linjc16/ctgov huggingface dataset:
Russian Disc Degeneration Study

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to establish disease-oriented biobank to facilitate research in biology of the lumbar disc degeneration. Diverse biological samples (whole blood, plasma, disc tissue) along with MRI imaging, clinical, socio-demographic and various omics data (e.g. genomic and transcriptomic) will be available for researchers and clinicians for a variety of further multi-omics studies. It will lay the groundwork for the development of early diagnostics of DDD and its personalized treatment. The study is planned to enroll up to 1,100 patients with different grades of lumbar disc degeneration. It is planned to recruit patients within 36 months.

Official Title
-----------------
Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration

Conditions
-----------------
Genetic Predisposition to Disease, Intervertebral Disc Degeneration

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18; Presence of lumbar MRI scans; Signed informed consent for voluntary participation is provided. Exclusion Criteria: Any contraindication or inability to undergo baseline procedures; Prior surgeries at any level of the lumbar spine; Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduction of the study; History or presence of HIV, hepatitis B, hepatitis C.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-interventional|Translational, observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotyping | DNA will be extracted from the whole blood samples according to the standard protocol | Through 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotype of patients with lumbar disc degeneration | General information about a patient, his medical history and MRI scans of lumbar spine | Through 3 years | 
| Total plasma proteins N-glycosylation profiling | The plasma glycans profiling will be performed according to standard protocol | Through 3 years | 
| Total RNA profiling | The intraoperative material will be homogenized and total RNA will be extracted and converted to cDNA using Kit for the isolation of total RNA and microRNA from cells and tissues and M-MuLV-RH First Strand cDNA Synthesis Kit respectively. The amount of extracted RNA and its quality will be estimated using Bioanalyzer 2100. | Through 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycomics, biobank, functional genomics, transcriptomics
Lidocaine Irrigation in Shoulder Arthroscopy

Study Overview
=================
Brief Summary
-----------------
Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid. The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.

Official Title
-----------------
Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study

Conditions
-----------------
Postoperative Pain, Analgesia

Intervention / Treatment
-----------------
* Drug: Lidocaine epinephrine
* Drug: Epinephrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-60 Both genders Shoulder arthroscopy ASA I-III Exclusion Criteria: Drug allergy Psychiatric disorder Opioid dependence Liver disease Patient refuse

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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine<br>The patients will undergo shoulder arthroscopy with lidocaine epinephrine fluids irrigation. | Drug: Lidocaine epinephrine<br>* Under aseptic condition every one litre of fluid irrigation will be mixture with 10 ml of lidocaine 2% and 0.25mg epinephrine and the last one use before end of surgery dexamethasone 8 mg will be added.<br>|
| Placebo Comparator: control group<br>The patients will undergo shoulder arthroscopy with epinephrine fluids irrigation only. | Drug: Epinephrin<br>* 0.25 mg epinephrine mixed with one litre of fluid irrigation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total analgesic consumption | total nalbuphine consumed one day after surgery | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first analgesic request | time of PCA request | 24 hours | 
| Visual analogue pain score | pain intensity at rest and movement from 0-10 which 0 no pain and 10 the worst pain | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lidocaine, Shoulder arthroscopy, Postoperative pain
Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin lesions for characterization of their morphologic and functional features. .

Detailed Description
-----------------
This study is performed using a multiphoton microscopy-based tomograph (MPTflex) developed by JenLab, GmbH (Germany) to image non-invasively normal and lesional skin. Skin lesions are imaged by multiphoton microscopy and images are compared to those obtained from histopathology through standard of care processed skin biopsies. Any biopsies will be performed by the health care provider as a standard of care procedure.

