Valve<br>In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management | Device: High-Flow Needleless Valve<br> <br> |
| Experimental: Both Divices<br>In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis | Device: High-Flow Needleless Valve<br> <br> Device: DualCap Disinfection Devices<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related bloodstream infection |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with catheter withdraw for any reason |  | through study completion, an average of 1 year | 
| Number of participants with catheter dysfunction |  | through study completion, an average of 1 year |
Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Published data regarding the temporal pattern of AML are scarce and old. The greater knowledge of these neoplasias has made that their classification has been remarkable modified. Therefore, we consider relevant to carry out the present study as it would allow us to analyze the potential existence of a spatio-temporal pattern in the incidence of AML in Spain.

Official Title
-----------------
Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with a first diagnostic of AML between 2004 and 2014. .
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AML diagnosis | Diagnosis of de-novo AML | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spatio-Temporal Diagnostic Pattern