linjc16/ctgov huggingface dataset:
Variable Perception of Cutaneous Stimulation

Study Overview
=================
Brief Summary
-----------------
Perception of cutaneous sensory stimulation shows a large range of variability across multiple populations. Understanding this variability is critical to medical practice as interpretation of discomfort and pain is critical to diagnosis and treatment. Further, procedural medicine involves inflicting pain on patients in the form of injection of local anesthetic. Our protocol aims to determine how patients differentially interpret the non-noxious stimulation of vibration and the differences in perceiving anesthestic injection after the vibratory stimulus. We will explore how this ranges across all patients treated in a dermatological surgery out-patient setting. The goal is to identify which variables, such as age, gender, medical history, influence how sensation is interpreted.

Official Title
-----------------
Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation

Conditions
-----------------
Pain, Acute, Anesthesia, Local, Dermatology/Skin - Other

Intervention / Treatment
-----------------
* Device: Vibratory Anesthetic Device (VAD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients Exclusion Criteria: Patients less than 18 years of age

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will be randomly assigned into one of two groups: Group 1: Vibratory anesthetic device (VAD) is in the OFF mode Group 2: VAD is in the ON mode We will use a random number generator to place patients into one of the two groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: VAD Off arm<br>This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration | Device: Vibratory Anesthetic Device (VAD)<br>* This is a handheld  10cm long tool, battery operated, which provides vibration at a rate of  150 Hz<br>|
| Experimental: VAD On arm<br>This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration | Device: Vibratory Anesthetic Device (VAD)<br>* This is a handheld  10cm long tool, battery operated, which provides vibration at a rate of  150 Hz<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Score | This is a tool used to measure the degree of pain perceived by the patient with application of the tool on their skin and following the injection of anesthetic which is part of the routine medical care of the patient. Score ranges from 0 to 10 with higher score indicating more pain. | Within 5 seconds of injection |
Cardiovascular Events in Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
Cardiovascular (CV) disease is a common comorbidity of Parkinson's disease (PD). The background incidence rate of CV events in a levodopa-treated PD population was assessed to better understand these comorbidities in the PD population. One objective of the study is to identify a population of prevalent PD patients with incident levodopa use within the years 2004-2010 on the Integrated Health Care Information Services (IHCIS) database. The second objective is to report the incidence of CV events overall and during intervals 0-6, 6-12 and 12-18 months after first prescription of levodopa among all new levodopa users.

Official Title
-----------------
Background Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact Database

Conditions
-----------------
Cardiovascular Event, Parkinson Disease

Intervention / Treatment
-----------------
* Drug: levodopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010 Individuals on the database with medical and pharmacy benefit for at least 6 months prior to date of first prescription of levodopa Individuals with one or more diagnosis codes for Parkinson's disease within the 6 months prior or 6 months post first prescription of levodopa Exclusion Criteria: Individuals less than 20 years of age on date of first prescription of levodopa Individuals previously prescribed levodopa prior to study period

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| New levodopa users<br>Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010 but no previous levodopa prescriptions prior to study period | Drug: levodopa<br>* levodopa use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of CV events during first 6 months |  | 0-6 months after first prescription of levodopa | 
| Occurrence of CV events during second 6 months |  | 6-12 months after first prescription of levodopa | 
| Occurrence of CV events during third 6 months |  | 12-18 months after first prescription of levodopa | 
| Overall occurrence of CV events |  | 0-18 months overall after first prescription of levodopa | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, cardiovascular events, Levodopa
Influence of Genetic Polymorphism of Donor on Tacrolimus Concentration in Liver Transplant

Study Overview
=================
Brief Summary
-----------------
To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus blood concentration in liver transplant recipients.

Detailed Description
-----------------
This study will start with a retrospective data analysis. The investigators will use the electronic databases of National Taiwan University Hospital to identify patients who underwent liver transplantation, received tacrolimus and were still followed up at the outpatient clinic. Inclusion and exclusion criteria will be applied to screen appropriate participants, and find their donors. And analyze the effect of genetic polymorphism (ABCB1、CYP3A4、CYP3A5、POR) of donors, including other factors of recipients, on the dose normalized trough concentration of tacrolimus.

