linjc16/ctgov huggingface dataset:
PET/CT and Sentinel Node in Oral Cancer

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral cancer and, after permission of each patient, also normal oral tissue will be analyzed molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers. The investigators want to see if PET/CT is able to detect any signs of sub-clinically metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the head-and-neck region.

Detailed Description
-----------------
These patients are normally preoperatively sent to a CT scan of the thorax and abdomen; in this study, this CT is replaced by a wholebody PET/CT scan. Afterwards, the patients goes to sentinel node lymphoscintigraphy and then to operation. By combining biomarkers and molecular imaging in patients with a clinically T1/T2N0M0 oral cancer, we want to characterize the tumor physiologically and correlate these physiological features to the clinical appearance of the cancer. Aims of the study: can PET/CT in this patient group metastases with consequently change of treatment? can fusion of SPECT/CT and PET/CT with calculation of standardized uptake value (SUV) indicate, how much tumor tissue there should be in a positive sentinel node to be detected by PET? can dual-time PET scanning better determine lymph node metastases, than single-time PET scanning? correlation between SUV in PET with molecular-biological findings both in the primary tumor and in metastases

Official Title
-----------------
Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer

Conditions
-----------------
Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-verified oral cancer over 18 years of age Exclusion Criteria: under 18 years of age inable patients pregnancy known allergy to contrast agents kidney insufficiency other known cancer diabetes mellitus acute medical conditions such as acute infection, acute cardial or lung disease or other intercurrent diseases

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dual-time PET/CT, sentinel node
Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.

Official Title
-----------------
A Randomized Controlled Trial of 2 Different Methods for Pain Relief During Intrauterine Device Insertion

Conditions
-----------------
Family Planning

Intervention / Treatment
-----------------
* Drug: diclofenac sodium (cataflam)
* Drug: hyoscine butyl bromide (buscopan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women not taken analgesics or anxiolytics in the 24 hours prior insertion Women not taken misoprostol prior to intrauterine device insertion Women who will accept to participate in the study Exclusion Criteria: Any contraindication to intrauterine device placement

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diclofenac<br>oral diclofuhenac sodium | Drug: diclofenac sodium (cataflam)<br>* The patients in the study group will take one tablet of cataflam 50 mg 30 min before the scheduled time of the procedure<br>|
| Active Comparator: hyoscine<br>oral hyoscine butyl bromide | Drug: hyoscine butyl bromide (buscopan)<br>* The patients in the study group will take one tablet of buscopan 10 mg 30 min before the scheduled time of the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during insertion |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction score |  | 5 minutes |
Is There a Correlation Between Surgical Technique for Primary Anterior Cruciate Ligament Surgery and the Risk of Subsequent Formation of Fibrous Cyst (Cyclops) in the Knee Joint, Which Leads to the Need for Surgical Removal of the Cyclops?

Study Overview
=================
Brief Summary
-----------------
Fibrous scar tissue formation (Cyclops) after a primary anterior cruciate ligament reconstruction (ACLr) may affect patients' ability to perform work and exercise to such an extent that further arthroscopic surgery may be necessary. The purpose of the study is to estimate the 2-year incidence of removal of cyclops lesion after ACLr for a cohort of approximal 3000 patients operated at Aarhus University Hospital in the period 2005-2019. Specifically, change in surgical technique and graft choice will be analyzed.

Official Title
-----------------
Is There a Correlation Between Surgical Technique for Primary Anterior Cruciate Ligament Surgery and the Risk of Subsequent Formation of Fibrous Cyst (Cyclops) in the Knee Joint, Which Leads to the Need for Surgical Removal of the Cyclops? A Registry Study With Patients Operated on With Cruciate Ligament Reconstruction at Aarhus University Hospital From 2005-2019.

Conditions
-----------------
Cyclop Arthrofibrosis Anterior Cruciate Ligament

Intervention / Treatment
-----------------
* Procedure: Patients with Cyclop lesion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient >18 years Primary ACL reconstruction Exclusion Criteria: Multiligament reconstruction Revisions ACL reconstruction with double bundle graft

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Cyclop lesion<br>Patients with an anterior cruciate ligament reconstruction with a symptomatic Cyclop lesion leading to a arthroscopy within 2 years after primary surgery | Procedure: Patients with Cyclop lesion<br>* Arthroscopy with resection of Cyclop formation<br>|
| Patients without Cyclop lesion<br>Patients without no arthroscopy within 2 years after primary surgery | Procedure: Patients with Cyclop lesion<br>* Arthroscopy with resection of Cyclop formation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cyclop lesion | Incidence of Arthroscopy with removal of Cyclop formation | 2 years |
Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC) transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem cell will be derived from patients' bone marrows and will be infused via peripheral vein. Liver biopsies will be performed in every patient in the beginning and at 6th month.

Official Title
-----------------
Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Genetic: autologous mesenchymal stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: radiological, clinical and histopathological diagnosis of liver cirrhosis absence of hepatocellular carcinoma or any malignancies no psychiatric disorder no serous cardiovascular and pulmonary comorbidities serum total bilirubin levels less than 5 mg/dL platelet counts more than 30.000 mm3 more than one year follow up period after initiation of antiviral drugs Exclusion Criteria: alcohol intake in last one year initiation of antiviral medication in last one year systemic diseases

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous mesenchymal stem cell transplantation<br> | Genetic: autologous mesenchymal stem cell transplantation<br>* Every patient is given 1x106 MSCs per kg infused via peripheral vein.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement | biochemical and hematologic parameters | clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver regeneration | histopathologic assesments comparing before and at 6th month liver biopsies | 6.th month after MSC transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver cirrhosis, autologous mesenchymal stem cell transplantation
Effect of Zinc on Barrett's Metaplasia

Study Overview
=================
Brief Summary
-----------------
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions: can this zinc administration cause molecular-level changes in the Barrett's tissue? are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

Detailed Description
-----------------
14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.

