linjc16/ctgov huggingface dataset:
Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty

Study Overview
=================
Brief Summary
-----------------
Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.

Conditions
-----------------
Penetrating Keratoplasty

Intervention / Treatment
-----------------
* Drug: FK506 0.06% (eye drops)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Penetrating keratoplasty for Keratoconus Penetrating keratoplasty for Fuchs endothelial dystrophie Penetrating keratoplasty for Bullous keratopathy Exclusion Criteria: Glaucoma Limbal stem cell deficiency Herpetic eye disease Repeat Keratoplasty

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FK506 0.06% (eye drops)|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
-----------------
penetrating keratoplasty, graft rejection, immunosuppression
Cardiorespiratory Responses to Treadmill Running at Different Slopes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. The investigators hypothesized that maximal oxygen uptake will be lower in downhill running. The investigators also anticipate attenuated cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or uphill running performed at similar velocity but not when the comparison is done at similar metabolic power.

Official Title
-----------------
Comparison of Cardiorespiratory Responses to Treadmill Running at Different Slopes in Well-trained Athletes

Conditions
-----------------
Cardiorespiratory Responses, Well-trained Athletes

Intervention / Treatment
-----------------
* Other: Each participant will perform:


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be a well-trained runner with a VO2max > à 55 ml/kg/min nonsmoker or stopped smoking for 5 years BMI < 25 affiliation to the social health insurance scheme signing an informed consent form. Exclusion criteria: impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, ...); subject under the protection of justice subject under guardianship or curatorship contraindication to the practice of physical and sport activities lower limbs musculotendinous or articular problems respiratory, cardiovascular or metabolic pathology drug treatment in progress and impossibility to stop it within 7 days before the beginning of the study

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

Sexes Eligible for Study
-----------------
Male

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: well-trained athletes<br>A cardiorespiratory stress test | Other: Each participant will perform:<br>* Part 1: Maximal incremental tests will require running at fixed slopes (+15%, 0% -15%) for stages (2min duration) of increasing velocities (0.5, 1 and 1.5 km/h) Part two: submaximal running tests will require running at constant velocity (80% VO2max uphill; 80%VO2max downhill and downhill at similar velocity as uphill)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen | The peak oxygen uptake will be collected during downhill, flat and uphill running | 15 minutes |
Supra High-intensity Interval Training for Police Officers

Study Overview
=================
Brief Summary
-----------------
Police work is extreme in terms of the physical activity and physical exertion spectrum as it is composed of a mixture of enforced sitting and sudden physical exertion. Police officers remain sitting for the majority of their working hours. In theory, regular physical activity exerts a number of health and fitness benefits that could act on most issues that police officers suffer from. Supra high-intensity interval training (supra HIIT) appears to be a perfect solution for police officers as the training modality can be accomplished in less than 5 minutes. The primary purpose of this proposal is to create and assess supra HIIT program that is suitable for police officers and then to assess feasibility of such exercise program in a small pilot study.

Official Title
-----------------
Supra High-intensity Interval Training for Austin Police Officers

Conditions
-----------------
Physical Fitness

Intervention / Treatment
-----------------
* Behavioral: Supra high intensity interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Police officers in the local Police Department who are capable of performing physical exercise Exclusion Criteria: Being pregnant Having had a recent illness History of diabetes, heart disease, or other cardiovascular problems Recent surgery, orthopedic, or musculoskeletal injuries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supra high intensity interval training<br>The experimental group will engage in the high intensity interval training. | Behavioral: Supra high intensity interval training<br>* The exercise program will consist of eight 20-second all-out exercise bouts followed by 10 seconds of rest for a total of 4 minutes of total exercise duration. The intensity of exercise is all out. The exercise will be conducted 3 times a week for 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic power | Aerobic fitness or maximal oxygen consumption will be evaluated during incremental treadmill exercise tests (1% grade increase per minute at individualized treadmill speed). | 8 weeks |
NETs Formation in Patients With Recurrent Pyogenic Infections (NETS)

Study Overview
=================
Brief Summary
-----------------
We aim to study if pathological NETs formation could be the underlying pathology among patients with recurrent infections and a normal screening of the immune system.

Detailed Description
-----------------
Our laboratory at Meir Medical Center, Kfar Saba, is the country's main center for neutrophil function, and serves about 80% of Israel's population. Patients are referred subsequent to recurrent, persistent, or unusual infections and after completing preliminary screening of the immune system and ruling out a humoral, cellular or complement immune deficiency. Initial workup includes chemotaxis, superoxide production (SOP), and bactericidal activity (BA). Based on test findings, further evaluation for a qualitative phagocytic disorder is conducted. Overall, impairment of phagocytic activity is found in about 33% (impaired chemotaxis in 16%, SOP in 6%, and BA in 24%). In the other 67%, no impairment of the immune function is found that can explain their tendency for recurrent pyogenic infections. In 2004 a novel function of the neutrophil was identified: formation of neutrophil extracellular traps (NETs). Apparently, neutrophils are able to extrude part of their cellular contents in the form of DNA, histones and proteases, to form extra cellular NETS that trap and kill bacterial pathogens without the need for phagocytosis. We aim to study if pathological NETs formation could be the underlying pathology among these patients with recurrent infections and a normal screening of the immune system.

Official Title
-----------------
The Ability of Neutrophils From Patients With Recurrent Infections to Produce Neutrophil Extracellular Traps (NET).