Official Title
-----------------
The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism of Donor on Tacrolimus Blood Concentration in Liver Transplant Patients

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:donors' recipients Living liver transplant during 20070101   20151231 and only received liver transplantation Lab data at least 8 months, Receiving tacrolimus as immunosuppressive drugs Transplantation at 20   65 years old Exclusion Criteria: donors' recipients Retransplantation or multi-organ transplantation Non-Asian Positive for human immunodeficiency virus.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| liver transplant patients and donors<br>To study clinical and genetic factors on tacrolimus dose normalized trough concentration. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation | Analyse the effect of the donor's genetic polymorphism to dose normalized trough concentration of tacrolimus in liver transplant patients. Trough level of tacrolimus was adjusted by liver recipient's body weight. | Within the first 6 months post-transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Pharmacokinetics, Genetic polymorphisms
Mortality of Cancer Surgery During SARS CoV2 Pandemic

Study Overview
=================
Brief Summary
-----------------
The impact of cancer surgery during covid epidemic is not clear. The published reports show contradictory findings that extend from no change in mortality to increased mortality, further no data on exposure and outcome of health care worker is available. This study is designed to address the above questions

Detailed Description
-----------------
This is a retrospective study from the prospectively collected data that is extracted from the electronic database of Department of Surgical Oncology, IMS, BHU The data is inform of two cohorts one extending from April 2019-April 2020 and other from May 2020 to May 2021 i.e. pre covid and during covid pandemic

Official Title
-----------------
Preoperative Screening for COVID-19 and Strict COVID Cancer Protocol Helps to Reduce Postoperative Infection, Mortality and Morbidity in Cancer Patients Undergoing Surgery. A Comparative Study

Conditions
-----------------
SARS CoV 2 Infection, Cancer

Intervention / Treatment
-----------------
* Other: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients operated during the study period Exclusion Criteria: None

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre covid<br>Cases operated one year prior to the date of declaration of corona pandemic in India | Other: Surgery<br>* Surgery for cancer as per the stage of the disease and protocol<br>|
| post covid<br>cases operated from the date of declaration of corona pandemic to one year after | Other: Surgery<br>* Surgery for cancer as per the stage of the disease and protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality | post operative deaths within one year | 30 days | 
| number of participants developing major or minor complications | Surgical complications classified as per Clavien Dindo classification | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of health care worker with SARS CoV2 infection | Covid infection in health care workers | 1 year |
Gait Disturbances and Hips Bone Mineral Density

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the role of gait disturbance as a cause for difference in Bone Mineral Density (BMD) between both hips. Each subject will undergo the following tests: Functional Mobility Testing, Gait analysis, Motion Analysis, Assessments for Balance and Gait and Cognitive assessments.

Conditions
-----------------
Difference in BMD Between Both Hips

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: differeneces in hips in Bone Mineral Density test in one group. Age 40-80. Exclusion Criteria: bone disease, arthritis, congenital skeletal malformations, pregnancy, neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks.

Official Title
-----------------
Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension. One Group Pretest Posttest Design

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension at the range 180-120 mm of Hg for Systole & 110-80 mm of Hg for Diastole Exclusion Criteria: Patients who are on ACEI / ARB for Hypertension Diseases in which life expectancy is less than six months Secondary hypertension CHD Family History of Mental Illness like Anxiety or depression. Nasal Congestion

