linjc16/ctgov huggingface dataset:
Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock

Official Title
-----------------
Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a

Conditions
-----------------
Septicemia

Intervention / Treatment
-----------------
* Procedure: Immunoadsorption of LPS, IL-6 and C5a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of severe sepsis or septic shock (ACCP/SCCM) Presence of 4 SIRS criteria/indicators Suspected or proven infection (refer also to: 1.) Age 18-80 APACHE II score > 18 At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral) Exclusion Criteria: Suspected or proven pregnancy Absolute contraindication for anticoagulation (active bleeding) Absolute IgA-deficiency History of anaphylactic reaction to egg-albumin Participants in other clinical trials (<12 wks. prior to study inclusion)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Immunoadsorption of LPS, IL-6 and C5a|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence

Study Overview
=================
Brief Summary
-----------------
Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and potassium. LPR was invented to treat the renal stone patients with high risk of stone recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse effect than current standard medicine.

Detailed Description
-----------------
Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants. LPR was tested and verified to be very less toxic in cell culture and animal models. The clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of LPR was very low.

Official Title
-----------------
Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.

Conditions
-----------------
Urolithiasis

Intervention / Treatment
-----------------
* Drug: Lime Powder Regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal stone patients who were identified and stone was removed by surgical method. Exclusion Criteria: Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: Randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lime Powder Regimen<br>Participants were asked to take LPR twice a day for 6 months | Drug: Lime Powder Regimen<br>* LPR and placebo were randomly given to subjects for 6 months<br>* Other names: LPR supplement;|
| Placebo Comparator: Placebo<br>Participants were asked to take Placebo twice a day for 6 months | Drug: Lime Powder Regimen<br>* LPR and placebo were randomly given to subjects for 6 months<br>* Other names: LPR supplement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal stone recurrence | The stone recurrence after surgical removal of stone that can be detected by CT scan | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Citrate, Urolithiasis, Recurrence, Antioxidants, Lime Powder Regimen
Microneedles for Diagnosis of LTBI

Study Overview
=================
Brief Summary
-----------------
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers

Detailed Description
-----------------
The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.

Official Title
-----------------
Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection

Conditions
-----------------
Latent Tuberculosis

Intervention / Treatment
-----------------
* Diagnostic Test: TST vs PPD microneedle test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sex : Male and Female Age : 20-60 years TB contacts or those at risk of TB e.g. health-care workers HIV-negative healthy individuals Exclusion Criteria: Presence of an acute infection, as determined by investigators Receiving immunosuppression drugs e.g. steroids Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous) Being pregnant or breastfeeding

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: volunteers<br>two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection | Diagnostic Test: TST vs PPD microneedle test<br>* TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of induration at 48 hours post-PPD injection | Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests | 48 hours |
Papilloma Virus Vaccine Therapy in Treating Young Patients With Recurrent Papilloma of the Larynx

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Vaccines made from papilloma virus cells may make the body build an immune response to and kill papilloma cells. PURPOSE: Phase II trial to study the effectiveness of papilloma virus vaccine in treating young patients with recurrent papilloma of the larynx.

Detailed Description
-----------------
OBJECTIVES: I. Determine the immune response in patients with juvenile papilloma of the larynx treated with autogenous vaccine derived from each patient's own tumor. OUTLINE: Patients receive autogenous papilloma vaccine intradermally and subcutaneously weekly for 20 weeks. PROJECTED ACCRUAL: Not specified

Official Title
-----------------
Phase II Study of Immunotherapy With Autogenous Papilloma Vaccine in Patients With Recurrent Juvenile Papilloma of the Larynx

Conditions
-----------------
Precancerous Condition

Intervention / Treatment
-----------------
* Biological: autologous tumor cell vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of severe recurrent juvenile papilloma of the larynx requiring surgery at least 4 times per year Condition must have existed for more than 1 year PATIENT CHARACTERISTICS: Age: 1 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: autologous tumor cell vaccine|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
-----------------
lung papilloma
National Tunisian Registry of Valvulopathies (NATURE-VALVE)

Study Overview
=================
Brief Summary
-----------------
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.

Official Title
-----------------
National Tunisian Registry of Valvulopathies (NATURE-VALVE)

Conditions
-----------------
Valvular Stenosis, Valvular Heart Disease, Valvular Insufficiency

Intervention / Treatment
-----------------
* Procedure: Valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients originated from Tunisia Signed informed consent Patients with at least one of the following conditions : moderate to severe native mitral and / or aortic and / or tricuspid native valve disease and / or a history of a previous percutaneous or surgical valve intervention and / or a history of infectious endocarditis Exclusion Criteria: Congenital valve diseases not including bicuspid aortic valve Isolated pulmonary valvulopathies

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 |
| --- |
|Procedure: Valve replacement|Description of valve replacements|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valvulopathies incidence | Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death. | at 6 months of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valvular, Heart, Aortic, Mitral, Tricuspid
OPERA Database - Crohn's Protocol

Study Overview
=================
Brief Summary
-----------------
The investigators believe that patients with Crohn's disease are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.

