linjc16/ctgov huggingface dataset:
Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether inhalation treatment with high-sulfide waters from some spas (referred to as thermal waters), performed for 12 consecutive days, is able to change circulating H2S levels and alter bone metabolism. Identifying a clear correlation between circulating levels of H2S and sulfur water administration, as well as a potential anabolic effect on bone, would set the stage for new studies that could have important clinical implications for promoting health and preventing osteoporosis

Official Title
-----------------
Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.

Conditions
-----------------
Hydrogen Sulfide, Osteoporosis

Intervention / Treatment
-----------------
* Other: inhalatory treatment with sulfureous aerosol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-menopausal women with a diagnosis of osteopenia Exclusion Criteria: concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 60 Years

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

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

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: Bone turnover markers<br>Concentrations of bone turnover markers will be assessed before and after treatment. Correlation will be sought for with H2S levels and clinical features of the patients | Other: inhalatory treatment with sulfureous aerosol<br>* osteopenic patients are subject to a 12-days cycle of 30 minutes-long inhalatory treatment with sulfureous aerosol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of biomarkers of bone turnover, marker #1 | Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation | 15 days | 
| Measurement of biomarkers of bone turnover, marker #2 | Bone-specific alkaline phosphatase (BAP), marker of bone formation | 15 days | 
| Measurement of biomarkers of bone turnover, marker #3 | serum C-terminal telopeptide of type I collagen (CTX-1), marker of bone resorption | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of serum H2S levels | serum H2S levels will be assessed through HPLC | 15 days |
The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)

Study Overview
=================
Brief Summary
-----------------
To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.

Detailed Description
-----------------
First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2) antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for HIV assay in patients with tumor and hematological diseases was calculated.

Official Title
-----------------
The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)

Conditions
-----------------
HIV Seropositivity, Cancer, Blood Disease

Intervention / Treatment
-----------------
* Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of tumor Disease or blood disease Blood samples must meet the test requirements Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Cancer patients<br>Cancer patints that confirmed by pathological examination | Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)<br>* Using the HIV Ag +Ab Assay Kit (Sysmex) to detect the HIV antigen and antibody in serum, then verified by Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit (Immunoimprinting). The specificity of the HIV Ag +Ab Assay Kit (Sysmex) is calculated according to the specificity calculation formula.<br>|
| Patients with blood diseases<br>Bone marrow aspiration and biopsy confirmed the blood disease | Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)<br>* Using the HIV Ag +Ab Assay Kit (Sysmex) to detect the HIV antigen and antibody in serum, then verified by Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit (Immunoimprinting). The specificity of the HIV Ag +Ab Assay Kit (Sysmex) is calculated according to the specificity calculation formula.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The HIV Ab/Ag results | The HIV Ab/Ag results generated using HIV Ag +Ab Assay Kit (Sysmex) and the gold standard method for HIV test. The results will be recoreded seperately. | through study completion, an average of 1.5 year |
A Study to Evaluate the PK, Safety and Tolerability of HCP1803.

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.

Official Title
-----------------
A Randomized, Open-label, Single-Dose, Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1803 in Healthy Male Volunteers.

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

Intervention / Treatment
-----------------
* Drug: HCP1803-3
* Drug: RLD2002
* Drug: HCP1904-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 45 years in healthy male volunteers Weight ≥ 55kg and BMI 18   30 kg/m^2 Subjects who agree to use clinically accepted dual contraceptives up to 14 days after the last administration date of the investigational product and not to provide sperm. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing. Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system Subjects who judged ineligible by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1<br>Period1 : HCP1803-3 | Drug: HCP1803-3<br>* Take it once per period<br>|
| Active Comparator: group2<br>Period1 : RLD2002, HCP1904-1 | Drug: RLD2002<br>* Take it once per period<br>Drug: HCP1904-1<br>* Take it once per period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | pharmacokinetic evaluation | 0 144hours | 
| AUC last | pharmacokinetic evaluation | 0 144hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC inf | pharmacokinetic evaluation | 0 144hours | 
| Tmax | pharmacokinetic evaluation | 0 144hours | 
| t1/2 | pharmacokinetic evaluation | 0 144hours | 
| CL/F | pharmacokinetic evaluation | 0 144hours | 
| Vd/F | pharmacokinetic evaluation | 0 144hours |
MCW Master Predict (Profile Related Evidence Determining Individualized Cancer Therapy)

Study Overview
=================
Brief Summary
-----------------
The study is an observational trial for patients undergoing cancer-related interventions and therapy at Medical College of Wisconsin Cancer Center. Projects under this protocol will use patient data that will be collected both retrospectively and prospectively. It will also enable prospective sample collection for specific cancer-related studies.

