linjc16/ctgov huggingface dataset:
Clinical Safety Study on an Eyelid Warming Device to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids. Prospective, non comparative, open, monocentre study. The objectives are: To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application To evaluate the ocular surface, NIBUT and IOP before and after device application To determine the acceptability of healthy volunteers on the practical use of this device The subjects will attend 2 visits.

Official Title
-----------------
Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Device: LT2420


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged from 18 to 80 years old. Healthy volunteers. For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week) Normal ocular examination in both eyes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: device arm<br> | Device: LT2420<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)

Study Overview
=================
Brief Summary
-----------------
This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.

Detailed Description
-----------------
This Individual Patient Expanded Access IND has been created per the request of a 65-year-old woman diagnosed with Systemic Lupus Erythematosus (SLE).

Official Title
-----------------
Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)

Conditions
-----------------
System; Lupus Erythematosus

Intervention / Treatment
-----------------
* Biological: HB-adMSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult individual 18 years of age or older. Cognitively intact and capable of giving informed consent. Clinical diagnosis of Systemic Lupus Erythematosus. Subject has mesenchymal stem cells banked at Hope Biosciences. The patient accepts to receive treatment and to comply with follow-up visits. Exclusion Criteria: Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine diseases that in the opinion of the investigator may increase the risks associated with study participation. Active Alcohol or Drug addiction. Participation in concurrent interventional research studies during this study. Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history. Unwillingness to return for follow-up visits.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HB-adMSCs|Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.

Detailed Description
-----------------
A randomized, placebo controlled, clinical trial to evaluate the safety and efficacy of low-intensity, pulsed ultrasound, applied to tibial fractures treated with intramedullary nailing.

Official Title
-----------------
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Conditions
-----------------
Tibial Fractures

Intervention / Treatment
-----------------
* Device: Exogen 4000+
* Device: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females age 18 years or older Have an open or closed tibial fracture amenable to intramedullary nail fixation Exclusion Criteria: Tibial fracture associated with a vascular injury requiring repair Pilon fractures Tibial fractures that extend into the joint and require reduction Pathologic fractures • Bilateral tibial fractures

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exogen 4000+<br>Single arm, Exogen 4000+ | Device: Exogen 4000+<br>* Low-intensity pulsed ultrasound (LIPUS)<br>* Other names: Exogen Bone Healing System - 4000+ series;|
| Sham Comparator: Sham<br>Single arm, sham (identical device with the exception of administration of ultrasound). | Device: Sham<br>* sham device identical to active device with the exception of administration of ultrasound<br>* Other names: Single arm, sham of the Exogen 4000+;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) | Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best | Over 365 days | 
| Time (Days) to Radiographic Healing of Tibial Fractures | Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier | over 365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tibia
Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

Study Overview
=================
Brief Summary
-----------------
The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.

Detailed Description
-----------------
The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.

Official Title
-----------------
Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Lenstec Softec HD IOL implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract requiring cataract extraction Study IOL to only be implanted in 1 eye Distance BCVA 20/40 or worse or glare acuity worse than 20/30 Ability to comply with study follow-up requirements Exclusion Criteria: Patients with serious corneal disease, previous surgery or serious systemic disease Ocular condition that could impact vision after cataract surgery Pregnant or lactating women Use of ocular or systemic medications that could impact vision

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenstec Softec HD IOL implantation<br>390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract | Device: Lenstec Softec HD IOL implantation<br>* surgical removal of cataract and implantation of Softec HD PCIOL<br>* Other names: Softec HD Posterior Chamber Intraocular Lens;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Best Corrected Visual Acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FDA IOL Grid Adverse Events |  | through 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, IOL, Intraocular lens
Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees

Study Overview
=================
Brief Summary
-----------------
Objective: To investigate the effects of a one-year worksite individual exercise intervention on lifestyle-related modifiable health risks, physical capacity and work performance. Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104 men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical activity levels were assessed by the long self-administrated version of the International Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were collected from participants at baseline survey, at 6 months and 1-year after. Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.

Conditions
-----------------
Exercise Therapy

Intervention / Treatment
-----------------
* Other: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Working in ASISA company, middle-age (20-60) Exclusion Criteria: No medical condition contraindicating exercise participation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise intervention<br>Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility. | Other: exercise training<br> <br> |
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaire-Long Form (IPAQ-L) |  | 1 week | 
| Graded cardiorespiratory fitness exercise test |  | 1 week |
Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)

Study Overview
=================
Brief Summary
-----------------
A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.