Official Title
-----------------
IBD-OPERA Database IBD OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database - Crohn's Protocol

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (over 18 years of age) with physician diagnosed Crohn's disease A current or past prescription of anti-TNF Access to medical record for validation of clinical information Exclusion Criteria: Unwilling or unable to provide informed consent for study participation Unable to access or use the internet Ulcerative colitis or IBD-U Illiterate or does not possess minimum level of literacy required to complete questionnaire

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 |
| --- | --- |
| 1st Group of 50 patients<br> | |
| 2nd Group of 50 patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of patient self reporting | The validity of patient self report on details of their Crohn's disease compared to chart review. Validity is defined as a match between patient self report and medical records. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, Crohn's
Obesity-hypoventilation in Metabolic Syndrom Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

Detailed Description
-----------------
After being informed about the study and potential risks, patient agreed to participate and undergo : a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.

Official Title
-----------------
Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.

Conditions
-----------------
Metabolic Syndrome, Obesity Hypoventilation Syndrome, Capnography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>30 kg/m2 no treatment with CPAP nor NIV Exclusion Criteria: obstructive respiratory disease non-treated cardiac dysfunction

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 |
| --- | --- | --- |
| Capnia | Arterial pression in CO2 and transcutaneous pression in CO2 | Up to one mont after inclusion | 
| Arterial pression in CO2 | PaCO2 | At the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | body mass index | At the inclusion | 
| Arterial pression in oxygen | PaO2 | At the inclusion | 
| somnolence | EPWORTH questionnaire; Minimum = 0; Maximum = 24, Higher score means a worth outcome | At the inclusion | 
| Physical activity level | Ricci&Gagnon questionnaire, Minimum = 9; Maximum = 45, Higher score means a worth outcome | At the inclusion | 
| Arterial blood bicarbonates | HCO3- | At the inclusion | 
| Arterial blood gases | pH | At the inclusion | 
| Hemoglobin | Hb | At the inclusion | 
| obstructive sleep apnea items | Apnea-hypopnea index | Up to one mont after inclusion | 
| Night Oxygen saturation | SpO2 | Up to one mont after inclusion |
Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery

Study Overview
=================
Brief Summary
-----------------
This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented at specific time points (the time a blood sample was obtained by the standard clinical care after physician/nurse orders it and, during that same time, the Hb value recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery procedure (depending on how many times the physician/nurse orders the Hb value to be tested), between the standard clinical practice {intermittent measure of Hb [Cedar Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb level measurements)*.

Detailed Description
-----------------
*See whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device

Official Title
-----------------
A Study to Determine the Agreement Between Masimo Monitor and Standard of Care

Conditions
-----------------
Major Spine Surgery Procedure

Intervention / Treatment
-----------------
* Device: Masimo Radical-7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo multiple level spine surgery procedures 18 - 80 years of age American Society of Anesthesiologists (ASA) Class I - III adults of either sex Pregnant women Exclusion Criteria: Patients with a perfusion index less than 1 or low confidence reading Patients with nail polish and /or a nail deformity on a finger that would used for sensor placement Patient undergoing cardio-pulmonary bypass

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

| Intervention/Treatment |
| --- |
|Device: Masimo Radical-7|The Masimo device will be placed on one finger of the patient. To see whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin value | During the time surgery last. | 0-8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion | During the time surgery last. | 0-8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major spine surgery, Hemoglobin, Blood transfusion
CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

Official Title
-----------------
CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: 18F-FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Aged >18 years old; ECOG 0 or 1; 2. Patients with solid tumors; 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1); 4. life expectancy >=12 weeks. Exclusion Criteria: 1. Significant hepatic or renal dysfunction; 2. Is pregnant or ready to pregnant; 3. Cannot keep their states for half an hour; 4. Refusal to join the clinical study; 5. Suffering from claustrophobia or other mental diseases; 6. Any other situation that researchers think it is not suitable to participate in the experiment.

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-ACN376<br>Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan. | Drug: 18F-FDG<br>* All study participants will undergo one 18F-FDG PET/CT scan.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value（SUV） | SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-ACN376） in solid tumor lesions by measuring SUV on PET/CT. | 2 years |