linjc16/ctgov huggingface dataset:
Mechanisms for Organ Dysfunction in Covid-19

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.

Detailed Description
-----------------
Consenting patients with suspected or verified SARS-COV-2 infection, COVID-19, will undergo daily blood, urine and sputum sampling during their stay in intensive care. Data on organ dysfunction will be collected through the electronic patient journal and electronic patient data management system. The collected samples will be analysed for a panel of potential biomarkers that will be correlated to organ dysfunction and clinical outcome.

Official Title
-----------------
Uppsala Intensive Care Study of Mechanisms for Organ Dysfunction in Covid-19

Conditions
-----------------
COVID-19, Organ Dysfunction Syndrome Sepsis, Organ Dysfunction Syndrome, Multiple, Septic Shock, Acute Kidney Injury, Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to intensive care suspected or verified COVID-19 Exclusion Criteria: Pregnancy or breastfeeding Under-age

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 |
| --- | --- |
| COVID-19<br>Patients with suspected or verified COVID-19 admitted to intensive care at Uppsala University Hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | KDIGO AKI score | During Intensive Care, an estimated average of 10 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARDS | Acute Respiratory Distress Syndrome yes/no | During intensive care, an estimated average of 10 days. | 
| 30 day mortality | Death within 30 days of ICU admission | 30 days | 
| 1 year mortality | Death within 1 year of ICU admission | 1 year | 
| Chronic Kidney Disease | Development of Chronic Kidney Disease | 60 days and 1 year after ICU admission | 
| SOFA-score | Sequential Organ Failure Score as a continuous variable | During Intensive Care, an estimated average of 10 days. | 
| Thromboembolic events | Occurence of thrombosis and/or embolous | During intensive care | 
| ICUAW | Intensive care acquired weakness | During intensive care or after intensive care |
Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5% mortality rate. All the modalities for bariatric surgery are involved in this type of complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and the severity of the fistula. The management of this complication is still controversial and potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic management has to be improved to reduce the duration of the treatment and the number of endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a more prehensive, deeper and larger suture area.

Official Title
-----------------
Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Conditions
-----------------
Bariatric Surgery (Sleeve Gastrectomy )

Intervention / Treatment
-----------------
* Device: CLIP OST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age upper to 18 years surgery bariatrique typical Sleeve presence of one or two fistulas < 1 cm, beforehand drained and without sepsis evolutionary signature of the consent Exclusion Criteria: surgery bariatrique other one than Sleeve refusal of the patient of this endoscopic repeated coverage(care) requiring several sessions of endoscopies under AG with hospitalizations Current Sepsis not drained cavity Absence of signed 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clips OST<br> | Device: CLIP OST<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacity of closure of fistulas by clips ovesco |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacity of the suture in 3 months of these complex refractory fistulas |  | 12 months |
Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

Study Overview
=================
Brief Summary
-----------------
This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.

Conditions
-----------------
Periodontitis, Alveolar Bone Loss, Periodontal Attachment Loss

Intervention / Treatment
-----------------
* Drug: Trafermin (genetical recombination)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Probing pocket depth 4mm or deeper Vertical intrabony defect 3 mm or deeper from radiographs at baseline Mobility of tooth 2 degree or less Exclusion Criteria: Using an investigational drug within the past 24 months Coexisting malignant tumour or history of the same Coexisting diabetes (HbA1C 6.5% or more) Taking bisphosphonates Coexisting gingival overgrowth or history of the same

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>positive drug (0.3% Trafermin contained) | Drug: Trafermin (genetical recombination)<br>* Administered to the bone defect during flap operation<br>* Other names: KCB-1D;|
| Placebo Comparator: P<br>control | Drug: Placebo<br>* Control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of increase in alveolar bone height |  | 36 weeks after administration | 
| clinical attachment level regained |  | 36 weeks after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time course of increase rate in alveolar bone height |  | within 36 weeks after administration | 
| time course of clinical attachment level regained |  | within 36 weeks after administration | 
| time course change of periodontal tissue inspection values |  | within 36 weeks after administration | 
| occurrence and level of adverse reaction |  | within 36 weeks after administration | 
| serum anti-Trafermin antibody level |  | within 4 weeks |
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.

Official Title
-----------------
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma

Conditions
-----------------
Pancreas Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings Availability of biopsies obtained during EUS-FNB Histological diagnosis of pancreatic ductal adenocarcinoma of any stage Patients must be fit for chemotherapy administration They have to express their willingness to be followed up at our pancreatic high volume centers Age >18 and <80 years Able to sign informed consent Exclusion Criteria: Histological diagnoses other than pancreatic ductal adenocarcinoma Pregnancy or lactation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free-survival (PFS) | To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse. | From date of enrollment assessed until death or up to 2 years | 
| Overall survival | To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death. | From date of enrollment assessed until death or up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, endoscopic ultrasound (EUS), personalized medicine
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.

Detailed Description
-----------------
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).