Detailed Description
-----------------
This is a master protocol that enables investigators to conduct observational research and correlative biospecimen studies. This study is non-therapeutic, with retrospective and prospective components. This will be a single-site study at MCW/FH. Retrospective data and, with consent, prospective observational data will be collected. The study will also include an opportunity for patients to consent to the analysis of specimens collected prospectively during care and for the collection of research-related testing of blood, stool, and/or urine. It is designed to decrease the burden on both patients and investigators by allowing consent to a protocol that will enable multiple minimal-risk studies. Studies under this master protocol may perform data analysis using standard statistical techniques, as well as with advanced bioinformatics, machine learning, artificial intelligence, and other related technologies. Collection and testing of biospecimens will only be performed if a proposed study that falls under this master protocol requires it. Studies may include a variety of simple or advanced techniques related to chemical, hematologic, molecular, proteomic, transcriptomic, immunomic, and metabolic analyses, as well as related multi-omic analysis for biomarker discovery, understanding correlations between treatment and molecular features, and/or for pharmacokinetic (PK) and pharmacodynamic (PD) parameters.

Official Title
-----------------
Medical College of Wisconsin Master Predict (Profile Related Evidence Determining Individualized Cancer)

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 18 years and older who were previously or are currently receiving care for a cancer-related condition at MCW/FH.

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 |
| --- | --- | --- |
| Number of subjects receiving precision therapies providing biospecimens of any kind. | Precision therapies are targeted against specific genomic mutations. | One year | 
| Number of subjects not receiving precision therapies and providing biospecimens. | Precision therapies are targeted against specific genomic mutations. | One year |
Blood Glucose Management in Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
The investigators propose to conduct a study of practices to describe the methods of managing glycemic control in hospitalized patients in critical care. This is a prospective multicenter observational study conducted in Intensive Medicine and Resuscitation departments in France and Belgium. The aim of this study is to carry out an inventory of the current practices of glycemia management as well as their modalities. Being one of the key points of the management, this work will have for main objective to raise the importance of the glycemic variabilities according to the methods of insulin therapies used.

Official Title
-----------------
Survey of Practices on the Management of Glycemia in Patients Hospitalized in Intensive Care Units

Conditions
-----------------
Insulin Hypoglycemia, Glucose Test Site Bleeding, Hyperglycemia

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with hyperglycaemia requiring an insulin prescription within 48 hours of admission Insulin therapy started less than 12 hours before inclusion of the patient in the study Expected duration of hospitalization greater than or equal to 48 hours Exclusion Criteria: Moribund patients Patients admitted for ketoacidosis or hyperosmolar coma Patients admitted for symptomatic hypoglycaemia Patient requiring insulin for serum potassium correction Severe acute hepatocellular insufficiency Age < 18 years old Pregnant or breastfeeding women Patients under legal protection measures

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 |
| --- |
|Drug: Insulin|insulin therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic variability | Study the impact of glycemic management protocols on the glycemic variability of patients hospitalized in intensive care | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse outcomes | incidence of hypoglycaemia | 48 hours | 
| Analysis of nursing workload | nurse / patient ratio | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose control, insulin
Investigating Engagement Patterns and Participation Trends Among Liposarcoma Patients

Study Overview
=================
Brief Summary
-----------------
The study seeks to delve into the firsthand experiences of patients diagnosed with liposarcoma who partake in a separate clinical research featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. By joining this clinical study, individuals have the unique opportunity to contribute to the betterment of future liposarcoma patients and play an active role in advancing medical research.

