linjc16/ctgov huggingface dataset:
25-hydroxyvitamin D and Fatigue: The VITALITY Study

Study Overview
=================
Brief Summary
-----------------
The burden of chronic disease is continuing to rise. Even though patients may be in remission or have quiescent disease, several studies have confirmed that symptoms, such as e.g., fatigue, is troublesome. The primary aim of this study is to investigate whether or not there might be an association between levels of vitamin D and the subjective experience of fatigue in conditions, such as inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel syndrome. Secondary aims is to study both the co-occurence and influence of pain, depression and anxiety.

Detailed Description
-----------------
The burden of chronic disease is continuing to rise. Even though patients may be in remission or have quiescent disease, several studies have confirmed that symptoms, such as e.g., fatigue, is troublesome.Previous studies have confirmed that vitamin D deficiency is associated with both Crohn's disease and Rheumatoid Arthritis. Since Vitamin D is associated with both onset of chronic disease and energy, we aim in this study to assess its impact on fatigue in various chronic diseases. The primary aim of this study is to investigate whether or not there might be an association between levels of vitamin D and the subjective experience of fatigue in conditions, such as inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel syndrome. Secondary aims is to study both the co-occurence and influence of pain, depression and anxiety.

Official Title
-----------------
Vitamin D, Fatigue and Patient Reported Outcome (PRO) in Chronic Somatic and Functional Disorders.

Conditions
-----------------
Irritable Bowel Syndrome, Inflammatory Bowel Disease, Diabetes, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent, over 18 years of age Exclusion Criteria: dementia, cognitive disorders, not able to comply with the study procedures, on active vitamin D treatment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory Bowel Disease<br>Ulcerative Colitis and Crohns's disease patients will be recruited from sqeduled outpatient follow-up | |
| Irritable Bowel Syndrome<br>Irritable Bowel patients will be recruited from sqeduled outpatient follow-up | |
| Rheumatoid Arthritis<br>Rheumatoid Arthritis patients will be recruited from sqeduled outpatient follow-up | |
| Diabetes Mellitus<br>Diabetes mellitus patients will be recruited from sqeduled outpatient follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Fatigue and the impact of vitamin d levels | 2 years |
Gore Tex Implants in the Treatment of Atrophic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore tex® implants in the nasal fossa. The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. Diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment already established, this technique improves the options of treatment. All patients have improved after the procedure.

Detailed Description
-----------------
Data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. The symptoms and complications were described.

Official Title
-----------------
Gore Tex Implants in the Treatment of Atrophic Rhinitis

Conditions
-----------------
Atrophic Rhinitis

Intervention / Treatment
-----------------
* Other: implants of polytetrafluoroethylene in tha nasal fossa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of atrophic rhinitis, with previous clinical treatment without good results Exclusion Criteria: Patients with mental illness
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| polytetrafluoroethylene<br> | Other: implants of polytetrafluoroethylene in tha nasal fossa<br>* surgical implants of polytetrafluoroethylene in the nasal fossa<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of fetid crusts and atrophy of the mucous bone covering |  | after surgery recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lack of side effects such as infection |  | after the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrophic rhinitis, implants, Polytetrafluoroethylene
Continous Assessment of Cerebral Autoregulation With Near-infrared Spectroscopy

Study Overview
=================
Brief Summary
-----------------
Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the context of changes in cerebral perfusion pressure. In this study, investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.

Detailed Description
-----------------
Near-infrared spectroscopy (NIRS) is a noninvasive technology that real-time monitors cerebral tissue oxygenation index (TOI). Investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation of hypertensive participants and non-hypertensive participants.

Official Title
-----------------
Continous Assessment of Cerebral Autoregulation With Near-infrared Spectroscopy

Conditions
-----------------
Cerebral Blood Flow, Cerebral Perfusion Pressure

Intervention / Treatment
-----------------
* Device: measure TOI and BP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health people, or people with hypertension Exclusion Criteria: diabetes, anemia, liver disease, kidney disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| normal<br>Human without hypertension, diabetes, anemia, liver disease and kidney disease. The group will measure TOI and BP. | Device: measure TOI and BP<br>* Both groups measure TOI and BP.<br>|
| hypertension<br>Human only have hypertension, without diabetes, anemia, liver disease and kidney disease. Hypertension group will measure TOI and BP. | Device: measure TOI and BP<br>* Both groups measure TOI and BP.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of cerebral autoregulation |  | 30min |
123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors.

Conditions
-----------------
Carcinoid Tumors, Paraganglioma, Pheochromocytoma, Neuroblastoma, Medullary Thyroid Carcinoma

Intervention / Treatment
-----------------
* Drug: 123I-meta-iodobenzylguanidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a clinical indication for 123I-MIBG imaging to evaluate for the presence, extent, or status of neuroendocrine tumors; subjects must be able and willing to comply with study procedures. Exclusion Criteria: Subjects with history of renal insufficiency (serum creatinine level > 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake; Subjects unable to tolerate lying supine; Subjects pregnant or breastfeeding, unless the information to be gained outweighs the possible hazardous effects of 123I-MIBG administration. Where the assessment of the risk/benefit ration suggests the use of 123I-MIBG in nursing mothers, the breastfeeding should be discontinued for at least 48 hours post-injection.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 123I-meta-iodobenzylguanidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.

