linjc16/ctgov huggingface dataset:
Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
To compare the performance of the QuantiFERON Monitor assay against existing methodology.

Conditions
-----------------
Cell-mediated Immune Response

Intervention / Treatment
-----------------
* Device: QuantiFERON Monitor Assay
* Device: Existing methodology


Participation Criteria
=================
Eligibility Criteria
-----------------
Solid Organ Transplant Recipient Inclusion Criteria: Provide Informed Consent Received a solid organ transplant Exclusion Criteria: Pregnancy or recent lactation (<1yr) Treatment of Rejection Healthy Control Inclusion Criteria: Provide Informed Consent Exclusion Criteria: Currently taking any immunomodulatory medication A history of immunosuppressive disease or immunosuppression condition or history of autoimmune diseases Current pregnancy or recent lactation (<1yr) Currently taking antiviral medication Currently being treated for infectious diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Solid Organ Transplant Recipients<br>Subjects who have received a Solid Organ Transplant. | Device: QuantiFERON Monitor Assay<br>* Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.<br>Device: Existing methodology<br>* Assay to measure cell-mediated immune function using existing methodology.<br>|
| Healthy Controls<br>Healthy individuals. | Device: QuantiFERON Monitor Assay<br>* Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.<br>Device: Existing methodology<br>* Assay to measure cell-mediated immune function using existing methodology.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell-mediated immune response. |  | 1 day (At time of enrollment) |
Exercise During Chemotherapy for Patients With Hematological Malignancies

Study Overview
=================
Brief Summary
-----------------
The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.

Official Title
-----------------
Exercise During Chemotherapy for Patients With Hematological Malignancies

Conditions
-----------------
Hematological Diseases, Hematological Malignancies

Intervention / Treatment
-----------------
* Other: Aerobic exercise
* Behavioral: Fatigue counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hematological malignant disease Current chemotherapy Understanding of written German Exclusion Criteria: Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise Pathological stress-ECG at recruitment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Behavioral: Fatigue counseling<br>* The patients will receive a counseling regarding the causes of fatigue, how to cope with this symptom, and general recommendations about exercise. However, they will not participate at a structured exercise program.<br>|
| Experimental: Exercise<br> | Other: Aerobic exercise<br>* The patients will carry out an aerobic exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The training will be carried out three times a week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  | At recruitment and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | At recruitment and after 12 weeks | 
| Physical performance |  | At recruitment and after 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Leukemia, Multiple myeloma, Hodgkin´s disease, Exercise, Sport, Fatigue, Hematological neoplastic diseases
Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network

Study Overview
=================
Brief Summary
-----------------
Survey on the prevalence of MDRO to monitor the import of MDRO from the community. Rectal swabs will be taken and cultivated. Survey on community-onset and nosocomial bloodstream infections will be documented and strains will be isolated. For each BSI a clinical data set will be obtained (e.g. patient age, gender, date of hospitalization, antibiotic therapy). Genetic analysis of MDRO from the prevalence and BSI study. In a subset of patients the microbiome-resistome interactome will be analysed in more detail. Furthermore, the impact of infection control measures due to the Covid-19 pandemic on nosocomial BSI will be investigated.

Official Title
-----------------
Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network

Conditions
-----------------
MDRO

Intervention / Treatment
-----------------
* Other: rectal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old informed consent inpatient Exclusion Criteria: less than 18 years old Not capable of giving informed consent outpatient

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: rectal swab|collection of rectal swabs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitoring of MDRO prevalence | obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure | at hospital admission | 
| monitoring of blood stream infections | obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure | during hospitalization, up to 4 weeks | 
| integrate novel techniques for microbiome-resistome interaction analysis | obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure | through study completion, after 4 years |
Impact of N-Acetylcysteine on Oxidative Stress and Renal Function in Deceased Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The aim of this interventional, prospective, randomized clinical trial is to evaluate the impact of the antioxidant N-acetylcysteine on oxidative stress in the first seven postoperative days and on renal function in the first three postoperative months in deceased kidney transplantation.

Official Title
-----------------
Oxidative Stress and Postoperatory Renal Function in Deceased Kidney Transplantation

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

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First transplant Deceased kidney transplant Exclusion Criteria: postoperative recovery at critical care unit illicit drug addiction psychiatric disorders

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NAC<br>treatment | Drug: N-acetylcysteine<br>* 600 mg bid orally from day 1 to 7 postoperative<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tiobarbituric acid reactive species measures |  | First seven postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine |  | 7, 15, 30, 60, 90 postoperative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney, deceased kidney transplant, oxidative stress, renal function measurements
A Study of Cognitive Health in Survivors of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information that may help the researchers understand the relationship between prostate cancer survivors' experiences of cancer-related cognitive dysfunction (CRCD) and their other conditions (co-morbid factors), including anxiety, depression, and insomnia. The researchers will also find out how additional things may contribute to CRCD, including social factors, the characteristics of participants' prostate cancer, and the type of cancer treatment or other medications they received.

Official Title
-----------------
Prostate Cancer Survivorship and Cognitive Health (PRO-HEALTH)

Conditions
-----------------
Prostate Cancer, Survivorship

Intervention / Treatment
-----------------
* Behavioral: PROMIS-SF v2.0 -Cognitive Function 8a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking Age 18 years or older History of histologically documented PC of any stage No evidence of PC Disease Exclusion Criteria: <1 month since completion of surgery, radiation, chemotherapy, or ADT Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder Score >10 indicative of dementia on Blessed Orientation Memory Concentration

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survivors of Prostate Cancer<br> | Behavioral: PROMIS-SF v2.0 -Cognitive Function 8a<br>* Patient-Reported Outcomes (PROs)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with co-morbid symptoms | All participants will be evaluable as long as they have completed the PROMIS-SF v2.0 - Cognitive Function 8a. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive health, Quality of Life, 22-223
Potential Research Study Participant Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the potential research study participant registry is to keep potential research subjects informed about any future research studies in which they may meet the criteria for enrollment. The purpose of this study is also to assist current and future clinical trials with recruitment of subjects.