Official Title
-----------------
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Device: Sinusys Dilation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CRS Subject in in need of frontal recess and/or sphenoid sinus dilation Exclusion Criteria: Pregnant or breastfeeding females Previous treatment site intervention Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: SinuSys Dilation System<br>Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty) | Device: Sinusys Dilation System<br>* Dilation of frontal recess and/or sphenoid sinus ostia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of treated target site | Patency assessed by investigator via endoscopic evaluation of the target site | Patency immediately post device expansion and removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of treated target site | Patency assessed by investigator via endoscopic evaluation of the target site | 1 month and 3 months | 
| Reports of sinus related adverse events during the 3 months follow-up period |  | up to 3 months |
Personalised Prediction Of Disease Course In Ulcerative Colitis Using Multimodal Machine Learning - Part Of The Presager Project

Study Overview
=================
Brief Summary
-----------------
In patients achieving clinical remission following a flare, artificial intelligence can reliably predict a new flare within the next 12 months utilizing clinical and objective information at day 0 and week 8. Secondary endpoints: An artificial intelligence model's precision in predicting a new flare within 2 and 3 years An artificial intelligence model's precision to rule out patients who will not experience a new flare within 1, 2 and 3 year

Official Title
-----------------
Personalised Prediction Of Disease Course In Ulcerative Colitis Using Multimodal Machine Learning - Part Of The Presager Project

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

Intervention / Treatment
-----------------
* Other: Deep learning model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Signed informed consent Diagnosis of UC for at least 1 year Relapse due to UC. First endoscopic and histological evaluation of the flare Exclusion criteria Well-founded doubt that the flare is due to other than the patients UC

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: Deep learning model|Use of deep learning model to predict individual patients disease course|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flare I | Evaluate the accuracy in predicting a flare within 1 year after the patient's initial flare using machine learning methods. | within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flare II | Evaluate the accuracy in predicting a flare within 2 years, after the patient's initial flare, using machine learning methods. | within 2 years | 
| Flare III | Evaluate the accuracy in predicting a flare within 3 years, after the patient's initial flare, using machine learning methods. | within 3 years |
Prospective Liver Study

Study Overview
=================
Brief Summary
-----------------
This study is designed for patients diagnosed with Liver cancer to collect information about the relationship between types of liver cancer, methods of treatment and outcomes over time.

Official Title
-----------------
Prospective Analysis of Liver Cancer Treatment and Interventions

Conditions
-----------------
Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Hepatocellular carcinoma and referred for percutaneous liver treatment. Exclusion Criteria: Severe liver disfunction Active uncontrolled infection Significant underlying medical of physical illness

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacy of percutaneous and transarterial treatments for liver cancer. | QOL questionnaire will be collected during follow up visit. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long term follow up | Patients will be administered QOL during 3 months, 6 months and 1 year follow up. | 3 months, 6 months 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RFA, Hepatocellular carcinoma, Liver metastases, Cholangiocarcinoma, Percutaneous treatments, TACE, DEB
Screening of Abdominal Aortic Aneurysms Among Male Patients With TIA Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with transient ischemic attack (TIA) symptoms. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these TIA patients, thus making screening of these patients (for AAA) more cost-efficient. Study will be carried out as a prospective screening study. Data will be collected in North Karelia Central Hospital within one year. All male patients with TIA symptoms will be recruited for the study and screened for AAA with ultrasound.

Official Title
-----------------
Screening of Abdominal Aortic Aneurysms Among Male Patients With TIA Symptoms

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Other: Ultrasound of aorta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patient who has had symptoms of transient ischemic attack (TIA) Exclusion Criteria: Patient's denial to participate Female gender Already diagnosed or treated abdominal aortic aneurysm
Sexes Eligible for Study
-----------------
Male

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

Design Details

Primary Purpose: Screening


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ultrasound of aorta<br> | Other: Ultrasound of aorta<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound |  | upon screening (collection of data will take one year) |
Skin and Acupuncture Needle Vibration Behaviors Through Observation

Study Overview
=================
Brief Summary
-----------------
Skin tremor induced by artery pulses are usually sensed by doctor's fingers in Traditional Chinese Medicine(TCM). On the other hand, vibration of acupuncture needle was also stated by Huang Di Nei Jing (Yellow Emperor). However; the characteristics of skin tremor and its correlation with vibrating acupuncture needles, how the skin tremor and vibration of needles varies from area to area, are not yet clarified.In this study, the abovementioned issues will be investigated experimentally through non-invasive method. About 10 healthy volunteers, aged 20 65, will be recruited. The investigators will measure the needle and the skin tremor by video optical microscopy. The variation of skin tremor and needle vibration and their spectra will be analyzed digitally. The model correlating skin tremor, needle vibration and basic physiological parameters will be constructed.The fact that the skin tremor and the needle vibration come from the same origin is expected. However; due to the leverage effects and different dynamical responses to the source vibrations at different frequencies, needle vibration might exhibit some difference from skin vibration in their power spectra. This study should be able to construct a clear model of the possible vibration sources such as heartbeat and breathing, the area dependence of vibrations, the correlation between the skin and the needle vibrations, and the correlation with other physiological parameters.

Official Title
-----------------
Skin and Acupuncture Needle Vibration Behaviors Through Observation

Conditions
-----------------
Skin Vibration, Acupuncture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy employees or students of National Central University aged between twenty to sixty-five. Exclusion Criteria: With chronic diseases, severe psychological disorder or injury, or been in a surgery in the past twelve months.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| The frequency and spectra of the vibrating acupuncture needle ,by video optical microscopy |  | 30 minutes | 
| The frequency and spectra of tremor of the skin surrounding the acupunctured point ,by video optical microscopy |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin vibration, Acupuncture needle vibration