Official Title
-----------------
Non-invasive Skin Imaging Using Multiphoton Microscopy

Conditions
-----------------
Skin Lesion

Intervention / Treatment
-----------------
* Device: MPTflex-multiphoton microscopy-based tomograph.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female all age groups Ability to understand and carry out subject instructions Exclusion Criteria: Pregnant women
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 |
| --- | --- |
| Human skin<br>Multiphoton microscopy imaging to collect information about changes in skin cells and fibrilar structure. | Device: MPTflex-multiphoton microscopy-based tomograph.<br>* non-invasive optical biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-resolution images of skin | The complementary imaging modalities (MPM, MI) will provide insights into a better understanding of the relationship between microscopic and macroscopic properties of the skin. | up to 12 months |
Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of Young Adults.

Study Overview
=================
Brief Summary
-----------------
The prevalence of IBS in the community has been reported in numerous cross-sectional surveys. However, less is known about the incidence of IBS ,mainly due to its slow development and to patients under-reporting. Furthermore, only one study has analyzed data concerning potential risk factors for the diagnosis of IBS. The investigators will examine the incidence of IBS in a large cohort of young adults and will look at the association of socioeconomic, anthropometric and occupational factors with IBS incidence.

Official Title
-----------------
Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of 440,822 Young Adults.

Conditions
-----------------
Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Israeli men and women aged 18-39 years served in active military service (mandatory and career service) between the years 2005-2011 Exclusion Criteria: Diagnosis of celiac disease Inflammatory bowel disease Cancer in the digestive system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| irritable bowel syndrome<br>All new cases of clinical diagnosis of irritable bowel syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinical diagnosis of irritable bowel syndrome | New diagnosis of irritable bowel syndrome during this priod | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive factors for the clinical diagnosis of irritable bowel syndrome | Anthropometric and demographic factors predictive for the clinicaldiagnosis of irritable bowel syndrome including gender, body mass index, ethnicity , type of service | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable bowel syndrome, Epidimiology, Deterioration in the severity of irritable bowel syndrome
Low Dose Peri- Operative Intra Venous Teranexamic Acid Reduces Blood Loss After Total Knee Arthroplasty: A Double Blind Randomized Placebo Controlled Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The null hypothesis of this study was that TA has no effect on post surgical bleeding in patients undergoes TKA.

Conditions
-----------------
Knee Arthroplasty, Total

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with osteoarthritis who indicated for primary TKA. Exclusion Criteria: Previous history of ceberovascular diseases Previous history of myocardial infarction Candidates for bilateral TKA
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br> | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Normal Saline<br> | Drug: Normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb Level 48 Hours After Total Knee Arthroplasty |  | 48 hours after TKA |
Quality Improvement Pilot

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to develop and pilot test the use of practice facilitation as an intervention for healthcare providers and staff, with the goal of improving the implementation of cancer prevention and screening guidelines in primary care settings.

Official Title
-----------------
Facilitation of Cancer Prevention and Screening Guideline Implementation: Pilot Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Quality Improvement Practice Facilitation Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal Volunteers Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br>Intervention | Behavioral: Quality Improvement Practice Facilitation Intervention<br>* The practice facilitation intervention (implementation strategy package) consists of QI projects designed for primary care providers with external practice facilitation and technical support provided by a QI Coach and Data Coach on our team. The QI projects focus on the implementation of cancer prevention and early detection guidelines in primary care settings, specifically one QI project for each of the following clinical guidelines: colorectal cancer screening, lung cancer screening, and tobacco treatment. The study participants are the healthcare providers and staff, not the patients, since the goal of the practice facilitation intervention (implementation strategy package) is to improve the implementation of existing standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer: Screening Rate (Patient Population) | Percent of patients age 50-75 who completed appropriate screening for colorectal cancer. | 6 months | 
| Lung Cancer: Screening Rate (Patient Population) | Percent of eligible patients with shared decision-making visit AND completed baseline LDCT scan. | 6 months | 
| Tobacco: Treatment Rate (Patient Population) | Percent of patients identified as tobacco user who received tobacco cessation intervention. | 6 months |
Characterization of Pseudoxanthoma Elasticum