Detailed Description
-----------------
Methods: Subjects will self identify themselves via the UCDMC Dermatology website to complete a survey regarding their interest in learning about future dermatology clinical research projects. Subjects provide contact information and check of a list of potential topics of interest. Procedures: Potential participants will find a link on the UCDMC Dermatology website to our registry. The potential participant will read information about the registry. If they wish additional information, they can follow a link to the potential research registry consent form. At this stage, the potential participant may answer, no to the consent form and they will be redirected back to the Clinical trials website. If they answer, yes then they will be linked to the registry questionnaire. The potential subject would then decide if they want to participate in the registry and if so what information they want to provide. The Clinical Research Coordinators would contact potential study participants to see if they meet the eligibility criteria for any of our current studies.

Official Title
-----------------
Potential Research Study Participant Registry

Conditions
-----------------
Leg Ulcers, Acne, Actinic Keratosis, Dysplastic Nevi, Eczema, Psoriasis, Skin Cancer, Rosacea, Foot Ulcers, Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Exclusion Criteria: Under 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify Dermatology Clinical research topics of interest in the community. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Acne, Actinic Keratosis, Dysplastic Nevi, Eczema, Vitiligo, Skin Cancer, Rosacea, Leg or Foot Ulcers, Atopic Dermatosis
Correspondence of Folate Dietary Intake and Biomarker Data

Study Overview
=================
Brief Summary
-----------------
This NHANES analysis compares self-reported dietary folate with serum and red blood cell folate status in U.S. adults.

Detailed Description
-----------------
Background: Public health concerns of both low and high folate status exist in the U.S. Recent publications have questioned the utility of self-reported dietary intake data in research and monitoring. Objective: The purpose of this analysis was to examine the relationship between self-reported folate intakes and folate status biomarkers, and to evaluate their usefulness for several types of applications. Design: Usual dietary intakes of folate were examined using the National Cancer Institute (NCI) method to adjust 2, 24-hour dietary recalls (including dietary supplements) for within-person variation and compared these intakes with serum and red blood cell (RBC) folate among 4,878 non-pregnant, non-lactating participants ≥19y in NHANES 2011-2012, a nationally representative, cross-sectional survey, with respect to consistency across prevalence estimates and rank order comparisons.

Official Title
-----------------
Correspondence of Dietary Intake and Biomarker Data

Conditions
-----------------
Folate Deficiency

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults, ages 19+ years Exclusion Criteria: missing data non-pregnant non-lactating

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Folate status | Comparison of folate in diet and blood | Up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NHANES, Folate, Folic Acid
Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
It is very important to evaluate the degree of gastrointestinal dysfunction in critical ill patients. Thus the investigators conducted transabdominal intestine ultrasonography(US) in critical ill patients to evaluated the degree of gastrointestinal dysfunction under the acute gastrointestinal injury (AGI)

Official Title
-----------------
Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients：A Prospective, Observational Study

Conditions
-----------------
Gastrointestinal Dysfunction, Critical Illness, Intestine Ultrasonography

Intervention / Treatment
-----------------
* Diagnostic Test: GIF score
* Diagnostic Test: US score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged more than 18 years Acute Physiology Chronic Health Evaluation II (APACHE II) score >8 Exclusion Criteria: uncontrolled mesenteric vascular disease uncontrolled chronic organ dysfunction advanced cancer any terminal stage disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| GIF score<br>assess the AGI by gastrointestinal failure(GIF) score | Diagnostic Test: GIF score<br>* assessment by GIF score<br>Diagnostic Test: US score<br>* assessment by ultrasonography score<br>|
| US score<br>assess the AGI by ultrasonography(US) score | Diagnostic Test: GIF score<br>* assessment by GIF score<br>Diagnostic Test: US score<br>* assessment by ultrasonography score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predict value of 28-day mortality | predict value of 28-day mortality | one and a half year |
Research Study in Patients With Severe Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Detailed Description
-----------------
A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

Official Title
-----------------
A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Visilizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry. Active disease despite ongoing treatment with steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Visilizumab|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
-----------------
Colitis, Gastrointestinal Disease, Digestive System Disease, Intestinal Disease, Colonic Disease
Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT

Study Overview
=================
Brief Summary
-----------------
In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.

Detailed Description
-----------------
This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men. The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months. The secondary study goals are to evaluate the effect of vitamin D supplementation on peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells and LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.

Official Title
-----------------
Pilot Study to Assess the Effects of Vitamin D Supplementation on the Number of Regulatory FoxP3+ T Cells in the Gastrointestinal Mucosa in Healthy Women and Men: Step 3 in the Austrian Diabetes Prevention Programme

Conditions
-----------------
Immune Tolerance

Intervention / Treatment
-----------------
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years non smoker BMI: 20-30 kg/m² Healthy Exclusion Criteria: hypercalcemia > 2,65 mmol/L pregnancy chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Cholecalciferol<br> | Drug: Cholecalciferol<br>* weekly dose (based on 70IU KG body weight/day)<br>* Other names: Oleovit D3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of regulatory FOXP3+ T cells | the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other immune cells in the gastrointestinal mucosa |  | 2 months | 
| serum calcium level |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, regulatory T cells, GUT