linjc16/ctgov huggingface dataset:
Evaluation of the Performance of a New Adhesive Strip

Study Overview
=================
Brief Summary
-----------------
This study investigates the performance of a new adhesive strip when impacted by output.

Official Title
-----------------
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: new adhesive strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had a stoma for more than one year Have intact skin on the area used in the evaluation Has a stoma with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist) Exclusion Criteria: 1 Currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal or abdominal area (assessed by investigating scientist) 5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test of a new adhesive strip<br>A new adhesive strip has been developed and will be tested in this investigation. | Other: new adhesive strip<br>* This is a strip made of a newly developed adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | The trans epidermal water loss is a measure of the skins barrier function. There is always a loss of water from the skin due to evaporation. However, when the barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess damage to the skin. | 8 hours |
Effects of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
Primary hyperparathyroidism (PHPT) is associated with increased cardiovascular morbidity. The benefit of surgical treatment in this respect is unclear. This study was performed to evaluate the impact of parathyroidectomy (PTX) on cardiovascular risk profile.

Detailed Description
-----------------
Patients with primary hyperparathyroidism (PHPT) have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of cardiovascular disease in PHPT is not well understood and probably multifactorial. Functional or structural alterations of vascular endothelial and smooth muscle cells may impair the vascular reactivity and lead to accelerated atherogenesis. Several cardiovascular risk factors such as obesity, hypertension, insulin resistance and hyperlipidemia are more prevalent in PHPT compared with controls.Patients with severe form of PHPT had a greater probability of metabolic syndrome (MS) and insulin resistance than patients with mild PHPT and eucalcemic subjects. Although the excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. Some studies suggest that hypertension, dyslipidemia, and derangement of glucose metabolism improve after removal of overactive parathyroid tissue. Others have shown that cardiovascular risk markers remained unaltered after parathyroidectomy (PTX). The aim of this study was to evaluate whether successful PTX is associated with decreased cardiovascular risk. We investigated indices of metabolic syndrome and insulin resistance as well as various cardiovascular risk factors in patients with manifest PHPT before and one year after successful PTX.

Official Title
-----------------
The Effect of Parathyroidectomy on Cardiovascular Risk Factors in Patients With Primary Hyperparathyroidism

Conditions
-----------------
Primary Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary hyperparthyroidism Exclusion Criteria: Individuals with known diabetes mellitus,coronary heart disease, stroke

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


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| primary hyperparathyroidism<br>patients with primary hyperparathyroidism | |
| controls<br>subjects without primary hyperparathyroidism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Compare the Quadriceps Function of Adductor Canal Block Versus Femoral Nerve Block With Electromyography Following Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Adductor canal block and femoral nerve block are the most commonly used nerve blocks for pain control after total knee arthroplasty. The block area for adductor canal is a sensory branch near the knee area, which can potentially reduce the effect of motor blockage of quadriceps muscle. We try to proof adductor canal block can reduce the pain level after surgery effectively and preserve the muscle power of quadriceps muscle. Therefore, the rehabilitation course can be reduced and further lowering the risks of falling and complications.

Official Title
-----------------
Compare the Quadriceps Function of Adductor Canal Block Versus Femoral Nerve Block With Electromyography Following Total Knee Arthroplasty

Conditions
-----------------
Quadriceps Function Monitored With Electromyography

Intervention / Treatment
-----------------
* Procedure: Nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 50 years old, not exceed 100 years old Diagnosed Primary Knee Osteoarthritis Accepted Total Knee Arthroplasty Exclusion Criteria: Diagnosed Osteonecrosis Diagnosed inflammatory Arthritis、Rheumatoid Arthritis Accepted Revision Total Knee Arthroplasty Quadriceps muscle rupture, suture or repair history Neurological or orthopedic disorders that could affect quadriceps muscle power Allergy to amide anesthetics Patients who cannot obey or follow directions

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 Years

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

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

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: Adductor canal block group<br>Adductor canal block group | Procedure: Nerve block<br>* Two different nerve block types, Adductor canal block group and Femoral nerve block group<br>|
| Experimental: Femoral nerve block group<br>Femoral nerve block group | Procedure: Nerve block<br>* Two different nerve block types, Adductor canal block group and Femoral nerve block group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps muscle Electromyography voltage level change before and after nerve block | surface electromyography level | compare difference of Quadriceps muscle Electromyography voltage level 12 weeks after surgery,data were measured post operation day 1, day 2, day 5, 2 weeks, 6 weeks and 12 weeks |
Exercise Testing in Peripheral Artery Disease Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD).

Detailed Description
-----------------
This is a non interventional prospective cross sectional, monocentric study. All patients addressed in our vascular unit for exercise testing were included. All patients' data performed in clinical routine can be analyzed.

