linjc16/ctgov huggingface dataset:
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Detailed Description
-----------------
Evaluate the relationship between treatment with MetroGel® 1% and cosmetic performance with the Subjects' usual cosmetic products. It is expected that the female subjects will be able to use their routine cosmetics after application without affecting the cosmetic product's performance or causing side effects.

Official Title
-----------------
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: Metronidazole Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with moderate Rosacea (Global Severity Score of 3), Subjects willing to stop their current rosacea medication for at least 2 weeks Subjects must have an established routine of cosmetics application (e.g. must have been using the same facial foundation for at least 3 months and it is not expected to change during the study) Subjects must be willing to use their routine facial foundation and not change products while on study Exclusion Criteria: Subjects who do not routinely wear facial foundation Subjects who failed to undergo a washout period of 14 days for the use of topical rosacea therapy, (for example: metronidazole, azelaic acid, sulfacetamide) Subjects who are unwilling to stop their current rosacea medications for 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| 1<br>Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea | Drug: Metronidazole Gel<br>* Topical, Once daily for 2 weeks<br>* Other names: MetroGel® 1%;|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Cosmetic Appearance by Investigator |  | Baseline and Week 2 | 
| Assessment of Cosmetic Appearance by Subject |  | Baseline and Week 2 | 
| Erythema Severity |  | Baseline and Week 2 | 
| Investigator Global Severity Score |  | Baseline and Week 2 | 
| Tolerability Assessments and incidence of adverse events |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rosacea, metronidazole
Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds

Study Overview
=================
Brief Summary
-----------------
The repair of large osseous defects remains still unsolved. Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.

Official Title
-----------------
Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds: Impact of Pre-engineered Capillaries in Critical Size Grafts

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Procedure: Cell Culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: German-speaking patients aged 18-70 admitted to the Clinic of Reconstructive surgery for reconstructive surgery and fat-excision. Exclusion criteria: Drug-abuse, neoplasia and metabolic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Fat Removal<br>Patients undergoing surgical fat removal | Procedure: Cell Culture<br>* Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

Study Overview
=================
Brief Summary
-----------------
To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines

Official Title
-----------------
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

Conditions
-----------------
Spinal Cord Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult subjects, 18 to 60 years of age; Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI); The diagnosis of SCI was confirmed by MRI; and Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures Exclusion Criteria: Severe head injury; Is medically or mentally unstable according to the judgement of the Investigator; History of Multiple Sclerosis or peripheral demyelinating disease; Likely to have experimental therapy; Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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 |
| --- | --- | --- |
| The primary study outcomes will be the subject recruitment rate, the subject drip out rate, the number of missing values and the number of submitted incorrect values |  | 6 months |
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.

Official Title
-----------------
A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Lanthanum carbonate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under a physician's care for CKD for > 2 months and are not expected to begin dialysis for 4 months Screening estimated GFR of 15-59 mL/1.73 m2 Serum phosphorus >= 4.7 mg/d following washout Exclusion Criteria: Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum, calcium or magnesium Rapidly progressing glomerulonephritis Cirrhosis or other clinically significant liver diseases Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed

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 |
| --- | --- |
| Experimental: 1<br> | Drug: Lanthanum carbonate<br>* Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period.<br>* Other names: FOSRENOL;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphorus levels at 8 weeks. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH levels, calcium-phosphorus product. |  | 8 weeks |
Parkinson's Disease and Experiences Throughout the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to examine the relationship between personal characteristics and satisfaction with care in those diagnosed with Parkinson's disease during the COVID-19 pandemic. Participants will take 4 different surveys regarding their satisfaction with care throughout the duration of the COVID-19 pandemic. The surveys in total should not take more than 30 minutes to complete

Official Title
-----------------
Does Locus of Control Affect Satisfaction and Quality of Life During COVID - 19?

Conditions
-----------------
Parkinson Disease, Covid19, Satisfaction, Patient, Quality of Life

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Diagnosed with Parkinson's Disease Must be able to complete the surveys without any help Exclusion Criteria: Under the age of 18 Not diagnosed with Parkinson's Disease Unable to complete the surveys without help

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

| Intervention/Treatment |
| --- |
|Other: No Intervention|There is no intervention for this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the relationship between Locus of Control and Quality of Life | Participants will take the Multidimensional Health Locus of Control (MHLC) Scale. This will determine if the participant has more of an internal or external locus of control. Participants will also take the Quality of Life Scale- U.S Parkinson's Disease Questionnaire (PDQ-39) to determine the quality of life they have been experiencing throughout the COVID-19 pandemic. Based on the results of both surveys, the researchers will be able to determine if external locus of control or internal locus of control leads to a better quality of life in PD patients throughout the COVID-19 pandemic. | 1 year | 
| Measure of secondary control and satisfaction with care | Participants will take the Multidimensional Health Locus Control (MHLC) scale. This will determine what type of control is most present in the participant's life. Additionally, participant's will take the Short Form Patient Satisfaction Questionnaire (PSQ-18). This will determine how satisfied participants are with their healthcare providers throughout the COVID-19 pandemic. Based off of the responses to the surveys, the researcher will be able to determine whether a higher or lower secondary control yields a higher satisfaction. | 1 year |
Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the possible preoperative predictive value of altered heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for postoperative adverse cardiac events (i.e. arrhythmia or myocardial ischemia needing hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.