Conditions
-----------------
Pyogenic Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrent, persistent, or unusual infections Referred for Neutrophil Functions Exclusion Criteria: None
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 |
| --- | --- | --- |
| Measure NET formation in patients with recurrent infections |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NETs, Infections, Neutrophil function
Pharmacogenomics Results Affect Patients' Plan of Care and Changes in Medication Prescription(s)

Study Overview
=================
Brief Summary
-----------------
Current providers' standard operating procedures on pharmacogenomic testing patients

Detailed Description
-----------------
The general design of this study is collecting data and reviewing Principal Investigators' Standard Operating Procedures on Pharmacogenomic testing and changes made to their specific SOP.

Official Title
-----------------
Medical Provider Experience and Assessment on Documenting Prescribing and Plan of Care Changes Due to Pharmacogenomics Testing

Conditions
-----------------
Pharmacogenomic

Intervention / Treatment
-----------------
* Genetic: pharmacogenomic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a Medical Practitioner Medical Doctor (MD) Doctor of Osteopathic (DO) Physician Assistant (PA) Advanced Practice Registered Nurse (APRN) Nurse Practioner (NP) Must have a current standard operating procedure that includes obtaining/reviewing medical history. Exclusion Criteria: Government-funded insurance data cannot be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: pharmacogenomic|Standard Operating Procedures on Pharmacogenomic testing and changes made to specific SOP|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Structures and Processes | Plan of Care Changes due to Pharmacogenomic testing. Provider based observational survey system on the health and well-being of patients and populations | 36 months |
Evaluation of Outcomes From Treatment of Benign or Malignant Gastrointestinal Diseases

Study Overview
=================
Brief Summary
-----------------
This study will be a retrospective, registry study collecting data of patients who were diagnosed with benign or malignant gastrointestinal diseases. Data will be collected from patient's chart retrospectively once the patients have completed proper treatment follow up with physicians' practice.

Detailed Description
-----------------
It is reported in the literature that the treatment of any gastrointestinal disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with gastrointestinal cancer continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. The goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity. The main aim of this study is to evaluate and compare the outcomes from our treatment of benign or malignant gastrointestinal diseases through medical chart review. There is a need to understand and improve the current diagnosis and treatment algorithm for gastrointestinal pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.

Official Title
-----------------
Evaluation of Outcomes From Treatment of Benign or Malignant Gastrointestinal Diseases

Conditions
-----------------
Gastrointestinal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed and treated for gastrointestinal diseases, benign or malignant from 2005 to 2030. Age ≥18 years Exclusion Criteria: Patients that are not diagnosed with or treated for gastrointestinal diseases Age <18 years

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 |
| --- | --- | --- |
| Overall survival | from day of diagnosis or procedure to death date | Jan 2005 - Jan 2030 | 
| Overall symptom | Difficulty swallowing, Heartburn, Regurgitation, Chest pain, Weight Loss, Quality of life | Jan 2005 - Jan 2030 | 
| Mortality | death or life | Jan 2005 - Jan 2030 | 
| Morbidity | yes or no to individual disease | Jan 2005 - Jan 2030 |
The Effect of UV-Irradiation on Cutaneous Cicatrices

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of UV-irradiation on human cutaneous cicatrices by clinical examinations and histological, immunohistochemical and biochemical analyses.

Official Title
-----------------
The Effect of UV-Irradiation on Cutaneous Cicatrices -A Randomised, Controlled Study With Clinical, Skin Reflectance, Histological and Biochemical Evaluations

Conditions
-----------------
Skin Cicatrices

Intervention / Treatment
-----------------
* Device: ultraviolet light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking volunteers, Skintypes II or III Exclusion Criteria: Atopic dermatitis, Tendency to produce keloids or hypertrophic scars, Exposure of UV light during the last 3 months, Medical treatment

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

Sexes Eligible for Study
-----------------
Male

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
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ultraviolet light|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors

Study Overview
=================
Brief Summary
-----------------
RIMRA is a prospective, longitudinal, observational study including patients with de novo symptoms of rheumatic disease or a flare of established rheumatic disease after treatment with an immune check point inhibitor. The aim of the study is to describe the clinical presentation, disease course and outcome of rheumatic irAEs in patients treated with immune check point inhibitors.

Official Title
-----------------
Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors - a Prospective Observational Study

Conditions
-----------------
Immune-related Adverse Event

Intervention / Treatment
-----------------
* Other: Antiinflammatory/DMARDs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo symptoms of rheumatic disease or a flare of established rheumatic disease after >/= 1 dose of treatment with an immune check point inhibitor Adult patients (> 18 years) Subject capable of understanding and signing an informed consent form Exclusion Criteria: • Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Antiinflammatory/DMARDs|Antiinflammatory/DMARDs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swollen joint count | Numbers (0-66) | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein | mg/L | 1 year | 
| Proportion of pateints with arthritis after one year |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthritis, check point inhibitor, irAE
Selenium Treatment in Autoimmune Thyroiditis (AIT)

Study Overview
=================
Brief Summary
-----------------
Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.

Official Title
-----------------
Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses

Conditions
-----------------
Autoimmune Thyroiditis, Hashimotos Thyroiditis

Intervention / Treatment
-----------------
* Drug: L-Selenomethionine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range. Exclusion Criteria: Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-Selenomethionine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| statistically important change in serum TPOAb titers. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe the long term effects to 9th mo. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroiditis, Autoimmune, Hashimoto's, TPOAb, Selenium