Official Title
-----------------
Sensitivity and Specificity of the AHA Post-exercise ABI Criteria

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Other: Data collected


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients addressed in our vascular unit for exercise limitation Exclusion Criteria: Incapacity to walk on the treadmill. A severe cardiopathy contraindicating a stress test

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected PAD<br>Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging | Other: Data collected<br>* Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-min Post-exercise Ankle-Brachial Index (ABI) | Post exercise pressures at 1 minute after the stop of walking on each ankle and arm. | at 1 minute after the stop of walking | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-min Post-exercise Ankle-Brachial Index (ABI) | Post exercise pressures at 3 minutes after the stop of walking on each ankle and arm. | at 3 minutes after the stop of walking | 
| 5-min Post-exercise Ankle-Brachial Index (ABI) | Post exercise pressures at 5 minutes after the stop of walking on each ankle and arm. | at 5 minutes after the stop of walking |
Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment

Study Overview
=================
Brief Summary
-----------------
People affected by SARS-CoV-2 infection, whether patients have developed mild forms or a severe form of the disease, complain of nonspecific and entirely new symptoms or complain about the persistence pf them.Investigators intend to follow over time the post-infectious phase of patients discharged from sub-intensive care unit. The aim is to identify symptoms and their frequency of presentation in the SARS-CoV-2 population in the post-acute period.

Official Title
-----------------
Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 Exclusion Criteria: Patients under 18

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Post-COVID patients<br>Patients recovered from Sars-CoV2 infection | Other: Data collection<br>* Data collection<br>|
| healthy control patients<br>Patients who did not have Sars-CoV2 | Other: Data collection<br>* Data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greater understanding of SARS-CoV-2 disease | Greater understanding of SARS-CoV-2 disease and its long-term manifestations. To this end, the clinical manifestations, any alterations in laboratory and instrumental parameters will be evaluated to identify organ damages and calculate its prevalence | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of psychological impact of SARS-CoV-2 disease | Understanding the impact of the disease and its sequelae on daily life and the impact on the psychological aspect of the person; | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long-COVID, post-COVID, SarS-CoV2
Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
Head and neck tumors comprise heterogeneous neoplasms that arise from surface epithelium of different anatomic subsites in head and neck region such as oral cavity, oropharynx, larynx and hypopharynx. Nasopharyngeal and hypopharyngeal carcinomas represent 0.26 % of all cancers in Egypt. Tobacco exposure and alcohol dependence, and infection with oncogenic viruses such as human Papilloma virus (HPV) are among the risk factors for development of these tumors. Currently, the main treatment of nasopharyngeal and hypopharyngeal carcinomas is radio-chemotherapy based in histological type, grade and stages of the tumors Tumor infiltrating lymphocytes (TILs) are considered as cornerstone in cancer immunotherapy and as a biomarker with effectiveness predictive value. The intensity and quality of immune cells, especially lymphocytes, in tumor microenvironment are strongly related to the outcome of immune checkpoint blockade therapy .

Official Title
-----------------
Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal and Hypopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: immunohistochemical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies. Exclusion Criteria: Patients received chemotherapy or radiotherapy. Patients with insufficient clinical data. Specimens with extensive necrosis Tiny specimens which are insufficient for accurate diagnosis.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: immunohistochemical|Immunohistochemical Evaluation: Corresponding sections of 4µm thickness from each Formalin-fixed paraffin blocks will be immunohistochemically stained by anti- PD-L1 antibody according to the recommended protocol.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of programmed death ligand-1 (PD-L1) in nasopharyngeal and hypopharyngeal carcinoma | evaluate expression of PD-L1 in nasopharyngeal and hypopharyngeal carcinomas and to correlate its expression to different clinical and histopathological parameters to address its prognostic value. | 12 months |
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery.

Conditions
-----------------
Dry Eye, Cataract Surgery

Intervention / Treatment
-----------------
* Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be at least 18 years of age Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation Exclusion Criteria: Patients for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria. Patients cannot have a history of hypersensitivity to any component of FID 112903. Patients cannot have previous intraocular or corneal surgery or any planned within 30 days. Patients cannot use any ocular medications other than test article and standard of care post-op medications in past 14 days or during study. Patients cannot be on chronic systemic corticosteroid or other immunosuppressive therapy. Patients cannot have a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative Intraocular pressure >25 millimeters mercury in either eye. Patients cannot have a history and/or current evidence of the following: clinically significant corneal scarring, blepharitis or macular pathology in either eye, Herpes zoster or Herpes simplex keratitis.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of Care plus FID 112903<br>SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily | Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care<br>* Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively<br>|
| Active Comparator: Standard of Care only<br>Post Cataract Standard of Care Regimen | Other: Standard of Care<br>* Post Cataract Surgery Standard of Care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Comfort | Ocular comfort will be reported by the patient on a questionnaire | 30 days |
Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.

Detailed Description
-----------------
The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Biological: AN-1792 also known as AIP-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Biological: AN-1792 also known as AIP-001|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
-----------------
Alzheimer's, AN-1792, AIP-001
Effect of Epidural Analgesia on the Length of Labor and Delivery and Fetal Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is a difference in the duration of the first and second stage of labor in nulliparous women , with or without epidural analgesia. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients, while the duration of the second stage will be longer in patient with analgesia.

Conditions
-----------------
Labor, Epidural Analgesia, Nulliparous

Intervention / Treatment
-----------------
* Procedure: epidural analgesia
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous > 18 years old term (>37 weeks gestation) singleton vertex pregnancies Exclusion Criteria: Non-vertex presentation cervical dilation > 4.0cm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| epidural analgesia<br>women in labor with epidural analgesia | Procedure: epidural analgesia<br> <br> Drug: Ropivacaine<br> <br> |
| no epidural analgesia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of labor |  | Onset of contractions or rupture of membrances to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of fetal heart rate decelerations |  | Time of first analgesic dose to 60 minutes | 
| fetal tachycardia |  | Time of first analgesic dose to 60 minutes |