Official Title
-----------------
Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages

Conditions
-----------------
Arteriosclerosis Obliterans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 40 years ASO Elective vascular surgery patient (i.e. infra-inguinal bypass procedure) Exclusion Criteria: Other than sinus rhythm Lack of co-operation Major surgery less than 3 months preoperatively Sleep apnoea Dialysis treatment CABG less than 3 years earlier

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| 1<br>Arteriosclerosis obliterans patients undergoing elective vascular surgery | |
| 2<br>Healthy age-matched volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Application of Antiosteoporosis Therapy in Osteolysis

Study Overview
=================
Brief Summary
-----------------
To report the postoperative complications and limb function of patients with osteolysis after surgery for bone tumors of the extremities who received anti-osteoporosis therapy in Henan Cancer Hospital in the next 10 years.

Detailed Description
-----------------
A total of 100 patients with osteolysis after surgery for bone tumors of the four extremities who received anti-osteoporosis treatment in Henan Cancer Hospital in the next 10 years were reported. The basic information, treatment methods, postoperative complications and limb function of these patients were collected.

Official Title
-----------------
Efficacy and Safety of Antiosteoporosis Therapy in Patients After Bone Tumor Resection: a Multicenter, Real-world Prospective Cohort Observational Study

Conditions
-----------------
Limb; Fusion, Complication

Intervention / Treatment
-----------------
* Other: Anti-osteoporosis therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No age restriction, male or female. A subtype of bone tumor (including benign, malignant, and metastatic cancer) was confirmed in the pathology department of the research institution. Received excision of bone tumor in research institution. Exclusion Criteria: Not applicable.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>Patients who received antiosteoporosis therapy after bone tumor resection | Other: Anti-osteoporosis therapy<br>* Bone healing, limb function, and complications of postoperative osteolysis in patients with bone tumors of the extremities treated with anti-osteoporosis therapy.<br>|
| Control group<br>Patients who underwent bone tumor resection without antiosteoporosis therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | The incidence of complications after anti-osteoporosis treatment was collected and the severity of complications was evaluated according to CTCAE5.0. | Collected from the beginning of treatment to 24 months after treatment. | 
| Limb function | Limb function was assessed using the Musculoskeletal Oncology Society (MSTS) scoring scale for seven items, namely movement, pain, stability, deformity, strength, functional activity, and emotional receptiveness. The highest possible score is 35, with 5 points allocated to each project. | Collected from the beginning of treatment to 24 months after treatment. |
NHF in Acute Hypercapnic Acute Exacerbation of COPD

Study Overview
=================
Brief Summary
-----------------
Patients with AECOPD and NIV failure and in absence will be treated with NHF device. Inclusion criteria are pH < 7,38 and pCO2 > 45 mm Hg. Patients were treated if pH >7,38 or refusal of therapy.

Official Title
-----------------
NHF in Acute Hypercapnic Acute Exacerbation of COPD

Conditions
-----------------
Safety of NHF in Acute Hypercapnic AECOPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pH < 7,38 hypercapnic AECOPD Exclusion Criteria: Need of intubation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NHF use<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH | Increase in pH | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCO2 | Decrease in pCO2 | up to 24 hours |
Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.

Official Title
-----------------
Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00

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

Intervention / Treatment
-----------------
* Device: One-Piece Tecnis Multifocal IOL
* Device: One-Piece Tecnis monofocal IOL, Model ZCB00


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral cataracts and otherwise healthy eyes visual potential of Decimal 0.8 in each eye Exclusion Criteria: any medications affecting vision any chronic disease/illness that would affect risk to subject or outcomes of the study any ocular pathology/abnormalities that may affect visual outcomes or confound study results desire for monovision

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal Intraocular Lens<br>ZMB00 multifocal intraocular lens | Device: One-Piece Tecnis Multifocal IOL<br>* One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.<br>* Other names: Model ZMB00;|
| Active Comparator: Monofocal Intraocular Lens<br>ZCB00 monofocal intraocular lens | Device: One-Piece Tecnis monofocal IOL, Model ZCB00<br>* Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.<br>* Other names: ZCB00;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm | Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group. | 4-6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity |  | 4-6 months |
Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry

Study Overview
=================
Brief Summary
-----------------
This will be a registry study that will enroll patients referred for an ECG treadmill test with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information will be recorded and analyzed automatically and simultaneous with the standard ECG signals by the HyperQ System. Results of subsequent tests performed on each patient will be collected and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery disease).

Official Title
-----------------
Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Referred for exercise MPI due to suspected coronary artery disease Exclusion Criteria: Acute Coronary Syndrome (Unstable angina/NSTEMI/STEMI) Pre-excitation syndrome QRS duration > 120 ms Atrial Fibrillation or significant ventricular arrhythmia Treatment with Digoxin Pacemaker with 100% pacemaker dependence

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

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 |
| --- | --- | --- |
| CAD status | The main goal of this registry will be to compare sensitivity, specificity, positive and negative predictive values of the HyperQ HFQRS analysis for detecting the presence of coronary artery disease to that of standard ECG analysis. | one month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, high frequency QRS analysis, ischemia, exercise testing, diagnosis of coronary artery disease