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)|Ten drops of Drug in 30 ml of distilled water with a frequency of three times a day for a duration of 12 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic and Diastolic blood pressure. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Cholesterol |  | 12 weeks | 
| Change in Serum Triglycerides |  | 12 weeks | 
| Change in Serum LDH |  | 12 weeks | 
| Change in Serum Urea |  | 12 weeks | 
| change in Serum CKMB | The blood sample was collected at the end of 12 weeks of medication followed by a drug free period of 4 weeks.The blood sample was collected again at the end of 4 weeks of drug free period to ascertain serum CKMB. | 12 weeks and 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential Hypertension, Viscum album mother tincture, one group pretest post-test study
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Official Title
-----------------
A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: AEB071
* Drug: Certican
* Drug: Neoral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Male and female patients 18 years or older Recipients of first kidney transplant from a deceased or living not related donor Exclusion criteria Need for medication prohibited in the study Patients with heart disease (own or family history) Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive Patients with high immunological risks Patients with a history of cancer Other protocol-defined inclusion/exclusion criteria may apply

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: Neoral<br> | Drug: Neoral<br>* twice daily<br>|
| Active Comparator: AEB071 high dose with Cetican reduced dose<br> | Drug: AEB071<br>* oral, twice daily<br>Drug: Certican<br>* twice daily<br>|
| Active Comparator: AEB071 low dose with Cetican standard dose<br> | Drug: AEB071<br>* oral, twice daily<br>Drug: Certican<br>* twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant, AEB071
Effect of Aging on Haemostasis Parameters

Study Overview
=================
Brief Summary
-----------------
Aging is an independent risk factor, without any clear explanation. The primary aim of the study is to depict the effect of aging on the coagulation fibrinolysis parameters and microparticles.

Detailed Description
-----------------
Patients older than 40, without any acute disease and not receiving any antiaggregant and anticoagulant therapy will be included in the study. Blood tests will be performed for coagulation, fibrinolysis and microparticles measurement.

Official Title
-----------------
Identifying Morphological and Biological Biomarkers of the Venous Thromboembolic Risk Risk Related to Aging

Conditions
-----------------
Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age <40 2 groups : 1 : no history of VTE 2 : history of VTE Exclusion Criteria: antiaggregant or anticoagulant therapy at curative dose arterial or thrombotic event in the last month

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?
-----------------
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
-----------------
venous thromboembolism risk,, elderly,, hypercoagulability, fibrinolysis, microparticles
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
Aerobic physical activity attenuates systemic inflammatory activity in individuals with cardiovascular risk.

Detailed Description
-----------------
Background: Observational studies suggest that exercise has anti-inflammatory effect, however this idea has not been definitively confirmed by randomized clinical trials. Objective: To test the hypothesis that aerobic exercise attenuates systemic inflammatory activity in individuals with cardiovascular risk. Methods: Randomized controlled trial, which included 68 sedentary individuals, with at least two risk factors for coronary heart disease or established cardiovascular disease. The volunteers were randomized to 3 months of supervised aerobic training or just advice when healthy lifestyles. C-reactive protein (CRP) was measured by the method of high sensitivity before and after 3 months of intervention.

Official Title
-----------------
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Behavioral: Aerobic Exercise
* Behavioral: Only Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Individuals with are between 40 to 70 years, no regular exercise, and at least two risk factor for cardiovascular disease (diabetes, hypertension, dyslipidemia, smoking) or documented cardiovascular disease. Exclusion Criteria: - Incapacity to exercise.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>Aerobic | Behavioral: Aerobic Exercise<br> <br> |
| Placebo Comparator: Control<br>Not exercise | Behavioral: Only Counseling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise
Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.

Conditions
-----------------
Breast Milk

Intervention / Treatment
-----------------
* Behavioral: Exposure to medical clown activities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nursing mothers of infants born less than 34th week Exclusion Criteria: Sick mothers Take medication forbidden during nursing

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mothers exposed to medical clowns<br>Mothers of premature infants who have been exposed to medical clown activities | Behavioral: Exposure to medical clown activities<br> <br> |
| Mothers not exposed to medical clown activity<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of breast milk produced | Mothers who have either been exposed or not exposed to medical clown activities will pump their breast milk. The milk will be measured and the two groups production will be compared. | One week |