Official Title
-----------------
A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: fluticasone propionate/formoterol fumarate
* Drug: fluticasone propionate
* Drug: formoterol fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand the requirements of the study and provide consent Medical diagnosis of COPD A current or prior history of at least 10-pack years of cigarette smoking Female of child-bearing potential to use adequate birth control Exclusion Criteria: Diagnosis of asthma Other significant disease than COPD Has donated a unit of blood within 30 days of study, or intends to donate QTc greater than 0.460 seconds Subjects who had radiation or chemotherapy in the previous 12 months Subjects who had lung resection History of illegal drug abuse or alcohol abuse within the past 5 years

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: fluticasone propionate/formoterol fumarate<br>* inhalation suspension<br>|
| Experimental: 2<br> | Drug: fluticasone propionate/formoterol fumarate<br>* inhalation suspension<br>|
| Active Comparator: 3<br> | Drug: fluticasone propionate<br>* inhalation suspension<br>|
| Active Comparator: 4<br> | Drug: fluticasone propionate<br>* inhalation suspension<br>|
| Active Comparator: 5<br> | Drug: formoterol fumarate<br>* inhalation solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma AUC(0-t) after 1 week of dosing |  | PK sampling over 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  | pre-dose and 2 hrs post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic, Obstructive, Pulmonary, Disease, COPD, Pharmacodynamic, Pharmacokinetic
Assessment of Hemostatic Profile in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Our study included both in- and outpatients suffering from liver cirrhosis attending the out- and inpatient care of the department of hepatology. Demographic and biochemical data as well as medical history including cause of liver cirrhosis, end stage kidney failure and medication with anticoagulants were recorded. To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM).

Official Title
-----------------
Assessment of Hemostatic Profile in Patients With Mild to Advanced Liver Cirrhosis

Conditions
-----------------
Coagulation Disorder

Intervention / Treatment
-----------------
* Other: Assessment of hemostatic profile


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver cirrhosis age of ≥ 18 years platelet count of at least 70 / nl Exclusion Criteria: transfusion of platelet concentrate three weeks prior to inclusion pregnancy age < 18 years missing informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low MELD score<br>MELD score of 6 - 11 | Other: Assessment of hemostatic profile<br>* To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM)<br>* Other names: Thrombelastometry; impedance aggregometry;|
| High MELD score<br>MELD score of ≥ 17 | Other: Assessment of hemostatic profile<br>* To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM)<br>* Other names: Thrombelastometry; impedance aggregometry;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregation of platelets | AUC of impedance aggregometry using multiple electrode aggregometry | Venous blood was collected via a cannula inserted into a cubital vein. Platelet function was measured by MEA using the Multiplate analyzer 15min after blood draw and after activation with commercially available standard reagents | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viscoelastic measurements | Viscoelastic measurements of ROTEM assays (EXTEM, INTEM, FIBTEM) | Venous blood was collected via a cannula inserted into a cubital vein. Thrombelastometric assays were performed 15min after blood draw. |
Quantitative COVID-19 SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

Detailed Description
-----------------
This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB). During CPB the patients' blood volume is removed from the body and sent through the CPB machine. CPB consists of a pump (to keep blood moving) and oxygenator (to oxygenate blood). The oxygenator or CPB circuitry may effect antibody levels. In addition, patients on CPB experience hemodilution from blood transfusion and priming volume from the CPB circuit. Hemodilution may effect antibody levels. Prior to CPB, during standard of care lab drawn from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for pre-CPB quantitative antibody testing. On morning of postoperative day 1, during standard of care lab draw from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing. On morning of postoperative day 5, during standard of care lab draw, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing. If patient is discharged from the hospital prior to postoperative day #5, this immunoassay will be omitted.

Official Title
-----------------
Quantitative SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass

Conditions
-----------------
Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 Antibody test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of FDA approved or Emergency Use Authorization Covid vaccine. Exclusion Criteria: Age < 18. Patients with indeterminant history of vaccination schedule.

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 |
| --- |
|Diagnostic Test: SARS-CoV-2 Antibody test|SARS-CoV-2 antibody test at Jefferson is Roche Elecsys Anti-SARS-CoV-2 immunoassays performed under FDA's Emergency Use Authorization.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess antibody levels before and after CPB. | assess antibody levels before and after CPB. | preop and up to 5 days post op |
Post Marketing Surveillance Study of Cuprimine

Study Overview
=================
Brief Summary
-----------------
Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a Compassionate Special Permit issued by the Bureau of Food and Drugs. Physicians were able to request the drug for their patients from the Sponsor. A Clinical Study Report form was completed for each purchase of Cuprimine.

Official Title
-----------------
Post Marketing Surveillance Study of Cuprimine (MK-0172-001)

Conditions
-----------------
Scleroderma

Intervention / Treatment
-----------------
* Drug: Cuprimine (penicillamine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - None Exclusion Criteria: - None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cuprimine (penicillamine)|Dosage determined by the physician based on indication for treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Vivity Outcomes in Patients With Early Stage Glaucoma

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).

Official Title
-----------------
Vivity Outcomes in Patients With Early Stage Glaucoma

Conditions
-----------------
Glaucoma, Cataract, Presbyopia

Intervention / Treatment
-----------------
* Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS) Subjects with documented diagnosis of pre-perimetric glaucoma Calculated lens power within Vivity/Vivity toric range Willing and able to comprehend informed consent and complete 4-6 month post-op visit Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion Exclusion Criteria: Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA Previous ocular surgery including refractive surgery Subjects who are pregnant or plan to become pregnant during the course of the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vivity<br>Patients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery. | Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL<br>* Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Distance Visual Acuity |  | 4-6 months | 
| Uncorrected Intermediate Visual Acuity |  | 4-6 months | 
| Uncorrected Near Visual Acuity |  | 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Sensitivity | As measured by Pelli Robson Chart | 4-6 months | 
| Patient Satisfaction and Spectacle Independence Survey Results |  | 4-6 months | 
| Mean Refractive Spherical Equivalent |  | 4-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extended Range of Vision, Intraocular Lens Technology, Glaucoma