Official Title
-----------------
Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: PYM50028
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening subjects who are not currently receiving any PD treatment Exclusion Criteria: female of child-bearing potential history of neurosurgical procedures for PD history of severe psychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 35 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose I<br> | Drug: PYM50028<br>* IMP<br>|
| Experimental: Dose II<br> | Drug: PYM50028<br>* IMP<br>|
| Experimental: Dose III<br> | Drug: PYM50028<br>* IMP<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo comprising identical vehicle to active doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale parts II & III combined score |  | 28 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early-stage
Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Studies suggest that dietary omega-3 fatty acids influence the extent to which the time interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated with increased risk of sudden cardiac death (SCD). The purpose of this research is to investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid levels in patients who have recently commenced haemodialysis.

Official Title
-----------------
Heart Rate Variability and Omega-3 Fatty Acid Status in Haemodialysis Patients: an Observational Pilot Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD stage 5 commencing haemodialysis, male or female, aged 40-80 y, written informed consent Exclusion Criteria: history of chronic liver disease or neuropathy, infection or antibiotics within the last month.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Chronic kidney disease, stage 5<br>Patients with stage 5 chronic kidney disease who have recently commenced haemodialysis treatment (within 6-10 weeks of starting treatment) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids) | Primary independent variable | 6-10 wk after commencing haemodialysis treatment | 
| 24 hour heart rate variability (Triangular index and SDNN) | Primary dependent variables. Triangular index and SDNN are indicators of overall variability | 6-10 weeks after commencing haemodialysis treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 h heart rate variability - longer phase parameters | Parameters of longer phase HRV: LF, VLF and SDANN | 6-10 weeks after commencing haemodialysis | 
| 24 h heart rate variability - short-phase parameters | RMSSD, pNN50, HF | 6-10 weeks after commencing haemodialysis | 
| Nocturnal heart rate variability - all parameters | SDNN, Triangular index, LF, HF, VLF, SDANN, RMSSD, pNN50 calculating during nocturnal sleep-time | 6-10 weeks after commencing haemodialysis | 
| Plasma EPA+DHA content (% weight of total fatty acids) |  | 6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemodialysis, Heart rate variability, n-3 PUFA
EUS-FNA for Patients With Antithrombotic Agents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for patients with antithrombotic agents.

Official Title
-----------------
Safety of Endoscopic Ultrasound-guided Fine Needle Aspiration for Patients With Antithrombotic Agents

Conditions
-----------------
Solid Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergo EUS-FNA take antithrombotic agents Exclusion Criteria: Cystic lesion
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antithrombotic agents<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients who suffered bleeding complication |  | One week |
Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir

Study Overview
=================
Brief Summary
-----------------
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.

Official Title
-----------------
Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV-1-Infected Patients (<100 CD4+ T Cells/μL) Taking Antiretroviral Regimens Based on Dolutegravir or Ritonavir-boosted Darunavir (the Advanz-4 Trial).

Conditions
-----------------
Acquired Immune Deficiency Syndrome Virus

Intervention / Treatment
-----------------
* Drug: Dolutegravir
* Drug: Darunavir/r


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV patients > 18 years old who provide signed and dated informed consent. Male and female. Chronic HIV infection. Antiretroviral naïve. Confirmed CD4+ T cell count below 100 cells/mm3 HLA B5701 negative patients. Exclusion Criteria: Active opportunistic infections requiring parenteral treatment Patients with cryptococcal meningitis treated with voriconazole AIDS-defining cancers needing chemotherapy. Female patients pregnant or breastfeeding. Patients with documented history of allergy to sulfonamides. Any contraindications to study drugs.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABC+3TC+DTG<br>Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen | Drug: Dolutegravir<br> <br> |
| Active Comparator: ABC+3TC+DRV/r<br>Abacavir+lamivudine+ritonavir-boosted darunavir, QD | Drug: Darunavir/r<br> <br> * Other names: Ritonavir-boosted Darunavir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median CD4 T cell count increase |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS, HIV Advanced Disease, Acquired Immune Deficiency Syndrome Virus, HIV, HIV-1, Antiretroviral treatment, Dolutegravir, Darunavir
Survey in Patients With Chronic Adrenal Insufficiency in Germany

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to assess patients with chronic primary or secondary adrenal failure regarding subjective health status, incidence and causes of adrenal crisis, hormone replacement regimens and concomitant endocrine or non endocrine disease.

Conditions
-----------------
Adrenal Insufficiency, Addison's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years chronic adrenal failure with disease duration > 12 months and hormone replacement therapy for cortisol deficiency Exclusion Criteria: adrenal insufficiency due to adrenocortical carcinoma AI due to long-term pharmacological glucocorticoid treatment glucocortiocid doses above 7.5 mg prednisolone equivalent for other reasons than AI
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
-----------------
adrenal insufficiency, subjective health status, quality of life, adrenal crisis, hormone replacement, DHEA