Official Title
-----------------
Inside Liposarcoma Clinical Trials: Patient Experiences Shared While Undergoing Clinical Trials

Conditions
-----------------
Liposarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has self-identified as planning to enroll in a clinical research Patient has been diagnosed with liposarcoma Patient is a minimum of 18 years or older Exclusion Criteria: Patient does not understand, sign, and return consent form Inability to perform regular electronic reporting Patient is pregnant

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 |
| --- | --- | --- |
| Number of patients who decide to participate in a liposarcoma clinical study |  | 3 months | 
| Rate of patients who remain in liposarcoma clinical study to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liposarcoma
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

Study Overview
=================
Brief Summary
-----------------
To investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting.

Detailed Description
-----------------
This investigation will be conducted to investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI Intravenous Infusion 120mg, 500mg in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting. The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Among the safety specifications defined in the Japan Risk Management Plan of IMFINZI, the following items are set as the safety specifications for this study. Interstitial lung disease, Colitis/Severe diarrhoea, Hepatic function disorder/Hepatis/Cholangitis Sclerosing, Endocrine disorders (Dysfunction thyroid, Dysfunction adrenal, Pituitary dysfunction), Type 1 diabetes mellitus, Renal disorder (interstitial nephritis, etc), Myositis, Myocarditis, Myasthenia gravis, Immune thrombocytopenic purpura, Encephalitis, Severe skin disorder, Nerve disorder (including guillain-barre syndrome), Infusion reaction, Pancreatitis, Gastrointestinal perforation, Rhabdomyolysis, Meningitis, Febrile neutropenia during combination treatment with chemotherapy, Embryo-fetal toxicity and Use in patients with a history of organ transplant (including haematopoietic stem cell transplant).

Official Title
-----------------
Specific Use-results Study of IMFINZI Intravenous Infusion 120 mg,500mg in Patients With Curatively Unresectable Biliary Tract Cancer

Conditions
-----------------
Biliary Tract Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with curatively unresectable biliary tract cancer who receive IMFINZI for the first time in combination with gemcitabine hydrochloride and cisplatin. Exclusion Criteria: -
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 |
| --- | --- | --- |
| Incidence of ADRs |  | 52 weeks |
Acute Effect of Sound Healing on Pain, Fatigue and Mood

Study Overview
=================
Brief Summary
-----------------
There is evidence that sound healing improves health and well-being. However, sound healing modalities, such as tuning forks, continue to be understudied, especially among people with chronic illnesses. This study examined responses to a single session of sound healing and explored whether responses varied based on analogue pain, fatigue, and mood.

Official Title
-----------------
Acute Effect of Sound Healing on Pain, Fatigue and Mood: A Retrospective Community Based Study

Conditions
-----------------
Pain, Fatigue, Mood Change

Intervention / Treatment
-----------------
* Other: Sound healing with tuning forks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with long term illnesses who attended 'Tuning for Health' virtual session Exclusion Criteria: Who did not complete 30-mins Sound Healing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Tuning for Health<br>Community based group 'Tuning for Health' was set up to provide chronic condition self-management support to people. Trained, experienced therapist-led group used half an hour of sound healing in virtual session. | Other: Sound healing with tuning forks<br>* Over the course of a half-hour virtual session, a specially developed triple OM track created by tuning forks was played.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity | Visual Analogical Scale (VAS) from 0 to 10 scores where 0 describes no pain and 10 worst pain. | From baseline to 30-minutes post intervention | 
| Change in Fatigue | Visual Analogue Scale for Fatigue (VAS-F) with18 items relating to the subjective experience of fatigue, with each item representing how they currently feel along a visual analogue scale extending between two extremes (e.g., not at all tired to extremely tired). | From baseline to 30-minutes post intervention | 
| Change in Mood | Visual Analogue Mood Scale using vertical 100 mm lines and schematic faces representing the following mood states: sad, afraid, angry, tired, energetic, happy, and confused. | From baseline to 30-minutes post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Satisfaction | Patients Satisfaction was measured using 5-Linkert Scale (Very dissatisfied, Somewhat dissatisfied, Neutral, Somewhat satisfied, Very satisfied) | From baseline to 30-minutes post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sound healing with tuning forks