Official Title
-----------------
Effect of Zinc on Barrett's Metaplasia

Conditions
-----------------
Barrett's Metaplasia

Intervention / Treatment
-----------------
* Drug: zinc gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:ages 18-80; prior diagnosis of Barrett's esophagus - Exclusion Criteria:unable to provide written, informed consent; prior history of Barrett's dysplasia or esophageal adenocarcinoma; drug exclusions: hormone replacement therapy, cholestyramine, amiloride diuretics, oral quinolone antibiotics, glucocorticoids, corticosteroids, anticoagulants (other than aspirin) -

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc<br> | Drug: zinc gluconate<br>* 26.6 mg zinc BID (as zinc gluconate)<br>|
| Placebo Comparator: sodium<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in zinc-regulated cellular proteins within Barrett's tissue |  | in biopsy tissue after 14 days of Zn exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cellular microRNA profile; changes in protein cancer biomarkers |  | in biopsy tissue after 14 days of Zn exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's esophagus, Esophagus, Adenocarcinoma
Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals

Official Title
-----------------
Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic

Conditions
-----------------
Hypoxia, Hypercapnia, COVID-19 Pandemic

Intervention / Treatment
-----------------
* Behavioral: face masks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dental professionals Exclusion Criteria: subjects not signing informed consent subjects unable to wear facemasks due to underlying conditions

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dental professionals wearing FFP2/N95 masks<br> | Behavioral: face masks<br>* wearing face masks<br>|
| dental professionals wearing type IIR fluid resistant surgical masks<br> | Behavioral: face masks<br>* wearing face masks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in peripheral oxygen saturation using FFP2/N95 masks |  | before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours |
Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.

Official Title
-----------------
Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: 2006-RD-05
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged 18 - 60 In good health BMI between 20 and 30 kg/m2 Non-smoking Exclusion Criteria: Allergic to study drug Use of immune-modulating drugs Uncontrolled hypertension (Systolic > 140 or diastolic > 90) Women of childbearing age not using proper contraception, that is pregnant or breastfeeding

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?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Dietary Supplement: Placebo<br>* Capsule similar in shape, weight and color from active, once a day for 28 consecutive days<br>|
| Experimental: Treated<br> | Dietary Supplement: 2006-RD-05<br>* 300 mg daily, once a day for 28 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | Baseline, 14 days, 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IgA titers |  | Baseline, 14 days, 28 days | 
| Salivary IgA titers |  | Baseline, 14 days, 28 days |
Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Study Overview
=================
Brief Summary
-----------------
Accuracy of the oximeter.

Detailed Description
-----------------
The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures the arterial blood oxygenation. There are many clinical situations where tissue hypoxia may exist despite normal values obtained by conventional pulse oximeter. This can be cause by inadequate monitoring of oxygen demand (i.e. venous oxygen saturation) of the tissues. The existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to those critically ill patients. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest. More complete information on patient hemodynamics can be provided by non-invasively monitoring of venous blood oxygenation.

Official Title
-----------------
Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: Mespere Oximeter
* Device: Radiometer OSM-3 Co-Oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between the ages of 21 and 49 years of either gender Exclusion Criteria: smokers pregnancy any chronic medical condition including heart disease, hypertension, pulmonary disease, liver or kidney disease obesity evidence of abnormal neck vein anatomy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 49 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 |
| --- | --- |
| Healthy volunteers<br>9 subjects (male and female) | Device: Mespere Oximeter<br>* Mespere oximeter provides non-invasive venous blood oxygen saturation.<br>Device: Radiometer OSM-3 Co-Oximeter<br>* OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Oxygen Saturation Accuracy Verification against Co-Oximeter |  | approximately 1 hour |
Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

Study Overview
=================
Brief Summary
-----------------
The aim is to explore the human urine composition and its relation to urine tract infections

Official Title
-----------------
Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Other: urine sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months For healthy volunteers without UTIs: No diag-nosed UTIs within the last year For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics) Exclusion Criteria: Be treated for urinary tract infection at time of enrolment May not take prophylactic treatment for urinary tract infections (antibiotics only)

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers with no urinary tract infections<br>people who don't experience urinary tract infections | Other: urine sample<br>* The subjects are asked to give a maximum of 15 urine samples during the study<br>|
| Healthy volunteers with urinary tract infections<br>people who frequently experience urinary tract infections | Other: urine sample<br>* The subjects are asked to give a maximum of 15 urine samples during the study<br>|
| Intermittent catheter users with neurogenic bladder<br> | Other: urine sample<br>* The subjects are asked to give a maximum of 15 urine samples during the study<br>|
| Intermittent catheter users with enlarged prostate<br> | Other: urine sample<br>* The subjects are asked to give a maximum of 15 urine samples during the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of bacteria present in the urine | The different bacteria isolated present in the urine will be identified | 1 year |