Study Overview
=================
Brief Summary
-----------------
Pseudoxanthoma elasticum (PXE) is a rare multisystem disorder of autosomal recessive inheritance (OMIM# 264800) and an estimated prevalence between 1:25.000 and 1:100.000. PXE is characterized by calcification and fragmentation of connective tissue rich in elastic fibers. Due to its high content of elastic fibers, Bruch Membrane in eyes of patients affected by PXE becomes thickened and calcified. The ocular phenotype is characterized by angioid streaks and peau d'orange but also choroidal neovascularizations and chorioretinal atrophy thereby in part mimicking the phenotype of age-related macular degeneration. The disease is due to mutations of the ABCC6-gene coding for a transmembrane protein which is mainly expressed in the liver and kidney. It is hypothesized that ABCC6 is involved in the excretion of a yet unknown factor from the liver which inhibits systemic calcification. In animal models several candidates for this factor have been identified but direct evidence for such a factor in patients with PXE is still missing. The primary purpose of this study is to further investigate the ocular phenotype of patients with PXE using multimodal imaging and functional testing to delineate the impact of Bruch membrane pathology on the eye. Furthermore, possible systemic anti-calcification factors, as well as associations with the vascular alterations are investigated to gain more insights into the pathogenesis of PXE..

Official Title
-----------------
Characterization of Patients With Pseudoxanthoma Elasticum

Conditions
-----------------
Pseudoxanthoma Elasticum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing
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 |
| --- | --- | --- |
| Ocular phenotype | Patients are investigated using a multimodal imaging approach and visual function testing. | patients will be followed longitudinally with an expected 1-year average interval between visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers in PXE | Potential systemic biomarkers are investigated by collecting blood samples of PXE patients | 1 day (first visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PXE, phenotype, eye, biomarkers
A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.

Official Title
-----------------
A PHASE II/III RANDOMIZED, DOUBLE-MASKED, CONTROLLED, DOSE-RANGING, MULTI-CENTER COMPARATIVE TRIAL, IN PARALLEL GROUPS, TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREAL INJECTIONS OF EYE001 (ANTI-VEGF PEGYLATED APTAMER) GIVEN EVERY 6 WEEKS FOR 54 WEEKS, IN PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION (AMD)

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Pegaptanib sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320. Exclusion Criteria: Any prior subfoveal thermal laser therapy.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Pegaptanib sodium|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
-----------------
Macugen, AMD, Age-Related Macular Degeneration, Macular Degeneration, pegaptanib sodium
A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy

Study Overview
=================
Brief Summary
-----------------
Nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. It is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy, with follow-up every six months. Nexus website: www.narcolepsyregistry.com

Official Title
-----------------
A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy

Conditions
-----------------
Narcolepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Diagnosed with narcolepsy by a doctor

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 |
| --- | --- | --- |
| Descriptive epidemiology of type 1 and type 2 narcolepsy | Assessments include disease/diagnosis characteristics, disease/symptom characteristics, health-related quality of life (HRQoL), functioning, work productivity, resource utilization, and comorbidity burden at the time of enrollment and their progression through the course of the study | Participants complete a survey every 6 months for 3 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication utilization and treatment outcomes for type 1 and type 2 narcolepsy | Assessments include: Medication use, non-pharmacologic disease management, symptom relief, quality of life (QoL), functionality and productivity associated with varying treatment regimens at baseline and their change throughout the course of the study | Participants complete a survey every 6 months for 3 years after enrollment |
Immunemodulation in Patients With Minor Head Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to try to prove the worth of the two (2) Serum Proteins S-100 Beta and NSE in combination with a diagnostic algorithm to help to establish diagnosis in patients with minor head injury.

Official Title
-----------------
Diagnostic Algorithm in Minor Head Injury

Conditions
-----------------
Head Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minor head injury Exclusion Criteria: severe head injury

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients from daily practice | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial Haematoma |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracranial bleeding, computed tomography scan